NCT04009837

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: University of Delaware · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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-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.

Conditions

• Chronic Low-back Pain
• Hip Impairments
• Hip-spine Syndrome
• Osteoarthritis

Interventions

Type	Name	Description
BEHAVIORAL	Hip-focused rehabilitation intervention	The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
BEHAVIORAL	Spine-focused rehabilitation intervention	The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.

Timeline

• Start date: 2019-11-01
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2019-07-05
• Last updated: 2024-04-11
• Results posted: 2024-04-11

Locations

3 sites across 1 country: United States