Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2025-12-25 @ 5:31 PM
Study NCT ID:
NCT07238504
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Acupuncture for Post-hemorrhoidectomy Pain Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-08-20', 'size': 601924, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2025-09-24T10:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-09-24', 'studyFirstSubmitQcDate': '2025-11-15', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal pain intensity', 'timeFrame': 'Post-operative day 1', 'description': "Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 means 'worst pain')"}], 'secondaryOutcomes': [{'measure': 'Maximal and resting pain intensity', 'timeFrame': 'Post-operative day 0, 2 to 7 and 14', 'description': "Numeric rating scale (minimum at 0 means 'no pain', maximum at 10 mean 'worst pain')"}, {'measure': 'Dosage of analgesics requirement', 'timeFrame': 'Post-operative 2 weeks', 'description': 'Dosage of paracetamol, tramadol and celecoxib tablets taken per day over the first post-operative 2 weeks'}, {'measure': 'Length of hospital stay', 'timeFrame': 'Post-operative day 1'}, {'measure': 'Functional recovery questionnaire', 'timeFrame': 'Post-operative 1 week (time to first bowel motion, time to first urination and time to return to work, counted from the day of operation)'}, {'measure': 'Adverse effect', 'timeFrame': 'Post-operative 2 weeks', 'description': 'Effect from analgesics and acupuncture'}, {'measure': 'Quality of recovery (QoR)', 'timeFrame': 'Post-operative day 1', 'description': 'QoR-15 questionnaire, which includes 15 questions scoring at a 10-point scale. Minimum at 0 means worst outcome and maximum at 10 means best outcome.'}, {'measure': 'Serum C-reactive protein level', 'timeFrame': 'Post-operative day 0 and 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhoidectomy', 'Hemorrhoid Pain', 'Acupuncture']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if acupuncture improves pain control after hemorrhoidectomy in patients with symptomatic hemorrhoids. It will also learn about the safety of using acupuncture in surgical patients. The main questions it aims to answer are:\n\nDoes acupuncture lower the maximal pain intensity after hemorrhoidectomy? Does acupuncture reduce analgesics requirement, length of hospital stay and quality of recovery?\n\nResearchers will compare fully active acupuncture to a sham treatment (a look-alike procedure with minimum acupuncture stimulation) to see if active acupuncture works to improve pain control.\n\nParticipants will:\n\nReceive acupuncture treatment for 7 times over first 5 days after surgery. Visit the clinic once 2 weeks after surgery for checkups and tests. Keep a diary of their symptoms and the number of times they take pain-killers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symptomatic grade III or IV hemorrhoids undergoing conventional hemorrhoidectomy\n\nExclusion Criteria:\n\n1. Patients scheduled for stapled hemorrhoidopexy\n2. Concomitant surgery other than conventional hemorrhoidectomy\n3. Bleeding tendency, thrombocytopenia (platelet count \\< 100 x 10\\^9/L)\n4. Immunocompromised status or use of chemotherapy\n5. Active dermatitis\n6. Patients with pacemaker or automated implantable cardioverter-defibrillator\n7. Pregnant patients\n8. Known allergy to opioids, local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDS) including cyclooxygenase-2 inhibitors\n9. History of chronic pain (duration for 3 months or more)\n10. Daily use of strong opioids (e.g. morphine, fentanyl, hydromorphone, methadone, oxycodone, or meperidine)\n11. Alcohol or drug abuse\n12. Psychiatric illness\n13. Impaired renal function (preoperative serum creatinine level \\> 120µmol/L)\n14. Recent acupuncture treatment for other medical conditions'}, 'identificationModule': {'nctId': 'NCT07238504', 'briefTitle': 'Acupuncture for Post-hemorrhoidectomy Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'The University of Hong Kong'}, 'officialTitle': 'Acupuncture for Post-hemorrhoidectomy Pain Control With Acute Anti-inflammatory Effects: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UW 25-302'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fully active acupuncture', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'Minimum acupuncture stimulation', 'interventionNames': ['Procedure: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'otherNames': ['Fully active acupuncture'], 'description': 'Acupuncture to 6 specific acupoints, 3 distant acupoints and electrical stimulation to 4 pairs of local acupoints.', 'armGroupLabels': ['Fully active acupuncture']}, {'name': 'Acupuncture', 'type': 'PROCEDURE', 'otherNames': ['Minimum acupuncture stimulation'], 'description': 'Minimal electrical stimulation to 1 local acupoint and 2 distant acupoints', 'armGroupLabels': ['Minimum acupuncture stimulation']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Pak Chiu Wong', 'role': 'CONTACT', 'email': 'pwongpc@connect.hku.hk', 'phone': '+852-70836168'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'School of Chinese Medicine, The University of Hong Kong', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Consultant', 'investigatorFullName': 'Pak Chiu WONG', 'investigatorAffiliation': 'The University of Hong Kong'}}}}