Manual Therapy and Strengthening for the Hip in Older Adults With Chronic Low Back Pain (MASH): A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 184
- 试验地点
- 6
- 主要终点
- Quebec Back Pain Disability Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Quebec Back Pain Disability Scale
时间窗: 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)
时间窗: 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.
次要结局
- Movement-evoked Pain From the 6MWT and the 30 Second Chair Stand Test(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- 10-Meter Walk Test at Fast Speed (10MWT)(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Timed Up-and-Go (TUG)(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Six-Minute Walk Test (6MWT)(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Patient-Reported Outcomes Measurement Information System (PROMIS)-29(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Hip Strength(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Quantitative Sensory Testing(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- 30 Second Chair Stand Test(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Hip Disability and Osteoarthritis Outcome Score (HOOS)(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Quebec Back Pain Disability Scale(Baseline to the 6-month assessment)
- 10 Meter Walk Test -- Self-Selected Gait Speed at 6 Months (Final Assessment)(Baseline to 6-months)
- Patient Health Questionnaire-9 (PHQ-9)(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Low Back Activity Confidence Scale (LOBACS)(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
- Pain Catastrophizing Scale (PCS)(Baseline, 8-weeks (i.e. post-intervention), and 6-months)
研究者
Gregory Evan Hicks
Professor, Chair of the Department of Physical Therapy
University of Delaware