Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-28 @ 11:21 AM
Study NCT ID:
NCT01957033
Status:
COMPLETED
Last Update Posted:
2016-09-14
First Post:
2013-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014911', 'term': 'Whiplash Injuries'}, {'id': 'D019547', 'term': 'Neck Pain'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D019838', 'term': 'Neck Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2013-09-29', 'studyFirstSubmitQcDate': '2013-10-07', 'lastUpdatePostDateStruct': {'date': '2016-09-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '1 year', 'description': 'As a pilot study, the main outcome of interest is feasibility. This includes: ability to train assessors and health care providers, time it takes to complete all assessments, ability to recruit 12 patients within 1 year, and completeness of data collected.'}, {'measure': 'Pain', 'timeFrame': '12 weeks (end of treatment) and 6- and 12- month follow-ups', 'description': 'Measured by the 4-item pain questionnaire (P4). This will be a primary outcome of the full trial.'}, {'measure': 'Function', 'timeFrame': '12 weeks (end of treatment) and 6- and 12- month follow-up', 'description': 'Measured by the Neck Disability Index (NDI). This will be a primary outcome measure of the full powered study.'}], 'secondaryOutcomes': [{'measure': 'Fidelity', 'timeFrame': '1 year', 'description': 'As a pilot study, the secondary outcome of interest is treatment fidelity. We will measure this through ability of health care providers to provide treatment at the dosage described in the protocol.'}, {'measure': 'Psychological measures', 'timeFrame': '12 weeks (end of treatment)', 'description': 'Catastrophic thinking measured by Pain Catastrophizing Scale (PCS) Anxiety and Depression measured by Hospital Anxiety and Depression Scale (HADS) Psychological distress measured by Trauma Anxiety and Distress Scale (TADS)'}, {'measure': 'Psychophysical measures', 'timeFrame': '12 weeks (end of treatment)', 'description': 'Vibration Pain Threshold (VPT), Current Perception Threshold (CPT), Pressure Pain Threshold (PPT), Response to Cold Provocation(RCP)'}, {'measure': 'Motor coordination', 'timeFrame': '12 weeks (end of treatment)', 'description': 'Neck Walk Index (NWI)'}, {'measure': 'Health Status', 'timeFrame': '12 weeks (end of study) and 6- and 12- month follow-ups', 'description': 'Measured by SF-36'}, {'measure': 'Global perceived effect', 'timeFrame': '12 weeks (end of treatment) and 6- and 12-month follow-ups', 'description': 'Global perceived effect will be measured on a 7 point scale (-3 to +3)'}, {'measure': 'Upper extremity function', 'timeFrame': '12 weeks (end of treatment) and 6- and 12-month follow-ups', 'description': 'As measured by the shortened version of the Disability of the Arm, Shoulder, Hand (qDASH).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['whiplash', 'neck pain', 'manual therapy', 'exercise', 'dosage'], 'conditions': ['Whiplash Injuries']}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot project is to determine the feasibility of a study design to investigate how many sessions of manual therapy and exercise produce the best results for people with whiplash injuries. Also, this study will help us determine the best way to measure the effect of treatment. Finally, the investigators will study how closely the physiotherapists follow the treatment instruction provided in the study protocol and training. In order to achieve these objectives, 12 people will receive manual therapy and exercise at one of twelve different doses. the investigators will have each of these people fill out questionnaires, measure sensation changes, and measure changes in the way people move their necks while walking. This study will help us determine if the study protocol can be carried out as planned. This includes: the training of all people involved in carrying out the assessments and treatments, the willingness and ability of participants to take part in all of the treatment and measures involved. This will provide us with important information to help us plan a larger study with 226 people with whiplash injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults ≥ 21 years\n* main complaint must be neck pain, but we expect some patients will also report symptoms that radiate to the shoulder and arm regions or have an associated headache.\n* pain intensity must be ≥ 12/40 on the 4-item pain scale (P4).\n\nExclusion Criteria:\n\n* non-mechanical sources of neck pain or over-riding comorbidity listed below:\n* rheumatoid arthritis\n* neurological diseases\n* fractures\n* dislocation\n* rheumatoid arthritis\n* upper motor neuron dysfunction or malignancy\n* pregnant women\n* closed head injury\n* on steroid-based medications within the past 6 months.'