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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03671473
• Other study ID #: TSGHIRB: 1-107-05-074
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• Extracorporeal shock wave
Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 µs). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

Ke MJ, Chen LC, Chou YC, Li TY, Chu HY, Tsai CK, Wu YT. The dose-dependent efficiency of radial shock wave therapy for patients with carpal tunnel syndrome: a prospective, randomized, single-blind, placebo-controlled trial. Sci Rep. 2016 Dec 2;6:38344. do — View Citation

Paoloni M, Tavernese E, Cacchio A, D'orazi V, Ioppolo F, Fini M, Santilli V, Mangone M. Extracorporeal shock wave therapy and ultrasound therapy improve pain and function in patients with carpal tunnel syndrome. A randomized controlled trial. Eur J Phys R — View Citation

Wu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) 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.	Change of the mean of total SSS and FSS from baseline at 24th weeks after treatment
Secondary	Visual analogue scale (VAS)	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.	Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
Secondary	Nerve conduction velocity	Change from baseline in conduction velocity of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.	Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
Secondary	Cross-sectional area (CSA) of the median nerve	Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th and 24th weeks after treatment.	Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
Secondary	Nerve conduction amplitude	Change from baseline in conduction amplitude of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.	Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment