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The Effect of ESWT for Cubital Tunnel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02801461
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

Tracking Information
First Submitted Date  ICMJE June 10, 2016
First Posted Date  ICMJE June 15, 2016
Last Update Posted Date April 25, 2018
Actual Study Start Date  ICMJE October 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment [ Time Frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment ]
Visual analog scale (VAS)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2016)
  • Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment ]
    Using the Disabilities of the Arm, Shoulder and Hand to measure the symptoms and functional status before treatment and multiple time frame after treatment.
  • Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment ]
    electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of ESWT for Cubital Tunnel Syndrome
Official Title  ICMJE The Effect of Extracorporeal Shock Wave Therapy in Patients With Cubital Tunnel Syndrome
Brief Summary The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the effect of extracorporeal shock wave therapy on cubital tunnel syndrome.
Detailed Description

Investigators perform a prospective randomized, single-blinded study to investigate the effect of ESWT in patients with cubital tunnel syndrome.

Patients were randomized into intervention and control group. Participants in intervention group received three-sessions of ESWT and single one session of ESWT was given in control group. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cubital Tunnel Syndrome
Intervention  ICMJE Device: extracorporeal shock wave therapy
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).
Study Arms  ICMJE
  • Experimental: Three-sessions of ESWT
    ESWT was given once a week for 3 weeks.
    Intervention: Device: extracorporeal shock wave therapy
  • Active Comparator: One-session of ESWT
    Single ESWT was given.
    Intervention: Device: extracorporeal shock wave therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 23, 2018)
7
Original Estimated Enrollment  ICMJE
 (submitted: June 14, 2016)
40
Actual Study Completion Date  ICMJE December 31, 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 20-80 year-old.
  2. Typical symptoms and signs of cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion Criteria:

  1. Cancer
  2. Coagulopathy
  3. Pregnancy
  4. Inflammation status
  5. Patients who had conditions mimicking cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02801461
Other Study ID Numbers  ICMJE TSGHIRB: 2-105-05-032
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Yung-Tsan Wu, Tri-Service General Hospital
Study Sponsor  ICMJE Tri-Service General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tri-Service General Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP