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Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome

7 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

84

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Turquía (Türkiye)
      • Izmir, Turquía (Türkiye), 35665
        • Reclutamiento
        • Izmir Bakircay University
        • Contacto:
          • Bülent Toğram
          • Número de teléfono: +90 232 493 00 00
          • Correo electrónico: sbf@bakircay.edu.tr

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Matrix Rhythm Therapy Group
This group will receive a conventional physiotherapy treatment combined with active matrix rhythm therapy.
Dispositivo: 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.
Otro: 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 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.
Comparador falso: Sham Matrix Rhythm Therapy Group
This group will receive a conventional physiotherapy treatment combined with a placebo application using the Hypervolt 2 Pro device.
Otro: 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 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.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks
Periodo de tiempo: 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.
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
Periodo de tiempo: 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.
Baseline, Post-treatment (Week 6), and Follow-up (Week 12)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from Baseline in Hand Grip Strength at 6 and 12 Weeks
Periodo de tiempo: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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).
Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
Change from Baseline in Pinch Strength at 6 and 12 Weeks
Periodo de tiempo: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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).
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
Periodo de tiempo: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)
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.
Baseline, Post-treatment (Week 6), and Follow-up (Week 12)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Izmir Bakircay University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de julio de 2026

Finalización primaria (Estimado)

1 de julio de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2963

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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