Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome
2026년 7월 7일 업데이트: 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.
연구 개요
상태
모병
정황
연구 유형
중재적
등록 (추정된)
84
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Ertan Şahinoğlu, PhD
- 전화번호: 14101 +90 232 493 00 00
- 이메일: ertan.sahinoglu@bakircay.edu.tr
연구 연락처 백업
- 이름: Ayşe Kayalı Vatansever, PhD
- 전화번호: 14046 +90 232 493 00 00
- 이메일: ayse.vatansever@bakircay.edu.tr
연구 장소
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Izmir, 터키 (Türkiye), 35665
- 모병
- Izmir Bakircay University
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연락하다:
- Bülent Toğram
- 전화번호: +90 232 493 00 00
- 이메일: sbf@bakircay.edu.tr
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
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건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change from Baseline in Hand Grip Strength at 6 and 12 Weeks
기간: 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
기간: 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
기간: 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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연구 기록 날짜
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연구 주요 날짜
연구 시작 (실제)
2026년 7월 1일
기본 완료 (추정된)
2027년 7월 1일
연구 완료 (추정된)
2027년 9월 1일
연구 등록 날짜
최초 제출
2026년 6월 16일
QC 기준을 충족하는 최초 제출
2026년 6월 16일
처음 게시됨 (실제)
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 7일
마지막으로 확인됨
2026년 7월 1일
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