Effectiveness of Matrix Rhythm Therapy on Symptom Severity and Function in Carpal Tunnel Syndrome: A Randomized, Placebo-Controlled, Assessor-Blinded Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks
研究概览
简要总结
The purpose of this study is to investigate the effects of matrix rhythm therapy, applied in addition to conventional treatment, on symptom severity, function, grip and pinch strength, and quality of life in patients with carpal tunnel syndrome.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a diagnosis of unilateral carpal tunnel syndrome confirmed by an orthopedist based on clinical examination and electromyography (EMG) testing.
- •Being classified with mild-to-moderate carpal tunnel syndrome severity.
- •Having symptoms persisting for at least 12 weeks.
- •Having a Mini-Mental State Examination (MMSE) score greater than
- •Being literate (able to read and write).
排除标准
- •History of prior carpal tunnel release surgery.
- •History of corticosteroid injection into the affected hand/wrist.
- •Having received physiotherapy for carpal tunnel syndrome within the last 6 months.
- •Presence of any neurological signs or symptoms in the upper extremity other than carpal tunnel syndrome.
- •History of prior surgery in the hand or wrist region due to other conditions.
- •Diagnosis of any systemic neurological disease.
- •Diagnosis of rheumatic diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus).
- •Having ongoing pain in the arm or hand due to any other underlying cause.
研究组 & 干预措施
Matrix Rhythm Therapy Group
This group will receive a conventional physiotherapy treatment combined with active matrix rhythm therapy.
干预措施: Matrix Rhythm Therapy (Device)
Sham Matrix Rhythm Therapy Group
This group will receive a conventional physiotherapy treatment combined with a placebo application using the Hypervolt 2 Pro device.
干预措施: Conservative Physiotherapy (Other)
Matrix Rhythm Therapy Group
This group will receive a conventional physiotherapy treatment combined with active matrix rhythm therapy.
干预措施: Conservative Physiotherapy (Other)
Sham Matrix Rhythm Therapy Group
This group will receive a conventional physiotherapy treatment combined with a placebo application using the Hypervolt 2 Pro device.
干预措施: Sham Matrix Rhythm Therapy (Device)
结局指标
主要结局
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks
时间窗: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
This scale evaluates the severity of symptoms including pain, numbness, and paresthesia over the past two weeks. It consists of 11 items, each scored on a Likert scale from 1 (no symptoms) to 5 (most severe symptoms). The total score is calculated by dividing the sum of individual item scores by 11. Final scores range from 1 to 5, where higher scores indicate greater symptom severity.
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Functional Status Scale at 6 and 12 Weeks
时间窗: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
This scale assesses hand-related functional limitations during daily activities. It consists of 8 items, each scored on a Likert scale from 1 (no difficulty) to 5 (cannot perform activity at all). The total score is calculated by dividing the sum of individual item scores by 8. Final scores range from 1 to 5, where higher scores indicate greater functional impairment.
次要结局
- Change from Baseline in Hand Grip Strength at 6 and 12 Weeks(Baseline, Post-treatment (Week 6), and Follow-up (Week 12))
- Change from Baseline in Pinch Strength at 6 and 12 Weeks(Baseline, Post-treatment (Week 6), and Follow-up (Week 12))
- Change from Baseline in the EQ-5D-5L Index Score at 6 and 12 Weeks(Baseline, Post-treatment (Week 6), and Follow-up (Week 12))
研究者
Ertan Şahinoğlu, PhD
Assistant Professor
Izmir Bakircay University