Chronic Low-back Pain, Hip Impairments, Hip-spine Syndrome, Osteoarthritis
Conditions
Keywords
older adult, geriatrics, chronic low back pain, low back pain, hip-spine, rehabilitation, physical therapy, spine, hip pain
Brief summary
Older adults with chronic low back pain (LBP) are at a greater risk for disability, loss of independence, and lower quality of life. Experts agree that LBP is not a homogeneous condition, and treatments should differ based upon clinical presentation. Our past work indicates that all of these hip and lumbar spine impairments may contribute to worse physical function and greater disability, but the relative importance of each impairment is unclear. Thus, clinicians have limited evidence to draw on for treatment decisions for this patient population. We have identified a vulnerable subgroup of older adults with hip and low back pain. The purpose of this study is to randomize participants into one of two treatment arms and analyze the outcomes.
Detailed description
This randomized clinical trial is designed to explore two different interventions: one that addresses these hip issues (hip-focused) and one that focuses more directly on the lumbar spine (spine-focused). We aim to recruit a sample of 180 older adults who have chronic LBP and hip impairments (i.e. pain and muscle weakness). To ensure our findings are generalizable, the study will be conducted across three sites in different geographical regions: University of Delaware, University of Pittsburgh, and Duke University. The goal of this clinical trial is to learn more about how older adults with low back and hip pain respond to physical therapy intervention. Participants will have three standardized assessments by licensed physical therapists, at baseline, 8 weeks, and 6 months. Once randomized, participants will attend on-site sessions 2x per week for 8 weeks and complete a home exercise log. People in the hip-focused group will receive mobilizations and stretching, and will participate in hip exercises and trunk muscle exercise. People in the spine-focused group will receive massage and gentle mobilizations to the lumbar spine and participate in stationary cycling and trunk muscle training.
Interventions
BEHAVIORALHip-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.
BEHAVIORALSpine-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.
Sponsors
University of Pittsburgh
Duke University
National Institute on Aging (NIA)
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* LBP duration ≥ 3 months * LBP an ongoing problem for at least half days in past 6 months * LBP intensity \> 3 on scale of 0 (no pain) to 10 (worst pain imaginable) * Classified into the weak+painful hip-spine subgroup based on two criterion. Participants must have: 1) hip internal rotation strength (normalized to body weight) in at least one hip that is \< 0.26; and, 2) from the Hip Disability and Osteoarthritis Outcome Score (HOOS) Pain items P4-P8, a raw score sum of \>5 (0-20 range, where higher scores indicate more pain interference with daily activities).
Exclusion criteria
* Previous hip fracture with surgical repair * Previous hip fracture without surgical repair within the past 15 years * Total hip replacement * Known spinal pathology other than osteoarthritis (e.g. recent back surgery, vertebral fractures in the past year, rheumatoid arthritis, metastases) * Non-ambulatory or severely impairment mobility (i.e. requires wheelchair) * Folstein Mini-Mental State Examination score of \< 24, indicating cognitive impairment * Severe visual or hearing impairment * Unable to read or speak English * Red flags indicative of serious disorder underlying LBP (e.g. fever associated with LBP, significant unintentional weight loss \> 10 pounds, pain that awakes or keeps one awake at night) * Significant pain the legs greater than the back * Acute illness (e.g. hospitalization within the past 3 months or current infection) * Inability to participate in study for the full six months for any known reason * Received physical therapy for low back or hip within the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quebec Back Pain Disability Scale | Baseline to 8-week assessment (i.e. post-intervention) | 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. |
