Clinical trial NCT03671473: Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome
Official title: Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Syndrome
Extracorporeal shock wave
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment
timeFrame: Change of the mean of total SSS and FSS from baseline at 24th weeks after treatment
Secondary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
measure: Nerve conduction velocity
timeFrame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
measure: Cross-sectional area (CSA) of the median nerve
timeFrame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
measure: Nerve conduction amplitude
timeFrame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. Epub 2015 Dec 10.
citation: 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.
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 Rehabil Med. 2015 Oct;51(5):521-8. Epub 2015 Feb 20.