Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain

Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH): A Randomized Clinical Trial

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.

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-focused). We aim to recruit a sample of 180 older adults who have chronic LBP and 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.

The goal of this clinical trial is to learn more about how older adults with low back and hip pain respond to physical therapy intervention.

Participants will have three standardized assessments by licensed physical therapists, at baseline, 8 weeks, and 6 months. Once randomized, participants will attend on-site sessions 2x per week for 8 weeks and complete a home exercise log. People in the hip-focused group will receive mobilizations and stretching, and will participate in hip exercises and trunk muscle exercise. People in the spine-focused group will receive massage and gentle mobilizations to the lumbar spine and participate in stationary cycling and trunk muscle training.

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 study for the full six months for any known reason
• Received physical therapy for low back or hip within the last 3 months