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

Not Applicable

Completed

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

Interventions: Behavioral: Spine-focused rehabilitation intervention
Behavioral: Hip-focused rehabilitation intervention

Registration Number: NCT04009837

Lead Sponsor: University of Delaware

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 184

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spine-focused	Spine-focused rehabilitation intervention	Spine-focused rehabilitation intervention
Hip-focused	Hip-focused rehabilitation intervention	Hip-focused rehabilitation intervention

Primary Outcome Measures

Name	Time	Method
Quebec Back Pain Disability Scale	Baseline to 8-week assessment (i.e. post-intervention)	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.
10-Meter Walk Test at Self-Selected Speed (10MWT)	Baseline to 8-week assessment (i.e. post-intervention)	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.

Secondary Outcome Measures

Name	Time	Method
Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
10-Meter Walk Test at Fast Speed (10MWT)	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Timed Up-and-Go (TUG)	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Six-Minute Walk Test (6MWT)	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Patient-Reported Outcomes Measurement Information System (PROMIS)-29	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Hip Strength	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Quantitative Sensory Testing	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
30 Second Chair Stand Test	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Hip Disability and Osteoarthritis Outcome Score (HOOS)	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Quebec Back Pain Disability Scale	Baseline to the 6-month assessment	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.
10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment)	Baseline to 6-months	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.
Patient Health Questionnaire-9 (PHQ-9)	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Low Back Activity Confidence Scale (LOBACS)	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.
Pain Catastrophizing Scale (PCS)	Baseline, 8-weeks (i.e. post-intervention), and 6-months	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.

Trial Locations

Locations (3): Duke University
🇺🇸
Durham, North Carolina, United States
University of Delaware
🇺🇸
Newark, Delaware, United States
University of Pittsburgh
🇺🇸
Pittsburgh, Pennsylvania, United States