Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-27 @ 9:35 PM
Study NCT ID:
NCT01431261
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2011-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neck Exercises, Training and Pain Management as a Treatment for Whiplash Patients With Chronic Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D014911', 'term': 'Whiplash Injuries'}, {'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019838', 'term': 'Neck Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D059408', 'term': 'Pain Management'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019468', 'term': 'Disease Management'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2011-08-30', 'studyFirstSubmitQcDate': '2011-09-08', 'lastUpdatePostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medical Outcomes Study Short Form 36 (SF36) - Physical Component Summary (PCS)', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'craniocervical flexion test', 'timeFrame': '12 months', 'description': 'test for the deep cervical flexor muscles'}, {'measure': 'cervical range of motion', 'timeFrame': '12 months'}, {'measure': 'neck positioning test', 'timeFrame': '12 months', 'description': 'neck joint position error test and gaze stability test'}, {'measure': 'Self-rated measure Global Perceived Effect', 'timeFrame': '12 months', 'description': 'questionnaire'}, {'measure': 'Neck Disability Index', 'timeFrame': '12 months', 'description': 'questionnaire'}, {'measure': 'Pain Bothersomeness', 'timeFrame': '12 months', 'description': 'questionnaire'}, {'measure': 'Pain Specific Functioning Scale', 'timeFrame': '4 months and 12 months', 'description': 'questionnaire'}, {'measure': 'TAMPA scale of Kinesiophobia', 'timeFrame': '12 months', 'description': 'questionnaire'}, {'measure': 'Impact of Event scale', 'timeFrame': '12 months', 'description': 'questionnaire'}, {'measure': 'Euroqol-5D', 'timeFrame': '12 months', 'description': 'questionnaire'}, {'measure': 'Mechanical allodynia', 'timeFrame': '12 months', 'description': 'Pressure pain treshold for selected points'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic neck pain', 'Whiplash', 'Whiplash Associated Disorders', 'Chronic Pain', 'Neck exercises', 'Training', 'Pacing', 'Patient Education', 'Pain Management', 'Whiplash Injuries', 'Musculoskeletal'], 'conditions': ['Neck Pain', 'Chronic Pain Syndrome']}, 'referencesModule': {'references': [{'pmid': '28850421', 'type': 'DERIVED', 'citation': 'Ris I, Juul-Kristensen B, Boyle E, Kongsted A, Manniche C, Sogaard K. Chronic neck pain patients with traumatic or non-traumatic onset: Differences in characteristics. A cross-sectional study. Scand J Pain. 2017 Jan;14:1-8. doi: 10.1016/j.sjpain.2016.08.008. Epub 2016 Oct 12.'}, {'pmid': '27598552', 'type': 'DERIVED', 'citation': 'Ris I, Sogaard K, Gram B, Agerbo K, Boyle E, Juul-Kristensen B. Does a combination of physical training, specific exercises and pain education improve health-related quality of life in patients with chronic neck pain? A randomised control trial with a 4-month follow up. Man Ther. 2016 Dec;26:132-140. doi: 10.1016/j.math.2016.08.004. Epub 2016 Aug 20.'}, {'pmid': '22136113', 'type': 'DERIVED', 'citation': 'Hansen IR, Sogaard K, Christensen R, Thomsen B, Manniche C, Juul-Kristensen B. Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial. BMC Musculoskelet Disord. 2011 Dec 2;12:274. doi: 10.1186/1471-2474-12-274.'}], 'seeAlsoLinks': [{'url': 'http://www.sdu.dk', 'label': 'University of Southern Denmark'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether a physiotherapy intervention containing pain management, general training and specific neck exercises can improve function for patients with chronic neck pain.', 'detailedDescription': 'Neck pain is widespread problem. The prevalence of neck pain in the Scandinavian countries is 36%. Of the working population the prevalence of chronic neck pain is 10 - 20%.The National Board of Health estimates that 5-6000 subjects per year in Denmark are involved in a traffic accident evoking whiplash-induced chronic neck pain. The main problems for patients with chronic neck pain are cervical dysfunction, reduced neck mobility and stability in addition to local and possibly generalised pain Besides chronic neck pain, patients may suffer from poor pain coping strategies and physical inactivity which influences physical function, general health and causes a poor quality of life.\n\nPhysical training including specific exercises targeting the deep postural muscles of the spine is effective in reducing neck pain for patients with chronic neck pain. Physical behavioural graded activity is a treatment approach with focus on increasing general physical fitness, reducing fear of movements and increasing psychological function. Educational sessions, where the focus is on understanding complex chronic pain mechanisms and development of appropriate pain coping and/or cognitive behavioural strategies have shown reduced general pain.\n\nThus this project is formulated on the expectation that rehabilitation of patients with chronic neck pain after a whiplash accident must target cervical dysfunctions, training of physical function and the understanding and management of chronic pain in a combined therapy approach.\n\nThe study is designed as a randomized control study including 200 patients. All participate in the educational sessions. The training group receives on top of that instruction in specific neck exercises and general training.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic neck pain for at least 6 months\n* reduced physical neck function (NDI minimum 10)\n* pain primarily in the neck region,\n* finished any medical /radiological examinations\n* able to read and understand Danish and\n* able to participate in the exercise program.\n\nExclusion Criteria:\n\n* radiculopathies upper extremity\n* neurological deficits\n* in a process of examining for unknown pathology,\n* experimental medical treatment,\n* being in a unstable social situation\n* pregnancy\n* fractures\n* suffering from depression\n* other known coexisting medical conditions which would severely restrict participation in the exercise program'}, 'identificationModule': {'nctId': 'NCT01431261', 'acronym': 'WADNECXT', 'briefTitle': 'Neck Exercises, Training and Pain Management as a Treatment for Whiplash Patients With Chronic Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Neck Exercises, Physical and Cognitive Behavioural Graded Activity as a Treatment for Adult Whiplash Patients With Chronic Neck Pain', 'orgStudyIdInfo': {'id': 'WADNECXT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Management + Training', 'description': 'Education in pain management strategies and treatment sessions including instructions in neck exercises and aerobic training', 'interventionNames': ['Other: Education and training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pain Management', 'description': 'Education in pain management strategies', 'interventionNames': ['Behavioral: Pain management']}], 'interventions': [{'name': 'Education and training', 'type': 'OTHER', 'description': 'Educational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times', 'armGroupLabels': ['Pain Management + Training']}, {'name': 'Pain management', 'type': 'BEHAVIORAL', 'description': 'Educational sessions in pain management 4 times', 'armGroupLabels': ['Pain Management']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'country': 'Denmark', 'facility': 'University of Southern Denmark, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Birgit Juul-Kristensen, ph.d.', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Southern Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region of Southern Denmark', 'class': 'OTHER'}, {'name': 'Association of Danish Physiotherapists', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD. student', 'investigatorFullName': 'Inge Ris Hansen', 'investigatorAffiliation': 'University of Southern Denmark'}}}}