Effectiveness of Extracorporeal Shock Wave Therapy and Short-Wave Diathermy in alleviating the symptoms of Adhesive Capsulitis: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pain Intensity, Range of Motion, and Functional Disability
研究概览
简要总结
This study is a randomized controlled trial (RCT) comparing the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) and Short-Wave Diathermy (SWD) in treating Adhesive Capsulitis (frozen shoulder). Participants (aged 35–60) will be recruited from UPUMS, Saifai’s Orthopaedics OPD, screened for eligibility, and randomly assigned to Group A (ESWT + SME Technique + Home Exercise) or Group B (SWD + SME Technique + Home Exercise). Each group will have 28 participants (adjusted for a 10% dropout rate).
Inclusion criteria: Diagnosis of Adhesive Capsulitis, shoulder pain/restricted movement (>2 months), willingness to attend follow-ups. Exclusion criteria: Prior shoulder surgery, active infections, fractures, or contraindications (e.g., pregnancy, pacemakers).
Treatment Protocols:
- Group A: Receives ESWT (2000 shocks, 0.06–0.14 mJ/mm², 8Hz) + SME Technique (7-step manual therapy) + Home Exercises (pendulum, wall climbing, pulley exercises).
- Group B: Receives SWD (27.12 MHz, 20 mins/session) + SME Technique + the same Home Exercises. Both groups undergo 3 sessions/week for 2 weeks, with follow-ups at 2 weeks post-treatment.
Outcome Measures:
- Pain: Numeric Pain Rating Scale (NPRS) and algometer (pressure pain threshold).
- Range of Motion (ROM): Digital goniometer.
- Functional Disability: Shoulder Pain and Disability Index (SPADI). Assessments occur at baseline (t0), post-treatment (t1), and 2-week follow-up (t2).
Statistical Analysis: Data analyzed using SPSS to test hypotheses:
- Null (H0): No difference between ESWT and SWD.
- Alternative (H1): Significant difference in pain reduction, ROM, or function.
Novelty: First direct comparison of ESWT+SME vs. SWD+SME, evaluating combined effects on pain, ROM, and function. Ethical approval and informed consent will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- ••Participants diagnosed with Adhesive Capsulitis by an Orthopaedics.
- ••Age 35 to 60 years.
- ••Both male and female.
- ••Willing to participate in the study and attend follow up session.
- ••Painful restricted movement of shoulder, for more than 2 months.
排除标准
- ••Surgical intervention on the affected shoulder.
- ••Active infection or abscess in the affected shoulder.
- ••Untreated shoulder subluxation, dislocation and fracture.
- ••Known Contraindication to ESWT and SWD e.g. Pregnancy, Artificial Pacemaker, Sensitive to heat, Malignancy, Osteoporosis.
结局指标
主要结局
Pain Intensity, Range of Motion, and Functional Disability
时间窗: Base line, After completing the two weeks of treatment and Follow up post two weeks of treatment.
次要结局
未报告次要终点