Effectiveness of Matrix Rhythm Therapy on Carpal Tunnel Syndrome

Official title

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

Overview

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

• Device Matrix 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.
• Device Sham 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.
• Other Conservative 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

Primary outcome measures

• 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)]
• 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)]

Secondary outcome measures (3)

• Change from Baseline in Hand Grip Strength at 6 and 12 Weeks [Time frame: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)]
• Change from Baseline in Pinch Strength at 6 and 12 Weeks [Time frame: 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 [Time frame: Baseline, Post-treatment (Week 6), and Follow-up (Week 12)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Izmir Bakircay University — Izmir

Identifiers

NCT: NCT07660913 · 2963

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