N/A
N=184
Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain
Chronic Low-back Pain · Hip Impairments · Hip-spine Syndrome · Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT04009837 ↗Enrolled (actual)
184
Serious AEs
7.1%
Results posted
Apr 2024
Primary outcome: Primary: Quebec Back Pain Disability Scale — 27.9; 27.9; 16.7; 20.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hip-focused rehabilitation intervention (Behavioral); Spine-focused rehabilitation intervention (Behavioral)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- University of Delaware
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quebec Back Pain Disability Scale |
27.9; 27.9; 15.8; 17.3 | — |
| PRIMARY 10-Meter Walk Test at Self-Selected Speed (10MWT) |
1.12; 1.12; 1.2; 1.21 | — |
| SECONDARY Quebec Back Pain Disability Scale |
27.9; 27.9; 15.8; 17.3 | — |
| SECONDARY 10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment) |
1.12; 1.12; 1.21; 1.24 | — |
| SECONDARY 10-Meter Walk Test at Fast Speed (10MWT) |
1.57; 1.59; 1.65; 1.67; 1.63; 1.66 | — |
| SECONDARY Timed Up-and-Go (TUG) |
9.73; 9.46; 8.92; 9.12; 8.99; 8.82 | — |
| SECONDARY Six-Minute Walk Test (6MWT) |
451.0; 451.9; 489.0; 468.2; 487.8; 477.9 | — |
| SECONDARY 30 Second Chair Stand Test |
10; 10; 11; 11; 12; 11 | — |
| SECONDARY Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test |
6.4; 6.7; 3.6; 5.2; 3.8; 4.1 | — |
| SECONDARY Patient Health Questionnaire-9 (PHQ-9) |
3.3; 2.9; 2.5; 2.6; 2.4; 2.5 | — |
| SECONDARY Low Back Activity Confidence Scale (LOBACS) |
70.1; 68.9; 78.4; 74.3; 76.2; 73.0 | — |
| SECONDARY Hip Disability and Osteoarthritis Outcome Score (HOOS) |
67.8; 68.6; 80.6; 77.4; 80.4; 81.6 | — |
| SECONDARY Patient-Reported Outcomes Measurement Information System (PROMIS)-29 |
41.8; 42.1; 46.2; 44.5; 46.5; 45.3 | — |
| SECONDARY Pain Catastrophizing Scale (PCS) |
11.8; 9.5; 7.1; 6.6; 5.5; 5.9 | — |
| SECONDARY Hip Strength |
0.071; 0.069; 0.077; 0.069; 0.078; 0.074 | — |
| SECONDARY Quantitative Sensory Testing |
4.27; 4.46; 4.59; 4.50; 4.22; 4.45 | — |
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.
Eligibility 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 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 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
Data sourced from ClinicalTrials.gov (NCT04009837). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.