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出境医 / 临床实验 / Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH)
Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH)
Study Description
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. One particular subgroup of older adults with chronic LBP are those that also have hip pain and muscle weakness; in addition, many of these individuals have limited and painful movement of the lumbar spine. 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. This randomized clinical trial is designed to explore two different interventions: one that addresses these hip issues (HIP+) and one that focuses more directly on the lumbar spine (SFR). We aim to recruit a sample of 180 older adults who have chronic LBP, as well as 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Low-back Pain Hip Impairments Hip-spine Syndrome Osteoarthritis | Behavioral: Hip-focused rehabilitation intervention Behavioral: Spine-focused rehabilitation intervention | Not Applicable |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 180 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH): A Randomized Clinical Trial |
| Actual Study Start Date : | November 1, 2019 |
| Estimated Primary Completion Date : | March 1, 2022 |
| Estimated Study Completion Date : | March 1, 2022 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
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Experimental: HIP+
Hip-focused rehabilitation intervention
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Behavioral: Hip-focused rehabilitation intervention
The hip-focused intervention (HIP+) includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. HIP+ includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. HIP+ will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 12 weeks.
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Active Comparator: SFR
Spine-focused rehabilitation intervention
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Behavioral: Spine-focused rehabilitation intervention
The spine focused rehabilitation (SFR) intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. SFR includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. SFR will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 12 weeks.
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Outcome Measures
Primary Outcome Measures :
- Quebec Back Pain Disability Scale [ Time Frame: Change from baseline to 8-weeks (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 (10MWT) [ Time Frame: Change from baseline to 8-weeks (i.e. post-intervention) ]A performance test where participants walk along a linear pathway at their 'usual pace' and 'as quickly as possible', for three trials per condition. Average gait speed is determined over the central 6 meters of the course. Faster walking speeds indicate better mobility.
Secondary Outcome Measures :
- Quebec Back Pain Disability Scale [ Time Frame: Change from baseline to 6-months ]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 (10MWT) [ Time Frame: Change from baseline to 6-months ]A performance test where participants walk along a linear pathway at their 'usual pace' and 'as quickly as possible', for three trials per condition. Average gait speed is determined over the central 6 meters of the course. Faster walking speeds indicate better mobility.
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29 [ Time Frame: 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 health-related quality of life.
- Low Back Activity Confidence Scale (LOBACS) [ Time Frame: 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.
- Pain Catastrophizing Scale (PCS) [ Time Frame: 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 indicate greater levels of pain catastrophizing.
- Hip Disability and Osteoarthritis Outcome Score (HOOS) [ Time Frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months ]A 40-item questionnaire that contains five domains (pain, symptoms, activity of daily living, sport and recreation function, and hip-related quality of life). Higher scores indicate lower hip-related disability.
- Hip Disability and Osteoarthritis Outcome Score - Pain (HOOS-Pain) [ Time Frame: Baseline, 8-weeks (i.e. post-intervention), and 6-months ]A 10-item subscale of the HOOS that measures different hip pain frequency and interference related to different activities, including walking, stair climbing, and sitting. Higher scores indicate less hip pain interference.
- Hip Strength [ Time Frame: 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 (e.g. greater trochanter). Because strength is impacted by lever arm length, all strength measures are normalized to landmark distance. Strength measurements are taken for the following hip motions: abduction, adduction, extension, external rotation, internal rotation, and flexion.
- Timed Up-and-Go (TUG) [ Time Frame: 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) [ Time Frame: 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 indicate better mobility and exercise tolerance.
Eligibility Criteria
| Ages Eligible for Study: | 60 Years to 85 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 < 15 (0-20 range, where higher scores indicate less 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
Contacts and Locations
Contacts
| Contact: Gregory E Hicks, PhD | 302-831-2690 | ghicks@udel.edu | |
| Contact: Jaclyn M Sions, PhD | 302-831-7231 | megsions@udel.edu |
Locations
| United States, Delaware | |
| University of Delaware | Recruiting |
| Newark, Delaware, United States, 19713 | |
| Contact: Gregory Hicks, PhD | |
| United States, North Carolina | |
| Duke University | Recruiting |
| Durham, North Carolina, United States, 27708 | |
| Contact: Steven George, PhD | |
| United States, Pennsylvania | |
| University of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15219 | |
| Contact: Sara Piva, PhD | |
Sponsors and Collaborators
University of Delaware
University of Pittsburgh
Duke University
National Institute on Aging (NIA)
Investigators
| Principal Investigator: | Gregory E Hicks, PhD | University of Delaware |
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | July 1, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | January 21, 2020 | ||||||||
| Actual Study Start Date ICMJE | November 1, 2019 | ||||||||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain | ||||||||
| Official Title ICMJE | Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH): A Randomized Clinical Trial | ||||||||
| 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. One particular subgroup of older adults with chronic LBP are those that also have hip pain and muscle weakness; in addition, many of these individuals have limited and painful movement of the lumbar spine. 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. This randomized clinical trial is designed to explore two different interventions: one that addresses these hip issues (HIP+) and one that focuses more directly on the lumbar spine (SFR). We aim to recruit a sample of 180 older adults who have chronic LBP, as well as 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Not Applicable | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
180 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 1, 2022 | ||||||||
| Estimated Primary Completion Date | March 1, 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 60 Years to 85 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04009837 | ||||||||
| Other Study ID Numbers ICMJE | 1210486 R01AG041202-06 ( U.S. NIH Grant/Contract ) |
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| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Responsible Party | Gregory Evan Hicks, University of Delaware | ||||||||
| Study Sponsor ICMJE | University of Delaware | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | University of Delaware | ||||||||
| Verification Date | January 2020 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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