Trial Outcomes & Findings for Spinal Control During Functional Activities to Improve Low Back Pain Outcomes (NCT NCT02027623)
NCT ID: NCT02027623
Last Updated: 2020-08-21
Results Overview
Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation.
COMPLETED
NA
154 participants
Baseline, completion of initial 6 week intervention phase
2020-08-21
Participant Flow
Recruitment was by way of flyers placed in the community and physician offices, ads and interviews through local media and clinics in the region. Recruitment spanned December 2013 to August 2016.
Participant milestones
| Measure |
Motor Skill Training
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Overall Study
STARTED
|
77
|
77
|
|
Overall Study
COMPLETED
|
68
|
65
|
|
Overall Study
NOT COMPLETED
|
9
|
12
|
Reasons for withdrawal
| Measure |
Motor Skill Training
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
6
|
9
|
Baseline Characteristics
Spinal Control During Functional Activities to Improve Low Back Pain Outcomes
Baseline characteristics by cohort
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.4 years
STANDARD_DEVIATION 11.8 • n=93 Participants
|
42.6 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
42.5 years
STANDARD_DEVIATION 11.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
91 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=93 Participants
|
56 Participants
n=4 Participants
|
110 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Body Mass Index (BMI)
|
25.3 kg/m^2
STANDARD_DEVIATION 3.2 • n=93 Participants
|
26.1 kg/m^2
STANDARD_DEVIATION 3.1 • n=4 Participants
|
25.7 kg/m^2
STANDARD_DEVIATION 3.2 • n=27 Participants
|
|
Married or living with significant other
|
45 Participants
n=93 Participants
|
55 Participants
n=4 Participants
|
100 Participants
n=27 Participants
|
|
Completed at least some college
|
67 Participants
n=93 Participants
|
72 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Employment situation
Working full-time
|
50 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Employment situation
Working part-time
|
15 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Employment situation
Student (not working)
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Employment situation
Other employment status
|
5 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Low Back Pain Classification
Rotation
|
42 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Low Back Pain Classification
Rotation with flexion
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Low Back Pain Classification
Rotation with extension
|
31 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Duration of Low Back Pain
|
7.0 years
n=93 Participants
|
7.0 years
n=4 Participants
|
7.0 years
n=27 Participants
|
|
Symptoms only in the back
|
58 Participants
n=93 Participants
|
54 Participants
n=4 Participants
|
112 Participants
n=27 Participants
|
|
Fear-Avoidance Beliefs Questionnaire - Physical Activity Subscale Score
|
14.7 units on a scale
STANDARD_DEVIATION 6.1 • n=93 Participants
|
14.1 units on a scale
STANDARD_DEVIATION 5.1 • n=4 Participants
|
14.4 units on a scale
STANDARD_DEVIATION 5.6 • n=27 Participants
|
|
Fear-Avoidance Beliefs Questionnaire - Work Subscale Score
|
10.9 units on a scale
STANDARD_DEVIATION 8.4 • n=93 Participants
|
11.8 units on a scale
STANDARD_DEVIATION 9.0 • n=4 Participants
|
11.4 units on a scale
STANDARD_DEVIATION 8.7 • n=27 Participants
|
|
Modified Oswestry Disability Questionnaire
|
32.3 units on a scale
STANDARD_DEVIATION 10.2 • n=93 Participants
|
32.6 units on a scale
STANDARD_DEVIATION 9.4 • n=4 Participants
|
32.4 units on a scale
STANDARD_DEVIATION 9.8 • n=27 Participants
|
|
NRS average pain prior 7 days
|
4.7 units on a scale
STANDARD_DEVIATION 1.9 • n=93 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 1.5 • n=4 Participants
|
4.7 units on a scale
STANDARD_DEVIATION 1.7 • n=27 Participants
|
|
NRS worst pain, prior 7 days
