Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome
ConditionCarpal Tunnel Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorIzmir Bakircay University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Matrix Rhythm Therapy
DeviceActive 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
DevicePlacebo 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 interventionParticipants 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Matrix Rhythm Therapy GroupExperimental treatment 2 interventions
Group B: Sham Matrix Rhythm Therapy GroupSham comparator 2 interventions
Trial outcomes
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)Sponsors and contacts
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Source ClinicalTrials.gov