| 10-Meter Walk Test at Self-Selected Speed (10MWT) | Baseline to 8-week assessment (i.e. post-intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10-Meter Walk Test at Fast Speed (10MWT) | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Timed Up-and-Go (TUG) | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Six-Minute Walk Test (6MWT) | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| 30 Second Chair Stand Test | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Patient Health Questionnaire-9 (PHQ-9) | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Quebec Back Pain Disability Scale | Baseline to the 6-month assessment | 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. |
| Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Pain Catastrophizing Scale (PCS) | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Hip Strength | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Quantitative Sensory Testing | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| Low Back Activity Confidence Scale (LOBACS) | Baseline, 8-weeks (i.e. post-intervention), and 6-months | 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. |
| 10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment) | Baseline to 6-months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 91 |
| 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. | 93 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not complete any aspect of of 8-week assessment | 3 | 7 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Hip-focused | Spine-focused | Total |
|---|---|---|---|
| Age, Continuous | 70.8 years STANDARD_DEVIATION 6 | 70.6 years STANDARD_DEVIATION 6.4 | 70.71 years STANDARD_DEVIATION 6.19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants | 92 Participants | 182 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Low Back Pain duration (years) | 15.7 years STANDARD_DEVIATION 14.6 | 14.0 years STANDARD_DEVIATION 12 | 14.8 years STANDARD_DEVIATION 13.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 15 Participants | 32 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 72 Participants | 77 Participants | 149 Participants |
| Region of Enrollment United States | 91 participants | 93 participants | 184 participants |
| Sex: Female, Male Female | 61 Participants | 60 Participants | 121 Participants |
| Sex: Female, Male Male | 30 Participants | 33 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 91 | 0 / 93 |
| other Total, other adverse events | 47 / 91 | 39 / 93 |
| serious Total, serious adverse events | 9 / 91 | 4 / 93 |
Outcome results
Primary
10-Meter Walk Test at Self-Selected Speed (10MWT)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | 10-Meter Walk Test at Self-Selected Speed (10MWT) | Baseline | 1.12 meters/second | Standard Deviation 0.25 |
| Hip-focused | 10-Meter Walk Test at Self-Selected Speed (10MWT) | 8-week (post-intervention) assessment | 1.2 meters/second | Standard Deviation 0.24 |
| Spine-focused | 10-Meter Walk Test at Self-Selected Speed (10MWT) | Baseline | 1.12 meters/second | Standard Deviation 0.24 |
| Spine-focused | 10-Meter Walk Test at Self-Selected Speed (10MWT) | 8-week (post-intervention) assessment | 1.21 meters/second | Standard Deviation 0.23 |
Primary
Quebec Back Pain Disability Scale
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Quebec Back Pain Disability Scale | Baseline | 27.9 score on a scale | Standard Deviation 15.8 |
| Hip-focused | Quebec Back Pain Disability Scale | 8-weeks (post-intervention) | 16.7 score on a scale | Standard Deviation 11.7 |
| Spine-focused | Quebec Back Pain Disability Scale | Baseline | 27.9 score on a scale | Standard Deviation 15.5 |
| Spine-focused | Quebec Back Pain Disability Scale | 8-weeks (post-intervention) | 20.3 score on a scale | Standard Deviation 14.3 |
Secondary
10-Meter Walk Test at Fast Speed (10MWT)
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | 10-Meter Walk Test at Fast Speed (10MWT) | Baseline | 1.57 meters/second | Standard Deviation 0.34 |
| Hip-focused | 10-Meter Walk Test at Fast Speed (10MWT) | 8-weeks (post-intervention) | 1.65 meters/second | Standard Deviation 0.31 |
| Hip-focused | 10-Meter Walk Test at Fast Speed (10MWT) | 6-months (final assessment) | 1.63 meters/second | Standard Deviation 0.31 |
| Spine-focused | 10-Meter Walk Test at Fast Speed (10MWT) | Baseline | 1.59 meters/second | Standard Deviation 0.38 |
| Spine-focused | 10-Meter Walk Test at Fast Speed (10MWT) | 8-weeks (post-intervention) | 1.67 meters/second | Standard Deviation 0.32 |
| Spine-focused | 10-Meter Walk Test at Fast Speed (10MWT) | 6-months (final assessment) | 1.66 meters/second | Standard Deviation 0.34 |
Secondary
10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment)
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.
