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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

154 participants

Primary outcome timeframe

Baseline, completion of initial 6 week intervention phase

Results posted on

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

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

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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 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
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
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
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

OTHER_PRE_SPECIFIED outcome

Timeframe: completion of initial 6 week intervention phase

Population: 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

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.
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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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 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 phase

Population: 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

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 phase

Population: 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 phase

Population: 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

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 phase

Population: 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

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 phase

Population: 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

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

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: Baseline

Population: 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

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: Baseline

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

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, Suitability/Appropriateness Subscale (0-4 Points)
Suitability of Motor Skill Training
2.43 units on a scale
Standard Deviation 1.14
2.48 units on a scale
Standard Deviation 1.20
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

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Population: 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

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 phase

Population: 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 phase

Population: 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 phase

Population: 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

Serious events: 1 serious events
Other events: 43 other events
Deaths: 0 deaths

Strength and Flexibility Exercise

Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: 314-286-1427

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place