Trial Outcomes & Findings for Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (NCT NCT04009837)
NCT ID: NCT04009837
Last Updated: 2024-04-11
Results Overview
A 20-item questionnaire that assesses limitations in daily activities due to back pain. Scores can range from 0-100% with higher scores indicating greater back pain-related disability.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
184 participants
Primary outcome timeframe
Baseline to 8-week assessment (i.e. post-intervention)
Results posted on
2024-04-11
Participant Flow
Older adults aged 60-85 with chronic low back pain and hip pain were recruited from communities in Newark, Delaware; Pittsburgh, Pennsylvania; and Durham, North Carolina. Recruitment (from November 1, 2019 through April 30, 2022) included newspaper advertisements, visits to senior centers, clinic referrals, research registries, and electronic medical records.
Participant milestones
| Measure |
Hip-focused
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
91
|
93
|
|
Overall Study
8-Weeks (Post-intervention)
|
83
|
82
|
|
Overall Study
COMPLETED
|
83
|
82
|
|
Overall Study
NOT COMPLETED
|
8
|
11
|
Reasons for withdrawal
| Measure |
Hip-focused
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
|
Overall Study
Did not complete any aspect of of 8-week assessment
|
3
|
7
|
Baseline Characteristics
Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain
Baseline characteristics by cohort
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Total
n=184 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70.8 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
70.6 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
70.71 years
STANDARD_DEVIATION 6.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
90 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
72 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
91 participants
n=5 Participants
|
93 participants
n=7 Participants
|
184 participants
n=5 Participants
|
|
Low Back Pain duration (years)
|
15.7 years
STANDARD_DEVIATION 14.6 • n=5 Participants
|
14.0 years
STANDARD_DEVIATION 12.0 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 13.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 8-week assessment (i.e. post-intervention)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A 20-item questionnaire that assesses limitations in daily activities due to back pain. Scores can range from 0-100% with higher scores indicating greater back pain-related disability.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Quebec Back Pain Disability Scale
Baseline
|
27.9 score on a scale
Standard Deviation 15.8
|
27.9 score on a scale
Standard Deviation 15.5
|
|
Quebec Back Pain Disability Scale
8-weeks (post-intervention)
|
16.7 score on a scale
Standard Deviation 11.7
|
20.3 score on a scale
Standard Deviation 14.3
|
PRIMARY outcome
Timeframe: Baseline to 8-week assessment (i.e. post-intervention)Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A performance test where participants walk along a 10-meter linear pathway at their 'usual pace' for three trials. Average self-selected gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
10-Meter Walk Test at Self-Selected Speed (10MWT)
Baseline
|
1.12 meters/second
Standard Deviation 0.25
|
1.12 meters/second
Standard Deviation 0.24
|
|
10-Meter Walk Test at Self-Selected Speed (10MWT)
8-week (post-intervention) assessment
|
1.2 meters/second
Standard Deviation 0.24
|
1.21 meters/second
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline to the 6-month assessmentPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A 20-item questionnaire that assesses limitations in daily activities due to back pain. Scores can range from 0-100% with higher scores indicating greater back pain-related disability.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Quebec Back Pain Disability Scale
Baseline
|
27.9 score on a scale
Standard Deviation 15.8
|
27.9 score on a scale
Standard Deviation 15.5
|
|
Quebec Back Pain Disability Scale
6-months (final assessment)
|
15.8 score on a scale
Standard Deviation 12.5
|
17.3 score on a scale
Standard Deviation 14.1
|
SECONDARY outcome
Timeframe: Baseline to 6-monthsPopulation: The number analyzed in some rows differs from overall number analyzed as some participants withdrew from the study over time.
