Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT01247935
Status:
COMPLETED
Last Update Posted:
2011-07-12
First Post:
2010-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Electroacupuncture and Trancutaneous Electrical Nervous Stimulation (TENS) for Colonoscopy Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D015671', 'term': 'Electroacupuncture'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-07-11', 'studyFirstSubmitDate': '2010-11-12', 'studyFirstSubmitQcDate': '2010-11-24', 'lastUpdatePostDateStruct': {'date': '2011-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evaluation of patients' discomfort and pain during and at the end of colonoscopy both in acupuncture group and in TENS group compare with controls.", 'timeFrame': "During colonoscopy, we'll evaluate pain at colorectal, left, trasversal and right colon position of colonscope. At the end of colonoscopy, before discharge, we' ll evaluate patient's general discomfort."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pain', 'Acupuncture', 'Transcutaneous electrical nerve stimulation', 'Colonoscopy'], 'conditions': ['Pain']}, 'referencesModule': {'references': [{'pmid': '12377792', 'type': 'BACKGROUND', 'citation': 'Sung JJ. Acupuncture for gastrointestinal disorders: myth or magic. Gut. 2002 Nov;51(5):617-9. doi: 10.1136/gut.51.5.617.'}, {'pmid': '19293789', 'type': 'BACKGROUND', 'citation': 'Camilleri M. Editorial: is adequate relief fatally flawed or adequate as an end point in irritable bowel syndrome? Am J Gastroenterol. 2009 Apr;104(4):920-2. doi: 10.1038/ajg.2009.20. Epub 2009 Mar 17.'}, {'pmid': '15135942', 'type': 'BACKGROUND', 'citation': 'Han JS. Acupuncture and endorphins. Neurosci Lett. 2004 May 6;361(1-3):258-61. doi: 10.1016/j.neulet.2003.12.019.'}, {'pmid': '12591047', 'type': 'BACKGROUND', 'citation': 'Fanti L, Gemma M, Passaretti S, Guslandi M, Testoni PA, Casati A, Torri G. Electroacupuncture analgesia for colonoscopy. a prospective, randomized, placebo-controlled study. Am J Gastroenterol. 2003 Feb;98(2):312-6. doi: 10.1111/j.1572-0241.2003.07231.x.'}, {'pmid': '11423594', 'type': 'BACKGROUND', 'citation': 'Robinson R, Darlow S, Wright SJ, Watters C, Carr I, Gadsby G, Mayberry J. Is transcutaneous electrical nerve stimulation an effective analgesia during colonoscopy? Postgrad Med J. 2001 Jul;77(909):445-6. doi: 10.1136/pmj.77.909.445.'}]}, 'descriptionModule': {'briefSummary': "To compare the effectiveness of acupuncture and transcutaneous electrical nervous stimulation (TENS) in reducing patient's discomfort during colonoscopy", 'detailedDescription': "Evaluation patient's pain and discomfort during colonoscopy, using two non invasive analgesic methods."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients scheduled for colonoscopy and in whom deep sedation was not planned will be included in the study\n\nExclusion Criteria:\n\n* age \\> 80 and less than 18 years old, severe cardiac or pulmonary disease, anticoagulant, benzodiazepines, antidepressants, opiates therapies, severe cognitive impairment, uncontrolled hypertension.'}, 'identificationModule': {'nctId': 'NCT01247935', 'briefTitle': 'Electroacupuncture and Trancutaneous Electrical Nervous Stimulation (TENS) for Colonoscopy Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Per I Servizi Sanitari N. 2 Isontina'}, 'officialTitle': 'Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy: a Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': '34115/14'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Acupuncture', 'description': 'Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy', 'interventionNames': ['Other: Acupuncture']}, {'type': 'EXPERIMENTAL', 'label': 'transcutaneous electrical stimulation', 'description': 'Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy', 'interventionNames': ['Other: Transcutaneous electrical stimulation']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'patient are monitored for pain and discomfort', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Acupuncture', 'type': 'OTHER', 'otherNames': ['Electroacupuncture'], 'description': 'Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy', 'armGroupLabels': ['Acupuncture']}, {'name': 'Transcutaneous electrical stimulation', 'type': 'OTHER', 'otherNames': ['TENS'], 'description': 'Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy', 'armGroupLabels': ['transcutaneous electrical stimulation']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['No treatment (only sedative drugs if request)'], 'description': 'Patients are monitored for pain and discomfort', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34170', 'city': 'Gorizia', 'country': 'Italy', 'facility': 'Presidio Ospedaliero di Gorizia', 'geoPoint': {'lat': 45.94088, 'lon': 13.62167}}], 'overallOfficials': [{'name': 'Corrado Thomann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ICU Gorizia Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Per I Servizi Sanitari N. 2 Isontina', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Corrado Thomann', 'oldOrganization': 'Azienda per i Servizi Sanitari n. 2 Isontina'}}}}