Last updated: March 17, 2024
Sponsor: University of Delaware
Overall Status: Completed
Phase
N/A
Condition
Osteoarthritis
Chronic Pain
Treatment
Spine-focused rehabilitation intervention
Hip-focused rehabilitation intervention
Clinical Study ID
NCT04009837
1210486
R01AG041202-06
Ages 60-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 OsteoarthritisOutcome Score (HOOS) Pain items P4-P8, a raw score sum of >5 (0-20 range, where higherscores indicate more pain interference with daily activities).
Exclusion
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, vertebralfractures 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 withLBP, significant unintentional weight loss > 10 pounds, pain that awakes or keeps oneawake 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
Study Design
Total Participants: 184
Treatment Group(s): 2
Primary Treatment: Spine-focused rehabilitation intervention
Phase:
Study Start date:
November 01, 2019
Estimated Completion Date:
October 03, 2022
Study Description
Connect with a study center
University of Delaware
Newark, Delaware 19713
United StatesSite Not Available
Duke University
Durham, North Carolina 27708
United StatesSite Not Available
University of Pittsburgh
Pittsburgh, Pennsylvania 15219
United StatesSite Not Available

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