Effectiveness of fESWT in the Treatment of CTS

Study Overview
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Brief Summary
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The carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the general population.The focus extracorporeal shock wave (fEWST) is a non invasive treatment for various diseases. FESWT is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . But there is still little known about the effects and long term effects of fESWT in the treatment of CTS.

Detailed Description
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The aim of this study is to determine the effectiveness of fESWT in patients with carpal tunnel syndrome compared to participants receiving only night splint. Therefore 40 patients with mild to moderate CTS (verified by nerve conduction velocity) will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints. Evaluation will be performed at baseline (VAS, hand grip, electrodiagnostic parameters, questionnaires), 3 weeks (VAS, hand grip, questionnaires), 12 and 24 weeks (VAS, hand grip, electrodiagnostic parameters, questionnaires) after treatment.

Official Title
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The Effectiveness of Focused Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome: A Pilot Study

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Other: focused extracorporeal shock wave therapy
* Other: sham focused extracorporeal shock wave therapy
* Other: night splint


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - mild to moderate CTS verified by nerve conduction velocity Exclusion Criteria: metabolic diseases blood clotting problems systemic diseases polyneuropathy chemotherapy during the study corticosteroid therapy use of anticoagulation history of trauma/surgery or nerve lesion of the teated extremity CTS surgery on the affected hand ICD/ pacemaker implantation other therapy for the affected hand during the study acute inflammation or infections severe mental illnesses/psychiatric diseases severe neurological diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator<br>fESWT | Other: focused extracorporeal shock wave therapy<br>* 40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.<br>Other: night splint<br>* 40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.<br>|
| Sham Comparator: Sham Comparator<br>Sham fESWT | Other: sham focused extracorporeal shock wave therapy<br>* 40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.<br>Other: night splint<br>* 40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS | Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment. | baseline, 3th,12th and 24th weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand grip strength | hand grip strength: | baseline, 3th,12th and 24th weeks after treatment | 
| distal motor latency of the median nerve | electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve. Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment. | baseline,12th and 24th weeks after treatment | 
| sensory conduction velocity of the median nerve | electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve. Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment. | baseline, 12th and 24th weeks after treatment | 
| SF-36 | 36-item Short Form Health Survey: Change from baseline in quality of life 3th,12th and 24th weeks after treatment. | baseline, 3th,12th and 24th weeks after treatment | 
| Boston Scale | Boston Symptom Severity Score: Change from baseline in severity of symptoms and functional status 3th,12th and 24th weeks after treatment. | baseline, 3th,12th and 24th weeks after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focused extracorporeal shock wave therapy