Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-04-10 @ 5:13 AM
Study NCT ID:
NCT00615732
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2008-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Qigong and Exercise for Neck Pain in Adults (QENA)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064906', 'term': 'Qigong'}, {'id': 'D005081', 'term': 'Exercise Therapy'}], 'ancestors': [{'id': 'D001945', 'term': 'Breathing Exercises'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-09', 'studyFirstSubmitDate': '2008-02-01', 'studyFirstSubmitQcDate': '2008-02-01', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'average pain intensity during the last 7 days measured on a visual analogue scale (VAS)', 'timeFrame': 'baseline, 3, 6, 12, and 24 months'}], 'secondaryOutcomes': [{'measure': 'Neck Pain and Disability Scale (NPAD, Wheeler 1999)', 'timeFrame': 'baseline, 3, 6, 12, and 24 months'}, {'measure': 'health related quality of life (SF-36)', 'timeFrame': 'baseline, 3, 6, 12 and 24 months'}, {'measure': 'patient expectation and self efficacy (questionnaire)', 'timeFrame': 'Baseline, 3, 6, 12, and 24 months'}, {'measure': "therapist's expectation", 'timeFrame': 'baseline, 3, 6, 12, and 24 months'}, {'measure': 'undesired effects', 'timeFrame': '3, 6, 12, and 24 months'}, {'measure': 'semi-structured interviews to detect changes due to therapy and to assess the used questionnaires', 'timeFrame': '3 and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['qigong', 'traditional chinese medicine', 'exercise therapy', 'neck pain'], 'conditions': ['Chronic Neck Pain']}, 'referencesModule': {'references': [{'pmid': '21178832', 'type': 'RESULT', 'citation': 'Rendant D, Pach D, Ludtke R, Reisshauer A, Mietzner A, Willich SN, Witt CM. Qigong versus exercise versus no therapy for patients with chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2011 Mar 15;36(6):419-27. doi: 10.1097/BRS.0b013e3181d51fca.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effectiveness of qigong for the treatment of chronic neck pain compared to exercise therapy and waiting list group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of chronic neck pain since at least 6 months and complaints for a maximum duration of 5 years\n* neck pain more prominent than other pain in the spine\n* average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)\n* normal mobility of the cervical spine\n* intellectual and physical ability to participate in the study\n* informed consent\n\nExclusion Criteria:\n\n* cervical pain related to malignancy\n* cervical pain due to an accident\n* inflammatory joint disorders\n* previous spine surgery\n* protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology\n* actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.\n* use of pain drugs for other diseases (\\> 1x/week)\n* pregnancy\n* severe chronic or acute disease interfering with therapy attendance\n* alcohol or substance abuse\n* participation in another clinical trial in the last 6 months before study entry'}, 'identificationModule': {'nctId': 'NCT00615732', 'acronym': 'QENA', 'briefTitle': 'Qigong and Exercise for Neck Pain in Adults (QENA)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain', 'orgStudyIdInfo': {'id': 'QENA-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'qigong', 'interventionNames': ['Procedure: Qigong']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'exercise therapy', 'interventionNames': ['Procedure: exercise therapy']}, {'type': 'NO_INTERVENTION', 'label': '3'}], 'interventions': [{'name': 'Qigong', 'type': 'PROCEDURE', 'description': '18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week', 'armGroupLabels': ['1']}, {'name': 'exercise therapy', 'type': 'PROCEDURE', 'description': '18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Claudia M Witt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, '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'}}}}