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Percutaneous Treatment of Carpal Tunnel Syndrome With Scan (ECHOCARPE)

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
percutaneous treatment
Ultrasound
Sponsored by
University Hospital, Caen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)Does not accept healthy volunteers

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)

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

percutaneous treatment

Arm Description

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

Outcomes

Primary Outcome Measures

Pain (visual analogic scale)
visual analogic scale
paresthesia
muscle strength (dynamometer JAMARD)
dynamometer JAMARD

Secondary Outcome Measures

Full Information

First Posted
July 23, 2015
Last Updated
July 31, 2015
Sponsor
University Hospital, Caen
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1. Study Identification

Unique Protocol Identification Number
NCT02514317
Brief Title
Percutaneous Treatment of Carpal Tunnel Syndrome With Scan
Acronym
ECHOCARPE
Official Title
Ultrasound-assisted Percutaneous Release of Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Caen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
percutaneous treatment
Arm Type
Experimental
Arm Description
percutaneous treatment of carpal tunnel syndrome under ultrasound guidance in interventional radiology room.
Intervention Type
Procedure
Intervention Name(s)
percutaneous treatment
Intervention Type
Device
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
Pain (visual analogic scale)
Description
visual analogic scale
Time Frame
change between baseline and day 90 after surgery
Title
paresthesia
Time Frame
change between baseline and day 90 after surgery
Title
muscle strength (dynamometer JAMARD)
Description
dynamometer JAMARD
Time Frame
change between baseline and day 90 after surgery

10. Eligibility

Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
University Hospital
City
Caen
ZIP/Postal Code
14000
Country
France

12. IPD Sharing Statement

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Percutaneous Treatment of Carpal Tunnel Syndrome With Scan

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