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
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome
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)
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
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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