Time frame: Baseline to 6-months
Population: The number analyzed in some rows differs from overall number analyzed as some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | 10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment) | Baseline | 1.12 Meters/second | Standard Deviation 0.25 |
| Hip-focused | 10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment) | 6-months | 1.21 Meters/second | Standard Deviation 0.25 |
| Spine-focused | 10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment) | Baseline | 1.12 Meters/second | Standard Deviation 0.24 |
| Spine-focused | 10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment) | 6-months | 1.24 Meters/second | Standard Deviation 0.22 |
Secondary
30 Second Chair Stand Test
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | 30 Second Chair Stand Test | Baseline | 10 number of repetitions | Standard Deviation 3.7 |
| Hip-focused | 30 Second Chair Stand Test | 8-weeks (post-intervention) | 11 number of repetitions | Standard Deviation 3.1 |
| Hip-focused | 30 Second Chair Stand Test | 6-months (final assessment) | 12 number of repetitions | Standard Deviation 3.4 |
| Spine-focused | 30 Second Chair Stand Test | Baseline | 10 number of repetitions | Standard Deviation 3.2 |
| Spine-focused | 30 Second Chair Stand Test | 8-weeks (post-intervention) | 11 number of repetitions | Standard Deviation 3.3 |
| Spine-focused | 30 Second Chair Stand Test | 6-months (final assessment) | 11 number of repetitions | Standard Deviation 3.8 |
Secondary
Hip Disability and Osteoarthritis Outcome Score (HOOS)
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks Pain | 73.8 score on a scale | Standard Deviation 13.7 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months ADL | 80.3 score on a scale | Standard Deviation 15.1 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks Symptoms | 80.6 score on a scale | Standard Deviation 12.8 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline Sports | 50.3 score on a scale | Standard Deviation 23.7 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months Pain | 74.1 score on a scale | Standard Deviation 15.6 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks Sports | 70.7 score on a scale | Standard Deviation 19.9 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline Pain | 56.1 score on a scale | Standard Deviation 12.4 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months Sports | 68.6 score on a scale | Standard Deviation 23.6 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline ADL | 64.9 score on a scale | Standard Deviation 16.7 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline Quality of life | 48.9 score on a scale | Standard Deviation 19.8 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months Symptoms | 80.4 score on a scale | Standard Deviation 13.6 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks Quality of Life | 63.9 score on a scale | Standard Deviation 18.6 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks ADL | 81.1 score on a scale | Standard Deviation 13.9 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months Quality of Life | 64.9 score on a scale | Standard Deviation 20.6 |
| Hip-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline Symptoms | 67.8 score on a scale | Standard Deviation 18.3 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months Quality of Life | 70.0 score on a scale | Standard Deviation 21.2 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline Symptoms | 68.6 score on a scale | Standard Deviation 15 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks Symptoms | 77.4 score on a scale | Standard Deviation 15.6 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months Symptoms | 81.6 score on a scale | Standard Deviation 15.5 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline Pain | 57.7 score on a scale | Standard Deviation 11.4 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks Pain | 71.9 score on a scale | Standard Deviation 17.2 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months Pain | 76.5 score on a scale | Standard Deviation 17.1 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline ADL | 66.0 score on a scale | Standard Deviation 16.6 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks ADL | 78.1 score on a scale | Standard Deviation 16.2 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months ADL | 80.6 score on a scale | Standard Deviation 16.9 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline Sports | 48.5 score on a scale | Standard Deviation 24.7 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks Sports | 64.2 score on a scale | Standard Deviation 24.7 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 6-months Sports | 66.2 score on a scale | Standard Deviation 27.4 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | Baseline Quality of life | 51.9 score on a scale | Standard Deviation 18.3 |
| Spine-focused | Hip Disability and Osteoarthritis Outcome Score (HOOS) | 8-weeks Quality of Life | 62.6 score on a scale | Standard Deviation 21.4 |
Secondary
Hip Strength
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Hip Strength | Hip External rotation--8-weeks | 0.11 unitless (kg/kg) | Standard Deviation 0.037 |
| Hip-focused | Hip Strength | Hip Extension--6-months | 0.15 unitless (kg/kg) | Standard Deviation 0.067 |
| Hip-focused | Hip Strength | Hip Internal rotation--8-weeks | 0.077 unitless (kg/kg) | Standard Deviation 0.029 |
| Hip-focused | Hip Strength | Hip Abduction--Baseline | 0.084 unitless (kg/kg) | Standard Deviation 0.033 |
| Hip-focused | Hip Strength | Hip External rotation--6-months | 0.11 unitless (kg/kg) | Standard Deviation 0.035 |
| Hip-focused | Hip Strength | Hip Abduction--8-weeks | 0.093 unitless (kg/kg) | Standard Deviation 0.031 |
| Hip-focused | Hip Strength | Hip External rotation--baseline | 0.09 unitless (kg/kg) | Standard Deviation 0.033 |
| Hip-focused | Hip Strength | Hip Abduction--6-months | 0.100 unitless (kg/kg) | Standard Deviation 0.035 |
| Hip-focused | Hip Strength | Hip Extension--baseline | 0.12 unitless (kg/kg) | Standard Deviation 0.06 |
| Hip-focused | Hip Strength | Hip Flexion--Baseline | 0.159 unitless (kg/kg) | Standard Deviation 0.063 |
| Hip-focused | Hip Strength | Hip Internal rotation--6-months | 0.078 unitless (kg/kg) | Standard Deviation 0.029 |
| Hip-focused | Hip Strength | Hip Flexion--8-weeks | 0.177 unitless (kg/kg) | Standard Deviation 0.061 |
| Hip-focused | Hip Strength | Hip Extension--8-weeks | 0.14 unitless (kg/kg) | Standard Deviation 0.067 |
| Hip-focused | Hip Strength | Hip Flexion--6-months | 0.192 unitless (kg/kg) | Standard Deviation 0.065 |
| Hip-focused | Hip Strength | Hip Internal rotation--Baseline | 0.071 unitless (kg/kg) | Standard Deviation 0.027 |
| Spine-focused | Hip Strength | Hip Flexion--6-months | 0.172 unitless (kg/kg) | Standard Deviation 0.061 |
| Spine-focused | Hip Strength | Hip Internal rotation--Baseline | 0.069 unitless (kg/kg) | Standard Deviation 0.028 |
| Spine-focused | Hip Strength | Hip Internal rotation--8-weeks | 0.069 unitless (kg/kg) | Standard Deviation 0.03 |
| Spine-focused | Hip Strength | Hip Internal rotation--6-months | 0.074 unitless (kg/kg) | Standard Deviation 0.041 |
| Spine-focused | Hip Strength | Hip External rotation--baseline | 0.089 unitless (kg/kg) | Standard Deviation 0.033 |
| Spine-focused | Hip Strength | Hip External rotation--8-weeks | 0.095 unitless (kg/kg) | Standard Deviation 0.033 |
| Spine-focused | Hip Strength | Hip External rotation--6-months | 0.092 unitless (kg/kg) | Standard Deviation 0.031 |
| Spine-focused | Hip Strength | Hip Extension--baseline | 0.10 unitless (kg/kg) | Standard Deviation 0.055 |
| Spine-focused | Hip Strength | Hip Extension--8-weeks | 0.12 unitless (kg/kg) | Standard Deviation 0.058 |
| Spine-focused | Hip Strength | Hip Extension--6-months | 0.12 unitless (kg/kg) | Standard Deviation 0.06 |
| Spine-focused | Hip Strength | Hip Abduction--Baseline | 0.079 unitless (kg/kg) | Standard Deviation 0.031 |
| Spine-focused | Hip Strength | Hip Abduction--8-weeks | 0.086 unitless (kg/kg) | Standard Deviation 0.032 |
| Spine-focused | Hip Strength | Hip Abduction--6-months | 0.088 unitless (kg/kg) | Standard Deviation 0.032 |
| Spine-focused | Hip Strength | Hip Flexion--Baseline | 0.158 unitless (kg/kg) | Standard Deviation 0.067 |
| Spine-focused | Hip Strength | Hip Flexion--8-weeks | 0.172 unitless (kg/kg) | Standard Deviation 0.066 |
Secondary
Low Back Activity Confidence Scale (LOBACS)
