Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-31 @ 5:42 PM
Study NCT ID:
NCT01368393
Status:
COMPLETED
Last Update Posted:
2012-12-17
First Post:
2011-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electroacupuncture Analgesia for Colonoscopy
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': 'D015671', 'term': 'Electroacupuncture'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D004561', 'term': 'Transcutaneous Electric Nerve Stimulation'}, {'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D000758', 'term': 'Anesthesia'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-14', 'studyFirstSubmitDate': '2011-06-06', 'studyFirstSubmitQcDate': '2011-06-06', 'lastUpdatePostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose of patient-controlled sedation/analgesia consumed', 'timeFrame': 'During the procedure (up to 1 day)'}], 'secondaryOutcomes': [{'measure': 'Pain score', 'timeFrame': 'During the procedure (up to 1 day)', 'description': 'Using a 10-cm unscaled visual analog scale; 0 = no pain, 10 = very painful'}, {'measure': "Patients' satisfaction score", 'timeFrame': 'During the procedure (up to 1 day)', 'description': 'Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied'}, {'measure': "Patients' willingness to repeat the procedure", 'timeFrame': 'Up to 1 day'}, {'measure': "Endoscopists' satisfaction score", 'timeFrame': 'During the procedure (up to 1 day)', 'description': 'Using a 10-cm unscaled visual analog scale; 0 = not satisfied, 10 = very satisfied'}, {'measure': 'Cecal intubation rate', 'timeFrame': 'During the procedure (up to 1 day)', 'description': 'Complete colonoscopy is defined as identification of ileocecal valve'}, {'measure': 'Cecal intubation time', 'timeFrame': 'During the procedure (up to 1 day)', 'description': 'The time from introduction of the colonoscope to the cecum'}, {'measure': 'Total procedure time', 'timeFrame': 'During the procedure (up to 1 day)'}, {'measure': 'Episodes of hypotension', 'timeFrame': 'During the procedure (up to 1 day)', 'description': 'Defined as systolic blood pressure \\<90 mmHg'}, {'measure': 'Episodes of desaturation', 'timeFrame': 'During the procedure (up to 1 day)', 'description': 'Defined as SaO2 \\<90%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Background:\n\nColonoscopy is often regarded as a painful and unpleasant procedure. Electroacupuncture (EA) has been used successfully to treat pain of various origins, but few good-quality studies have evaluated its role in treating pain and anxiety during colonoscopy.\n\nObjective:\n\nTo investigate the efficacy of EA in reducing procedure-related pain and the consumption of sedatives/analgesics during colonoscopy.\n\nDesign:\n\nProspective, randomized, double-blind, sham-controlled study.\n\nSubjects:\n\nOne hundred and twenty eight consecutive patients undergoing first-time elective day-case colonoscopy without previous experience of acupuncture will be recruited.\n\nInterventions:\n\nPatients will be randomized to receive either 45 minutes of EA or sham acupuncture (SA) before colonoscopy. The acupoints relevant to the treatment of abdominal pain, including Zusanli, Hegu, and Neiguan will be used. For the SA group, blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. Foam blocks will be used to stabilize the needles and to blind the patients and endoscopists to the treatment allocation. EA and SA will be continued throughout colonoscopy. A mixture of Propofol and Alfentanil, delivered by a patient-controlled syringe pump, will be used for sedation/analgesia in both groups.\n\nOutcome measures:\n\nPrimary outcome: doses of patient-controlled sedation/analgesia consumed. Secondary outcomes: pain and satisfaction scores according to a visual analog scale, cecal intubation rate/time, and episodes of hypotension/desaturation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Consecutive patients (aged between 18 and 60 years) undergoing first-time elective day-case colonoscopy\n* Patients with American Society of Anesthesiologists (ASA) grading I-II\n* Informed consent available\n\nExclusion criteria:\n\n* Patients with previous experience of acupuncture\n* Patients with previous history of colorectal surgery\n* Patients who are diagnosed with irritable bowel syndrome according to Rome III criteria\n* Patients with chronic pain syndrome\n* Patients with psychiatric disorder\n* Patients with poor cognitive function\n* Patients with renal impairment\n* Patients with obstructive sleep apnea syndrome\n* Patients with cardiac arrhythmias\n* Patients with cardiac pacemaker\n* Patients who are pregnant\n* Patients who are allergic to the acupuncture needles or Propofol/Alfentanil'}, 'identificationModule': {'nctId': 'NCT01368393', 'briefTitle': 'Electroacupuncture Analgesia for Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Electroacupuncture Analgesia for Colonoscopy: a Prospective, Randomized, Double-blind, Sham-controlled Study', 'orgStudyIdInfo': {'id': 'CRE-2010.404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Electroacupuncture', 'interventionNames': ['Procedure: Electroacupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sham acupuncture', 'interventionNames': ['Procedure: Sham acupuncture']}], 'interventions': [{'name': 'Electroacupuncture', 'type': 'PROCEDURE', 'description': 'Patients randomized to the experimental group will receive electroacupuncture at acupoints relevant to the treatment of abdominal pain and anxiety, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), and Neiguan (pericardium meridian PC-6). Electric stimulation will be employed to the needles', 'armGroupLabels': ['Electroacupuncture']}, {'name': 'Sham acupuncture', 'type': 'PROCEDURE', 'description': 'Sterile blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. "Pseudostimulation" will be given by deliberately connecting the needle to the incorrect output socket of the electroacupuncture device, thus there will be no flow of electric current.', 'armGroupLabels': ['Sham acupuncture']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong SAR', 'country': 'China', 'facility': 'Prince of Wales Hospital, The Chinese University of Hong Kong'}], 'overallOfficials': [{'name': 'Simon SM Ng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Simon S. M. Ng', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}