Effectiveness of fESWT in the Treatment of CTS

Not Applicable

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: sham focused extracorporeal shock wave therapy; Other: focused extracorporeal shock wave therapy; Other: night splint

• Registration Number: NCT04302909
• Lead Sponsor: Medical University of Vienna

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-24
• Status Verified: 2020-03
• Study First Submitted: 2020-03-02
• Study First Submitted QC: 2020-03-06
• Last Update Submitted: 2020-03-06
• Study First Posted: 2020-03-10
• Last Update Posted: 2020-03-10
• Primary Completion: 2021-05
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• mild to moderate CTS verified by nerve conduction velocity

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Comparator	sham focused extracorporeal shock wave therapy	Sham fESWT
Sham Comparator	night splint	Sham fESWT
Active Comparator	focused extracorporeal shock wave therapy	fESWT
Active Comparator	night splint	fESWT

Primary Outcome Measures

Name	Time	Method
VAS	baseline, 3th,12th and 24th weeks after treatment	Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment.

Secondary Outcome Measures

Name	Time	Method
hand grip strength	baseline, 3th,12th and 24th weeks after treatment	hand grip strength:
sensory conduction velocity of the median nerve	baseline, 12th and 24th weeks after treatment	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.
SF-36	baseline, 3th,12th and 24th weeks after treatment	36-item Short Form Health Survey: Change from baseline in quality of life 3th,12th and 24th weeks after treatment.
distal motor latency of the median nerve	baseline,12th and 24th weeks after treatment	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.
Boston Scale	baseline, 3th,12th and 24th weeks after treatment	Boston Symptom Severity Score: Change from baseline in severity of symptoms and functional status 3th,12th and 24th weeks after treatment.

Trial Locations

Locations (1)

Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine; 🇦🇹 Vienna, Austria