|
6.3 units on a scale
STANDARD_DEVIATION 2 • n=93 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 1.6 • n=4 Participants
|
6.6 units on a scale
STANDARD_DEVIATION 1.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline
|
32.3 score on a scale
Standard Deviation 10.2
|
32.6 score on a scale
Standard Deviation 9.4
|
|
Change in Modified Oswestry Disability Questionnaire (0-100%) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment
|
12.8 score on a scale
Standard Deviation 10.7
|
21.2 score on a scale
Standard Deviation 10.7
|
PRIMARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment
|
12.8 score on a scale
Standard Deviation 10.7
|
21.2 score on a scale
Standard Deviation 10.7
|
|
Change in Modified Oswestry Disability Questionnaire (0-100%) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
12.0 score on a scale
Standard Deviation 12.6
|
18.2 score on a scale
Standard Deviation 10.5
|
PRIMARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: The 10-item Modified Oswestry Disability Questionnaire is a disease-specific measure that provides an index of a participant's perceived low back pain-related functional limitation. Procedure: Participants will answer each of the 10 questions by placing a mark in the one box that best describes his current condition. Since a participant may feel that 2 of the statements describe his condition, he is instructed to mark only the box that most closely describes his current condition. Scoring: Each item is given a value from 0-5. The total score is the sum of all questions divided by 50, multiplied by 100 to get a percent. 100 represents the highest level of limitation.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12
|
10.8 score on a scale
Standard Deviation 11.3
|
16.7 score on a scale
Standard Deviation 11.3
|
|
Change in Modified Oswestry Disability Questionnaire (0-100%) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6
|
12.0 score on a scale
Standard Deviation 12.6
|
18.2 score on a scale
Standard Deviation 10.5
|
SECONDARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst).
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline (Average)
|
4.7 units on a scale
Standard Deviation 1.9
|
4.7 units on a scale
Standard Deviation 1.5
|
|
Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment (Average)
|
1.4 units on a scale
Standard Deviation 1.1
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline (Worst)
|
6.3 units on a scale
Standard Deviation 2.0
|
6.9 units on a scale
Standard Deviation 1.6
|
|
Change in Numeric Pain Rating Scale (0-10) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment (Worst)
|
2.7 units on a scale
Standard Deviation 1.7
|
4.0 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst).
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6 (Worst)
|
2.9 units on a scale
Standard Deviation 2.2
|
3.8 units on a scale
Standard Deviation 2.2
|
|
Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment (Average)
|
1.4 units on a scale
Standard Deviation 1.1
|
2.1 units on a scale
Standard Deviation 1.2
|
|
Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6 (Average)
|
2.0 units on a scale
Standard Deviation 1.8
|
2.6 units on a scale
Standard Deviation 1.8
|
|
Change in Numeric Pain Rating Scale (0-10) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment (Worst)
|
2.7 units on a scale
Standard Deviation 1.7
|
4.0 units on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to give the therapist information on the intensity of a participant's LBP symptoms. Procedure: Participants will rate their LBP symptoms on a numeric scale of 0-10 where 0 represents no symptoms and 10 represents symptoms as bad as can be. They will rate their average symptoms over the prior 7 days, and worst symptoms over the prior 7 days. Scoring: The score for each item is the rating the participant provides for each symptom category (average and worst).
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12 (Average)
|
1.8 units on a scale
Standard Deviation 1.9
|
2.6 units on a scale
Standard Deviation 2.0
|
|
Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6 (Worst)
|
2.9 units on a scale
Standard Deviation 2.2
|
3.8 units on a scale
Standard Deviation 2.2
|
|
Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12 (Worst)
|
2.8 units on a scale
Standard Deviation 2.3
|
3.9 units on a scale
Standard Deviation 2.5
|
|
Change in Numeric Pain Rating Scale (0-10) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6 (Average)
|
2.0 units on a scale
Standard Deviation 1.8
|
2.6 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months. Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months. Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From Baseline to 6 Months After Initial Intervention Phase
Baseline
|
7.1 acute flare-ups
Standard Deviation 7.6
|
9.8 acute flare-ups
Standard Deviation 11.9
|
|
Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From Baseline to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
2.0 acute flare-ups
Standard Deviation 3.3
|
4.2 acute flare-ups
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to give the therapist information about the history of a participant's LBP flare-ups in the past 6 months. Definition: A flare-up is an increase in symptoms of at least 2 points on the NRS above a person's typical low back pain and lasts for at least 2 consecutive days Procedure: Participants will fill in information on how many acute flare-ups they have had over the past 6 months. Scoring: The score will be the number the participant provides for the number of acute flare-ups over the last 6 months.
Outcome measures
| Measure |
Motor Skill Training
n=67 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=64 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From 6 Months After the Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6
|
2.0 acute flare-ups
Standard Deviation 3.3
|
4.2 acute flare-ups
Standard Deviation 8.2
|
|
Change in Number of Acute Flare-ups of Low Back Pain (#) in Past 6 Months, From 6 Months After the Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12
|
1.3 acute flare-ups
Standard Deviation 1.8
|
2.0 acute flare-ups
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline
|
50 Participants
|
47 Participants
|
|
Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment
|
21 Participants
|
31 Participants
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP.
Outcome measures
| Measure |
Motor Skill Training
n=70 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment
|
21 Participants
|
31 Participants
|
|
Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
27 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to provide general information on the use of medication for a participant's LBP. Procedure: Participants will answer each question by marking if they are taking non-prescription medication and prescription medication for their LBP. Reported as number of participants currently using medication for LBP.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=66 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From 6 Months After Completion of Initial Intervention Phase to 12 Months After Completion of Initial Intervention Phase
Follow-Up Month 6
|
27 Participants
|
29 Participants
|
|
Change in Current Medication Use for Low Back Pain (Number of Participants Currently Using Medication) From 6 Months After Completion of Initial Intervention Phase to 12 Months After Completion of Initial Intervention Phase
Follow-Up Month 12
|
23 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline
|
42 Participants
|
47 Participants
|
|
Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment
|
11 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment
|
11 Participants
|
29 Participants
|
|
Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess the number of days a participant has been kept from his usual activities (work, school or housework) because of LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Reported as the number of participants who reported absenteeism from usual activities over the past 4 weeks.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6
|
9 Participants
|
11 Participants
|
|
Change in Absenteeism From Usual Activities Due to Low Back Pain (Number of Participants Who Report Absenteeism) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12
|
11 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment.
Outcome measures
| Measure |
Motor Skill Training
n=66 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=63 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline
|
20.3 score on a scale
Standard Deviation 5.3
|
19.9 score on a scale
Standard Deviation 6.2
|
|
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment
|
17.4 score on a scale
Standard Deviation 4.6
|
18.3 score on a scale
Standard Deviation 5.2
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment.
Outcome measures
| Measure |
Motor Skill Training
n=59 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=59 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment
|
17.4 score on a scale
Standard Deviation 4.6
|
18.3 score on a scale
Standard Deviation 5.2
|
|
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
15.9 score on a scale
Standard Deviation 5.6
|
16.5 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess how a participant's LBP affected his participation in usual activities and the impact of LBP on his ability to do his job over the past 4 weeks. Scoring: A Work Impairment Score (WIS) is calculated as the sum of answers on the questions regarding how LBP has affected job ability over the past 4 weeks. Each of the WIS questions is ranked on a 5-point Likert scale. All scores are 1-5, with questions 2, 5, 6, 8, and 10 reverse scored (5-1). The score ranges from 10-50 with 50 indicating the highest degree of impairment.
