Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome
Primary Purpose
Carpal Tunnel Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Extracorporeal shock wave
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal Tunnel Syndrome, Extracorporeal shock wave
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
Sites / Locations
- Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Focused
Radial
Arm Description
fESWT (0.05-0.29 mJ/mm2, 2000 shocks, 5 Hz)
rESWT (2000shocks, 4 Bar, 5Hz)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Nerve conduction velocity
Change from baseline in conduction velocity of median nerve on 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.
Nerve conduction amplitude
Change from baseline in conduction amplitude of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.
Full Information
NCT ID
NCT03671473
First Posted
July 31, 2018
Last Updated
October 5, 2021
Sponsor
Tri-Service General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03671473
Brief Title
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
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
It is difficult to enroll patients
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal Tunnel Syndrome, Extracorporeal shock wave
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Focused
Arm Type
Experimental
Arm Description
fESWT (0.05-0.29 mJ/mm2, 2000 shocks, 5 Hz)
Arm Title
Radial
Arm Type
Active Comparator
Arm Description
rESWT (2000shocks, 4 Bar, 5Hz)
Intervention Type
Device
Intervention Name(s)
Extracorporeal shock wave
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment
Description
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.
Time Frame
Change of the mean of total SSS and FSS from baseline at 24th weeks after treatment
Secondary Outcome Measure Information:
Title
Visual analogue scale (VAS)
Description
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.
Time Frame
Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
Title
Nerve conduction velocity
Description
Change from baseline in conduction velocity of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.
Time Frame
Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
Title
Cross-sectional area (CSA) of the median nerve
Description
Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th and 24th weeks after treatment.
Time Frame
Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
Title
Nerve conduction amplitude
Description
Change from baseline in conduction amplitude of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.
Time Frame
Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
26610183
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.
Results Reference
result
PubMed Identifier
27910920
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.
Results Reference
result
PubMed Identifier
25697763
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.
Results Reference
result
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Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome
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