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Clinical Trials/NCT02514317
NCT02514317
Completed
Phase 2

Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome

University Hospital, Caen1 site in 1 country40 target enrollmentJanuary 1, 2012

Overview

Phase
Phase 2
Intervention
percutaneous treatment
Conditions
Carpal Tunnel Syndrome
Sponsor
University Hospital, Caen
Enrollment
40
Locations
1
Primary Endpoint
Pain (visual analogic scale)
Status
Completed
Last Updated
29 days ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2012
End Date
April 1, 2013
Last Updated
29 days ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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)

Arms & Interventions

percutaneous treatment

percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.

Intervention: percutaneous treatment

percutaneous treatment

percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.

Intervention: Ultrasound

Outcomes

Primary Outcomes

Pain (visual analogic scale)

Time Frame: change between baseline and day 90 after surgery

visual analogic scale

paresthesia

Time Frame: change between baseline and day 90 after surgery

muscle strength (dynamometer JAMARD)

Time Frame: change between baseline and day 90 after surgery

dynamometer JAMARD

Study Sites (1)

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