Outcome measures
| Measure |
Motor Skill Training
n=59 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=59 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6
|
15.9 score on a scale
Standard Deviation 5.6
|
16.5 score on a scale
Standard Deviation 5.3
|
|
Change in Stanford Presenteeism Scale (Work Impairment Score: 10-50) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12
|
15.4 score on a scale
Standard Deviation 5.1
|
16.7 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline
|
43.2 T-scores
Standard Deviation 6.6
|
40.8 T-scores
Standard Deviation 6.9
|
|
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment
|
50.8 T-scores
Standard Deviation 6.5
|
46.3 T-scores
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment
|
50.8 T-scores
Standard Deviation 6.5
|
46.3 T-scores
Standard Deviation 7.0
|
|
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
50.9 T-scores
Standard Deviation 6.6
|
47.8 T-scores
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Outcome measures
| Measure |
Motor Skill Training
n=66 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=64 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6
|
50.9 T-scores
Standard Deviation 6.6
|
47.8 T-scores
Standard Deviation 7.4
|
|
Change in 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12
|
51.2 T-scores
Standard Deviation 8.0
|
48.3 T-scores
Standard Deviation 7.4
|
SECONDARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline
|
49.2 T-scores
Standard Deviation 11.6
|
52.1 T-scores
Standard Deviation 9.3
|
|
Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment
|
50.7 T-scores
Standard Deviation 8.6
|
51.0 T-scores
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment
|
50.7 T-scores
Standard Deviation 8.6
|
51.0 T-scores
Standard Deviation 11.6
|
|
Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
49.6 T-scores
Standard Deviation 10.5
|
50.8 T-scores
Standard Deviation 10.4
|
SECONDARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess information about a participant's mental and physical health, and how well he is able to do his usual activities. Procedure: Participants will answer each question by marking the answer as indicated. If participants are unsure how to answer a question, they are instructed to choose the best answer they can. Scoring: Using a scoring application, the SF-36 provides 8 scales: a Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and a Mental Health score. The scores are combined to provide a Physical Component (PCS) and Mental Component (MCS) Summary score. For the PCS and the MCS, norm-based scores are scaled and normalized to have a mean of 50 and a standard deviation of 10 based on the 1998 population norms. Higher scores indicate better health.
Outcome measures
| Measure |
Motor Skill Training
n=66 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=64 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6
|
49.6 T-scores
Standard Deviation 10.5
|
50.8 T-scores
Standard Deviation 10.4
|
|
Change in 36-Item Short Form Health Survey (SF-36) Mental Component Summary Score From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12
|
50.4 T-scores
Standard Deviation 10.3
|
50.3 T-scores
Standard Deviation 11.5
|
SECONDARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline (Care Seeking)
|
35 Participants
|
29 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment (Care Seeking)
|
7 Participants
|
6 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline (Equipment Use)
|
66 Participants
|
65 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment (Equipment Use)
|
62 Participants
|
48 Participants
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment (Care Seeking)
|
7 Participants
|
6 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6 (Care Seeking)
|
13 Participants
|
13 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment (Equipment Use)
|
62 Participants
|
48 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6 (Equipment Use)
|
33 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to provide general information on the use of additional treatments for a participant's LBP. Health Professional Care Seeking Procedure: Participants will answer each question by marking yes or no for a list of other healthcare professionals they are seeing for treatment of their LBP. Equipment Use Procedure: Participants will answer each question by marking yes or no for a list of equipment they are using to treat their LBP. Scoring: Reported as the number of participants seeking care from health professionals for LBP or using equipment for LBP.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6 (care seeking)
|
13 Participants
|
13 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12 (care seeking)
|
8 Participants
|
11 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 6 (equipment use)
|
33 Participants
|
29 Participants
|
|
Change in Use of Other Low Back Pain-related Treatments (Health Professional Care Seeking or Equipment Use (# of Participants)) From 6 Months After Initial Intervention Phase to 12 Months After Initial Intervention Phase
Follow-Up Month 12 (equipment use)
|
28 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire assesses information about how satisfied a participant feels with the physical therapist and treatment he was provided. Procedure: Participants will answer each question by marking the answer as indicated. They may only check off one answer per item. Scoring: Each question is ranked on a 5-point Likert scale. All scores are 1-5, with questions 1, 3, 4, 8, 9, 10 and 13 reverse scored (5-1). The total score is the sum of all of the answers (15-75) with higher scores indicating more satisfaction with care.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Satisfaction With Care (15-75 Points)
|
68.8 score on a scale
Standard Deviation 0.9
|
61.4 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: These are laboratory measures of (1) movement of the lumbar region, hips and knees or (2) static alignment of the lumbar region during functional activities. Procedures: Angular data is quantified based on data from retro-reflective markers that are tracked with a 3-dimensional video system while the person performs an activity. Coordinate data from the video system is processed to provide quantification of movement or alignment. The variables of interest are (1) angular excursion in the first 50% of the descent phase for each region or joint during picking up an object and (2) lumbar curvature angle for preferred sitting. For movement, smaller numbers from baseline to post-treatment represent decreased movement of a region or joint. For alignment, larger negative numbers from baseline to post-treatment represent a more extended lumbar region alignment. Measures are obtained at baseline and immediately after a 6-week intervention phase.
Outcome measures
| Measure |
Motor Skill Training
n=76 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=77 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline: Knee joint excursion
|
11.08 Angle in degrees
Interval 8.04 to 14.11
|
8.86 Angle in degrees
Interval 5.81 to 11.9
|
|
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-intervention: Lumbar region curvature
|
-7.51 Angle in degrees
Interval -9.7 to -5.33
|
-6.45 Angle in degrees
Interval -8.52 to -4.38
|
|
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline: Lumbar region excursion
|
11.32 Angle in degrees
Interval 10.36 to 12.29
|
11.23 Angle in degrees
Interval 10.28 to 12.17
|
|
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-intervention: Lumbar region
|
9.17 Angle in degrees
Interval 8.33 to 10.0
|
11.05 Angle in degrees
Interval 9.94 to 12.16
|
|
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline: Hip joint excursion
|
21.17 Angle in degrees
Interval 19.18 to 23.16
|
20.84 Angle in degrees
Interval 18.78 to 22.9
|
|
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-intervention: Hip joint excursion
|
31.98 Angle in degrees
Interval 29.84 to 34.13
|
20.36 Angle in degrees
Interval 18.46 to 22.25
|
|
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-intervention: Knee joint excursion
|
30.10 Angle in degrees
Interval 26.96 to 33.25
|
9.69 Angle in degrees
Interval 6.15 to 13.24
|
|
Change in Kinematics During Functional Activities (Degrees) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline: Lumbar region curvature
|
-5.91 Angle in degrees
Interval -7.91 to -3.88
|
-3.18 Angle in degrees
Interval -5.09 to -1.27
|
SECONDARY outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: These are laboratory measures of (1) movement of the lumbar region, hips and knees or (2) static alignment of the lumbar region during functional activities. Procedures: Angular data is quantified based on data from retro-reflective markers that are tracked with a 3-dimensional video system while the person performs an activity. Coordinate data from the video system is processed to provide quantification of movement or alignment. The variables of interest are (1) angular excursion in the first 50% of the descent phase for each region or joint during picking up an object and (2) lumbar curvature angle for preferred sitting. For movement, smaller numbers from baseline to post-treatment represent decreased movement of a region or joint. For alignment, larger negative numbers from baseline to post-treatment represent a more extended lumbar region alignment. Measures are obtained after a 6 week intervention phase and 6 months after intervention.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
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|---|---|---|
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Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
Post-intervention: Knee joint excursion
|
30.10 Angle in degrees
Interval 26.96 to 33.25
|
9.69 Angle in degrees
Interval 6.15 to 13.2
|
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Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
Post-intervention: Lumbar excursion
|
9.17 Angle in degrees
Interval 8.33 to 10.0
|
11.05 Angle in degrees
Interval 9.94 to 12.16
|
|
Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
6 months post-intervention: Lumbar excursion
|
8.63 Angle in degrees
Interval 7.71 to 9.55
|
10.84 Angle in degrees
Interval 9.73 to 11.96
|
|
Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
Post-intervention: Hip joint excursion
|
31.98 Angle in degrees
Interval 29.84 to 34.13
|
20.36 Angle in degrees
Interval 18.46 to 22.25
|
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Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
6 months post-intervention: Hip joint excursion
|
30.03 Angle in degrees
Interval 27.7 to 32.35
|
20.08 Angle in degrees
Interval 18.39 to 21.78
|
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Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
6 months post intervention: Knee joint excursion
|
26.90 Angle in degrees
Interval 23.83 to 29.97
|
9.81 Angle in degrees
Interval 6.43 to 13.2
|
|
Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
Post-intervention: Lumbar curvature
|
-7.51 Angle in degrees
Interval -9.7 to -5.33
|
-6.45 Angle in degrees
Interval -8.52 to -4.38
|
|
Change in Kinematics During Functional Activities (Degrees) From Completion of Initial 6 Week Intervention Phase to 6 Months After Intervention Phase
6 months post-intervention: Lumbar curvature
|
-5.43 Angle in degrees
Interval -7.63 to -3.24
|
-5.89 Angle in degrees
Interval -7.79 to -3.99
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OTHER_PRE_SPECIFIED outcome
Timeframe: completion of initial 6 week intervention phasePopulation: Data available at this time point
Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate for each day the percentage of the treatment they were able to perform as prescribed. At each clinic visit the therapist will ask the participant to provide an estimate of the average percentage of the treatment he was able to perform as prescribed in the interval of time between 2 clinic visits. Scoring: Average adherence is calculated by averaging the participants' daily adherence. Scores range from 0-100%. Higher values indicate higher adherence to treatment.
Outcome measures
| Measure |
Motor Skill Training
n=71 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=72 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
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|---|---|---|
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Adherence to Home Program (0-100%) at Completion of Initial 6 Week Intervention Phase
|
83 percentage of adherence to home program
Standard Deviation 14
|
90 percentage of adherence to home program
Standard Deviation 15
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after initial intervention phasePopulation: Data available at this time point
Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate an average percent adherence to performance of the treatment as prescribed over the past month. Scoring: Value (percentage of treatment performed) provided by the participant on each monthly survey. Scores range from 0-100%. Higher values indicate higher adherence to treatment.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Adherence to Home Program (0-100%) at 6 Months After Completion of Initial Intervention Phase
|
70 percentage of adherence to home program
Standard Deviation 21
|
42 percentage of adherence to home program
Standard Deviation 31
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 months after initial intervention phasePopulation: Data available at this time point
Background/Purpose: This questionnaire is designed to provide information about how often a participant performs his treatment as it was prescribed. Procedure: Participants will use a VAS to indicate an average percent adherence to performance of the treatment as prescribed over the past month. Scoring: Value (percentage of treatment performed) provided by the participant on each monthly survey. Scores range from 0-100%. Higher values indicate higher adherence to treatment.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=65 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Adherence to Home Program (0-100%) at 12 Months After Initial Intervention Phase
|
66 percentage of adherence to home program
Standard Deviation 21
|
52 percentage of adherence to home program
Standard Deviation 35
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
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|---|---|---|
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Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline
|
10.9 score on a scale
Standard Deviation 8.4
|
11.8 score on a scale
Standard Deviation 9.0
|
|
Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Baseline to Completion of Initial 6 Week Intervention Phase
Post-Treatment
|
7.7 score on a scale
Standard Deviation 7.1
|
10.9 score on a scale
Standard Deviation 9.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment
|
7.7 score on a scale
Standard Deviation 7.1
|
10.9 score on a scale
Standard Deviation 9.5
|
|
Change in Fear-Avoidance Beliefs Questionnaire Work Subscale Score (0-42 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
7.2 score on a scale
Standard Deviation 8.2
|
9.0 score on a scale
Standard Deviation 8.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data for 12 months after the initial intervention phase were not collected. The decision not to collect 12 month data was made prior to finalization of the protocol and participant enrollment.
Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42.
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Baseline to Completion of Initial 6 Week Intervention Phase
Baseline
|
14.7 score on a scale
Standard Deviation 6.1
|
14.1 score on a scale
Standard Deviation 5.1
|
|
Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Baseline to Completion of Initial 6 Week Intervention Phase
Follow-Up Month 6
|
11.4 score on a scale
Standard Deviation 5.9
|
11.6 score on a scale
Standard Deviation 5.3
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: Data available at the time points
Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42.
Outcome measures
| Measure |
Motor Skill Training
n=68 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=67 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Post-Treatment
|
11.4 score on a scale
Standard Deviation 5.9
|
11.6 score on a scale
Standard Deviation 5.3
|
|
Change in Fear-Avoidance Beliefs Questionnaire Physical Activity Subscale Score (0-24 Points) From Completion of Initial 6 Week Intervention Phase to 6 Months After Initial Intervention Phase
Follow-Up Month 6
|
11.0 score on a scale
Standard Deviation 5.8
|
11.4 score on a scale
Standard Deviation 5.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: Data for 12 months after the initial intervention phase were not collected. The decision not to collect 12 month data was made prior to finalization of the protocol and participant enrollment.
Background/Purpose: This questionnaire is designed to assess a participant's fear of pain and beliefs about how work and physical activity affect his LBP. Procedure: Participants will answer each question by marking the answer as indicated. Scoring: Each question is ranked on a 7-point Likert scale (0-6). Higher scores indicate higher fear-avoidance. Two subscale scores are calculated. The physical activity subscale score (FABQ-PA) is the sum of questions 2, 3, 4, and 5 and ranges from 0-24. The work subscale score (FABQ-W) is the sum of items 6, 7, 9, 10, 11, 12, and 15 and ranges from 0-42.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineBackground/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4).
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Treatment Preference Assessment Measure, Effectiveness Subscale (0-4 Points)
Effectiveness of Motor Skill Training
|
2.28 units on a scale
Standard Deviation 1.14
|
2.36 units on a scale
Standard Deviation 1.00
|
|
Treatment Preference Assessment Measure, Effectiveness Subscale (0-4 Points)
Effectiveness of Strength and Flexibility Exercise
|
3.19 units on a scale
Standard Deviation 0.81
|
2.92 units on a scale
Standard Deviation 0.82
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Data available at this time point
Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4).
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Treatment Preference Assessment Measure, Acceptability Subscale (0-4 Points)
Acceptability of Strength and Flexibility Exercise
|
3.37 units on a scale
Standard Deviation 0.69
|
3.21 units on a scale
Standard Deviation 0.70
|
|
Treatment Preference Assessment Measure, Acceptability Subscale (0-4 Points)
Acceptability of Motor Skill Training
|
2.66 units on a scale
Standard Deviation 1.09
|
2.72 units on a scale
Standard Deviation 0.97
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselineBackground/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4).
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
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Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
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|---|---|---|
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Treatment Preference Assessment Measure, Suitability/Appropriateness Subscale (0-4 Points)
Suitability of Motor Skill Training
|
2.43 units on a scale
Standard Deviation 1.14
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2.48 units on a scale
Standard Deviation 1.20
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|
Treatment Preference Assessment Measure, Suitability/Appropriateness Subscale (0-4 Points)
Suitability of Strength and Flexibility Exercise
|
3.31 units on a scale
Standard Deviation 0.74
|
3.15 units on a scale
Standard Deviation 0.80
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OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Data available at this time point
Background/Purpose: This questionnaire is designed to provide information about a participant's treatment preferences and the participant's perceptions of four attributes of each treatment: effectiveness, acceptability, suitability/appropriateness, and convenience. The questionnaire is modified from a preference questionnaire designed by Sidani et al to reflect the treatments provided in the trial. Procedure: The two treatment descriptions will be given in a random order to each participant. Scoring: The four treatment attributes (effectiveness, acceptability, suitability/appropriateness, and convenience) will be rated on a 5-point Likert scale (0-4). The anchors are not at all (rating=0) and very much (rating=4).
Outcome measures
| Measure |
Motor Skill Training
n=74 Participants
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 Participants
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Treatment Preference Assessment Measure, Convenience Subscale (0-4 Points)
Convenience of Motor Skill Training
|
2.65 units on a scale
Standard Deviation 0.96
|
2.45 units on a scale
Standard Deviation 0.96
|
|
Treatment Preference Assessment Measure, Convenience Subscale (0-4 Points)
Convenience of Strength and Flexibility Exercise
|
3.01 units on a scale
Standard Deviation 0.89
|
2.76 units on a scale
Standard Deviation 0.93
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, completion of initial 6 week intervention phasePopulation: The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses
Background/Purpose: These are measures of costs associated with healthcare over the intervention phase. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Completion of initial 6 week intervention phase, 6 months after initial intervention phasePopulation: The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses
Background/Purpose: These are measures of costs associated with healthcare from completion of the initial 6 week intervention phase to 6 months after the initial intervention phase.. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months after initial intervention phase, 12 months after initial intervention phasePopulation: The exploratory economic analyses we proposed to examine direct (medication and health services use and medical equipment) and indirect (absenteeism and presenteeism) health costs are not to be conducted. The decision was based on large budget cuts that limited our ability to financially support the personnel to conduct the analyses
Background/Purpose: These are measures of costs associated with healthcare from 6 months after the initial intervention phase to 12 months after the initial intervention phase. Procedure: Direct health costs will be estimates of the cost of (1) medication using average wholesale price and wholesale acquisition cost and (2) health services and medical equipment using the Medicare allowable cost. Indirect health costs will be estimated using absenteeism and presenteeism measures.
Outcome measures
Outcome data not reported
Adverse Events
Motor Skill Training
Strength and Flexibility Exercise
Serious adverse events
| Measure |
Motor Skill Training
n=74 participants at risk
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 participants at risk
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Related to Treatment: Ductal Carcinoma
|
1.4%
1/74 • Number of events 1 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
0.00%
0/75 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
|
Surgical and medical procedures
Non-Related to Treatment: Disc Herniation Surgery
|
0.00%
0/74 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
1.3%
1/75 • Number of events 1 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
Other adverse events
| Measure |
Motor Skill Training
n=74 participants at risk
The motor skill training condition involves supervised, massed practice of novel, challenging functional activities that are difficult or painful for the participant to perform due to his low back pain.
Motor skill training: The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment provided as needed.
|
Strength and Flexibility Exercise
n=75 participants at risk
The strength and flexibility exercise condition involves performance of 1) strengthening exercises that target all trunk muscles, and 2) flexibility exercises that target all trunk and lower extremity motions.
Strength and flexibility exercise: Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Non-Related to Treatment: Worsening of symptoms
|
50.0%
37/74 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
33.3%
25/75 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
|
Musculoskeletal and connective tissue disorders
Related to Treatment: Worsening of symptoms
|
1.4%
1/74 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
2.7%
2/75 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
|
General disorders
Non-Related to Treatment: non-serious
|
6.8%
5/74 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
9.3%
7/75 • Study recruitment began in December of 2013 and all study participation ended November of 2017 therefore any adverse event data would be collected between those study time points. Participation for any given individuals was approximately 14 months.
|
Additional Information
Linda van Dillen, PT, PhD, FAPTA; Research Division Director
Washington University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place