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

Comparative Study on the Effect of Auriculotherapy in the Treatment of Postoperative Pain in Outpatient Surgery: Rhizarthrosis PARALLEL COMPARATIVE STUDY RANDOMIZED AND DOUBLE-BLIND

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

Study Overview

• Status: Not yet recruiting
• Conditions: Thumb Arthritis
• Intervention / Treatment: Other: real auricolothery; Other: sham auriculotherapy; Procedure: outpatient prosthetic surgery for rhizarthrosis.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christian COUTURIER, Dr
• Study Contact Backup: Name: Bouchra BENKESSOU, PM; Phone Number: 0140693525; Email: b.benkessou@hexagone-sante-paris.fr

Study Locations

• France
  • Paris, France, 75016
    • Benkessou
  • Paris, France, 75016
    • Bizet Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real auriculotherapy + standard medical care group A; Real auriculotherapy + standard medical care	Other: real auricolothery; 3 days before the intervention, patients will have an auriculotherapy session with an experimental group; Procedure: outpatient prosthetic surgery for rhizarthrosis.; 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.
Sham Comparator: sham auriculotherapy + standard medical care group B; Sham auriculotherapy + standard medical care	Other: sham auriculotherapy; 3 days before the intervention, patients will have an auriculotherapy session with an sham group; Procedure: outpatient prosthetic surgery for rhizarthrosis.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the onset of neuropathic pain using the DN4 questionnaire during follow-up.	The DN4 questionnaire is a validated diagnostic instrument designed to differentiate neuropathic pain from nociceptive pain. It comprises 10 items, including 7 symptom-based descriptors (e.g., burning, painful cold, electric shocks, tingling, pins and needles, numbness, itching) and 3 clinical examination findings (hypoesthesia to touch, hypoesthesia to pinprick, and pain provoked by brushing). Minimum score: 0, indicating the absence of neuropathic pain features. Maximum score: 10, indicating the presence of all evaluated neuropathic characteristics. Interpretation: A score ≥ 4 is considered the diagnostic threshold and is associated with a high probability of neuropathic pain, based on the tool's validated sensitivity and specificity. Scores < 4 suggest that neuropathic pain is unlikely.	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	analgesic consumption (number, name, and analgesic step)	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.	The CGI-C is a validated clinician-rated scale used to assess the patient's overall change in clinical status compared with baseline. It provides a global, integrative judgment that incorporates all available clinical information, including symptoms, functioning, and therapeutic response. Minimum score: 1 - Very much improved Maximum score: 7 - Very much worse Interpretation: 1-2: Marked or clear improvement 3: Minimal improvement 4: No change 5: Minimal worsening 6-7: Clear to marked worsening	at one-month postoperative follow-up
Assessment of postoperative anxiety reduction between the two groups using the State-Trait Anxiety Inventory (STAI) score.	State-Trait Anxiety Inventory (STAI - Form Y) The State-Trait Anxiety Inventory is a validated psychometric instrument designed to assess two distinct components of anxiety: State Anxiety (STAI-S): reflects a transient emotional condition characterized by feelings of tension, apprehension, and heightened autonomic activity. It measures anxiety "right now, at this moment." Trait Anxiety (STAI-T): reflects a stable predisposition to perceive situations as threatening and to respond with elevated anxiety across time. Each subscale contains 20 items, rated on a 4-point Likert scale.; Minimum score: 20; Maximum score: 80 Interpretation: Higher scores indicate higher levels of anxiety.; 20-37: low anxiety; 38-44: moderate anxiety; ≥ 45: high anxiety	At baseline and at one-month postoperative follow-up

Collaborators and Investigators

• Sponsor: Clinique Bizet

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: January 2, 2026
• First Submitted That Met QC Criteria: January 2, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2025-A02330-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No