Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Matrix Rhythm Therapy; Other: Conservative Physiotherapy; Device: Sham Matrix Rhythm Therapy

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ertan Şahinoğlu, PhD; Phone Number: 14101 +90 232 493 00 00; Email: ertan.sahinoglu@bakircay.edu.tr
• Study Contact Backup: Name: Ayşe Kayalı Vatansever, PhD; Phone Number: 14046 +90 232 493 00 00; Email: ayse.vatansever@bakircay.edu.tr

Study Locations

• Turkey (Türkiye)
  • Izmir, Turkey (Türkiye), 35665
    • Izmir Bakircay University
    • Contact: Bülent Toğram; Phone Number: +90 232 493 00 00; Email: sbf@bakircay.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Matrix Rhythm Therapy Group; This group will receive a conventional physiotherapy treatment combined with active matrix rhythm therapy.	Device: 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.; Other: 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.
Sham Comparator: Sham Matrix Rhythm Therapy Group; This group will receive a conventional physiotherapy treatment combined with a placebo application using the Hypervolt 2 Pro device.	Other: 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.; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks	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	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Hand Grip Strength at 6 and 12 Weeks	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	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	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)

Collaborators and Investigators

• Sponsor: Izmir Bakircay University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Median Neuropathy; Mononeuropathies; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID Numbers: 2963

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No