Percutaneous Treatment of Carpal Tunnel Syndrome With Scan

Phase 2

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: percutaneous treatment; Device: Ultrasound

• Registration Number: NCT02514317
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-01
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-23
• Study First Submitted QC: 2015-07-31
• Last Update Submitted: 2015-07-31
• Study First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
percutaneous treatment	Ultrasound	percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.
percutaneous treatment	percutaneous treatment	percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.

Primary Outcome Measures

Name	Time	Method
Pain (visual analogic scale)	change between baseline and day 90 after surgery	visual analogic scale
paresthesia	change between baseline and day 90 after surgery
muscle strength (dynamometer JAMARD)	change between baseline and day 90 after surgery	dynamometer JAMARD

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Caen, France