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NCT Number: NCT07660913

Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome

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.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Primary outcomes

  1. Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks

    Time frame: 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.

  2. Change from Baseline in the Boston Carpal Tunnel Questionnaire - Functional Status Scale at 6 and 12 Weeks

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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).

  2. Change from Baseline in Pinch Strength at 6 and 12 Weeks

    Time frame: 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).

  3. Change from Baseline in the EQ-5D-5L Index Score at 6 and 12 Weeks

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ayşe Kayalı Vatansever, PhD

CONTACT

[email protected]

+90 232 493 00 00 ext. 14046

Ertan Şahinoğlu, PhD

CONTACT

[email protected]

+90 232 493 00 00 ext. 14101

Sponsors and collaborators

Lead sponsor

Izmir Bakircay University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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