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Percutaneous Treatment of Carpal Tunnel Syndrome With Scan (ECHOCARPE)

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ClinicalTrials.gov Identifier: NCT02514317
Recruitment Status : Completed
First Posted : August 3, 2015
Last Update Posted : August 3, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Caen

Brief Summary:
The objective of the study is to evaluate in patients suffering from carpal tunnel syndrome resistant to medical treatment, clinical course after percutaneous treatment under ultrasound guidance. 40 patients will be included in the study. The following parameters will be evaluated: patient satisfaction, pain, functional disability, quality of life and time to return to work. The medico-economic aspect will be analyzed.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: percutaneous treatment Device: Ultrasound Phase 2

Detailed Description:

Ultrasound analysis of Carpal tunnel is used for many years, especially for diagnostic purposes. Investigators have shown, first by a study of 104 cadavers that it was possible to reduce the opening by making the gesture under ultrasound guidance and to perform the procedure under local anesthesia. Then investigators performed an open study of 25 patients confirming the absence of iatrogenic lesions with this new technique.

The percutaneous treatment of carpal tunnel syndrome under ultrasound guidance is a gesture of interventional radiology. One can envisage making this type of treatment in interventional radiology room which overcomes the operating room and thus reduce costs.

The objective of the study is to continue the study of percutaneous treatment of carpal tunnel syndrome under ultrasound guidance by an open study conducted in interventional radiology room.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome
Study Start Date : January 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013


Arm Intervention/treatment
Experimental: percutaneous treatment
percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.
Procedure: percutaneous treatment
Device: Ultrasound



Primary Outcome Measures :
  1. Pain (visual analogic scale) [ Time Frame: change between baseline and day 90 after surgery ]
    visual analogic scale

  2. paresthesia [ Time Frame: change between baseline and day 90 after surgery ]
  3. muscle strength (dynamometer JAMARD) [ Time Frame: change between baseline and day 90 after surgery ]
    dynamometer JAMARD



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient older than 18 years who signed the informed consent.
  • Patient with an Carpal Tunnel Syndrome

Exclusion Criteria:

  • patient has already undergone surgery of Carpal Tunnel Syndrome
  • Patient with contra-indications to anesthesia (heart failure, kidney, liver).
  • Pregnant women
  • alcoholics in weaning period
  • Patient whose consent is altered or unable to get a safety procedure
  • Patient with contra-indication to lidocaine
  • Patient with contra-indication for the realization of ultrasound endoscopy (carpal tunnel syndrome secondary or anastomosis between the median and ulnar nerves: anastomosis Berritini)

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): NCT02514317


Locations
France
University Hospital
Caen, France, 14000
Sponsors and Collaborators
University Hospital, Caen

Responsible Party: University Hospital, Caen
ClinicalTrials.gov Identifier: NCT02514317     History of Changes
Other Study ID Numbers: 11-058
First Posted: August 3, 2015    Key Record Dates
Last Update Posted: August 3, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries