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

NCT03671473 | Withdrawn DMC

• 1 other identifier: TSGHIRB: 1-107-05-074
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel Syndrome; Extracorporeal shock wave

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Visual analogue scale (VAS)

  Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment

• Nerve conduction velocity

  Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment

• Cross-sectional area (CSA) of the median nerve

  Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment

• Nerve conduction amplitude

  Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment

Study Arms (2)

Focused

EXPERIMENTAL

fESWT (0.05-0.29 mJ/mm2, 2000 shocks, 5 Hz)

Device: Extracorporeal shock wave

Radial

ACTIVE COMPARATOR

rESWT (2000shocks, 4 Bar, 5Hz)

Device: Extracorporeal shock wave

Interventions

Extracorporeal shock wave DEVICE

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.

Focused; Radial

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical and electrophysiological diagnosis of CTS

You may not qualify if:

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

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (3)

• 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.

  PMID: 26610183 RESULT

• 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.

  PMID: 27910920 RESULT

• 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.

  PMID: 25697763 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Yung-Tsan Wu, MD

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2018
• First Posted: September 14, 2018
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

TW (1)