Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2026-02-27 @ 11:59 AM
Study NCT ID:
NCT06779812
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-17
First Post:
2025-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, '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 Group B (Control): Sham auriculotherapy + standard medical care'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-13', 'studyFirstSubmitDate': '2025-01-08', 'studyFirstSubmitQcDate': '2025-01-13', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of Postoperative Pain After Carpal Tunnel Surgery From Day 1 to Day 3, Based on Real or Sham Auriculotherapy Sessions', 'timeFrame': 'day1 to day 3', 'description': 'Visual analog scale'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the Effects of Real or Sham Auriculotherapy Sessions on Analgesic Consumption', 'timeFrame': 'Follow-up Logbook from Day 1 to Day 3', 'description': 'Analgesic Consumption'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain After Carpal Tunnel Surgery']}, 'descriptionModule': {'briefSummary': 'Auriculotherapy shows promising potential for pain management in patients with carpal tunnel syndrome (CTS). Studies have demonstrated encouraging results in pain reduction and improvement in quality of life. However, further research is required to strengthen these findings and fully integrate auriculotherapy into standard treatment protocols for CTS.\n\nthis prospective, double-blind comparative study aims to evaluate the effectiveness of auricular acupuncture in managing postoperative pain following outpatient carpal tunnel surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged over 20 years\n* Patients with carpal tunnel syndrome scheduled for endoscopic surgery\n* Patients who have never undergone auriculotherapy sessions before\n* No participation in another clinical study\n\nExclusion Criteria:\n\n* Patients under 20 years of age\n* Unable to undergo medical follow-up for the study\n* Legally protected adult subjects, under guardianship or curatorship'}, 'identificationModule': {'nctId': 'NCT06779812', 'acronym': 'AURDO', 'briefTitle': 'Impact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Bizet'}, 'officialTitle': 'Impact of Auriculotherapy on Postoperative Pain in Patients Undergoing Surgery for SCC. Parallel, Randomized, and Double-Blind Comparative Study', 'orgStudyIdInfo': {'id': '2024-A02150-47'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Real auriculotherapy + standard medical care', 'interventionNames': ['Procedure: Carpal Tunnel Surgery', 'Other: real auricolothery']}, {'type': 'SHAM_COMPARATOR', 'label': 'Group B', 'description': 'Sham auriculotherapy + standard medical care', 'interventionNames': ['Procedure: Carpal Tunnel Surgery', 'Other: sham auriculotherapy']}], 'interventions': [{'name': 'Carpal Tunnel Surgery', 'type': 'PROCEDURE', 'description': 'Carpal tunnel surgery is performed endoscopically, using smaller incisions. Endoscopic surgery is a minimally invasive method that allows for faster and less painful recovery', 'armGroupLabels': ['Group A', 'Group B']}, {'name': 'real auricolothery', 'type': 'OTHER', 'description': '3 days before the intervention, patients will have an auriculotherapy session with an experimental group', 'armGroupLabels': ['Group A']}, {'name': 'sham auriculotherapy', 'type': 'OTHER', 'description': '3 days before the intervention, patients will have an auriculotherapy session with an sham group', 'armGroupLabels': ['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': '0033764486016'}, {'name': 'Christian COUTURIER, Dr', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Bizet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}