Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome

NCT07660913 | Recruiting

• 1 other identifier: 2963
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change from Baseline in Hand Grip Strength at 6 and 12 Weeks

  Baseline, Post-treatment (Week 6), and Follow-up (Week 12)

• Change from Baseline in Pinch Strength at 6 and 12 Weeks

  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

  Baseline, Post-treatment (Week 6), and Follow-up (Week 12)

Study Arms (2)

Matrix Rhythm Therapy Group

EXPERIMENTAL

This group will receive a conventional physiotherapy treatment combined with active matrix rhythm therapy.

Device: Matrix Rhythm Therapy; Other: Conservative Physiotherapy

Sham Matrix Rhythm Therapy Group

SHAM COMPARATOR

This group will receive a conventional physiotherapy treatment combined with a placebo application using the Hypervolt 2 Pro device.

Device: Sham Matrix Rhythm Therapy; Other: Conservative Physiotherapy

Interventions

Matrix Rhythm Therapy DEVICE

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.

Matrix Rhythm Therapy Group

Sham Matrix Rhythm Therapy DEVICE

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.

Sham Matrix Rhythm Therapy Group

Conservative Physiotherapy OTHER

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.

Matrix Rhythm Therapy Group; Sham Matrix Rhythm Therapy Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Izmir Bakircay University: lead

Study Sites (1)

Izmir Bakircay University

Izmir, 35665, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Central Study Contacts

Ertan Şahinoğlu, PhD

CONTACT

+90 232 493 00 00; ertan.sahinoglu@bakircay.edu.tr

Ayşe Kayalı Vatansever, PhD

CONTACT

+90 232 493 00 00; ayse.vatansever@bakircay.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Eligible participants will be randomly assigned to either the intervention group or the control group in a 1:1 allocation ratio. To eliminate potential confounding effects on the outcome measures, stratified randomization will be implemented based on the affected hand (dominant vs. non-dominant extremity), ensuring an equal distribution of dominant and non-dominant hand involvement between the two groups.

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)