- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06779812
Impact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC (AURDO)
Impact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC. Parallel, Randomized, and Double-Blind Comparative Study
Auriculotherapy shows promising potential for pain management in patients with carpal tunnel syndrome (CTS). Studies have demonstrated encouraging results in pain reduction and improvement in quality of life. However, further research is required to strengthen these findings and fully integrate auriculotherapy into standard treatment protocols for CTS.
this prospective, double-blind comparative study aims to evaluate the effectiveness of auricular acupuncture in managing postoperative pain following outpatient carpal tunnel surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: bouchra BENKESSOU, PM
- Phone Number: 0033764486016
- Email: b.benkessou@hexagone-sante-paris.fr
Study Contact Backup
- Name: Christian COUTURIER, Dr
Study Locations
-
-
-
Paris, France, 75016
- Recruiting
- Bizet Clinic
-
Contact:
- benkessou BOUCHRA
- Phone Number: 0764486016
- Email: b.benkessou@hexagone-sante-paris.fr
-
Principal Investigator:
- Christian COUTURIER, doctor
-
Sub-Investigator:
- Carine Chaix COUTURIER, Doctor
-
Paris, France, 75016
- Recruiting
- Benkessou
-
Contact:
- benkessou BOUCHRA
- Phone Number: 0764486016
- Email: b.benkessou@hexagone-sante-paris.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subjects aged over 20 years
- Patients with carpal tunnel syndrome scheduled for endoscopic surgery
- Patients who have never undergone auriculotherapy sessions before
- No participation in another clinical study
Exclusion Criteria:
- Patients under 20 years of age
- Unable to undergo medical follow-up for the study
- Legally protected adult subjects, under guardianship or curatorship
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
Real auriculotherapy + standard medical care
|
Carpal tunnel surgery is performed endoscopically, using smaller incisions.
Endoscopic surgery is a minimally invasive method that allows for faster and less painful recovery
3 days before the intervention, patients will have an auriculotherapy session with an experimental group
|
|
Sham Comparator: Group B
Sham auriculotherapy + standard medical care
|
Carpal tunnel surgery is performed endoscopically, using smaller incisions.
Endoscopic surgery is a minimally invasive method that allows for faster and less painful recovery
3 days before the intervention, patients will have an auriculotherapy session with an sham group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of Postoperative Pain After Carpal Tunnel Surgery From Day 1 to Day 3, Based on Real or Sham Auriculotherapy Sessions
Time Frame: day1 to day 3
|
Visual analog scale
|
day1 to day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of the Effects of Real or Sham Auriculotherapy Sessions on Analgesic Consumption
Time Frame: Follow-up Logbook from Day 1 to Day 3
|
Analgesic Consumption
|
Follow-up Logbook from Day 1 to Day 3
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-A02150-47
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain After Carpal Tunnel Surgery
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University of PittsburghWithdrawnPain After Carpal Tunnel ReleaseUnited States
-
Issa, Abdulhamid Sayed, M.D.CompletedCarpal Tunnel Syndrome | CTS | Carpal Tunnel Release | Carpal Tunnel Surgery | Carpal Tunnel Transverse ApproachSyrian Arab Republic
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Haisco Pharmaceutical Group Co., Ltd.Not yet recruiting
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