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

Osteoarthritis Clinical Trial

— MASH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04009837
• Other study ID #: 1210486
• Secondary ID: R01AG041202-06
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: October 3, 2022

Study information

• Verified date: March 2024
• Source: University of Delaware
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 184
• Est. completion date: October 3, 2022
• Est. primary completion date: October 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	University of Delaware	Newark	Delaware
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
University of Delaware	Duke University, National Institute on Aging (NIA), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quebec Back Pain Disability Scale	A 20-item questionnaire that assesses limitations in daily activities due to back pain. Scores can range from 0-100% with higher scores indicating greater back pain-related disability.	Baseline to 8-week assessment (i.e. post-intervention)
Primary	10-Meter Walk Test at Self-Selected Speed (10MWT)	A performance test where participants walk along a 10-meter linear pathway at their 'usual pace' for three trials. Average self-selected gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.	Baseline to 8-week assessment (i.e. post-intervention)
Secondary	Quebec Back Pain Disability Scale	A 20-item questionnaire that assesses limitations in daily activities due to back pain. Scores can range from 0-100% with higher scores indicating greater back pain-related disability.	Baseline to the 6-month assessment
Secondary	10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment)	A performance test where participants walk along a 10-meter linear pathway at their 'usual pace' for three trials. Average self-selected gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.	Baseline to 6-months
Secondary	10-Meter Walk Test at Fast Speed (10MWT)	A performance test where participants walk along a 10-meter linear pathway 'as quickly as possible', for three trials. Average fast gait speed is determined over the central 6 meters of the course in meters/second. Faster walking speeds indicate better mobility.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Timed Up-and-Go (TUG)	A performance test where participants rise from a chair, walk 3 meters at their regular pace, and return to a seated position in the same chair. One practice trial is performed followed by three timed trials; performance times are averaged. Greater times indicate worse physical function.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Six-Minute Walk Test (6MWT)	A performance test where participants are asked to walk as far as they can in six minutes around a continuous track. Greater distances (in meters) indicate better mobility and exercise tolerance.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	30 Second Chair Stand Test	A performance test where participants perform as many sit-to-stands as possible in 30 seconds while their arms are folded across their chest. The number of stands are counted. Higher numbers correlate with better scores.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test	Post-test pain intensities, i.e., 0-10, for both the Six-Minute Walk Test and the 30 Second Chair Stand Test were used in the calculation of aggregate movement-evoked pain. Scores for this measure were the sum of both post-test pain intensities, resulting in a score range of 0-20, where higher numbers indicate worse pain.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Patient Health Questionnaire-9 (PHQ-9)	A 9-item questionnaire that assesses the presence/absence of depressive symptoms. Scores above 5 indicate likeliness of depressive symptoms. Scores range from 0-27.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Low Back Activity Confidence Scale (LOBACS)	A 15-item questionnaire that measures a person's confidence in their ability to perform different activities, including carrying, pushing, sitting, walking, and exercising, which may be directly affected by low back pain. There is an overall score, as well as three Self-Efficacy Subscales: Functional, Self-Regulatory, and Exercise. Overall, as well as subscales, range from 0-100%, where higher numbers indicate higher confidence.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Hip Disability and Osteoarthritis Outcome Score (HOOS)	A 40-item questionnaire that contains five domains (symptoms, pain, activity of daily living (ADL), sport and recreation, and quality of life). Each scale ranges from 0-100, where higher scores are better, indicating lower hip-related disability.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Patient-Reported Outcomes Measurement Information System (PROMIS)-29	A 29-item short form questionnaire developed by the National Institutes of Health that assesses the following domains of health-related quality of life: physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity. Higher scores indicate better greater presence of each outcome. Possible T-scores for each domain as follows, where a T-score of 50 equals the mean of the United States population and every 10 points above or below the mean is 1 standard deviation away (e.g., a 60 is 1 standard deviation above the mean): Physical Function: 22.5-57.0; Anxiety: 40.3-81.6; Depression: 41.0-79.4; Fatigue: 33.7-75.8; Sleep Disturbance: 32.0-73.3; Social Roles: 27.5-64.2; Pain Interference: 41.6-75.6.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Pain Catastrophizing Scale (PCS)	A 13-item questionnaire that that assesses how a person perceives pain. Items can be scored as three subscales to evaluate constructs of rumination, magnification, and helplessness. Higher scores (scale of 0-52) indicate greater levels of pain catastrophizing.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Hip Strength	A series of strength testing measurements will be conducted using a hand-held dynamometer. All participant and examiner body positions are standardized using study protocols, and measurement locations are standardized using anatomical landmarks. Strength measurements (in kilograms) are taken for the following hip motions: abduction, extension, external rotation, internal rotation, and flexion. Measurements from the weaker side were normalized to, i.e., divided by, body weight (in kilograms), therefore, there is no unit for the measure.	Baseline, 8-weeks (i.e. post-intervention), and 6-months
Secondary	Quantitative Sensory Testing	A test where the assessor uses an algometer (i.e., handheld device that calculates the amount of force applied to the skin) to measure pressure pain sensitivity at 4 sites: upper trapezius, posterior superior iliac spine, greater trochanter, and tibialis anterior; higher values indicate higher pain thresholds, with values ranging from 0 to 10.1, where 10.1 indicates the participant tolerated 10 kilograms of force/cm squared without pain and therefore, no further pressure was applied. Pressure starts at 0.00 kilograms-of-force per square centimeter and is increased by 1-kgf/cm squared per second until the participant first experiences pain.	Baseline, 8-weeks (i.e. post-intervention), and 6-months