Carpal Tunnel Syndrome
Conditions
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.
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.
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.
Sponsors
Izmir Bakircay University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in the Boston Carpal Tunnel Questionnaire - Symptom Severity Scale at 6 and 12 Weeks | 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. |
| Change from Baseline in the Boston Carpal Tunnel Questionnaire - Functional Status Scale at 6 and 12 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Hand Grip Strength at 6 and 12 Weeks | 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). |
| Change from Baseline in Pinch Strength at 6 and 12 Weeks | 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). |
| 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) | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTErtan Şahinoğlu, PhD
CONTACTAyşe Kayalı Vatansever, PhD
Outcome results
None listed