Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT01772966
Status:
COMPLETED
Last Update Posted:
2016-10-31
First Post:
2012-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chiropractic Manual Therapy and Neck Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020393', 'term': 'Manipulation, Spinal'}], 'ancestors': [{'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 319}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-27', 'studyFirstSubmitDate': '2012-09-21', 'studyFirstSubmitQcDate': '2013-01-17', 'lastUpdatePostDateStruct': {'date': '2016-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety', 'timeFrame': 'Daily over 7-10 days.', 'description': 'All adverse events will be described and tallied. Adverse events will be categorized in two modes: 1\\] Serious vs. Not Serious, and, 2\\] Attributable to the trial vs. Not Attributable. Both the absolute number of adverse events as well as the percentage of subjects experiencing an adverse event will be reported.'}, {'measure': 'Expectations related to improvement', 'timeFrame': 'Baseline', 'description': "Participants' expectations of the efficacy of the interventions will be obtained at baseline with the protocol of Fulda et al."}], 'primaryOutcomes': [{'measure': 'Group registration', 'timeFrame': 'At exit assessment following the third intervention session', 'description': 'Participants will be asked to identify which of the two interventions they feel they received.'}], 'secondaryOutcomes': [{'measure': 'Pain severity', 'timeFrame': '1. at baseline, and 2. At exit assessment following the third intervention session', 'description': 'Pain scores on the PROMIS pain severity instrument.'}, {'measure': 'Improvement', 'timeFrame': 'At exit assessment following the third intervention session', 'description': 'Participants will be asked to rate their level of improvement on the The Global Rating of Change instrument.'}, {'measure': 'Disability', 'timeFrame': '1. at baseline, and 2. At exit assessment following the third intervention session', 'description': 'Participants will score the The Neck Disability Index (score out of 50).'}, {'measure': 'Tenderness', 'timeFrame': '1. at baseline, and 2. At exit assessment following the third intervention session', 'description': 'Pressure algometry over a single specified spinal site will be used to measure tenderness in kg/sq.sm.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['neck', 'pain', 'chronic', 'manipulation', 'control', 'randomized trial'], 'conditions': ['Chronic Mechanical Neck Pain']}, 'referencesModule': {'references': [{'pmid': '16326235', 'type': 'RESULT', 'citation': 'Vernon H, MacAdam K, Marshall V, Pion M, Sadowska M. Validation of a sham manipulative procedure for the cervical spine for use in clinical trials. J Manipulative Physiol Ther. 2005 Nov-Dec;28(9):662-6. doi: 10.1016/j.jmpt.2005.07.020.'}]}, 'descriptionModule': {'briefSummary': "Eligible subjects with chronic neck pain will be randomly allocated to one of two intervention groups: real vs control spinal manipulation. They will receive three intervention sessions.\n\nH1: Chronic neck pain patients treated longitudinally over a series of three encounters in one week by random assignment to treatment group with either of the dual delivery procedures (Intervention 1=typical-control or Intervention 2=control-control) will have a 50% error rate of self-report of group allocation at exit interview.\n\nH2: Patients treated by the typical-control dual procedure over a typical sequence of encounters (3 times in one week) will show statistically significant improvement in clinical outcomes; defined quantitatively by visual analogue pain scale (VAS), Neck Disability Index (NDI), range of motion and pressure algometry; compared to those treated by the control-control dual procedure.\n\nH3: Patients stratified by 'a priori' patient expectation for treatment outcome will show no significant difference in self-report of group allocation or clinical outcome measures.\n\nA total of 372 subjects will be recruited."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female\n* 21 to 60 years of age\n* Chronic neck pain\n* Neck pain duration greater than 6 weeks\n* Numeric Rating Scale greater than 30, less than 65\n* Pain distribution between nuchal ridge and spine of the scapula\n* Pain aggravated by local provocation maneuvers at single motion segment\n* Antero-posterior glide\n* Paraspinal tenderness\n* Negative provocative maneuvers at adjacent segment\n* Able to tolerate neck movement to 50 percent normal in all directions\n\nExclusion Criteria:\n\n* Worker's compensation or other medico-legal claim\n* Cervical spine surgery or fracture or dislocation\n* Uncontrolled hypertension (Blood Pressure over 140 over 90)\n* Stroke or Transient Ischemic Attack\n* Upper respiratory infection within 4 weeks\n* Severe degenerative disease of the cervical spine\n* New or significantly altered pattern of headache complaint\n* Connective tissue disease\n* Primary fibromyalgia\n* Metabolic or metaplastic bone disease\n* Whiplash injury within 12 months\n* High cholesterol levels not well-managed medically\n* Cardiovascular surgery in the past 6 months or planned\n* Use of narcotic analgesic, prescription anti-inflammatory, or muscle relaxants, anti-convulsants\n* Angina pectoris\n* Dizziness\n* Tinnitus\n* Blurred vision, vertigo, undiagnosed sensory and motor disturbances\n* Radicular symptoms and signs\n* Current use of anticoagulant therapy\n* Upper respiratory infection\n* Neck pain on provocation greater than 7 out of 10\n* Provocation of radicular pain or sensory disturbance\n* Hypermobility of multiple peripheral joints,\n* Physical or mental impairment precluding following instructions or participating -in supine recumbent postures"}, 'identificationModule': {'nctId': 'NCT01772966', 'briefTitle': 'Chiropractic Manual Therapy and Neck Pain', 'organization': {'class': 'OTHER', 'fullName': 'Canadian Memorial Chiropractic College'}, 'officialTitle': 'Generalizing a Valid Control Manipulation to a Multiple Operator, Longitudinal Randomized Controlled Study for Chronic Neck Pain', 'orgStudyIdInfo': {'id': '122008'}, 'secondaryIdInfos': [{'id': 'R01AT007311-01', 'link': 'https://reporter.nih.gov/quickSearch/R01AT007311-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal manipulation', 'description': 'Participants will receive spinal manipulation delivered as segmental thrust to a specific site in the neck. They will receive three intervention sessions over 7-10 days.', 'interventionNames': ['Procedure: Spinal manipulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control manipulation', 'description': 'Participants will receive spinal manipulation delivered as non-segmental thrust to the neck. They will receive three intervention sessions over 7-10 days.', 'interventionNames': ['Procedure: Spinal manipulation']}], 'interventions': [{'name': 'Spinal manipulation', 'type': 'PROCEDURE', 'armGroupLabels': ['Control manipulation', 'Spinal manipulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M2H 3J1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Canadian Memorial Chiropractic College', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Howard T Vernon, DC, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Canadian Memorial Chiropractic College'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Canadian Memorial Chiropractic College', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}