Efficacy of Focused Shockwave Therapy in Patients With Moderate to Severe Carpal Tunnel Syndrome, a Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ)
研究概览
简要总结
Carpal tunnel syndrome (CTS) is the most common entrapment of upper extremity. Patients with CTS will experience symptoms of pain, numbness of tingling sensation along the median nerve distribution. In more severe case, patients may have difficult manipulating objects that disturb function and patient's quality of life. Extracorporeal Shockwave Therapy (ESWT) is one of physical modalities that uses to treat many musculoskeletal disorders. For CTS, previous evidence showed that ESWT can improve symptoms, function as well as electrophysiologic parameters. However, standardized guidelines as well as the study in patients with moderate to severe CTS has not been established. Thus, the objective of the present study was to evaluate efficacy of ESWT in term of symptoms, function, electrophysiologic parameters, as well as sonography of median nerve in patients with moderate to severe CTS.
详细描述
- The present study was a single-blinded randomized controlled trial comparing the efficacy of focused ESWT (F-ESWT) to conservative treatment in patients with CTS.
- 24 patients who was diagnosed as CTS based on symptoms of CTS and physical examination. They were randomly allocated into two groups (21 patients per group), mainly F-ESWT plus conservative treatment and conservative treatment only.
- Outcome measures were BCTQ including symptom and function subscales, electrophysiologic parameters, and sonography to evaluate cross-sectional area (CSA) of the median nerve. All measures were recorded at baseline, 3 weeks and 6 weeks of treatment.
- Statistical analysis was performed to determine changes within the same group and compare difference between the two groups.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participants who were diagnosed as CTS based on the American Academy of neurology
- •Participants who have electrodiagnostic evidence of CTS according to American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) guidelines for diagnosis of CTS. The severity of median nerve compression at wrist was moderate to severe degree.
- •Patients who were not treated by NSAIDs within 2 weeks prior to participating in the study.
排除标准
- •The below exclusion criteria were applied only on the affected hand that were enrolled to the study
- •History of previous carpal tunnel release.
- •Receiving steroid injections for the treatment of CTS
- •History of infection or severe inflammation on the wrist
- •Contraindications for focused ESWT, such as arrhythmias, pacemakers, bleeding disorders, pregnancy, severe osteoporosis, and cancer.
- •Participants who refused or requested withdrawal from the study.
结局指标
主要结局
Thai version of Boston Carpal Tunnel Questionnaire (T-BCTQ)
时间窗: BCTQs and BCTQf were assessed changes from baseline to at 6 weeks of treatment.
T-BCTQ was used to assess symptom severity and hand function in patients with CTS. This questionnaire consists of two parts, mainly BCTQ symptom severity (BCTQs) and BCTQ functional status (BCTQf). Total questions for each part were 11 and 8 questions, respectively with scores raging from 1-5.
次要结局
- Electrodiagnostic parameters: Distal Sensory Latency (DSL)(Changes of DSL was assessed from baseline to at 6 weeks of treatment.)
- Electrodiagnostic parameters: Sensory Nerve Action Potential (SNAP) amplitude(SNAP amplitude was assessed from baseline to at 6 weeks of treatment.)
- Electrodiagnostic parameters: Distal Motor Latency (DML)(Changes of DSL was assessed from baseline to at 6 weeks of treatment.)
- Electrodiagnostic parameters: Compound Muscle Action Potential (CMAP) amplitude(Changes of CMAP amplitude was assessed from baseline to at 6 weeks of treatment.)
- Electrodiagnostic parameters: Total area under curve (TAUC)(Changes of TAUC was assessed from baseline to at 6 weeks of treatment.)