Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome

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• Carpal Tunnel Syndrome 589

Carpal Tunnel Syndrome

589 studies on the registry are indexed under Carpal Tunnel Syndrome; 139 are open to participants now.

This study's planned enrollment of 84 is above the median of 60 across 445 interventional studies indexed under Carpal Tunnel Syndrome.

Lead sponsor

Izmir Bakircay University is the lead sponsor of 73 studies on the registry; 17 are open to participants now.

Study arms

• Experimental
  Matrix Rhythm Therapy Group

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

  Device: Matrix Rhythm Therapy · Other: Conservative Physiotherapy

• 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.

  Device: Sham Matrix Rhythm Therapy · Other: Conservative Physiotherapy

Interventions

• DeviceMatrix 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.

• DeviceSham 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.

• OtherConservative 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.

Primary outcomes

1. 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.

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

2. 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.

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

Secondary outcomes

1. 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).

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

2. 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).

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

3. 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.

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

Individual participant data

Plan to share: No