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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-10-03

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Hip-focused

Hip-focused rehabilitation intervention

Group Type EXPERIMENTAL

Hip-focused rehabilitation intervention

Intervention Type BEHAVIORAL

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.

Spine-focused

Spine-focused rehabilitation intervention

Group Type ACTIVE_COMPARATOR

Spine-focused rehabilitation intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No