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | Baseline: Overall | 70.1 score on a scale | Standard Deviation 16.4 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | 8-week: Overall | 78.4 score on a scale | Standard Deviation 14.9 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | 6-month: Overall | 76.2 score on a scale | Standard Deviation 18.8 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | Baseline: Functional Subscale | 56.2 score on a scale | Standard Deviation 23.9 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | 8-week: Functional Subscale | 68.2 score on a scale | Standard Deviation 21.1 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | 6-month: Functional Subscale | 70.0 score on a scale | Standard Deviation 23.9 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | Baseline: Self-Regulatory Subscale | 78.4 score on a scale | Standard Deviation 19.1 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | 8-week: Self-Regulatory Subscale | 86.3 score on a scale | Standard Deviation 17.7 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | 6-month: Self-Regulatory Subscale | 84.4 score on a scale | Standard Deviation 23 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | Baseline: Exercise Subscale | 84.8 score on a scale | Standard Deviation 16.8 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | 8-week: Exercise Subscale | 87.8 score on a scale | Standard Deviation 14.3 |
| Hip-focused | Low Back Activity Confidence Scale (LOBACS) | 6-month Exercise Subscale | 80.3 score on a scale | Standard Deviation 21.8 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | 8-week: Exercise Subscale | 84.9 score on a scale | Standard Deviation 20.5 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | Baseline: Overall | 68.9 score on a scale | Standard Deviation 18.8 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | Baseline: Self-Regulatory Subscale | 77.9 score on a scale | Standard Deviation 23.6 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | 8-week: Overall | 74.3 score on a scale | Standard Deviation 19.9 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | Baseline: Exercise Subscale | 83.9 score on a scale | Standard Deviation 18.5 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | 6-month: Overall | 73.0 score on a scale | Standard Deviation 20.3 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | 8-week: Self-Regulatory Subscale | 82.5 score on a scale | Standard Deviation 21.6 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | Baseline: Functional Subscale | 54.3 score on a scale | Standard Deviation 23.4 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | 6-month Exercise Subscale | 77.7 score on a scale | Standard Deviation 24.2 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | 8-week: Functional Subscale | 63.1 score on a scale | Standard Deviation 26 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | 6-month: Self-Regulatory Subscale | 83.1 score on a scale | Standard Deviation 20.4 |
| Spine-focused | Low Back Activity Confidence Scale (LOBACS) | 6-month: Functional Subscale | 65.2 score on a scale | Standard Deviation 25.6 |
Secondary
Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test | Baseline | 6.4 score on a scale | Standard Deviation 4.3 |
| Hip-focused | 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 |
| Hip-focused | 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 |
| Spine-focused | Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test | Baseline | 6.7 score on a scale | Standard Deviation 4.7 |
| Spine-focused | Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test | 8-weeks (post-intervention) | 5.2 score on a scale | Standard Deviation 4.5 |
| Spine-focused | Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test | 6-months (final assessment) | 4.1 score on a scale | Standard Deviation 4.1 |
Secondary
Pain Catastrophizing Scale (PCS)
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Pain Catastrophizing Scale (PCS) | Baseline | 11.8 score on a scale | Standard Deviation 9.4 |
| Hip-focused | Pain Catastrophizing Scale (PCS) | 8 weeks (post-intervention) | 7.1 score on a scale | Standard Deviation 6.7 |
| Hip-focused | Pain Catastrophizing Scale (PCS) | 6-months (final assessment) | 5.5 score on a scale | Standard Deviation 6.6 |
| Spine-focused | Pain Catastrophizing Scale (PCS) | Baseline | 9.5 score on a scale | Standard Deviation 9.2 |
| Spine-focused | Pain Catastrophizing Scale (PCS) | 8 weeks (post-intervention) | 6.6 score on a scale | Standard Deviation 7.9 |
| Spine-focused | Pain Catastrophizing Scale (PCS) | 6-months (final assessment) | 5.9 score on a scale | Standard Deviation 8 |
Secondary
Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Patient Health Questionnaire-9 (PHQ-9) | Baseline | 3.3 score on a scale | Standard Deviation 4.1 |
| Hip-focused | Patient Health Questionnaire-9 (PHQ-9) | 8 week (post-intervention) | 2.5 score on a scale | Standard Deviation 2.7 |
| Hip-focused | Patient Health Questionnaire-9 (PHQ-9) | 6 months (final assessment) | 2.4 score on a scale | Standard Deviation 2.8 |
| Spine-focused | Patient Health Questionnaire-9 (PHQ-9) | Baseline | 2.9 score on a scale | Standard Deviation 3.6 |
| Spine-focused | Patient Health Questionnaire-9 (PHQ-9) | 8 week (post-intervention) | 2.6 score on a scale | Standard Deviation 3.6 |
