Percutaneous Treatment of Carpal Tunnel Syndrome With Scan

NCT ID: NCT02514317

Last Updated: 2015-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-04-30

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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percutaneous treatment

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

Group Type EXPERIMENTAL

percutaneous treatment

Intervention Type PROCEDURE

Ultrasound

Intervention Type DEVICE

Interventions

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percutaneous treatment

Intervention Type PROCEDURE

Ultrasound

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Caen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital

Caen, , France

Site Status

Countries

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France

Other Identifiers

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11-058

Identifier Type: -

Identifier Source: org_study_id

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