A performance test where participants walk along a 10-meter linear pathway at their 'usual pace' for three trials. Average self-selected gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment)
Baseline
|
1.12 Meters/second
Standard Deviation 0.25
|
1.12 Meters/second
Standard Deviation 0.24
|
|
10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment)
6-months
|
1.21 Meters/second
Standard Deviation 0.25
|
1.24 Meters/second
Standard Deviation 0.22
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A performance test where participants walk along a 10-meter linear pathway 'as quickly as possible', for three trials. Average fast gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
10-Meter Walk Test at Fast Speed (10MWT)
Baseline
|
1.57 meters/second
Standard Deviation 0.34
|
1.59 meters/second
Standard Deviation 0.38
|
|
10-Meter Walk Test at Fast Speed (10MWT)
8-weeks (post-intervention)
|
1.65 meters/second
Standard Deviation 0.31
|
1.67 meters/second
Standard Deviation 0.32
|
|
10-Meter Walk Test at Fast Speed (10MWT)
6-months (final assessment)
|
1.63 meters/second
Standard Deviation 0.31
|
1.66 meters/second
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A performance test where participants rise from a chair, walk 3 meters at their regular pace, and return to a seated position in the same chair. One practice trial is performed followed by three timed trials; performance times are averaged. Greater times indicate worse physical function.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Timed Up-and-Go (TUG)
Baseline
|
9.73 Seconds
Standard Deviation 2.68
|
9.46 Seconds
Standard Deviation 2.07
|
|
Timed Up-and-Go (TUG)
8-weeks (post-intervention)
|
8.92 Seconds
Standard Deviation 1.89
|
9.12 Seconds
Standard Deviation 1.93
|
|
Timed Up-and-Go (TUG)
6-months (final assessment)
|
8.99 Seconds
Standard Deviation 1.93
|
8.82 Seconds
Standard Deviation 2.03
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A performance test where participants are asked to walk as far as they can in six minutes around a continuous track. Greater distances (in meters) indicate better mobility and exercise tolerance.
Outcome measures
| Measure |
Hip-focused
n=89 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Six-Minute Walk Test (6MWT)
Baseline
|
451.0 Meters
Standard Deviation 116.7
|
451.9 Meters
Standard Deviation 101.6
|
|
Six-Minute Walk Test (6MWT)
8-weeks (post-intervention)
|
489.0 Meters
Standard Deviation 100.4
|
468.2 Meters
Standard Deviation 108.8
|
|
Six-Minute Walk Test (6MWT)
6-months (final assessment)
|
487.8 Meters
Standard Deviation 100.1
|
477.9 Meters
Standard Deviation 105.9
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A performance test where participants perform as many sit-to-stands as possible in 30 seconds while their arms are folded across their chest. The number of stands are counted. Higher numbers correlate with better scores.
Outcome measures
| Measure |
Hip-focused
n=89 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
30 Second Chair Stand Test
Baseline
|
10 number of repetitions
Standard Deviation 3.7
|
10 number of repetitions
Standard Deviation 3.2
|
|
30 Second Chair Stand Test
8-weeks (post-intervention)
|
11 number of repetitions
Standard Deviation 3.1
|
11 number of repetitions
Standard Deviation 3.3
|
|
30 Second Chair Stand Test
6-months (final assessment)
|
12 number of repetitions
Standard Deviation 3.4
|
11 number of repetitions
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
Post-test pain intensities, i.e., 0-10, for both the Six-Minute Walk Test and the 30 Second Chair Stand Test were used in the calculation of aggregate movement-evoked pain. Scores for this measure were the sum of both post-test pain intensities, resulting in a score range of 0-20, where higher numbers indicate worse pain.
Outcome measures
| Measure |
Hip-focused
n=89 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test
Baseline
|
6.4 score on a scale
Standard Deviation 4.3
|
6.7 score on a scale
Standard Deviation 4.7
|
|
Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test
8-weeks (post-intervention)
|
3.6 score on a scale
Standard Deviation 3.6
|
5.2 score on a scale
Standard Deviation 4.5
|
|
Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test
6-months (final assessment)
|
3.8 score on a scale
Standard Deviation 4.1
|
4.1 score on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from overall number analyzed because some participants withdrew from the study over time.
A 9-item questionnaire that assesses the presence/absence of depressive symptoms. Scores above 5 indicate likeliness of depressive symptoms. Scores range from 0-27.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
3.3 score on a scale
Standard Deviation 4.1
|
2.9 score on a scale
Standard Deviation 3.6
|
|
Patient Health Questionnaire-9 (PHQ-9)
8 week (post-intervention)
|
2.5 score on a scale
Standard Deviation 2.7
|
2.6 score on a scale
Standard Deviation 3.6
|
|
Patient Health Questionnaire-9 (PHQ-9)
6 months (final assessment)
|
2.4 score on a scale
Standard Deviation 2.8
|
2.5 score on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A 15-item questionnaire that measures a person's confidence in their ability to perform different activities, including carrying, pushing, sitting, walking, and exercising, which may be directly affected by low back pain. There is an overall score, as well as three Self-Efficacy Subscales: Functional, Self-Regulatory, and Exercise. Overall, as well as subscales, range from 0-100%, where higher numbers indicate higher confidence.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Low Back Activity Confidence Scale (LOBACS)
Baseline: Overall
|
70.1 score on a scale
Standard Deviation 16.4
|
68.9 score on a scale
Standard Deviation 18.8
|
|
Low Back Activity Confidence Scale (LOBACS)
8-week: Overall
|
78.4 score on a scale
Standard Deviation 14.9
|
74.3 score on a scale
Standard Deviation 19.9
|
|
Low Back Activity Confidence Scale (LOBACS)
6-month: Overall
|
76.2 score on a scale
Standard Deviation 18.8
|
73.0 score on a scale
Standard Deviation 20.3
|
|
Low Back Activity Confidence Scale (LOBACS)
Baseline: Functional Subscale
|
56.2 score on a scale
Standard Deviation 23.9
|
54.3 score on a scale
Standard Deviation 23.4
|
|
Low Back Activity Confidence Scale (LOBACS)
8-week: Functional Subscale
|
68.2 score on a scale
Standard Deviation 21.1
|
63.1 score on a scale
Standard Deviation 26.0
|
|
Low Back Activity Confidence Scale (LOBACS)
6-month: Functional Subscale
|
70.0 score on a scale
Standard Deviation 23.9
|
65.2 score on a scale
Standard Deviation 25.6
|
|
Low Back Activity Confidence Scale (LOBACS)
Baseline: Self-Regulatory Subscale
|
78.4 score on a scale
Standard Deviation 19.1
|
77.9 score on a scale
Standard Deviation 23.6
|
|
Low Back Activity Confidence Scale (LOBACS)
8-week: Self-Regulatory Subscale
|
86.3 score on a scale
Standard Deviation 17.7
|
82.5 score on a scale
Standard Deviation 21.6
|
|
Low Back Activity Confidence Scale (LOBACS)
6-month: Self-Regulatory Subscale
|
84.4 score on a scale
Standard Deviation 23.0
|
83.1 score on a scale
Standard Deviation 20.4
|
|
Low Back Activity Confidence Scale (LOBACS)
Baseline: Exercise Subscale
|
84.8 score on a scale
Standard Deviation 16.8
|
83.9 score on a scale
Standard Deviation 18.5
|
|
Low Back Activity Confidence Scale (LOBACS)
8-week: Exercise Subscale
|
87.8 score on a scale
Standard Deviation 14.3
|
84.9 score on a scale
Standard Deviation 20.5
|
|
Low Back Activity Confidence Scale (LOBACS)
6-month Exercise Subscale
|
80.3 score on a scale
Standard Deviation 21.8
|
77.7 score on a scale
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A 40-item questionnaire that contains five domains (symptoms, pain, activity of daily living (ADL), sport and recreation, and quality of life). Each scale ranges from 0-100, where higher scores are better, indicating lower hip-related disability.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Baseline Symptoms
|
67.8 score on a scale
Standard Deviation 18.3
|
68.6 score on a scale
Standard Deviation 15.0
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
8-weeks Symptoms
|
80.6 score on a scale
Standard Deviation 12.8
|
77.4 score on a scale
Standard Deviation 15.6
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
6-months Symptoms
|
80.4 score on a scale
Standard Deviation 13.6
|
81.6 score on a scale
Standard Deviation 15.5
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Baseline Pain
|
56.1 score on a scale
Standard Deviation 12.4
|
57.7 score on a scale
Standard Deviation 11.4
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
8-weeks Pain
|
73.8 score on a scale
Standard Deviation 13.7
|
71.9 score on a scale
Standard Deviation 17.2
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
6-months Pain
|
74.1 score on a scale
Standard Deviation 15.6
|
76.5 score on a scale
Standard Deviation 17.1
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Baseline ADL
|
64.9 score on a scale
Standard Deviation 16.7
|
66.0 score on a scale
Standard Deviation 16.6
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
8-weeks ADL
|
81.1 score on a scale
Standard Deviation 13.9
|
