Percutaneous Treatment of Carpal Tunnel Syndrome With Scan

Carpal Tunnel Syndrome Clinical Trial

— ECHOCARPE  

Official title:

Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02514317
• Other study ID #: 11-058
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2015
• Last updated: July 31, 2015
• Start date: January 2012
• Est. completion date: April 2013

Study information

• Verified date: July 2015
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• percutaneous treatment

Device:
• Ultrasound

Locations

Country	Name	City	State
France	University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain (visual analogic scale)	visual analogic scale	change between baseline and day 90 after surgery	No
Primary	paresthesia		change between baseline and day 90 after surgery	No
Primary	muscle strength (dynamometer JAMARD)	dynamometer JAMARD	change between baseline and day 90 after surgery	No