Impact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC

NCT06779812 | Recruiting DMC

• 1 other identifier: 2024-A02150-47
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pain After Carpal Tunnel Surgery

Outcome Measures

Primary Outcomes (1)

• Evaluation of Postoperative Pain After Carpal Tunnel Surgery From Day 1 to Day 3, Based on Real or Sham Auriculotherapy Sessions

  Visual analog scale

  day1 to day 3

Secondary Outcomes (1)

• Evaluation of the Effects of Real or Sham Auriculotherapy Sessions on Analgesic Consumption

  Follow-up Logbook from Day 1 to Day 3

Study Arms (2)

Group A

EXPERIMENTAL

Real auriculotherapy + standard medical care

Procedure: Carpal Tunnel Surgery; Other: real auricolothery

Group B

SHAM COMPARATOR

Sham auriculotherapy + standard medical care

Procedure: Carpal Tunnel Surgery; Other: sham auriculotherapy

Interventions

Carpal Tunnel Surgery PROCEDURE

Carpal tunnel surgery is performed endoscopically, using smaller incisions. Endoscopic surgery is a minimally invasive method that allows for faster and less painful recovery

Group A; Group B

real auricolothery OTHER

3 days before the intervention, patients will have an auriculotherapy session with an experimental group

Group A

sham auriculotherapy OTHER

3 days before the intervention, patients will have an auriculotherapy session with an sham group

Group B

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients under 20 years of age
• Unable to undergo medical follow-up for the study
• Legally protected adult subjects, under guardianship or curatorship

Sponsors & Collaborators

• Clinique Bizet: lead

Study Sites (2)

Benkessou

Paris, 75016, France

RECRUITING

Bizet Clinic

Paris, 75016, France

RECRUITING

Central Study Contacts

bouchra BENKESSOU, PM

CONTACT

0033764486016; b.benkessou@hexagone-sante-paris.fr

Christian COUTURIER, Dr

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Group A (Experimental): Real auriculotherapy + standard medical care Group B (Control): Sham auriculotherapy + standard medical care

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 17, 2025
• Study Start: April 11, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 6, 2026

Record last verified: 2026-01

Locations

FR (2)