}, 'identificationModule': {'nctId': 'NCT01957033', 'briefTitle': 'Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Clinical and Biological Responses of People With Neck Pain Being Treated With Varying Doses of Manual Therapy: A Pilot Study', 'orgStudyIdInfo': {'id': '13-569'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Duration 6 weeks, frequency 3/week', 'description': 'Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for 6 weeks', 'interventionNames': ['Behavioral: Exercise and education 3 times/week for 6 weeks', 'Other: Manual therapy 3 times/week for 6 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Duration 6 weeks, Frequency twice/week', 'description': 'Exercise and education twice/week for 6 weeks Manual therapy twice/week for 6 weeks', 'interventionNames': ['Behavioral: Exercise and education twice/week for 6 weeks', 'Other: Manual therapy twice/week for 6 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Duration 6 weeks, Frequency once/week', 'description': 'Exercise and education once/week for 6 weeks Manual therapy once/week for first 6 weeks', 'interventionNames': ['Behavioral: Exercise and education once/week for 6 weeks', 'Other: Manual therapy once/week for 6 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Duration 3 weeks, Frequency 3 times/week', 'description': 'Exercise and education 3 times/week for 6 weeks Manual therapy 3 times/week for first 3 weeks', 'interventionNames': ['Behavioral: Exercise and education 3 times/week for 6 weeks', 'Other: Manual therapy 3 times/week for 3 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Duration 3 weeks, Frequency twice/week', 'description': 'Exercise and education twice/week for 6 weeks Manual therapy twice/week for first 3 weeks', 'interventionNames': ['Behavioral: Exercise and education twice/week for 6 weeks', 'Other: Manual therapy twice/week for 3 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Duration 3 weeks, frequency once/week', 'description': 'Exercise and education once/week for 6 weeks Manual therapy once/week for first 3 weeks', 'interventionNames': ['Behavioral: Exercise and education once/week for 6 weeks', 'Other: Manual therapy once/week for 3 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Duration 0 weeks, Frequency 3 times/week', 'description': 'Exercise and education 3 times/week for 6 weeks No manual therapy', 'interventionNames': ['Behavioral: Exercise and education 3 times/week for 6 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Duration 0 weeks, Frequency twice/week', 'description': 'Exercise and education twice/week for 6 weeks. No manual therapy', 'interventionNames': ['Behavioral: Exercise and education twice/week for 6 weeks']}, {'type': 'EXPERIMENTAL', 'label': 'Duration 0 weeks, Frequency once/week', 'description': 'Exercise and education once/week for 6 weeks No manual therapy', 'interventionNames': ['Behavioral: Exercise and education once/week for 6 weeks']}], 'interventions': [{'name': 'Exercise and education once/week for 6 weeks', 'type': 'BEHAVIORAL', 'description': 'Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book', 'armGroupLabels': ['Duration 0 weeks, Frequency once/week', 'Duration 3 weeks, frequency once/week', 'Duration 6 weeks, Frequency once/week']}, {'name': 'Exercise and education twice/week for 6 weeks', 'type': 'BEHAVIORAL', 'description': 'Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.', 'armGroupLabels': ['Duration 0 weeks, Frequency twice/week', 'Duration 3 weeks, Frequency twice/week', 'Duration 6 weeks, Frequency twice/week']}, {'name': 'Exercise and education 3 times/week for 6 weeks', 'type': 'BEHAVIORAL', 'description': 'Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.', 'armGroupLabels': ['Duration 0 weeks, Frequency 3 times/week', 'Duration 3 weeks, Frequency 3 times/week', 'Duration 6 weeks, frequency 3/week']}, {'name': 'Manual therapy once/week for 3 weeks', 'type': 'OTHER', 'description': 'Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.', 'armGroupLabels': ['Duration 3 weeks, frequency once/week']}, {'name': 'Manual therapy twice/week for 3 weeks', 'type': 'OTHER', 'description': 'Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.', 'armGroupLabels': ['Duration 3 weeks, Frequency twice/week']}, {'name': 'Manual therapy 3 times/week for 3 weeks', 'type': 'OTHER', 'description': 'Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.', 'armGroupLabels': ['Duration 3 weeks, Frequency 3 times/week']}, {'name': 'Manual therapy once/week for 6 weeks', 'type': 'OTHER', 'description': 'Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.', 'armGroupLabels': ['Duration 6 weeks, Frequency once/week']}, {'name': 'Manual therapy twice/week for 6 weeks', 'type': 'OTHER', 'description': 'Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.', 'armGroupLabels': ['Duration 6 weeks, Frequency twice/week']}, {'name': 'Manual therapy 3 times/week for 6 weeks', 'type': 'OTHER', 'description': 'Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.', 'armGroupLabels': ['Duration 6 weeks, frequency 3/week']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8S 1C7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'McMaster Univervisty', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8S 4P9', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Lifemark Health, Hamilton', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Western University', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Jordan D Miller, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Joy C MacDermid, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan Miller, Graduate Student', 'class': 'OTHER'}, 'collaborators': [{'name': 'Physiotherapy Foundation of Canada', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Graduate student, School of Rehabilitation Science', 'investigatorFullName': 'Jordan Miller, Graduate Student', 'investigatorAffiliation': 'McMaster University'}}}}