78.1 score on a scale
Standard Deviation 16.2
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
6-months ADL
|
80.3 score on a scale
Standard Deviation 15.1
|
80.6 score on a scale
Standard Deviation 16.9
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Baseline Sports
|
50.3 score on a scale
Standard Deviation 23.7
|
48.5 score on a scale
Standard Deviation 24.7
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
8-weeks Sports
|
70.7 score on a scale
Standard Deviation 19.9
|
64.2 score on a scale
Standard Deviation 24.7
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
6-months Sports
|
68.6 score on a scale
Standard Deviation 23.6
|
66.2 score on a scale
Standard Deviation 27.4
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
Baseline Quality of life
|
48.9 score on a scale
Standard Deviation 19.8
|
51.9 score on a scale
Standard Deviation 18.3
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
8-weeks Quality of Life
|
63.9 score on a scale
Standard Deviation 18.6
|
62.6 score on a scale
Standard Deviation 21.4
|
|
Hip Disability and Osteoarthritis Outcome Score (HOOS)
6-months Quality of Life
|
64.9 score on a scale
Standard Deviation 20.6
|
70.0 score on a scale
Standard Deviation 21.2
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A 29-item short form questionnaire developed by the National Institutes of Health that assesses the following domains of health-related quality of life: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Higher scores indicate better greater presence of each outcome. Possible T-scores for each domain as follows, where a T-score of 50 equals the mean of the United States population and every 10 points above or below the mean is 1 standard deviation away (e.g., a 60 is 1 standard deviation above the mean): Physical Function: 22.5-57.0; Anxiety: 40.3-81.6; Depression: 41.0-79.4; Fatigue: 33.7-75.8; Sleep Disturbance: 32.0-73.3; Social Roles: 27.5-64.2; Pain Interference: 41.6-75.6.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Physical function--Baseline
|
41.8 T-Score
Standard Deviation 5.6
|
42.1 T-Score
Standard Deviation 6.1
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Physical function--8-weeks
|
46.2 T-Score
Standard Deviation 6.4
|
44.5 T-Score
Standard Deviation 7.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Physical function--6-months
|
46.5 T-Score
Standard Deviation 7.2
|
45.3 T-Score
Standard Deviation 7.0
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Anxiety--Baseline
|
48.4 T-Score
Standard Deviation 8.4
|
46.0 T-Score
Standard Deviation 8.1
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Anxiety--8-weeks
|
45.0 T-Score
Standard Deviation 6.9
|
45.8 T-Score
Standard Deviation 8.1
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Anxiety--6-months
|
45.4 T-Score
Standard Deviation 7.2
|
44.1 T-Score
Standard Deviation 6.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Depression--Baseline
|
46.3 T-Score
Standard Deviation 6.8
|
45.3 T-Score
Standard Deviation 6.8
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Depression--8-weeks
|
43.9 T-Score
Standard Deviation 5.9
|
45.6 T-Score
Standard Deviation 7.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Depression--6-months
|
44.3 T-Score
Standard Deviation 5.9
|
44.8 T-Score
Standard Deviation 6.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Fatigue--Baseline
|
47.4 T-Score
Standard Deviation 7.9
|
47.6 T-Score
Standard Deviation 8.8
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Fatigue--8-weeks
|
45.5 T-Score
Standard Deviation 8.2
|
46.4 T-Score
Standard Deviation 8.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Fatigue--6-months
|
44.5 T-Score
Standard Deviation 8.8
|
45.7 T-Score
Standard Deviation 9.3
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Sleep Disturbance--Baseline
|
51.2 T-Score
Standard Deviation 8.2
|
49.2 T-Score
Standard Deviation 7.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Sleep Disturbance--8-weeks
|
47.3 T-Score
Standard Deviation 7.9
|
48.7 T-Score
Standard Deviation 7.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Sleep Disturbance--6-months
|
48.4 T-Score
Standard Deviation 8.2
|
47.9 T-Score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Social Roles--Baseline
|
50.3 T-Score
Standard Deviation 7.7
|
51.5 T-Score
Standard Deviation 8.6
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Social Roles--8-weeks
|
53.9 T-Score
Standard Deviation 7.6
|
52.8 T-Score
Standard Deviation 7.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Social Roles--6-months
|
53.8 T-Score
Standard Deviation 8.7
|
54.3 T-Score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Interference--Baseline
|
58.8 T-Score
Standard Deviation 4.8
