Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome

Not Applicable

Withdrawn

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: Extracorporeal shock wave

• Registration Number: NCT03671473
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

Extracorporeal shock wave is a novel treatment for peripheral nerve entrapment. This study was designed to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.

Detailed Description

Both focused and radial extracorporeal shock wave had been proved to treat carpal tunnel syndrome by several studies. However, there was no study comparing these two methods. Considering different mechanisms and costs, this randomized comparative trial would be conducted to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.

Study Timeline

• Study First Submitted: 2018-07-31
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-14
• Study Start: 2019-01-01
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Clinical and electrophysiological diagnosis of CTS

Exclusion Criteria

• Cervical radiculopathy
• Polyneuropathy
• Brachial plexopathy
• Thoracic outlet syndrome
• Previous wrist surgery or steroid injection for CTS

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Focused	Extracorporeal shock wave	fESWT (0.05-0.29 mJ/mm2, 2000 shocks, 5 Hz)
Radial	Extracorporeal shock wave	rESWT (2000shocks, 4 Bar, 5Hz)

Primary Outcome Measures

Name	Time	Method
Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment	Change of the mean of total SSS and FSS from baseline at 24th weeks after treatment	Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses two components. eleven questions and eight items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Each question or item ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score of SSS ranges from 11-55 and FSS from 8-40. The mean of total SSS and FSS divided with each item score were used for further analysis.

Secondary Outcome Measures

Name	Time	Method
Cross-sectional area (CSA) of the median nerve	Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment	Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th and 24th weeks after treatment.
Nerve conduction amplitude	Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment	Change from baseline in conduction amplitude of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.
Nerve conduction velocity	Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment	Change from baseline in conduction velocity of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.
Visual analogue scale (VAS)	Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment	Digital pain severity or paresthesia/dysthesia within 1 week prior to evaluation was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan