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

Sponsor

University of Delaware (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04009837

Collaborator

University of Pittsburgh (Other), Duke University (Other), National Institute on Aging (NIA) (NIH)

180

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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. One particular subgroup of older adults with chronic LBP are those that also have hip pain and muscle weakness; in addition, many of these individuals have limited and painful movement of the lumbar spine. 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. 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, as well as 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Low-back Pain Hip Impairments Hip-spine Syndrome Osteoarthritis	Behavioral: Hip-focused rehabilitation intervention Behavioral: Spine-focused rehabilitation intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Nov 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hip-focused Hip-focused rehabilitation 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.
Active Comparator: Spine-focused Spine-focused rehabilitation intervention	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.

Arm

Intervention/Treatment

Experimental: Hip-focused

Hip-focused rehabilitation 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.

Active Comparator: Spine-focused

Spine-focused rehabilitation intervention

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.

Outcome Measures

Primary Outcome Measures

Quebec Back Pain Disability Scale [Change from baseline to 8-weeks (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) [Change from baseline to 8-weeks (i.e. post-intervention)]
A performance test where participants walk along a linear pathway at their 'usual pace' for three trials. Average self-selected gait speed is determined over the central 6 meters of the course. Faster walking speeds indicate better mobility.

Secondary Outcome Measures

Quebec Back Pain Disability Scale [Change from baseline to 6-months]
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 Fast Speed (10MWT) [Change from baseline to 6-months]
A performance test where participants walk along a linear pathway 'as quickly as possible', for three trials. Average fast gait speed is determined over the central 6 meters of the course. 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
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.
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 indicate greater levels of pain catastrophizing.
Quantitative Sensory Testing [Baseline, 8-weeks (i.e. post-intervention), and 6-months]
A test where the assessor uses an algometer 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
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.
Movement-evoked Pain from the 6MWT [Baseline, 8-weeks (i.e. post-intervention), and 6-months]
Participant self-reports pain intensity using the Numeric Rating of Pain Scale (0=no pain; 10=worst pain imaginable) before, during (1 minute, 2 minutes, 3 minutes, 4, minutes, and 5 minutes into the test), and after (at 6 minutes) the 6MWT. The change in pain intensity (0-10 points) from beginning to end of the performance test is calculated.
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.
Movement-evoked Pain from the 30 Second Chair Stand Test [Baseline, 8-weeks (i.e. post-intervention), and 6-months]
Participant self-reports pain intensity using the Numeric Rating of Pain Scale (0=no pain; 10=worst pain imaginable) before, during (10 seconds and 20 seconds into the test), and after (at 30 seconds) the 30 Second Chair Stand Test. The change in pain intensity (0-10) from beginning to end of the performance test is calculated.
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 (pain, symptoms, activity of daily living, sport and recreation function, and hip-related quality of life). Higher scores indicate lower hip-related disability.
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.
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 are taken for the following hip motions: abduction, extension, external rotation, internal rotation, and flexion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Delaware	Newark	Delaware	United States	19713
2	Duke University	Durham	North Carolina	United States	27708
3	University of Pittsburgh	Pittsburgh	Pennsylvania	United States	15219