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

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ClinicalTrials.gov Identifier: NCT03671473
Recruitment Status : Withdrawn (It is difficult to enroll patients)
First Posted : September 14, 2018
Last Update Posted : October 13, 2021
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: Extracorporeal shock wave Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Focused and Radial Extracorporeal Shock Wave for Carpal Tunnel Syndrome
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment [ Time Frame: Change of the mean of total SSS and FSS from baseline 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 :
  1. Visual analogue scale (VAS) [ Time Frame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment ]
    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.

  2. Nerve conduction velocity [ Time Frame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment ]
    Change from baseline in conduction velocity of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.

  3. Cross-sectional area (CSA) of the median nerve [ Time Frame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment ]
    Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th and 24th weeks after treatment.

  4. Nerve conduction amplitude [ Time Frame: Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment ]
    Change from baseline in conduction amplitude of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671473


Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, Taiwan, 886
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
More Information
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Publications of Results:

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Responsible Party: Yung-Tsan Wu, Principal Investigator, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03671473    
Other Study ID Numbers: TSGHIRB: 1-107-05-074
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
Carpal Tunnel Syndrome
Extracorporeal shock wave
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries