Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT00952432
Status:
UNKNOWN
Last Update Posted:
2011-04-12
First Post:
2009-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002349', 'term': 'Carpal Tunnel Syndrome'}], 'ancestors': [{'id': 'D020423', 'term': 'Median Neuropathy'}, {'id': 'D020422', 'term': 'Mononeuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009408', 'term': 'Nerve Compression Syndromes'}, {'id': 'D012090', 'term': 'Cumulative Trauma Disorders'}, {'id': 'D013180', 'term': 'Sprains and Strains'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002220', 'term': 'Carbamazepine'}, {'id': 'D015670', 'term': 'Acupuncture Therapy'}], 'ancestors': [{'id': 'D003984', 'term': 'Dibenzazepines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-04-11', 'studyFirstSubmitDate': '2009-08-03', 'studyFirstSubmitQcDate': '2009-08-04', 'lastUpdatePostDateStruct': {'date': '2011-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use QtracW and NCS to evaluate the changes between pre-treatment and post-treatment in patients in both arms.', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'use BCTQ to evaluate the efficacy of 2 arms at week 4 and at week 12.', 'timeFrame': '12 weeks'}, {'measure': 'use VAS to evaluate the efficacy of 2 arms at week 5, 8 and 12.', 'timeFrame': '12 weeks'}, {'measure': 'Use Quality of Life questionnaire to compare the efficacy of 2 arms at week 12.', 'timeFrame': '12 weeks'}, {'measure': 'Evaluate the safety of 2 arms during the study period', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carpal Tunnel Syndrome', 'Multiple Excitability Test', 'Nerve Conduction Study', 'QtracW', 'carbamazepine', 'Acupuncture'], 'conditions': ['Carpal Tunnel Syndrome', 'Multiple Excitability Test']}, 'descriptionModule': {'briefSummary': 'The goal of the study is to utilize BCTQ(Boston Carpal Tunnel Questionnaire), VAS (Visual Analog Scale), NCS (Nerve Conduction Study), and MET(Multiple Excitability Test) to evaluate and compare the efficacy of Acupuncture Therapy and Carbamazepine in Patients with Carpal Tunnel Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 20 years old\n* outpatient or inpatient subject with numbness of arm, clinically met diagnostic criteria of AAEM(American association of Electrodiagnostic Medicine CTS task force), and proven to have distal motor neurological disorder through nerve Conduction Study (distal motor latency \\>4.6 msec, decreased SNAP \\< 12uV or prolonged median sensory distal latency (palm to wrist) \\> 2.5msec)。\n* Willing to sign the Informed Consent form\n\nExclusion Criteria:\n\n* subject with external hand injury or disformation\n* subject with Polyneuritis or Cervical nerve root lesions\n* Subject with peripheral hypertrophy, hypothyroidism, multiple myeloma, or amyloidosis\n* Allergic to Carbamazepine or similar type of medicine\n* inability to act independently, or in the opinion of the investigator, not suitable for the study\n* In the opinion of the investigator, the subject requires surgical repair of the Carpal Tunnel Syndrome, or the symptoms will be worsen result in irreversible damage to the subject if not treated with surgical repair within 3 months.'}, 'identificationModule': {'nctId': 'NCT00952432', 'briefTitle': 'Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'A Single-center, Prospective, Randomized, Positive Controlled, Parallel Design Trial to Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test', 'orgStudyIdInfo': {'id': '2008WFCRC-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACUPUNCTURE', 'description': 'ACUPUNCTURE', 'interventionNames': ['Procedure: Acupuncture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MEDICATION', 'description': 'Carbamazepine', 'interventionNames': ['Drug: Carbamazepine']}], 'interventions': [{'name': 'Carbamazepine', 'type': 'DRUG', 'description': 'Carbamazepine 200mg, 1/2 tablet, TID for 1 month', 'armGroupLabels': ['MEDICATION']}, {'name': 'Acupuncture', 'type': 'PROCEDURE', 'description': 'Acupuncture', 'armGroupLabels': ['ACUPUNCTURE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '116', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jia-Ying Sung, MD', 'role': 'CONTACT', 'email': '96317@wanfang.gov.tw', 'phone': '+886-2-2930-7930', 'phoneExt': '6940'}, {'name': 'Jia-Ying Sung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Taipei Medical University - Wan Fang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jia-Ying Sung, MD', 'role': 'CONTACT', 'email': '96317@wanfang.gov.tw', 'phone': '+886-2-2930-7930', 'phoneExt': '6940'}], 'overallOfficials': [{'name': 'Jia-Ying Sung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University-Wan Fang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jia-Ying Sung', 'oldOrganization': 'Wan Fang Hospital'}}}}