Status:
COMPLETED
Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain
Lead Sponsor:
University of Delaware
Collaborating Sponsors:
University of Pittsburgh
Duke University
Conditions:
Chronic Low-back Pain
Hip Impairments
Eligibility:
All Genders
60-85 years
Phase:
NA
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 treatmen...
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-focus...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04009837
Start Date
November 1 2019
End Date
October 3 2022
Last Update
April 11 2024
Active Locations (3)
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1
University of Delaware
Newark, Delaware, United States, 19713
2
Duke University
Durham, North Carolina, United States, 27708
3
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219