The Effectiveness of Traditional Physical Therapy Versus Home Exercise in Conjunction With Glenohumeral and Subacromial Corticosteroid Injection for the Treatment of Shoulder Adhesive Capsulitis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in Shoulder Pain and Disability Index(SPADI)
研究概览
简要总结
This study aims to evaluate physical therapy (standard of care) and home exercise vs. home exercise alone for the treatment of adhesive capsulitis.
详细描述
Patients with adhesive capsulitis receive a glenohumeral and subacromial injection routinely for treatment. In addition, the patients are routinely prescribed physical therapy with a home exercise component. The purpose of this study is to evaluate whether home exercise alone is an alternative option to physical therapy. Patients will be approached about the study after they have agreed to receive a glenohumeral and subacromial injection per standard of care for their clinical treatment. The hypothesis being tested is whether home exercise is alone is as beneficial for pain relief, restoration of range of motion, and improvement in shoulder disability from adhesive capsulitis as physical therapy. Additionally sex differences, diabetes mellitus, endocrine, and mental health histories will be noted.
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
- 是
入选标准
- •Clinical Diagnosis of Adhesive Capsulitis (limited range of motion)
- •Given glenohumeral and subacromial injection as part of standard care.
- •Capacity to conduct home exercise program or physical therapy (based upon physician judgment, proximity to physical therapy office and as decided by patient)
- •English speaking
- •18 years of age or greater
排除标准
- •Prior glenohumeral or subacromial corticosteroid injection within 6 months
- •Prior ipsilateral shoulder surgery
- •Current prescription (narcotic) pain medication use
- •Pain disorder (ex. Fibromyalgia, Reflex Sympathetic Dystrophy)
- •Cervical radiculopathy
- •Full-thickness rotator cuff tear
- •Calcific Tendinopathy (past or present)
- •Advanced Stage osteoarthritis as seen on radiograph
- •Past/present ipsilateral shoulder fracture
- •Women that may be pregnant or nursing (self report)
- •Past/present physical therapy treatment will be documented, but will not be considered an exclusion factor. The reasoning behind this is that the physical therapy likely was not properly targeting the adhesive capsulitis for the patient to arrive in an orthopaedic clinic and is likely at a similar starting point to most other patients regardless of previous physical therapy. All patients currently enrolled in physical therapy will be assigned to either our physical therapy or home exercise program.
结局指标
主要结局
Change in Shoulder Pain and Disability Index(SPADI)
时间窗: 6 months compared to baseline score
shoulder pain and disability index to evaluate shoulder pain and function
次要结局
- Change in Sane Normal and Pain Visual Analogue Score (SANE)(6 months compared to baseline score)
- Change in Range of Motion (ROM)(6 months compared to baseline score)
- Change in Mental Health Index- 5 (MHI-5)(6 months compared to baseline score)
- Change in Short Form- 36 (SF-36)(6 months compared to baseline score)
- Change in Visual Analog Scale Pain (VAS-Pain)(6 months compared to baseline score)