Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (NCT04009837) | Clinical Trial Compass
CompletedNot Applicable
Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain
United States184 participantsStarted 2019-11-01
Plain-language 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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 stu…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Quebec Back Pain Disability Scale
Timeframe: Baseline to 8-week assessment (i.e. post-intervention)
2
10-Meter Walk Test at Self-Selected Speed (10MWT)
Timeframe: Baseline to 8-week assessment (i.e. post-intervention)