| Spine-focused | Patient Health Questionnaire-9 (PHQ-9) | 6 months (final assessment) | 2.5 score on a scale | Standard Deviation 3.5 |
Secondary
Patient-Reported Outcomes Measurement Information System (PROMIS)-29
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical function--6-months | 46.5 T-Score | Standard Deviation 7.2 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression--6-months | 44.3 T-Score | Standard Deviation 5.9 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue--Baseline | 47.4 T-Score | Standard Deviation 7.9 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue--8-weeks | 45.5 T-Score | Standard Deviation 8.2 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue--6-months | 44.5 T-Score | Standard Deviation 8.8 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance--Baseline | 51.2 T-Score | Standard Deviation 8.2 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance--8-weeks | 47.3 T-Score | Standard Deviation 7.9 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance--6-months | 48.4 T-Score | Standard Deviation 8.2 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Social Roles--Baseline | 50.3 T-Score | Standard Deviation 7.7 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Social Roles--8-weeks | 53.9 T-Score | Standard Deviation 7.6 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Social Roles--6-months | 53.8 T-Score | Standard Deviation 8.7 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference--Baseline | 58.8 T-Score | Standard Deviation 4.8 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference--8-weeks | 53.9 T-Score | Standard Deviation 6.5 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference--6-months | 54.3 T-Score | Standard Deviation 7.5 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical function--Baseline | 41.8 T-Score | Standard Deviation 5.6 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical function--8-weeks | 46.2 T-Score | Standard Deviation 6.4 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety--Baseline | 48.4 T-Score | Standard Deviation 8.4 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety--8-weeks | 45.0 T-Score | Standard Deviation 6.9 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety--6-months | 45.4 T-Score | Standard Deviation 7.2 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression--Baseline | 46.3 T-Score | Standard Deviation 6.8 |
| Hip-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression--8-weeks | 43.9 T-Score | Standard Deviation 5.9 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical function--6-months | 45.3 T-Score | Standard Deviation 7 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression--8-weeks | 45.6 T-Score | Standard Deviation 7.5 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference--Baseline | 58.3 T-Score | Standard Deviation 5.4 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression--6-months | 44.8 T-Score | Standard Deviation 6.7 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Depression--Baseline | 45.3 T-Score | Standard Deviation 6.8 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue--Baseline | 47.6 T-Score | Standard Deviation 8.8 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference--8-weeks | 55.7 T-Score | Standard Deviation 6.7 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue--8-weeks | 46.4 T-Score | Standard Deviation 8.3 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety--Baseline | 46.0 T-Score | Standard Deviation 8.1 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Fatigue--6-months | 45.7 T-Score | Standard Deviation 9.3 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Pain Interference--6-months | 53.4 T-Score | Standard Deviation 8.2 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance--Baseline | 49.2 T-Score | Standard Deviation 7.9 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety--6-months | 44.1 T-Score | Standard Deviation 6.7 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance--8-weeks | 48.7 T-Score | Standard Deviation 7.4 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical function--Baseline | 42.1 T-Score | Standard Deviation 6.1 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Sleep Disturbance--6-months | 47.9 T-Score | Standard Deviation 8.5 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Anxiety--8-weeks | 45.8 T-Score | Standard Deviation 8.1 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Physical function--8-weeks | 44.5 T-Score | Standard Deviation 7.3 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Social Roles--8-weeks | 52.8 T-Score | Standard Deviation 7.9 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Social Roles--Baseline | 51.5 T-Score | Standard Deviation 8.6 |
