Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:15 AM
Study NCT ID:
NCT07336303
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-13
First Post:
2026-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Auriculotherapy on the Treatment of Postoperative Pain in Outpatient Rhizarthrosis Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Group A (Experimental): Real auriculotherapy + standard medical care\n* Group B (Control): Sham auriculotherapy + standard medical care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-01-02', 'studyFirstSubmitQcDate': '2026-01-02', 'lastUpdatePostDateStruct': {'date': '2026-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': 'Day 1 to Day 3', 'description': '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.\n\nValeur minimale :\n\n0 - corresponds to "no pain".\n\nValeur maximale :\n\n10 - corresponds to "the worst pain imaginable".\n\nInterprétation générale :\n\n0 : No pain\n\n1-3 : Mild pain\n\n4-6 : Moderate pain\n\n7-10 : Severe pain'}], 'secondaryOutcomes': [{'measure': 'Assessment of the onset of neuropathic pain using the DN4 questionnaire during follow-up.', 'timeFrame': 'At baseline and at one-month postoperative follow-up', 'description': "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).\n\nMinimum score:\n\n0, indicating the absence of neuropathic pain features.\n\nMaximum score:\n\n10, indicating the presence of all evaluated neuropathic characteristics.\n\nInterpretation:\n\nA 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."}, {'measure': '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', 'timeFrame': 'from the end of the hand regional anesthesia until Day 3, and again at one month postoperative follow-up', 'description': 'analgesic consumption (number, name, and analgesic step)'}, {'measure': 'Assessment of patient satisfaction using the CGI-C scale.', 'timeFrame': 'at one-month postoperative follow-up', 'description': "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.\n\nMinimum score: 1 - Very much improved\n\nMaximum score: 7 - Very much worse\n\nInterpretation:\n\n1-2: Marked or clear improvement\n\n3: Minimal improvement\n\n4: No change\n\n5: Minimal worsening\n\n6-7: Clear to marked worsening"}, {'measure': 'Assessment of postoperative anxiety reduction between the two groups using the State-Trait Anxiety Inventory (STAI) score.', 'timeFrame': 'At baseline and at one-month postoperative follow-up', 'description': 'State-Trait Anxiety Inventory (STAI - Form Y)\n\nThe State-Trait Anxiety Inventory is a validated psychometric instrument designed to assess two distinct components of anxiety:\n\nState 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."\n\nTrait Anxiety (STAI-T): reflects a stable predisposition to perceive situations as threatening and to respond with elevated anxiety across time.\n\nEach subscale contains 20 items, rated on a 4-point Likert scale.\n\n* Minimum score: 20\n* Maximum score: 80\n\nInterpretation:\n\nHigher scores indicate higher levels of anxiety.\n\n* 20-37: low anxiety\n* 38-44: moderate anxiety\n* ≥ 45: high anxiety'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thumb Arthritis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject aged over 18 years\n* Patients hospitalized for endoscopic treatment of thumb carpometacarpal osteoarthritis (rhizarthrosis)\n* Patient with no prior history of auriculotherapy sessions\n* No participation in another clinical study\n* Subject affiliated with, or beneficiary of, a social security system\n* Agrees to complete all study questionnaires\n\nExclusion Criteria:\n\n* Patient under 18 years of age\n* Unable to comply with medical follow-up required for the study\n* Adult subject under legal protection, guardianship, or trusteeship\n* Patient with neuropathic pain'}, 'identificationModule': {'nctId': 'NCT07336303', 'acronym': 'AURDOII', 'briefTitle': 'The Effect of Auriculotherapy on the Treatment of Postoperative Pain in Outpatient Rhizarthrosis Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Bizet'}, 'officialTitle': 'Comparative Study on the Effect of Auriculotherapy in the Treatment of Postoperative Pain in Outpatient Surgery: Rhizarthrosis PARALLEL COMPARATIVE STUDY RANDOMIZED AND DOUBLE-BLIND', 'orgStudyIdInfo': {'id': '2025-A02330-49'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Real auriculotherapy + standard medical care group A', 'description': 'Real auriculotherapy + standard medical care', 'interventionNames': ['Procedure: outpatient prosthetic surgery for rhizarthrosis.', 'Other: real auricolothery']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham auriculotherapy + standard medical care group B', 'description': 'Sham auriculotherapy + standard medical care', 'interventionNames': ['Procedure: outpatient prosthetic surgery for rhizarthrosis.', 'Other: sham auriculotherapy']}], 'interventions': [{'name': 'outpatient prosthetic surgery for rhizarthrosis.', 'type': 'PROCEDURE', 'description': '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.\n\nThe 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.', 'armGroupLabels': ['Real auriculotherapy + standard medical care group A', 'sham auriculotherapy + standard medical care group B']}, {'name': 'real auricolothery', 'type': 'OTHER', 'description': '3 days before the intervention, patients will have an auriculotherapy session with an experimental group', 'armGroupLabels': ['Real auriculotherapy + standard medical care group A']}, {'name': 'sham auriculotherapy', 'type': 'OTHER', 'description': '3 days before the intervention, patients will have an auriculotherapy session with an sham group', 'armGroupLabels': ['sham auriculotherapy + standard medical care group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75016', 'city': 'Paris', 'country': 'France', 'facility': 'Benkessou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75016', 'city': 'Paris', 'country': 'France', 'facility': 'Bizet Clinic', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Bouchra BENKESSOU, PM', 'role': 'CONTACT', 'email': 'b.benkessou@hexagone-sante-paris.fr', 'phone': '0140693525'}, {'name': 'Christian COUTURIER, Dr', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Bizet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}