Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-11 @ 1:45 AM
Study NCT ID:
NCT06783556
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-22
First Post:
2025-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Analgesia Effect of Electroacupuncture Battlefield Acupuncture Versus Sham Electroakupuncture Post Surgery
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', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The participants, the outcome assessors will be blinded to group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy will be designated as the intervention group, while the sham electroacupuncture and paracetamol intravenous therapy will be designated as the control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-18', 'studyFirstSubmitDate': '2025-01-09', 'studyFirstSubmitQcDate': '2025-01-14', 'lastUpdatePostDateStruct': {'date': '2025-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': 'Before therapy, minute 0, hour 8, hour 24, hour 48', 'description': 'Visual Analogue Scale is the tool that measures pain intensity. It use a scale with a minimum range of 0 and a maximum of 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate worse pain.'}], 'secondaryOutcomes': [{'measure': 'Analgesic dose reduction', 'timeFrame': 'hour 8, hour 24, hour 48', 'description': "Paracetamol 1000 mg IV is given to patient with a maximum of 3 times administration per 24 hours. The dose of paracetamol can be reduced when the patien's pain score of Visual Analogue Score is less than 3. Measurements were made by measuring the cumulative dose of analgesics after acupuncture therapy. Then compared between the two groups, which group had a greater decrease in analgesic dose."}, {'measure': 'Short Form 36 (SF-36) Questionnaire', 'timeFrame': 'Before therapy, day 7', 'description': 'The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). To score the SF-36, scales are standardized with a scoring algorithm to obtain a score ranging from 0 to 100. Higher scores indicate better health status.'}, {'measure': 'Adverse effects', 'timeFrame': 'Day 7', 'description': 'Record the adverse effects that occur after acupuncture therapy. It will be monitored for 7 days after therapy and recorded on the 7th day by assessor.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Percutaneous Nephrolithotomy']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn the effect of ear electroacupuncture BFA therapy in reducing pain, analgesic dose, and improving patient quality of live post percutaneous nephrolithotomy surgery. The main questions it aims to answer are:\n\n* Does BFA ear electroacupuncture reduce postoperative pain of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?\n* Does BFA ear electroacupuncture reduce postoperative analgesic dose of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?\n* Does BFA ear electroacupuncture improve postoperative quality of life of percutaneous nephrolithotomy surgery better than sham electroacupuncture group?\n\nResearchers will compare ear electroacupuncture BFA to sham electroacupuncture to see the different analgesia effect between these groups.\n\nParticipants will:\n\n* Get ear electroacupuncture BFA or sham electroacupuncture therapy, 2 hours before surgery for 30 minutes\n* Take drug paracetamol 1000 mg intravenous after surgery according to the needs of the patient's pain complaints after surgery in both groups"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged 18-65 years\n* Patients who have been diagnosed with kidney stones measuring \\> 2 cm and will undergo PCNL surgery\n* VAS score \\<7, assessed 2 hours before PCNL surgery\n* Receive standard analgesic therapy\n* Willing to participate in this study until completion and sign an informed consent.\n\nExclusion Criteria:\n\n* Kidney anatomical abnormalities\n* Ear deformities (microtia)\n* Patients with cognitive impairment, uncooperative (receiving antidepressants or strong opioid or narcotic analgesics)\n* Tumors, wounds or skin infections in the needling area.\n* Heart rhythm disorder, unstable hemodynamics that require intensive care including extremely high body temperature and using a pacemaker.\n* Allergy to acupuncture needles or certain metals\n* Patients who have had a DJ stent or nephrostomy before PCNL\n* History of metal implants in the body except amalgam'}, 'identificationModule': {'nctId': 'NCT06783556', 'briefTitle': 'The Analgesia Effect of Electroacupuncture Battlefield Acupuncture Versus Sham Electroakupuncture Post Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'The Analgesia Effect of Electroacupuncture of Battlefield Acupuncture (BFA) Versus Sham Electroacupuncture on Pain, Analgesic Dose Reduction and Quality of Life Post Percutaneous Nephrolithotomy Surgery', 'orgStudyIdInfo': {'id': '24-12-1845'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy', 'interventionNames': ['Device: The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'The sham electroacupuncture and paracetamol intravenous therapy', 'interventionNames': ['Device: The sham electroacupuncture and paracetamol intravenous therapy']}], 'interventions': [{'name': 'The Ear Electroacupuncture of Battlefield Acupuncture (BFA) and paracetamol intravenous therapy', 'type': 'DEVICE', 'description': "Electroacupuncture therapy was performed 2 hours before PCNL surgery. Needle insertion was performed perpendicularly at the Battlefield Acupuncture (BFA) points of the ear, namely MA-IT1 Cingulate gyrus, MA-AT2 Thalamus, MA-H2 Omega2, MA-H1 Point Zero and MA-TF1 Shenmen bilaterally. Then the electrostimulator cable was connected to the ear acupuncture points MA-AT2 and MA-TF1 bilaterally on the same side and then fixed with plaster. Electroacupuncture uses continuous waves of 2 Hz frequency with an intensity that can be tolerated by the patient for 30 minutes.\n\nPatients also received standard therapy with 1000 mg intravenous paracetamol with a maximum of 3 times administration per 24 hours and can be reduced according to the needs of the patient's pain complaints.", 'armGroupLabels': ['Intervention Group']}, {'name': 'The sham electroacupuncture and paracetamol intravenous therapy', 'type': 'DEVICE', 'description': "Sham electroacupuncture therapy was performed 2 hours before PCNL surgery. Needle only attached using plester (not inserted) at the Battlefield Acupuncture (BFA) points of the ear, namely MA-IT1 Cingulate gyrus, MA-AT2 Thalamus, MA-H2 Omega2, MA-H1 Point Zero and MA-TF1 Shenmen bilaterally. Then the electrostimulator cable was connected to the ear acupuncture points MA-AT2 and MA-TF1 bilaterally on the same side and then fixed with plaster. Electroacupuncture device is not turned on. The therapy is carried out for 30 minutes.\n\nPatients also received standard therapy with 1000 mg intravenous paracetamol with a maximum of 3 times administration per 24 hours and can be reduced according to the needs of the patient's pain complaints.", 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'contacts': [{'name': 'Hermin Widyaprastuti', 'role': 'CONTACT', 'email': 'hermin.widyaprastuti1@gmail.com', 'phone': '+6281286190436'}], 'facility': 'Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'centralContacts': [{'name': 'Hermin Widyaprastuti, MD', 'role': 'CONTACT', 'email': 'widyaprastuti.hermin1@gmail.com', 'phone': '+6281286190436'}], 'overallOfficials': [{'name': 'KPEK FKUI-RSCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Hermin Widyaprastuti', 'investigatorAffiliation': 'Indonesia University'}}}}