|
58.3 T-Score
Standard Deviation 5.4
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Interference--8-weeks
|
53.9 T-Score
Standard Deviation 6.5
|
55.7 T-Score
Standard Deviation 6.7
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
Pain Interference--6-months
|
54.3 T-Score
Standard Deviation 7.5
|
53.4 T-Score
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A 13-item questionnaire that that assesses how a person perceives pain. Items can be scored as three subscales to evaluate constructs of rumination, magnification, and helplessness. Higher scores (scale of 0-52) indicate greater levels of pain catastrophizing.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Pain Catastrophizing Scale (PCS)
Baseline
|
11.8 score on a scale
Standard Deviation 9.4
|
9.5 score on a scale
Standard Deviation 9.2
|
|
Pain Catastrophizing Scale (PCS)
8 weeks (post-intervention)
|
7.1 score on a scale
Standard Deviation 6.7
|
6.6 score on a scale
Standard Deviation 7.9
|
|
Pain Catastrophizing Scale (PCS)
6-months (final assessment)
|
5.5 score on a scale
Standard Deviation 6.6
|
5.9 score on a scale
Standard Deviation 8.0
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A series of strength testing measurements will be conducted using a hand-held dynamometer. All participant and examiner body positions are standardized using study protocols, and measurement locations are standardized using anatomical landmarks. Strength measurements (in kilograms) are taken for the following hip motions: abduction, extension, external rotation, internal rotation, and flexion. Measurements from the weaker side were normalized to, i.e., divided by, body weight (in kilograms), therefore, there is no unit for the measure.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Hip Strength
Hip Internal rotation--Baseline
|
0.071 unitless (kg/kg)
Standard Deviation 0.027
|
0.069 unitless (kg/kg)
Standard Deviation 0.028
|
|
Hip Strength
Hip Internal rotation--8-weeks
|
0.077 unitless (kg/kg)
Standard Deviation 0.029
|
0.069 unitless (kg/kg)
Standard Deviation 0.030
|
|
Hip Strength
Hip Internal rotation--6-months
|
0.078 unitless (kg/kg)
Standard Deviation 0.029
|
0.074 unitless (kg/kg)
Standard Deviation 0.041
|
|
Hip Strength
Hip External rotation--baseline
|
0.09 unitless (kg/kg)
Standard Deviation 0.033
|
0.089 unitless (kg/kg)
Standard Deviation 0.033
|
|
Hip Strength
Hip External rotation--8-weeks
|
0.11 unitless (kg/kg)
Standard Deviation 0.037
|
0.095 unitless (kg/kg)
Standard Deviation 0.033
|
|
Hip Strength
Hip External rotation--6-months
|
0.11 unitless (kg/kg)
Standard Deviation 0.035
|
0.092 unitless (kg/kg)
Standard Deviation 0.031
|
|
Hip Strength
Hip Extension--baseline
|
0.12 unitless (kg/kg)
Standard Deviation 0.060
|
0.10 unitless (kg/kg)
Standard Deviation 0.055
|
|
Hip Strength
Hip Extension--8-weeks
|
0.14 unitless (kg/kg)
Standard Deviation 0.067
|
0.12 unitless (kg/kg)
Standard Deviation 0.058
|
|
Hip Strength
Hip Extension--6-months
|
0.15 unitless (kg/kg)
Standard Deviation 0.067
|
0.12 unitless (kg/kg)
Standard Deviation 0.060
|
|
Hip Strength
Hip Abduction--Baseline
|
0.084 unitless (kg/kg)
Standard Deviation 0.033
|
0.079 unitless (kg/kg)
Standard Deviation 0.031
|
|
Hip Strength
Hip Abduction--8-weeks
|
0.093 unitless (kg/kg)
Standard Deviation 0.031
|
0.086 unitless (kg/kg)
Standard Deviation 0.032
|
|
Hip Strength
Hip Abduction--6-months
|
0.100 unitless (kg/kg)
Standard Deviation 0.035
|
0.088 unitless (kg/kg)
Standard Deviation 0.032
|
|
Hip Strength
Hip Flexion--Baseline
|
0.159 unitless (kg/kg)
Standard Deviation 0.063
|
0.158 unitless (kg/kg)
Standard Deviation 0.067
|
|
Hip Strength
Hip Flexion--8-weeks
|
0.177 unitless (kg/kg)
Standard Deviation 0.061
|
0.172 unitless (kg/kg)
Standard Deviation 0.066
|
|
Hip Strength
Hip Flexion--6-months
|
0.192 unitless (kg/kg)
Standard Deviation 0.065
|
0.172 unitless (kg/kg)
Standard Deviation 0.061
|
SECONDARY outcome
Timeframe: Baseline, 8-weeks (i.e. post-intervention), and 6-monthsPopulation: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
A test where the assessor uses an algometer (i.e., handheld device that calculates the amount of force applied to the skin) to measure pressure pain sensitivity at 4 sites: upper trapezius, posterior superior iliac spine, greater trochanter, and tibialis anterior; higher values indicate higher pain thresholds, with values ranging from 0 to 10.1, where 10.1 indicates the participant tolerated 10 kilograms of force/cm squared without pain and therefore, no further pressure was applied. Pressure starts at 0.00 kilograms-of-force per square centimeter and is increased by 1-kgf/cm squared per second until the participant first experiences pain.
