Clinical trial NCT04302909: Effectiveness of fESWT in the Treatment of CTS
Official title: The Effectiveness of Focused Extracorporeal Shock Wave Therapy in the Treatment of Carpal Tunnel Syndrome: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: focused extracorporeal shock wave therapy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: VAS
timeFrame: baseline, 3th,12th and 24th weeks after treatment
Secondary outcomes:
measure: hand grip strength
timeFrame: baseline, 3th,12th and 24th weeks after treatment
measure: distal motor latency of the median nerve
timeFrame: baseline,12th and 24th weeks after treatment
measure: sensory conduction velocity of the median nerve
timeFrame: baseline, 12th and 24th weeks after treatment
measure: SF-36
timeFrame: baseline, 3th,12th and 24th weeks after treatment
measure: Boston Scale
timeFrame: baseline, 3th,12th and 24th weeks after treatment
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine
Study officials:
affiliation: Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine
name: Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA
role: PRINCIPAL_INVESTIGATOR
References: