Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome
2026年7月7日 更新者：Ertan Şahinoğlu, PhD、Izmir Bakircay University
Effectiveness of Matrix Rhythm Therapy on Symptom Severity and Function in Carpal Tunnel Syndrome: A Randomized, Placebo-Controlled, Assessor-Blinded Trial
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.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
84
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ertan Şahinoğlu, PhD
- 电话号码：14101 +90 232 493 00 00
- 邮箱：ertan.sahinoglu@bakircay.edu.tr
研究联系人备份
- 姓名：Ayşe Kayalı Vatansever, PhD
- 电话号码：14046 +90 232 493 00 00
- 邮箱：ayse.vatansever@bakircay.edu.tr
学习地点
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Izmir、土耳其（türkiye）、35665
- 招聘中
- Izmir Bakircay University
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接触：
- Bülent Toğram
- 电话号码：+90 232 493 00 00
- 邮箱：sbf@bakircay.edu.tr
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- 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 24.
- Being literate (able to read and write).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Matrix Rhythm Therapy Group
This group will receive a conventional physiotherapy treatment combined with active matrix rhythm therapy.
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Active matrix rhythm therapy applied for 40 minutes per session (10 min paraspinal muscles, 10 min over the flexor retinaculum, 10 min to extensor muscles, and 10 min to flexor muscles), 2 sessions per week for 6 weeks.
Participants use a night splint holding the wrist in neutral position.
On clinic days, conservative physiotherapy sessions are administered immediately following the active or sham matrix rhythm therapy sessions, 2 days per week for 6 weeks.
These supervised sessions include median nerve sliding exercises (3 sets, 5 reps) and passive stretching for wrist flexors/extensors (15-sec hold, 3 sets, 5 reps).
In addition to clinical sessions, the same exercise protocol is performed at home twice daily and continued independently up to the 12th-week follow-up.
Compliance with both splint wear and home exercises is strictly monitored using participant usage logs and exercise diaries.
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假比较器：Sham Matrix Rhythm Therapy Group
This group will receive a conventional physiotherapy treatment combined with a placebo application using the Hypervolt 2 Pro device.
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Participants use a night splint holding the wrist in neutral position.
On clinic days, conservative physiotherapy sessions are administered immediately following the active or sham matrix rhythm therapy sessions, 2 days per week for 6 weeks.
These supervised sessions include median nerve sliding exercises (3 sets, 5 reps) and passive stretching for wrist flexors/extensors (15-sec hold, 3 sets, 5 reps).
In addition to clinical sessions, the same exercise protocol is performed at home twice daily and continued independently up to the 12th-week follow-up.
Compliance with both splint wear and home exercises is strictly monitored using participant usage logs and exercise diaries.
Placebo application using the Hypervolt 2 Pro device for 40 minutes per session (10 min paraspinal, 10 min flexor retinaculum, 10 min extensors, 10 min flexors), 2 sessions per week for 6 weeks.
It mimics the physical vibration and head shape of the matrix rhythm therapy device to maintain blinding.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks
大体时间：Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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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.
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Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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Change from Baseline in the Boston Carpal Tunnel Questionnaire - Functional Status Scale at 6 and 12 Weeks
大体时间：Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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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.
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Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in Hand Grip Strength at 6 and 12 Weeks
大体时间：Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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Measured using a hand dynamometer.
The participant is seated with the shoulder adducted at 0 degrees, elbow flexed at 90 degrees, and forearm/wrist in neutral position.
The measurement will be repeated three times for the affected hand with 5-second intervals, and the arithmetic mean will be recorded.
Higher values indicate greater grip strength measured in kilograms (kg).
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Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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Change from Baseline in Pinch Strength at 6 and 12 Weeks
大体时间：Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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Assessed using a pinch gauge to measure tip pinch strength.
The participant is seated with the shoulder adducted at 0 degrees, elbow flexed at 90 degrees, and forearm/wrist in neutral position, and asked to squeeze the device with maximum effort using the tips of the thumb and index finger.
The measurement will be repeated three times for the affected hand with 5-second intervals, and the arithmetic mean will be recorded.
Higher values indicate greater pinch strength measured in kilograms (kg).
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Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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Change from Baseline in the EQ-5D-5L Index Score at 6 and 12 Weeks
大体时间：Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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Evaluated using the EuroQol (EQ-5D-5L) scale, which covers 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Each dimension has 5 response levels.
These responses are converted into a single health-state index score using the country-specific value set.
Index scores typically range from less than 0 to 1, where higher scores indicate a better health-related quality of life.
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Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月1日
初级完成 (估计的)
2027年7月1日
研究完成 (估计的)
2027年9月1日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月22日
研究记录更新
最后更新发布 (实际的)
2026年7月8日
上次提交的符合 QC 标准的更新
2026年7月7日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.