Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:44 PM
Study NCT ID:
NCT01029951
Status:
COMPLETED
Last Update Posted:
2009-12-10
First Post:
2009-12-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial
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': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-09', 'studyFirstSubmitDate': '2009-12-09', 'studyFirstSubmitQcDate': '2009-12-09', 'lastUpdatePostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient Global Impression of Change', 'timeFrame': 'end of treatment, 3 months, 6 months and 12 months'}], 'secondaryOutcomes': [{'measure': 'Numerical rating scale for pain', 'timeFrame': 'end of treatment, 3 months, 6 months, and 12 months'}, {'measure': 'Bournemouth Questionnaire', 'timeFrame': 'end of treatment, 3 months, 6 months, and 12 months'}, {'measure': 'Adverse effects to treatment', 'timeFrame': 'end of treatment'}, {'measure': 'SF-36 version 2', 'timeFrame': 'end of treatment, 3 months, 6 months and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chiropractic; osteopathic physicians; manipulation; neck pain; adverse effects; randomized clinical trial', 'Subacute non-specific neck pain'], 'conditions': ['Neck Pain']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study was to compare the relative effectiveness of cervical manipulation, mobilisation and the Activator instrument in the treatment of subacute non-specific neck pain. The secondary purpose was to describe any adverse effects of these treatments.', 'detailedDescription': 'Neck pain is a common disorder. About 70% of adults will experience neck pain during their lifetime. After low back pain, neck pain is the most common reason patients give for seeking chiropractic care, and the second most common reason for the use of spinal manipulation. Usually, the underlying cause of neck pain is non-specific and cannot be related to a particular pathology as a cause of the presenting symptoms. Due to the uncertainty of the results obtained in the limited number of studies of manipulation and mobilisation for neck pain, further studies are needed to compare the different therapies available for neck pain. Participants in the study were treated as they would normally be with the exception of the type of spinal manipulation. There were three groups: a manipulation group, a mobilisation group, and an Activator instrument group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 18-64 years; a new or recurrent episode of neck pain present for more than 4 weeks, but no longer than 12 weeks;\n* neck pain that could extend to the shoulder region or upper extremities, and be accompanied by headache, but neck pain was more painful;\n* the patient agreed not to take medication or receive other treatment for neck pain during the course of the study (paracetamol 500 mg 4 times a day was allowed as rescue medication);\n* and a baseline pain level of at least 4 on the 11-point numerical rating scale.\n\nExclusion Criteria:\n\n* Exclusion criteria were treatment with any of the interventions during 6 months prior to recruitment to the study; specific neck pain due to fracture, neoplasm, infection, inflammatory arthropathy, radiculopathy or myelopathy;\n* factors contraindicating manipulation, such as blood coagulation disorders, long-term use of corticosteroids, anticoagulant medications, history of neck surgery, stroke or transient ischaemic attacks; plans to relocate;\n* inability to read or understand English;\n* and third-party liability or workers' compensation claims."}, 'identificationModule': {'nctId': 'NCT01029951', 'briefTitle': 'Relative Effectiveness and Adverse Effects of Cervical Manipulation, Mobilisation and the Activator Instrument in Patients With Sub-acute Non-specific Neck Pain: a Pragmatic Randomised Trial', 'organization': {'class': 'OTHER', 'fullName': 'Anglo-European College of Chiropractic'}, 'officialTitle': 'Neck Pain Comparative Study', 'orgStudyIdInfo': {'id': 'A.06-2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'manipulation', 'type': 'PROCEDURE'}, {'name': 'Mobilisation', 'type': 'PROCEDURE'}, {'name': 'Activator instrument', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BH5 2DF', 'city': 'Bournemouth', 'state': 'Dorset', 'country': 'United Kingdom', 'facility': 'Anglo-European College of Chiropractic Out Patient Clinic', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}], 'overallOfficials': [{'name': 'Hugh A Gemmell, DC. EdD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asociación Española contra el Cáncer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anglo-European College of Chiropractic', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Chiropractors Union', 'class': 'UNKNOWN'}, {'name': 'National Institute for Chiropractic Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Hugh Gemmell Principal Lecturer', 'oldOrganization': 'Anglo-European College of Chiropractic'}}}}