| Spine-focused | Patient-Reported Outcomes Measurement Information System (PROMIS)-29 | Social Roles--6-months | 54.3 T-Score | Standard Deviation 8.5 |
Secondary
Quantitative Sensory Testing
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Quantitative Sensory Testing | Right Upper trapezius--8-weeks | 4.59 kgf/cm squared | Standard Deviation 1.95 |
| Hip-focused | Quantitative Sensory Testing | Left Upper trapezius--baseline | 4.09 kgf/cm squared | Standard Deviation 2.24 |
| Hip-focused | Quantitative Sensory Testing | Right Greater trochanter--baseline | 5.48 kgf/cm squared | Standard Deviation 2.61 |
| Hip-focused | Quantitative Sensory Testing | Left Upper trapezius--8-weeks | 4.39 kgf/cm squared | Standard Deviation 1.93 |
| Hip-focused | Quantitative Sensory Testing | Right Posterior Superior Iliac Spine--baseline | 4.76 kgf/cm squared | Standard Deviation 2.29 |
| Hip-focused | Quantitative Sensory Testing | Left Upper trapezius--6-months | 4.19 kgf/cm squared | Standard Deviation 1.84 |
| Hip-focused | Quantitative Sensory Testing | Right Greater trochanter--8-weeks | 6.03 kgf/cm squared | Standard Deviation 2.33 |
| Hip-focused | Quantitative Sensory Testing | Left Posterior Superior Iliac Spine--baseline | 4.93 kgf/cm squared | Standard Deviation 2.45 |
| Hip-focused | Quantitative Sensory Testing | Right Upper trapezius--baseline | 4.27 kgf/cm squared | Standard Deviation 2.17 |
| Hip-focused | Quantitative Sensory Testing | Left Posterior Superior Iliac Spine--8-weeks | 5.52 kgf/cm squared | Standard Deviation 2.33 |
| Hip-focused | Quantitative Sensory Testing | Right Greater trochanter--6-months | 6.05 kgf/cm squared | Standard Deviation 2.65 |
| Hip-focused | Quantitative Sensory Testing | Left Posterior Superior Iliac Spine--6-months | 5.57 kgf/cm squared | Standard Deviation 2.44 |
| Hip-focused | Quantitative Sensory Testing | Right Posterior Superior Iliac Spine--8-weeks | 5.34 kgf/cm squared | Standard Deviation 2.25 |
| Hip-focused | Quantitative Sensory Testing | Left Greater trochanter--baseline | 5.46 kgf/cm squared | Standard Deviation 2.63 |
| Hip-focused | Quantitative Sensory Testing | Right Anterior tibialis--baseline | 4.79 kgf/cm squared | Standard Deviation 2.47 |
| Hip-focused | Quantitative Sensory Testing | Left Greater trochanter--8-weeks | 6.35 kgf/cm squared | Standard Deviation 2.34 |
| Hip-focused | Quantitative Sensory Testing | Left Greater trochanter--6-months | 6.00 kgf/cm squared | Standard Deviation 2.71 |
| Hip-focused | Quantitative Sensory Testing | Right Upper trapezius--6-months | 4.22 kgf/cm squared | Standard Deviation 1.84 |
| Hip-focused | Quantitative Sensory Testing | Left Anterior tibialis--baseline | 4.77 kgf/cm squared | Standard Deviation 2.55 |
| Hip-focused | Quantitative Sensory Testing | Right Anterior tibialis--8-weeks | 5.32 kgf/cm squared | Standard Deviation 2.39 |
| Hip-focused | Quantitative Sensory Testing | Left Anterior tibialis--8-weeks | 5.31 kgf/cm squared | Standard Deviation 2.43 |
| Hip-focused | Quantitative Sensory Testing | Right Posterior Superior Iliac Spine--6-months | 5.43 kgf/cm squared | Standard Deviation 2.33 |
| Hip-focused | Quantitative Sensory Testing | Left Anterior tibialis--6-months | 5.07 kgf/cm squared | Standard Deviation 2.65 |
| Hip-focused | Quantitative Sensory Testing | Right Anterior tibialis--6-months | 5.12 kgf/cm squared | Standard Deviation 2.58 |
| Spine-focused | Quantitative Sensory Testing | Left Anterior tibialis--6-months | 4.66 kgf/cm squared | Standard Deviation 2.38 |
| Spine-focused | Quantitative Sensory Testing | Right Upper trapezius--baseline | 4.46 kgf/cm squared | Standard Deviation 2.25 |
| Spine-focused | Quantitative Sensory Testing | Right Upper trapezius--8-weeks | 4.50 kgf/cm squared | Standard Deviation 2.14 |
| Spine-focused | Quantitative Sensory Testing | Right Upper trapezius--6-months | 4.45 kgf/cm squared | Standard Deviation 2.15 |
| Spine-focused | Quantitative Sensory Testing | Right Posterior Superior Iliac Spine--baseline | 5.08 kgf/cm squared | Standard Deviation 2.51 |
| Spine-focused | Quantitative Sensory Testing | Right Posterior Superior Iliac Spine--8-weeks | 5.79 kgf/cm squared | Standard Deviation 2.34 |
| Spine-focused | Quantitative Sensory Testing | Right Posterior Superior Iliac Spine--6-months | 5.33 kgf/cm squared | Standard Deviation 2.42 |
