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

Overview

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.

Full Title of Study: “Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH): A Randomized Clinical Trial”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Investigator, Outcomes Assessor)
• Study Primary Completion Date: October 3, 2022

Interventions

• 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.
• 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.

Arms, Groups and Cohorts

• Experimental: Hip-focused
  • Hip-focused rehabilitation intervention
• Active Comparator: Spine-focused
  • Spine-focused rehabilitation intervention

Clinical Trial Outcome Measures

Primary Measures

• Quebec Back Pain Disability Scale
  • Time Frame: 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)
  • Time Frame: 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 Measures

• Quebec Back Pain Disability Scale
  • Time Frame: 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)
  • Time Frame: 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)
  • Time Frame: 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)
  • Time Frame: 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)
  • Time Frame: 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
  • Time Frame: 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)
  • Time Frame: 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)
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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)
  • Time Frame: 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
  • Time Frame: 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
  • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • University of Delaware
• Collaborator
  • University of Pittsburgh
• Provider of Information About this Clinical Study
  • Principal Investigator: Gregory Evan Hicks, Professor, Chair of the Department of Physical Therapy – University of Delaware
• Overall Official(s)
  • Gregory E Hicks, PhD, Principal Investigator, University of Delaware