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Trial record 97 of 337 for:    Charcot Marie Tooth

The Effect of ESWT for Cubital Tunnel Syndrome

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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

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.

Condition or disease Intervention/treatment Phase
Cubital Tunnel Syndrome Device: extracorporeal shock wave therapy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Extracorporeal Shock Wave Therapy in Patients With Cubital Tunnel Syndrome
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 31, 2017


Arm Intervention/treatment
Experimental: Three-sessions of ESWT
ESWT was given once a week for 3 weeks.
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).

Active Comparator: One-session of ESWT
Single ESWT was given.
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).




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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



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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:

  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.

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): NCT02801461


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

Publications:
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Responsible Party: Yung-Tsan Wu, Attending physician of physical medicine and rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02801461     History of Changes
Other Study ID Numbers: TSGHIRB: 2-105-05-032
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Ulnar Nerve Compression Syndromes
Nerve Compression Syndromes
Cubital Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Ulnar Neuropathies
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries