Effectiveness of fESWT in the Treatment of CTS

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

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.

Study Overview

• Status: Unknown
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: focused extracorporeal shock wave therapy; Other: night splint; Other: sham focused extracorporeal shock wave therapy

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christina Gesslbauer, Dr.; Phone Number: 0043 40040043330; Email: christina.gesslbauer@meduniwien.ac.at
• Study Contact Backup: Name: Christina Gesslbauer

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine
    • Contact: Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA; Email: richard.crevenna@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator; fESWT	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.; Other: 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.
Sham Comparator: Sham Comparator; Sham fESWT	Other: 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.; Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Richard Crevenna, Ao.Univ.-Prof. Dr., MMSc, MBA, Medical University of Vienna, Department of Physical Medicine, Rehabilitation and Occupational Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2019
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: March 2, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: focused extracorporeal shock wave therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: 1080/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No