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Chronic Low-back PainMASHNCT04009837

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

A study testing Hip-focused rehabilitation intervention and Spine-focused rehabilitation intervention in people with Chronic Low-back Pain and Hip Impairments, run by University of Delaware at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 60 to 85 years
What is being tested?
Hip-focused rehabilitation intervention and Spine-focused rehabilitation intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
3 sitesUnited States
Study dates
1 Nov 2019to 3 Oct 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Duke University

    Durham, North Carolina, 27708

  • University of Delaware

    Newark, Delaware, 19713

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15219

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Hip-focused rehabilitation intervention, Spine-focused rehabilitation intervention
Keywords
older adult, geriatrics, chronic low back pain, low back pain, hip-spine, rehabilitation, physical therapy, spine, hip pain
Medical subject headings
Osteoarthritis, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hip-focused rehabilitation interventionBehavioural

    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 interventionBehavioural

    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.

Study groups in NCT04009837
Study groupRoleWhat they receive
Hip-focusedExperimentalHip-focused rehabilitation intervention
Receives: Behavioral: Hip-focused rehabilitation intervention
Spine-focusedActive comparatorSpine-focused rehabilitation intervention
Receives: Behavioral: Spine-focused rehabilitation intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 8-week assessment (i.e. post-intervention)

  2. 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.

    Measured: Baseline to 8-week assessment (i.e. post-intervention)

Secondary outcomes (14)
  1. 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.

    Measured: Baseline to the 6-month assessment

  2. 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.

    Measured: Baseline to 6-months

  3. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  4. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  5. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  6. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  7. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  8. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  9. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  10. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  11. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  12. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  13. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

  14. 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.

    Measured: Baseline, 8-weeks (i.e. post-intervention), and 6-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jul 2019
  2. Study start1 Nov 2019
  3. Primary completion3 Oct 2022
  4. Study completion3 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04009837
Sponsor's protocol ID
1210486
Other IDs
R01AG041202-06
Acronym
MASH
Status last verified
Mar 2024
First submitted
1 Jul 2019
Last updated
11 Apr 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sions JM, George SZ, Pugliese JM, Patterson CG, Piva S, Simon CB, Hicks GE. Adverse Events in the MASH Randomized Controlled Trial With Detailed Reporting of Musculoskeletal and Connective Tissue Disorders Events. Phys Ther. 2025 Nov 3;105(11):pzaf124. doi: 10.1093/ptj/pzaf124.

    PubMed 41081735
  • Hicks GE, George SZ, Pugliese JM, Coyle PC, Sions JM, Piva S, Simon CB, Kakyomya J, Patterson CG. Hip-focused physical therapy versus spine-focused physical therapy for older adults with chronic low back pain at risk for mobility decline (MASH): a multicentre, single-masked, randomised controlled trial. Lancet Rheumatol. 2024 Jan;6(1):e10-e20. doi: 10.1016/S2665-9913(23)00267-9.

    PubMed 38258673
  • 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.

    PubMed 34751784

Questions about this trial

What is this clinical trial studying?

A study testing Hip-focused rehabilitation intervention and Spine-focused rehabilitation intervention in people with Chronic Low-back Pain and Hip Impairments, run by University of Delaware at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quebec Back Pain Disability Scale (time frame: Baseline to 8-week assessment (i.e. post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04009837, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2024.

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