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

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.

Study Overview

• Status: Withdrawn
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Device: Extracorporeal shock wave

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Neihu District
    • Taipei, Neihu District, Taiwan, 886
      • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Focused; fESWT (0.05-0.29 mJ/mm2, 2000 shocks, 5 Hz)	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.
Active Comparator: Radial; rESWT (2000shocks, 4 Bar, 5Hz)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital

Publications and helpful links

General Publications

• 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. Epub 2015 Dec 10.
• 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. doi: 10.1038/srep38344.
• 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 Rehabil Med. 2015 Oct;51(5):521-8. Epub 2015 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): October 13, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Carpal Tunnel Syndrome; Extracorporeal shock wave
• 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: TSGHIRB: 1-107-05-074

Drug and device information, study documents

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