Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-26 @ 2:16 AM
Study NCT ID:
NCT01923493
Status:
COMPLETED
Last Update Posted:
2015-02-09
First Post:
2013-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tuina for Patients With Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-06', 'studyFirstSubmitDate': '2013-08-13', 'studyFirstSubmitQcDate': '2013-08-13', 'lastUpdatePostDateStruct': {'date': '2015-02-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean neck pain intensity of the last seven days', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'mean neck pain intensity of the last seven days', 'timeFrame': '12 weeks'}, {'measure': 'Neck Pain and Disability Scale (NPDS)', 'timeFrame': '4 weeks, 12 weeks'}, {'measure': 'Neck Disability Index (NDI)', 'timeFrame': '4 weeks, 12 weeks'}, {'measure': 'SF-12 health related quality of life', 'timeFrame': '4 weeks, 12 weeks'}, {'measure': 'Costs', 'timeFrame': '4 weeks, 12 weeks', 'description': 'Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.'}, {'measure': 'Body efficacy expectation', 'timeFrame': '4 weeks, 12 weeks', 'description': "Body-Efficacy Expectation (BEE) is a scale to measure the conviction that one's body is able to deal with health-threatening factors by itself. It is a six items' scale developed in the Institute of Social Medicine, Epidemiology and Health Economics"}, {'measure': 'medication intake', 'timeFrame': '4 weeks, 12 weeks', 'description': 'number and type of medication used'}, {'measure': 'number of serious adverse events', 'timeFrame': '4 weeks, 12 weeks'}, {'measure': 'adverse reactions', 'timeFrame': '4 weeks, 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neck pain', 'tuina'], 'conditions': ['Chronic Neck Pain']}, 'descriptionModule': {'briefSummary': 'The aim is to evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.', 'detailedDescription': 'Objective: To evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.\n\nStudy Design: Open single-centre randomized two-armed controlled trial. Setting: The study will be performed at a University out-patient clinic specialized in Integrative Medicine, with experience in the treatment of chronic pain.\n\nParticipants: 88 outpatients with chronic neck pain, who will be randomly allocated to two groups (tuina, or no intervention (control)).\n\nIntervention: Patients receive either six tuina treatments within 3 weeks or no additional intervention.\n\nMain outcome measure: The primary outcome is the mean neck pain intensity over the last seven days on a visual analogue scale (Huskisson, 1974) (VAS, 0-100 mm, 0 = no pain, 100= worst imaginable pain) after four weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female or male\n* 18 to 60 years of age\n* clinical diagnosis "chronic neck pain", i.e. neck pain for at least 12 weeks\n* if additional back pain is reported, neck pain has to be predominant\n* intensity of the average neck pain over the last 7 days had to be more than 40 mm on a 100-mm visual analogue scale (VAS)\n* ability to give oral and signed written informed consent\n* patient\'s mental and physical ability to participate in the trial\n* willingness to be randomized, to attend visits, to complete questionnaires\n* written and oral informed consent\n\nExclusion Criteria:\n\n* neck pain caused by a malignant disease\n* neck pain caused by trauma\n* rheumatic disorder\n* prior spinal column surgery\n* neurological symptoms, e.g. radicular symptoms because of a prolapsed vertebral disc\n* suspected osteoporosis\n* obesity with BMI ≥30 Kg/m2\n* known vascular anomaly such as aneurysm\n* regular intake of analgesics (\\>1x per week) because of a additional diseases\n* intake of centrally acting analgesics\n* current application for a benefit\n* pregnancy\n* severe acute and or chronic disease which does not allow participation in the therapy\n* other limitations which do not allow participation in the therapy\n* alcohol or substance abuse\n* tuina treatment during the six months before study entry\n* participation in another clinical trial during six months before the study and parallel to the study\n* anticipated new treatments which have a positive influence on the neck pain such as physiotherapy against neck pain, acupuncture, massage during the study\n* no sufficient German language skills'}, 'identificationModule': {'nctId': 'NCT01923493', 'acronym': 'tuina', 'briefTitle': 'Tuina for Patients With Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List', 'orgStudyIdInfo': {'id': 'Tuina-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'no intervention waiting list', 'description': 'Patients in the no intervention waiting list group will not receive a study intervention.', 'interventionNames': ['Other: no intervention']}, {'type': 'EXPERIMENTAL', 'label': 'tuina', 'description': 'tuina treatment', 'interventionNames': ['Other: tuina']}], 'interventions': [{'name': 'tuina', 'type': 'OTHER', 'otherNames': ['chinese massage'], 'description': 'Patients in the tuina group will receive a tuina therapy (also known as Chinese massage). A Chinese massage lasts about 20 to 30 minutes. A series of 6 sessions with 2 treatments per week is applied.', 'armGroupLabels': ['tuina']}, {'name': 'no intervention', 'type': 'OTHER', 'description': 'Patients in the no intervention waiting list group will not receive a study intervention. They will continue their respective pre-study therapy during the study period.', 'armGroupLabels': ['no intervention waiting list']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia M Witt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Claudia M. Witt', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}