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Recruiting NCT07336303

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

No phase Interventional Thumb Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: outpatient prosthetic surgery for rhizarthrosis., real auricolothery, sham auriculotherapy.
Who it may be relevant to
Registry conditions: Thumb Arthritis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Interventions

  • 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
  • Other real auricolothery
    3 days before the intervention, patients will have an auriculotherapy session with an experimental group
  • Other sham auriculotherapy
    3 days before the intervention, patients will have an auriculotherapy session with an sham group

Primary outcome measures

  • 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 [Time frame: Day 1 to Day 3]
Secondary outcome measures (4)
  • Assessment of the onset of neuropathic pain using the DN4 questionnaire during follow-up. [Time frame: 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 [Time frame: 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. [Time frame: at one-month postoperative follow-up]
  • Assessment of postoperative anxiety reduction between the two groups using the State-Trait Anxiety Inventory (STAI) score. [Time frame: At baseline and at one-month postoperative follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

France · 2 centers
  • Benkessou — Paris
  • Bizet Clinic — Paris

Identifiers

NCT: NCT07336303 · 2025-A02330-49

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