Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT06197620
Status:
COMPLETED
Last Update Posted:
2024-01-23
First Post:
2023-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point Combined With Standard Therapy After Laparoscopic Living Donor Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-22', 'studyFirstSubmitDate': '2023-11-23', 'studyFirstSubmitQcDate': '2023-12-26', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain severity with Visual Analog Scale', 'timeFrame': '7 days before laparoscopic living donor nephrectomy and on 1st, 2nd, 14th day after laparoscopic living donor nephrectomy procedure', 'description': 'Visual Analog Scale (VAS) that score 0 is no pain to 100 the worse pain A higher result means worse outcomes and lower result means better outcomes'}], 'secondaryOutcomes': [{'measure': 'Quality of Life with Short Form 36', 'timeFrame': '7 days before laparoscopic living donor nephrectomy, and on 1st, 2nd, and 14th day after laparoscopic living donor nephrectomy procedure', 'description': 'Quality of life using Short Form 36 scoring system. It contains 8 domains such as physical function, role limitation due to physical health, role limitation due to emotional health, energy/fatigue, emotional well-being, social functioning, pain, general health. The scoring s calculated with online calculator provided by MDApp website. The result is in percentage, with higher result means better quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic Living Donor Nephrectomy', 'Post Operative Acute Pain', 'Quality of Life', 'Thread Embedding Acupuncture'], 'conditions': ['Post Operative Pain, Acute', 'Renal Transplant Donor of Left Kidney', 'Quality of Life', 'Acupuncture Analgesia']}, 'descriptionModule': {'briefSummary': 'Kidney transplantation is the main option besides hemodialysis and continuous ambulatory peritoneal dialysis (CAPD) to prolong and improve the quality of life for patients with end-stage renal disease. The main option for obtaining organs from living donors is surgical action to remove the kidney (nephrectomy) using the laparoscopic method (laparoscopic live donor nephrectomy or LLDN). Postoperative management of LDNH in the form of intravenous paracetamol 1000 mg cannot overcome innovative pain and has drug-related risk effects.\n\nNon-pharmacological pain management is the first line of pain management. One non-pharmacological therapy that can be an option is acupuncture. Thread embedding acupuncture (TEA) is an acupuncture method that uses certain medical threads such as catgut or polydioxanone (PDO) which are inserted into subcutaneous tissue or muscle at certain acupuncture points.\n\nThe working mechanism of TEA in treating pain is through local mechanisms in the form of releasing adenosine which binds to adenosine A1 receptors, releasing substance P, inhibiting the expression and activation of Nuclear Factor Kappa B; through a segmental mechanism in the form of a control gate mechanism; through extrasegmental mechanisms in the form of downward pain inhibition pathways; through a central mechanism in the form of release of endogenous opioids in the hypothalamus. ATB can provide a continuous stimulating effect of infiltration and acceleration of tissue regeneration, increasing anti-pain.', 'detailedDescription': 'The main outcome is to determine the effect of thread embedding acupuncture at the EX-B2 point on first lumbar on pain intensity in patients after laparoscopic living donor nephrectomy (LLDN) and to determine the effect of thread embedding acupuncture at the EX-B2 point on first lumbar on the quality of life in patients after laparoscopic living donor nephrectomy (LLDN).\n\nThe thread embedding will use Polydioxanone thread size 30G x 25,4 mm. This thread will last maximum 7 months before fully absorbed.\n\nPain intensity will be assessed using the VAS score 7 days before LLDN surgery (before the thread implant acupuncture procedure); and on the first, second, third, and fourteenth days after the LLDN procedure.\n\nQuality of life scores will be measured with the Indonesian version of SF-36 questionnaire carried out seven days before LLDN surgery, on the first postoperative day, and on the fourteenth day after LLDN surgery.\n\nThe research design in this study was a case series with 6 subject only.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects are prospective kidney donors who will undergo laparoscopic living donor nephrectomy (LLDN).\n2. Adult patients with an age range of 21-60 years.\n3. Willing to take part in this research and sign informed consent.\n\nExclusion Criteria:\n\n1. The patient has a history of hypersensitive reactions to thread embedding acupuncture (TEA).\n2. The patient has a history of keloids or is prone to keloid formation.\n3. The patient has skin disease at the location of the TEA installation area in the back area.\n4. There are abnormalities in the neurological examination of the lower extremities.\n5. Have a history of spinal surgery or are scheduled to undergo spinal surgery within 7 months after the LLDN procedure.\n6. There is scoliosis based on clinical examination.\n7. There are other specific diagnoses that can cause secondary low back pain such as inflammatory spondylitis, spinal infection, or tumor.\n8. Female patients who plan to become pregnant within 7 months after the LLDN procedure.\n9. The patient has a body mass index (BMI) below 18 kg/m2\n10. The patient has uncontrolled diabetes mellitus.'}, 'identificationModule': {'nctId': 'NCT06197620', 'briefTitle': 'Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point Combined With Standard Therapy After Laparoscopic Living Donor Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Effectiveness of Thread Embedding Acupuncture Analgesia at the EX-B2 Point at the First Lumbar Level Combined With Standard Therapy on Acute Pain and Quality of Life After Post Laparoscopic Living Donor Nephrectomy', 'orgStudyIdInfo': {'id': '23-08-1375'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thread Embedding Acupuncture and Standard Therapy', 'description': 'The patients are pre-operative laparoscopic living donor nephrectomy patients that receive standard analgetic drug treatment according to post-operative kidney donor transplant protocol and receive thread embedding acupuncture. All patients are also given standard therapy after surgery in the form of intravenous Paracetamol 1000 mg, 3 times a day.', 'interventionNames': ['Other: Thread embedding acupuncture and standard therapy']}], 'interventions': [{'name': 'Thread embedding acupuncture and standard therapy', 'type': 'OTHER', 'description': 'In the treatment, thread embedding acupuncture was performed using a needle containing polydioxanone (PDO) thread at the EX-B2 acupuncture point (12.5 mm lateral to the spinous process) at the level of the 1st lumbar vertebra with an insertion angle perpendicular to the skin surface. All patients are also given standard therapy after surgery in the form of intravenous Paracetamol 1000 mg, 3 times a day.', 'armGroupLabels': ['Thread Embedding Acupuncture and Standard Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Jakarta Pusat', 'state': 'Jakarta Special Capital Region', 'country': 'Indonesia', 'facility': 'Faculty of Medicine Universitas Indonesia', 'geoPoint': {'lat': -6.1818, 'lon': 106.8223}}], 'overallOfficials': [{'name': 'KEPK FKUI RSCM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Urology, University of Indonesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Hartono Gunarso', 'investigatorAffiliation': 'Indonesia University'}}}}