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.
調査の概要
状態
募集
条件
研究の種類
介入
入学 (推定)
84
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ertan Şahinoğlu, PhD
- 電話番号：14101 +90 232 493 00 00
- メール：ertan.sahinoglu@bakircay.edu.tr
研究連絡先のバックアップ
- 名前：Ayşe Kayalı Vatansever, PhD
- 電話番号：14046 +90 232 493 00 00
- メール：ayse.vatansever@bakircay.edu.tr
研究場所
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-
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Izmir、トルコ（Türkiye）、35665
- 募集
- Izmir Bakircay University
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コンタクト：
- Bülent Toğram
- 電話番号：+90 232 493 00 00
- メール：sbf@bakircay.edu.tr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change from Baseline in Hand Grip Strength at 6 and 12 Weeks
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年9月1日
試験登録日
最初に提出
2026年6月16日
QC基準を満たした最初の提出物
2026年6月16日
最初の投稿 (実際)
2026年6月22日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月8日
QC基準を満たした最後の更新が送信されました
2026年7月7日
最終確認日
2026年7月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。