Thumb ArthritisAURDOIINCT07336303
The Effect of Auriculotherapy on the Treatment of Postoperative Pain in Outpatient Rhizarthrosis Surgery
A study testing outpatient prosthetic surgery for rhizarthrosis. and real auricolothery in people with Thumb Arthritis, run by Clinique Bizet at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thumb Arthritis
- What is being tested?
- outpatient prosthetic surgery for rhizarthrosis. and real auricolothery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Feb 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Christian COUTURIER, Dr contact
France2 sites, 2 recruiting
- Recruiting
Benkessou
Paris, 75016
benkessou BOUCHRA, 0764486016, b.benkessou@hexagone-sante-paris.fr
- Recruiting
Bizet Clinic
Paris, 75016
benkessou BOUCHRA, 0764486016, b.benkessou@hexagone-sante-paris.fr
Christian COUTURIER, doctor
About this study
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
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
- Being tested
- outpatient prosthetic surgery for rhizarthrosis., real auricolothery, sham auriculotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
outpatient prosthetic surgery for rhizarthrosis.Procedure or surgery
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 auricolotheryOther
3 days before the intervention, patients will have an auriculotherapy session with an experimental group
sham auriculotherapyOther
3 days before the intervention, patients will have an auriculotherapy session with an sham group
| Study group | Role | What they receive |
|---|---|---|
| Real auriculotherapy + standard medical care group A | Experimental | Real auriculotherapy + standard medical care Receives: Procedure: outpatient prosthetic surgery for rhizarthrosis.; Other: real auricolothery |
| sham auriculotherapy + standard medical care group B | Sham comparator | Sham auriculotherapy + standard medical care Receives: Procedure: outpatient prosthetic surgery for rhizarthrosis.; Other: sham auriculotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 3
Secondary outcomes (4)
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.
Measured: 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)
Measured: 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
Measured: 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
Measured: At baseline and at one-month postoperative follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Feb 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group A (Experimental): Real auriculotherapy + standard medical care * Group B (Control): Sham auriculotherapy + standard medical care
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Bizet
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336303
- Sponsor's protocol ID
- 2025-A02330-49
- Acronym
- AURDOII
- Status last verified
- Feb 2026
- First submitted
- 2 Jan 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07336303
- Acronym / sponsor ID
- AURDOII / 2025-A02330-49
- Conditions
- Thumb Arthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinique BizetUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- * Group A (Experimental): Real auriculotherapy + standard medical care * Group B (Control): Sham auriculotherapy + standard medical care
| Arm | Type | Receives |
|---|---|---|
| Real auriculotherapy + standard medical care group A | Experimental | Procedure: outpatient prosthetic surgery for rhizarthrosis., Other: real auricolotheryReal auriculotherapy + standard medical care |
| sham auriculotherapy + standard medical care group B | Sham comparator | Procedure: outpatient prosthetic surgery for rhizarthrosis., Other: sham auriculotherapySham auriculotherapy + standard medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Real auriculotherapy + standard medical care group A, sham auriculotherapy + standard medical care group B |
| real auricolothery3 days before the intervention, patients will have an auriculotherapy session with an experimental group | Other | Real auriculotherapy + standard medical care group A |
| sham auriculotherapy3 days before the intervention, patients will have an auriculotherapy session with an sham group | Other | sham auriculotherapy + standard medical care group B |
Primary outcome
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
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian COUTURIER, Dr contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing outpatient prosthetic surgery for rhizarthrosis. and real auricolothery in people with Thumb Arthritis, run by Clinique Bizet at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bouchra BENKESSOU, PM (0140693525, b.benkessou@hexagone-sante-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.