Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-23 @ 9:23 PM
Study NCT ID:
NCT02222051
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2014-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tai Chi for Chronic Non-specific Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D059350', 'term': 'Chronic 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': 'D026302', 'term': 'Tai Ji'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2014-08-18', 'studyFirstSubmitQcDate': '2014-08-20', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Experiences', 'timeFrame': 'Week 24', 'description': 'Experiences with Tai Chi and neck exercises, qualitative interviews'}], 'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'week 12', 'description': 'pain intensity on a visual analogue scale (0-100mm)'}], 'secondaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'week 24', 'description': 'pain intensity on a visual analogue scale (0-100mm)'}, {'measure': 'pain on movement', 'timeFrame': 'week 12, week 24', 'description': 'pain intensity on a visual analogue scale (0-100mm) evoked by head movement into 6 directions POM validated by Lauche et al., 2014, Pain Medicine'}, {'measure': 'neck disability', 'timeFrame': 'week 12, week 24', 'description': 'neck disability index (NDI), Vernon et al.'}, {'measure': 'health related quality of life', 'timeFrame': 'week 12, week 24', 'description': 'short form quality of life questionnaire (SF-36), Bullinger and Kirchberger'}, {'measure': 'Anxiety and Depression', 'timeFrame': 'week 12, week 24', 'description': 'Hospital Anxiety and Depression Scale (HADS)'}, {'measure': 'Wellbeing', 'timeFrame': 'week 12, week 24', 'description': 'Wellbeing on the FEW16 Questionnaire'}, {'measure': 'Stress', 'timeFrame': 'week 12, week 24', 'description': 'Subjective stress perception, Perceived Stress Scale (PSS)'}, {'measure': 'interoceptive awareness', 'timeFrame': 'week 12, week 24', 'description': 'The Multidimensional Assessment of Interoceptive Awareness (MAIA)'}, {'measure': 'Postural Awareness', 'timeFrame': 'week 12, week 24', 'description': 'Postural Awareness Questionnaire (PAS)'}, {'measure': 'Safety', 'timeFrame': 'week 24', 'description': 'All adverse and serious adverse events'}, {'measure': 'pain intensity ratings', 'timeFrame': 'week 12', 'description': 'daily rating of pain intensity, visual analog scales'}, {'measure': 'use of analgetics', 'timeFrame': 'week 12', 'description': 'daily information on use of analgetics'}, {'measure': 'use of concomitant therapies', 'timeFrame': 'week 12', 'description': 'daily information on use of concomitant therapies for neck pain'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['neck pain', 'chronic pain'], 'conditions': ['Neck Pain']}, 'referencesModule': {'references': [{'pmid': '28146026', 'type': 'BACKGROUND', 'citation': 'Lauche R, Wayne PM, Fehr J, Stumpe C, Dobos G, Cramer H. Does Postural Awareness Contribute to Exercise-Induced Improvements in Neck Pain Intensity? A Secondary Analysis of a Randomized Controlled Trial Evaluating Tai Chi and Neck Exercises. Spine (Phila Pa 1976). 2017 Aug 15;42(16):1195-1200. doi: 10.1097/BRS.0000000000002078.'}, {'pmid': '27345663', 'type': 'RESULT', 'citation': 'Lauche R, Stumpe C, Fehr J, Cramer H, Cheng YW, Wayne PM, Rampp T, Langhorst J, Dobos G. The Effects of Tai Chi and Neck Exercises in the Treatment of Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. J Pain. 2016 Sep;17(9):1013-27. doi: 10.1016/j.jpain.2016.06.004. Epub 2016 Jun 23.'}, {'pmid': '36930781', 'type': 'DERIVED', 'citation': 'Allende S, Cramer H, Wayne P, Lauche R. Investigating Inter- and Intra-individual Differences in Tai Chi Practice Time, Pain, and Mood Among Participants with Chronic Nonspecific Neck Pain: Secondary Analysis of a Randomized Controlled Trial. J Integr Complement Med. 2023 Apr;29(4):234-240. doi: 10.1089/jicm.2022.0789. Epub 2023 Mar 17.'}]}, 'descriptionModule': {'briefSummary': 'In this study the efficacy of Tai Chi will be tested in comparison to conventional neck exercises and usual care in a randomized controlled trial. Tai Chi and neck exercises will be lead by a trained exercise therapist and Tai Chi instructor, both groups receive 12 weeks of training, once weekly for 60-90 min in a group setting. Pain, Disability, quality of life, wellbeing, stress perception, psychological distress will be used to determine effects.', 'detailedDescription': 'see above'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic non specific neck pain (3 months at least)\n* 45mm pain intensity on average on the visual analog scale\n\nExclusion Criteria:\n\n* specific neck pain due to\n* inflammatory diseases\n* rheumatic diseases\n* neurological diseases\n* prolapse or protrusion\n* oncological disease\n* trauma (whiplash)\n* congenital deformity of the spine\n* severe comorbidity (somatic, psychiatric)\n* pregnancy\n* participation in other clinical trials\n* regular practice of tai chi, qigong, yoga in the past 6 months\n* medication with opioids'}, 'identificationModule': {'nctId': 'NCT02222051', 'acronym': 'TaiChiNe', 'briefTitle': 'Tai Chi for Chronic Non-specific Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Universität Duisburg-Essen'}, 'officialTitle': 'Tai Chi for Chronic Non-specific Neck Pain: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '13-5672 Tai Chi Neck Pain'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tai Chi', 'description': 'Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes', 'interventionNames': ['Behavioral: Tai Chi']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Neck exercise', 'description': 'conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education', 'interventionNames': ['Behavioral: Neck exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'Usual care, no specific study intervention this group is offered Tai Chi or neck exercises at the end of the study'}], 'interventions': [{'name': 'Tai Chi', 'type': 'BEHAVIORAL', 'otherNames': ['Taiji', "T'ai Chi"], 'description': 'traditional chinese martial art meditative movement technique', 'armGroupLabels': ['Tai Chi']}, {'name': 'Neck exercises', 'type': 'BEHAVIORAL', 'otherNames': ['neck training'], 'description': 'group exercises for strengthening and stretching neck and back muslces to alleviate neck pain', 'armGroupLabels': ['Neck exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45276', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Gustav Dobos, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Internal and Integrative Medicine, Kliniken Essen-Mitte'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universität Duisburg-Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Romy Lauche', 'investigatorAffiliation': 'Universität Duisburg-Essen'}}}}