Effectiveness of fESWT in the Treatment of CTS

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04302909
• Other study ID #: 1080/2019
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: June 2021

Study information

• Verified date: March 2020
• Source: Medical University of Vienna
• Contact: Christina Gesslbauer, Dr.
• Phone: 0043 40040043330
• Email: christina.gesslbauer[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Other:
• focused extracorporeal shock wave therapy
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.
• sham focused extracorporeal shock wave therapy
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.
• night splint
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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hand grip strength	hand grip strength:	baseline, 3th,12th and 24th weeks after treatment
Secondary	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
Secondary	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
Secondary	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
Secondary	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