A Prospective Randomized Trial Comparing Physical Therapy or Home Exercise With No Treatment for Patients With Glenohumeral Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Visual analog scale (VAS)
研究概览
简要总结
Arthritis of the shoulder glenohumeral joint is a growing problem in an aging population. Treatment options for glenohumeral arthritis can be grouped into three main categories: 1) shoulder replacement surgery, 2) injections (corticosteroid, hyaluronic acid and PRP) and physical therapy (PT). Surgery comes with risks and the potential for implant failure or revision over time. Therefore, it is typical for doctors to prescribe injections and/or PT before discussing surgery. Sometimes, insurance companies will require PT before considering a shoulder operation. It is unknown if PT is effective for improving function or pain with patients with glenohumeral arthritis. The aim of this study is to compare pain and functional outcomes after undergoing a 12 week PT program, at home PT exercises or delaying conservative treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with glenohumeral arthritis
- •Patient > 18 years of age (adults)
- •Patient provided written informed consent for study participation with IRB approved consent form
- •Patient is willing and able to comply with scheduled clinical and radiographic evaluations and physical therapy regimen
排除标准
- •-Have had corticosteroid injections in the affected shoulder(s) within 6 weeks of starting physical therapy.
- •Those that have glenohumeral arthritis that is inflammatory, post traumatic or related to rotator cuff tear arthropathy in nature
- •Have avascular necrosis of the glenohumeral joint
- •Have failed a course of 6 weeks of physical therapy within the last year
- •Have had surgery on the symptomatic shoulder in the past year
- •Daily use of opioid (excluding tramadol or codeine).
- •Have dementia
- •Currently in a physical therapy program for more than 2 weeks
- •Have planned total shoulder arthroplasty in the next 6 months.
- •Live in a nursing home
- •Additionally special populations listed below such as pregnant women, and prisoners will be excluded.
结局指标
主要结局
Visual analog scale (VAS)
时间窗: Time 0, 6 weeks, 12 weeks, 1 year
measures pain from 0 being none and 10 as the worst pain ever felt.
American Shoulder and Elbow Surgeons (ASES)
时间窗: Time 0, 6 weeks, 12 weeks, 1 year
This score is a 100-point shoulder evaluation tool divided evenly into a pain subscore (50 points) and an activities of daily living (ADL) function subscore (50 points). Higher scores indicate less pain and better shoulder function.
次要结局
未报告次要终点
研究者
Matthew DiPaola, MD
Clinical Associate Professor Orthopedics and Sports Medicine
State University of New York at Buffalo