Effectiveness of Radial Extracorporeal Shockwave Therapy Combined With Evidence-Based Physical Therapy for Adhesive Capsulitis Shoulder: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Visual analogue scale
研究概览
简要总结
The goal of this clinical trial is to evaluate the combined effects of radial extracorporeal shockwave therapy (rESWT) and evidence-based physical therapy (EBPT) interventions for patients with adhesive capsulitis. The main questions it aims to answer are:
What is the effectiveness of combining rESWT with EBPT interventions for the management of adhesive capsulitis compared to EBPT alone? How does the combination of rESWT and EBPT affect pain, range of motion, and functional outcomes in patients with adhesive capsulitis?
Researchers will compare rESWT plus EBPT to a sham rESWT plus EBPT to see if rESWT provides better results for subjects with adhesive capsulitis.
The study will randomly assign participants to receive either rESWT plus EBPT or sham rESWT plus EBPT over a 6-week intervention period. The primary outcomes will be pain and disability, while secondary outcomes will include shoulder range of motion, psychological distress, and health-related quality of life. These outcomes will be assessed at baseline, post-intervention, and 12 weeks post-randomization.
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
- Single (Participant)
盲法说明
Single blinded
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
- •Having a relapsed or episode of pain score ≥5 at the assessment with a past history of pain for at least 2 weeks.
- •phase 1 or 2 frozen shoulder confirmed by a physician
- •ROM restriction (>75% ROM loss in ≥2 directions including abduction, flexion and external rotation)
- •no treatment other than analgesics with unresponsive ROM restriction for the past 2 months
- •unwilling or waiting and did not undergo joint injection
- •Diagnosed with shoulder adhesive capsulitis,
- •≥18 years
- •Diabetes mellitus
排除标准
- •bilateral shoulder involvement
- •History of previous surgery on the shoulder
- •Shoulder fracture
- •Glenohumeral or Acromioclavicular arthritis
- •Inflammatory disorders
- •Bleeding disorders
- •Presence of severe osteoporosis
- •Pulmonary diseases
- •Any neuromuscular disorders
- •Pregnancy
- •Implanted pacemaker
结局指标
主要结局
Visual analogue scale
时间窗: baseline, and at 7 and 12 weeks
Visual analogue scale for pain intensity measurement (0 (no pain) - 10 (worst pain))
Disabilities of the Arm, Shoulder, and Hand Quick version (DASH)
时间窗: baseline, and at 7 and 12 weeks
Shoulder disability was measured using the Disabilities of the Arm, Shoulder, and Hand Quick version (DASH) questionnaire (0-100). It's an 11-item questionnaire that measures a patient's ability to perform specific upper extremity tasks, and higher scores on the scale indicate a higher disability. The scale ranges from 0 to 100; where higher score indicates higher disability.
次要结局
- Short Form-12(baseline, and at 7 and 12 weeks)
- Range of Motion (passive and active)(baseline, and at 7 and 12 weeks)
- Depression Anxiety Stress Scales (DASS-12)(baseline, and at 7 and 12 weeks)
研究者
Hosam Alzahrani
Assistant Professor; Department of Physical Therapy
Taif University