Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome

Официальное название

Effectiveness of Matrix Rhythm Therapy on Symptom Severity and Function in Carpal Tunnel Syndrome: A Randomized, Placebo-Controlled, Assessor-Blinded Trial

Обзор

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.

Вмешательства

• Устройство Matrix Rhythm Therapy
  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.
• Устройство Sham Matrix Rhythm Therapy
  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.
• Другое Conservative Physiotherapy
  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

Первичные конечные точки

• Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks [Срок оценки: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)]
• Change from Baseline in the Boston Carpal Tunnel Questionnaire - Functional Status Scale at 6 and 12 Weeks [Срок оценки: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)]

Вторичные конечные точки (3)

• Change from Baseline in Hand Grip Strength at 6 and 12 Weeks [Срок оценки: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)]
• Change from Baseline in Pinch Strength at 6 and 12 Weeks [Срок оценки: 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 [Срок оценки: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Turkey (Türkiye) · 1 центр

• Izmir Bakircay University — Izmir

Идентификаторы

NCT: NCT07660913 · 2963

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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