Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-01-01 @ 12:58 AM
Study NCT ID:
NCT06693167
Status:
COMPLETED
Last Update Posted:
2024-11-18
First Post:
2024-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjuvant Treatment of Postoperative Pain Following Endoscopic Carpal Tunnel Surgery by Auriculotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'targetDuration': '7 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-14', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2024-11-14', 'lastUpdatePostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'demonstrate the effectiveness of auriculotherapy in the management of postoperative pain', 'timeFrame': 'Day1, Day2 and Day 3', 'description': 'pain assessment scale'}], 'secondaryOutcomes': [{'measure': 'reducing the consumption of painkillers', 'timeFrame': 'Day1, Day2 and Day 3', 'description': 'number of tablets in grams'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chirurgical Intervention', 'Auriculotherapy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/15105215/', 'label': '6- Sator-Katzenschlager, S. M., Scharbert, G., Kozek-Langenecker, S. A., Dolezal, S., Michalek-Sauberer, A., Kress, H. G., \\& Heinze, G. (2003). The short- and long-term benefit in chronic low back pain through adjuvant electrical versus manual auricular'}]}, 'descriptionModule': {'briefSummary': 'Retrospective study on the effect of auriculotherapy on postoperative pain after carpal tunnel surgery', 'detailedDescription': 'the project consists of a retrospective analysis of data from the medical records of patients followed by Doctor, between 2016 and 2017, at the Bizet Clinic. This study includes measurements of pain levels and analgesic consumption in patients who received during their care in the clinic a preoperative auriculotherapy session offered by the clinic, during the three days following carpal tunnel surgery. For comparison, this studie also includes a group who underwent the same surgery treated only with analgesics. The objective of study is to analyze the results obtained in the two groups in order to evaluate the effectiveness of auriculotherapy for the management of postoperative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients aged 18 to 84 years.\n* Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated\n\nExclusion Criteria:\n\n* Have already benefited from an auriculotherapy session.\n* Presence of cryoglobulinemia.\n* Presence of Raynaud's syndrome.\n* Presence of hemoglobinopathy (hemoglobin and capillary abnormalities).\n* Allergy to cold.\n* Presence of dermatological lesions on the auricle of one of the two ears"}, 'identificationModule': {'nctId': 'NCT06693167', 'acronym': 'AURDO1', 'briefTitle': 'Adjuvant Treatment of Postoperative Pain Following Endoscopic Carpal Tunnel Surgery by Auriculotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Clinique Bizet'}, 'officialTitle': 'Adjuvant Treatment of Postoperative Pain Following Endoscopic Carpal Tunnel Surgery by Auriculotherapy', 'orgStudyIdInfo': {'id': '0990-0279'}}, 'armsInterventionsModule': {'interventions': [{'name': 'chirurgie canal carpien', 'type': 'PROCEDURE', 'description': 'study compares a group of patients who received a preoperative auriculotherapy session followed by standard analgesic treatment to a group who received only standard analgesic treatment, and this, during the three days following surgery (D1, D2, and D3).'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Bizet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}