Ignite Creation Date:
2025-12-24 @ 2:40 PM
Ignite Modification Date:
2025-12-26 @ 9:17 AM
Study NCT ID:
NCT01622959
Status:
COMPLETED
Last Update Posted:
2020-01-30
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of ACUPUNCTURE in Emergency Departement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'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'}], 'ancestors': [{'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-28', 'studyFirstSubmitDate': '2012-06-15', 'studyFirstSubmitQcDate': '2012-06-15', 'lastUpdatePostDateStruct': {'date': '2020-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'analgisia effect of acupuncture', 'timeFrame': 'one year', 'description': 'subjuctive outcome'}], 'secondaryOutcomes': [{'measure': 'use of acupuncture in emergency departement', 'timeFrame': 'one year', 'description': 'objective outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emergency departement', 'acute pain', 'acupuncture', 'morphine'], 'conditions': ['Age ≥18 Years', 'Presigned Consentement to Participate in the Study']}, 'referencesModule': {'references': [{'pmid': '11926601', 'type': 'BACKGROUND', 'citation': 'MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R; STandards for Reporting Interventions in Controlled Trails of Acupuncture. Standards for reporting interventions in controlled trials of acupuncture: The STRICTA recommendations. STandards for Reporting Interventions in Controlled Trails of Acupuncture. Acupunct Med. 2002 Mar;20(1):22-5. doi: 10.1136/aim.20.1.22.'}]}, 'descriptionModule': {'briefSummary': 'Pain is the most common reason that patients present to an emergency department (ED) and is often inadequately managed. Evidence suggests that acupuncture is effective for pain relief, yet it is rarely practiced in the ED.\n\nIn 1998, a United States National Institute of Health Consensus Conference Panel reviewed the status of acupuncture and concluded that: "There is sufficient evidence of acupuncture\'s value to expand its use into conventional medicine and to encourage further studies of its physiology and clinical value." Similarly, in 2002, the World Health Organisation (WHO) stated that acupuncture is a safe, simple and convenient therapy and that its effectiveness as analgesia has been established in controlled clinical studies.\n\nNotwithstanding these difficulties, it has been shown that acupuncture analgesia in the treatment of chronic pain is comparable to morphine and that its better safety profile and lack of dependence makes it the preferred method of choice for these conditions.\n\nThere are very few clinical trials of acupuncture for acute pain to inform clinical practice; that\'s why we have the idea to do this study in our emergency department.', 'detailedDescription': 'The objective is to evaluate the efficacy and the tolerance of acupuncture compared to intravenous morphine in the management of acute pain.\n\nThe results will also identify the impact that acupuncture treatment may have upon health resource utilization in the ED setting.\n\nIt is a randomized, prospective, controlled, conducted into emergency department. Acupuncture will be applied according to Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA).\n\nIn all included we recorded at baseline :\n\nAge, sex, job, comorbidity, hour of beginning of pain. Injury nature and severity assessed by the Injury Severity Score (ISS) Mechanism of the injury and radiologic findings. VAPS : 0-100%'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Traumatic and non traumatic acute (\\<72 hours) musculoskeletal pain with visual analog pain scale ( VAS or NRS ) \\> 40 (on a scale 0-100)\n* Age ≥18 years\n* Presigned consentement to participate in the study.\n* no evidence of fracture or dislocation, including ankle and knee sprains without signs of severity (ligament rupture, laxity); shoulder and elbow tendonitis; upper and lower limb mechanical pains and lower back pain with no evidence of neurological deficit; acute abdominal pain with no urgent surgical intervention including renal colic and dysmenorrhea; and acute headache .\n\nExclusion Criteria:\n\n* Temperature \\> 37.7° C,\n* Anticoagulation medication use or the presence of a mechanical heart valve,\n* Skin infections that would preclude certain acupuncture points being used,\n* Refusal, inability to consent or communication difficulties,\n* Acute major trauma,\n* Any form of analgesia up to 60 minutes prior to study start,\n* An initial pain score ≤ 40 on the pain scale (score range 0-100),\n* Opiate contraindication,\n* Pregnancy,\n* Presentation to the ED \\> 4 times in the previous 3 months with the same condition.'}, 'identificationModule': {'nctId': 'NCT01622959', 'briefTitle': 'Use of ACUPUNCTURE in Emergency Departement', 'organization': {'class': 'OTHER', 'fullName': 'University of Monastir'}, 'officialTitle': 'Acupuncture Versus Intravenous Morphine in the Management of Acute Pain in Emergency Department (ED)', 'orgStudyIdInfo': {'id': 'use of ACUPUNCTURE in ED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'acupuncture', 'description': 'Inclusion criteria:\n\nTraumatic and non traumatic acute pain with visual analog pain scale ( VAPS) \\> 40 (on a scale 0-100) Age ≥18 years Presigned consentement to participate in the study.\n\nExclusion criteria:\n\nTemperature \\> 37.7° C, Anticoagulation medication use or the presence of a mechanical heart valve, Skin infections that would preclude certain acupuncture points being used, Refusal, inability to consent or communication difficulties, Acute major trauma, Any form of analgesia up to 60 minutes prior to study start, An initial pain score ≤ 40 on the pain scale (score range 0-100), Opiate contraindication, Pregnancy, Presentation to the ED \\> 4 times in the previous 3 months with the same condition.', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'SHAM_COMPARATOR', 'label': 'morphine', 'description': 'drug:5mg of morphine followed by intravenous administration of 2,5 mg morphine each 5 min, until VAPS becomes \\<30%.', 'interventionNames': ['Procedure: Acupuncture']}], 'interventions': [{'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': "-Group Acupuncture: Receiving protocol of acupuncture. Acupuncture is performed by a trained certificied resident.\n\nThe protocols, which allow acupuncture points to be selected from a pool of pre-determined points for each condition, provide sufficient standardization to assist replication, yet are flexible enough to allow individualized treatments. These protocols also allow for additional points, such as 'ashi points', to be used at the discretion of the acupuncturist. The location of the points, angle of insertion and depth of insertion were sourced from a popular text 'A Manual of Acupuncture'.\n\n-Group Morphine: Receiving 5mg of morphine followed by intravenous administration of 2,5 mg morphine each 5 min, until VAPS becomes \\<30%. Treatment failure is defined as VAPS\\>30 %, 30min after beginning of the protocol. In this case, analgesic treatment was administered according to the treating physician discretion.", 'armGroupLabels': ['acupuncture', 'morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Monastir', 'country': 'Tunisia', 'facility': 'Emergency Departement', 'geoPoint': {'lat': 35.77799, 'lon': 10.82617}}], 'overallOfficials': [{'name': 'nouira semir, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Monastir'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Monastir', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Pr. Semir Nouira', 'investigatorAffiliation': 'University of Monastir'}}}}