Outcome measures
| Measure |
Hip-focused
n=91 Participants
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 Participants
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Quantitative Sensory Testing
Right Upper trapezius--6-months
|
4.22 kgf/cm squared
Standard Deviation 1.84
|
4.45 kgf/cm squared
Standard Deviation 2.15
|
|
Quantitative Sensory Testing
Right Posterior Superior Iliac Spine--baseline
|
4.76 kgf/cm squared
Standard Deviation 2.29
|
5.08 kgf/cm squared
Standard Deviation 2.51
|
|
Quantitative Sensory Testing
Right Posterior Superior Iliac Spine--8-weeks
|
5.34 kgf/cm squared
Standard Deviation 2.25
|
5.79 kgf/cm squared
Standard Deviation 2.34
|
|
Quantitative Sensory Testing
Right Posterior Superior Iliac Spine--6-months
|
5.43 kgf/cm squared
Standard Deviation 2.33
|
5.33 kgf/cm squared
Standard Deviation 2.42
|
|
Quantitative Sensory Testing
Right Greater trochanter--baseline
|
5.48 kgf/cm squared
Standard Deviation 2.61
|
5.87 kgf/cm squared
Standard Deviation 2.79
|
|
Quantitative Sensory Testing
Right Greater trochanter--8-weeks
|
6.03 kgf/cm squared
Standard Deviation 2.33
|
6.20 kgf/cm squared
Standard Deviation 2.61
|
|
Quantitative Sensory Testing
Right Greater trochanter--6-months
|
6.05 kgf/cm squared
Standard Deviation 2.65
|
6.11 kgf/cm squared
Standard Deviation 2.54
|
|
Quantitative Sensory Testing
Right Anterior tibialis--baseline
|
4.79 kgf/cm squared
Standard Deviation 2.47
|
4.81 kgf/cm squared
Standard Deviation 2.45
|
|
Quantitative Sensory Testing
Right Anterior tibialis--8-weeks
|
5.32 kgf/cm squared
Standard Deviation 2.39
|
5.07 kgf/cm squared
Standard Deviation 2.57
|
|
Quantitative Sensory Testing
Right Anterior tibialis--6-months
|
5.12 kgf/cm squared
Standard Deviation 2.58
|
4.85 kgf/cm squared
Standard Deviation 2.40
|
|
Quantitative Sensory Testing
Left Upper trapezius--baseline
|
4.09 kgf/cm squared
Standard Deviation 2.24
|
4.40 kgf/cm squared
Standard Deviation 2.44
|
|
Quantitative Sensory Testing
Left Upper trapezius--8-weeks
|
4.39 kgf/cm squared
Standard Deviation 1.93
|
4.37 kgf/cm squared
Standard Deviation 2.06
|
|
Quantitative Sensory Testing
Left Upper trapezius--6-months
|
4.19 kgf/cm squared
Standard Deviation 1.84
|
4.40 kgf/cm squared
Standard Deviation 2.24
|
|
Quantitative Sensory Testing
Left Posterior Superior Iliac Spine--8-weeks
|
5.52 kgf/cm squared
Standard Deviation 2.33
|
5.59 kgf/cm squared
Standard Deviation 2.39
|
|
Quantitative Sensory Testing
Left Posterior Superior Iliac Spine--baseline
|
4.93 kgf/cm squared
Standard Deviation 2.45
|
5.03 kgf/cm squared
Standard Deviation 2.50
|
|
Quantitative Sensory Testing
Left Posterior Superior Iliac Spine--6-months
|
5.57 kgf/cm squared
Standard Deviation 2.44
|
5.43 kgf/cm squared
Standard Deviation 2.47
|
|
Quantitative Sensory Testing
Left Greater trochanter--baseline
|
5.46 kgf/cm squared
Standard Deviation 2.63
|
5.73 kgf/cm squared
Standard Deviation 2.80
|
|
Quantitative Sensory Testing
Left Greater trochanter--8-weeks
|
6.35 kgf/cm squared
Standard Deviation 2.34
|
6.09 kgf/cm squared
Standard Deviation 2.58
|
|
Quantitative Sensory Testing
Left Greater trochanter--6-months
|
6.00 kgf/cm squared
Standard Deviation 2.71
|
6.04 kgf/cm squared
Standard Deviation 2.69
|
|
Quantitative Sensory Testing
Left Anterior tibialis--baseline
|
4.77 kgf/cm squared
Standard Deviation 2.55
|
4.55 kgf/cm squared
Standard Deviation 2.46
|
|
Quantitative Sensory Testing
Left Anterior tibialis--8-weeks
|
5.31 kgf/cm squared
Standard Deviation 2.43
|
4.85 kgf/cm squared
Standard Deviation 2.51
|
|
Quantitative Sensory Testing
Left Anterior tibialis--6-months
|
5.07 kgf/cm squared
Standard Deviation 2.65
|
4.66 kgf/cm squared
