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

CompletedNot applicableNCT04009837
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH): A Randomized Clinical Trial
Conditions
Interventions
  • Behavioral: Hip-focused rehabilitation intervention
  • Behavioral: Spine-focused rehabilitation intervention
Sponsor
University of Delaware
Collaborators
University of Pittsburgh; Duke University; National Institute on Aging (NIA)
Start date
2019-11-01
Primary completion
2022-10-03
Sex
All
Age range
from 60 Years to 85 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
3

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04009837