| Spine-focused | Quantitative Sensory Testing | Right Greater trochanter--baseline | 5.87 kgf/cm squared | Standard Deviation 2.79 |
| Spine-focused | Quantitative Sensory Testing | Right Greater trochanter--8-weeks | 6.20 kgf/cm squared | Standard Deviation 2.61 |
| Spine-focused | Quantitative Sensory Testing | Right Greater trochanter--6-months | 6.11 kgf/cm squared | Standard Deviation 2.54 |
| Spine-focused | Quantitative Sensory Testing | Right Anterior tibialis--baseline | 4.81 kgf/cm squared | Standard Deviation 2.45 |
| Spine-focused | Quantitative Sensory Testing | Right Anterior tibialis--8-weeks | 5.07 kgf/cm squared | Standard Deviation 2.57 |
| Spine-focused | Quantitative Sensory Testing | Right Anterior tibialis--6-months | 4.85 kgf/cm squared | Standard Deviation 2.4 |
| Spine-focused | Quantitative Sensory Testing | Left Upper trapezius--baseline | 4.40 kgf/cm squared | Standard Deviation 2.44 |
| Spine-focused | Quantitative Sensory Testing | Left Upper trapezius--8-weeks | 4.37 kgf/cm squared | Standard Deviation 2.06 |
| Spine-focused | Quantitative Sensory Testing | Left Upper trapezius--6-months | 4.40 kgf/cm squared | Standard Deviation 2.24 |
| Spine-focused | Quantitative Sensory Testing | Left Posterior Superior Iliac Spine--baseline | 5.03 kgf/cm squared | Standard Deviation 2.5 |
| Spine-focused | Quantitative Sensory Testing | Left Posterior Superior Iliac Spine--8-weeks | 5.59 kgf/cm squared | Standard Deviation 2.39 |
| Spine-focused | Quantitative Sensory Testing | Left Posterior Superior Iliac Spine--6-months | 5.43 kgf/cm squared | Standard Deviation 2.47 |
| Spine-focused | Quantitative Sensory Testing | Left Greater trochanter--baseline | 5.73 kgf/cm squared | Standard Deviation 2.8 |
| Spine-focused | Quantitative Sensory Testing | Left Greater trochanter--6-months | 6.04 kgf/cm squared | Standard Deviation 2.69 |
| Spine-focused | Quantitative Sensory Testing | Left Anterior tibialis--baseline | 4.55 kgf/cm squared | Standard Deviation 2.46 |
| Spine-focused | Quantitative Sensory Testing | Left Anterior tibialis--8-weeks | 4.85 kgf/cm squared | Standard Deviation 2.51 |
| Spine-focused | Quantitative Sensory Testing | Left Greater trochanter--8-weeks | 6.09 kgf/cm squared | Standard Deviation 2.58 |
Secondary
Quebec Back Pain Disability Scale
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.
Time frame: Baseline to the 6-month assessment
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Quebec Back Pain Disability Scale | Baseline | 27.9 score on a scale | Standard Deviation 15.8 |
| Hip-focused | Quebec Back Pain Disability Scale | 6-months (final assessment) | 15.8 score on a scale | Standard Deviation 12.5 |
| Spine-focused | Quebec Back Pain Disability Scale | Baseline | 27.9 score on a scale | Standard Deviation 15.5 |
| Spine-focused | Quebec Back Pain Disability Scale | 6-months (final assessment) | 17.3 score on a scale | Standard Deviation 14.1 |
Secondary
Six-Minute Walk Test (6MWT)
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Six-Minute Walk Test (6MWT) | Baseline | 451.0 Meters | Standard Deviation 116.7 |
| Hip-focused | Six-Minute Walk Test (6MWT) | 8-weeks (post-intervention) | 489.0 Meters | Standard Deviation 100.4 |
| Hip-focused | Six-Minute Walk Test (6MWT) | 6-months (final assessment) | 487.8 Meters | Standard Deviation 100.1 |
| Spine-focused | Six-Minute Walk Test (6MWT) | Baseline | 451.9 Meters | Standard Deviation 101.6 |
| Spine-focused | Six-Minute Walk Test (6MWT) | 8-weeks (post-intervention) | 468.2 Meters | Standard Deviation 108.8 |
| Spine-focused | Six-Minute Walk Test (6MWT) | 6-months (final assessment) | 477.9 Meters | Standard Deviation 105.9 |
Secondary
Timed Up-and-Go (TUG)
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.
Time frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Population: The number analyzed in one or more rows differs from the overall number analyzed because some participants withdrew from the study over time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Hip-focused | Timed Up-and-Go (TUG) | Baseline | 9.73 Seconds | Standard Deviation 2.68 |
| Hip-focused | Timed Up-and-Go (TUG) | 8-weeks (post-intervention) | 8.92 Seconds | Standard Deviation 1.89 |
| Hip-focused | Timed Up-and-Go (TUG) | 6-months (final assessment) | 8.99 Seconds | Standard Deviation 1.93 |
| Spine-focused | Timed Up-and-Go (TUG) | Baseline | 9.46 Seconds | Standard Deviation 2.07 |
| Spine-focused | Timed Up-and-Go (TUG) | 8-weeks (post-intervention) | 9.12 Seconds | Standard Deviation 1.93 |
| Spine-focused | Timed Up-and-Go (TUG) | 6-months (final assessment) | 8.82 Seconds | Standard Deviation 2.03 |