Standard Deviation 2.38
|
|
Quantitative Sensory Testing
Right Upper trapezius--baseline
|
4.27 kgf/cm squared
Standard Deviation 2.17
|
4.46 kgf/cm squared
Standard Deviation 2.25
|
|
Quantitative Sensory Testing
Right Upper trapezius--8-weeks
|
4.59 kgf/cm squared
Standard Deviation 1.95
|
4.50 kgf/cm squared
Standard Deviation 2.14
|
Adverse Events
Hip-focused
Serious events: 9 serious events
Other events: 47 other events
Deaths: 0 deaths
Spine-focused
Serious events: 4 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Hip-focused
n=91 participants at risk
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 participants at risk
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Cardiac disorders
Myocardial Infarction
|
1.1%
1/91 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Atrial Fibrillation
|
1.1%
1/91 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/93 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Cardiac Disorders-others, specify
|
1.1%
1/91 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/93 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/91 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/93 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Surgical and medical procedures
Surgical and Medical Procedures-other, specify
|
2.2%
2/91 • Number of events 2 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Chest Pain
|
2.2%
2/91 • Number of events 2 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/93 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Heart Failure
|
1.1%
1/91 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/93 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders-other, specify
|
1.1%
1/91 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
0.00%
0/93 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
0.00%
0/91 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Nervous system disorders
Tremor
|
0.00%
0/91 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
1.1%
1/93 • Number of events 1 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
Other adverse events
| Measure |
Hip-focused
n=91 participants at risk
Hip-focused rehabilitation intervention
Hip-focused rehabilitation intervention: The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
Spine-focused
n=93 participants at risk
Spine-focused rehabilitation intervention
Spine-focused rehabilitation intervention: The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
9.9%
9/91 • Number of events 9 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
6.5%
6/93 • Number of events 7 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Surgical and medical procedures
Surgical and medical procedures-other, specify
|
6.6%
6/91 • Number of events 7 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
6.5%
6/93 • Number of events 6 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.9%
19/91 • Number of events 26 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
18.3%
17/93 • Number of events 23 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.7%
17/91 • Number of events 21 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
17.2%
16/93 • Number of events 20 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.1%
11/91 • Number of events 15 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
14.0%
13/93 • Number of events 16 • Adverse event data were collected from baseline to the 6-month post-baseline final assessment.
Our definitions of adverse events and/or serious adverse events does not differ from the clinicaltrials.gov definitions.
|
Additional Information
Dr. Gregory Hicks, PT, PhD, FAPTA, FGSA
University of Delaware
Phone: (302) 831-2690
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place