The Effect of Auriculotherapy on the Treatment of Postoperative Pain in Outpatient Rhizarthrosis Surgery

NCT07336303 | Not Yet Recruiting DMC

• 1 other identifier: 2025-A02330-49
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Auriculotherapy has demonstrated promising potential in the management of postoperative pain. Additionally, one study reported encouraging outcomes regarding the reduction of anxiety levels among patients in primary healthcare settings. Nevertheless, further high-quality research is required to substantiate these findings and to support the integration of auriculotherapy into standardized therapeutic protocols. The objective of this prospective, comparative, double-blind study is to assess the efficacy of auricular acupuncture in the management of postoperative pain following outpatient prosthetic surgery for rhizarthrosis

Conditions

Thumb Arthritis

Outcome Measures

Primary Outcomes (1)

• Assessment of pain reduction using the Numerical Rating Scale (NRS) questionnaire during the postoperative period from Day 1 to Day 3. From Day 1 to Day 3, Based on Real or Sham Auriculotherapy Sessions

  The Numerical Rating Scale (NRS) is a validated, unidimensional tool used to assess pain intensity. Patients are asked to rate their pain by selecting a number that best reflects its severity. Valeur minimale : 0 - corresponds to "no pain". Valeur maximale : 10 - corresponds to "the worst pain imaginable". Interprétation générale : 0 : No pain 1-3 : Mild pain 4-6 : Moderate pain 7-10 : Severe pain

  Day 1 to Day 3

Secondary Outcomes (4)

• Assessment of the onset of neuropathic pain using the DN4 questionnaire during follow-up.

  At baseline and at one-month postoperative follow-up

• Assessment of analgesic consumption (number, name, and analgesic step) from the end of the hand regional anesthesia until Day 3, and again at one month

  from the end of the hand regional anesthesia until Day 3, and again at one month postoperative follow-up

• Assessment of patient satisfaction using the CGI-C scale.

  at one-month postoperative follow-up

• Assessment of postoperative anxiety reduction between the two groups using the State-Trait Anxiety Inventory (STAI) score.

  At baseline and at one-month postoperative follow-up

Study Arms (2)

Real auriculotherapy + standard medical care group A

EXPERIMENTAL

Real auriculotherapy + standard medical care

Procedure: outpatient prosthetic surgery for rhizarthrosis.; Other: real auricolothery

sham auriculotherapy + standard medical care group B

SHAM COMPARATOR

Sham auriculotherapy + standard medical care

Procedure: outpatient prosthetic surgery for rhizarthrosis.; Other: sham auriculotherapy

Interventions

outpatient prosthetic surgery for rhizarthrosis. PROCEDURE

surgery / procedures : Outpatient surgery (thumb osteoarthritis). On the day of the procedure, the patient arrives on an outpatient basis, is positioned on a stretcher, and is then taken to the pre-anesthesia room where regional anesthesia is performed. The block is carried out under ultrasound guidance following a standardized protocol. The patient is then transferred to the operating room, where the tourniquet is applied. The surgical technique is endoscopic, following the AGEE method. At the end of the procedure, the surgeon places two or three absorbable sutures (4/0 or 5/0) on the thinnest areas of skin. The sutures are then covered with a dressing.

Real auriculotherapy + standard medical care group A; sham auriculotherapy + standard medical care group B

real auricolothery OTHER

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

Real auriculotherapy + standard medical care group A

sham auriculotherapy OTHER

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

sham auriculotherapy + standard medical care group B

Eligibility Criteria

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

You may qualify if:

• Subject aged over 18 years
• Patients hospitalized for endoscopic treatment of thumb carpometacarpal osteoarthritis (rhizarthrosis)
• Patient with no prior history of auriculotherapy sessions
• No participation in another clinical study
• Subject affiliated with, or beneficiary of, a social security system
• Agrees to complete all study questionnaires

You may not qualify if:

• Patient under 18 years of age
• Unable to comply with medical follow-up required for the study
• Adult subject under legal protection, guardianship, or trusteeship
• Patient with neuropathic pain

Sponsors & Collaborators

• Clinique Bizet: lead

Study Sites (2)

Benkessou

Paris, 75016, France

Location

Bizet Clinic

Paris, 75016, France

Location

Central Study Contacts

Bouchra BENKESSOU, PM

CONTACT

0140693525; 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 2, 2026
• First Posted: January 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)