Effectiveness of fESWT in the Treatment of CTS

Medical University of Vienna

Status: Unknown

Conditions: Carpal Tunnel Syndrome

Treatments: Other: focused extracorporeal shock wave therapy; Other: sham focused extracorporeal shock wave therapy; Other: night splint

Study type: Interventional

Funder types: Other

Identifiers

NCT04302909

1080/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Active Comparator

Active Comparator group

Description:

fESWT

Treatment:

Other: focused extracorporeal shock wave therapy

Other: night splint

Sham Comparator

Sham Comparator group

Description:

Sham fESWT

Treatment:

Other: sham focused extracorporeal shock wave therapy

Other: night splint