Clinical trial NCT04009837: Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain
Official title: Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH): A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Hip Impairments
Hip-spine Syndrome
Osteoarthritis
Keywords: older adult
geriatrics
chronic low back pain
low back pain
hip-spine
rehabilitation
physical therapy
spine
hip pain
Lead sponsor: University of Delaware
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Duke University
name: National Institute on Aging (NIA)
First posted: 2019-07-05
Enrollment: 184
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 \< 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

Primary outcomes:
measure: Quebec Back Pain Disability Scale
timeFrame: Baseline to 8-week assessment (i.e. post-intervention)
measure: 10-Meter Walk Test at Self-Selected Speed (10MWT)
timeFrame: Baseline to 8-week assessment (i.e. post-intervention)
Secondary outcomes:
measure: Quebec Back Pain Disability Scale
timeFrame: Baseline to the 6-month assessment
measure: 10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment)
timeFrame: Baseline to 6-months
measure: 10-Meter Walk Test at Fast Speed (10MWT)
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Timed Up-and-Go (TUG)
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Six-Minute Walk Test (6MWT)
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: 30 Second Chair Stand Test
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Low Back Activity Confidence Scale (LOBACS)
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Hip Disability and Osteoarthritis Outcome Score (HOOS)
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)-29
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Hip Strength
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
measure: Quantitative Sensory Testing
timeFrame: Baseline, 8-weeks (i.e. post-intervention), and 6-months
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Delaware
state: Delaware
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Delaware
name: Gregory E Hicks, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pugliese JM, Coyle PC, Knox PJ, Sions JM, Patterson CG, Pohlig RT, Simon CB, Weiner DK, George SZ, Piva S, Hicks GE. The Manual Therapy and Strengthening for the Hip (MASH) Trial: Protocol for a Multisite Randomized Trial of a Subgroup of Older Adults With Chronic Back and Hip Pain. Phys Ther. 2022 Jan 1;102(1):pzab255. doi: 10.1093/ptj/pzab255.