Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT00695006
Status:
UNKNOWN
Last Update Posted:
2008-06-25
First Post:
2008-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011843', 'term': 'Radiculopathy'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014143', 'term': 'Traction'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-06-24', 'studyFirstSubmitDate': '2008-06-09', 'studyFirstSubmitQcDate': '2008-06-10', 'lastUpdatePostDateStruct': {'date': '2008-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neck Disability Index', 'timeFrame': '2wk, 4wk, 3mo, 6mo'}, {'measure': 'Patient Specific Functional Scale', 'timeFrame': '2wk, 4wk, 3mo, 6mo'}, {'measure': 'Numeric Pain Rating Scale', 'timeFrame': '2wk, 4wk, 3mo, 6mo'}], 'secondaryOutcomes': [{'measure': 'Global Rating Of Change', 'timeFrame': '2wk, 4wk, 3mo, 6mo'}, {'measure': 'Body Diagram', 'timeFrame': '2wk, 4wk, 3mo, 6mo'}, {'measure': 'Fear Avoidance Belief Questionnaire', 'timeFrame': '2wk, 4wk, 3mo, 6mo'}, {'measure': 'Satisfaction', 'timeFrame': '2wk, 4wk, 3mo, 6mo'}, {'measure': 'Grip Strength', 'timeFrame': '2wk, 4wk'}]}, 'conditionsModule': {'keywords': ['manual therapy, cervical traction, cervical radiculopathy'], 'conditions': ['Cervical Radiculopathy']}, 'descriptionModule': {'briefSummary': 'To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 3 of 4 positive on CPR, 18-70yrs\n\nExclusion Criteria:\n\n* history of previous cervical or thoracic spine surgery\n* bilateral upper extremity symptoms\n* signs or symptoms of UMN disease\n* medical "red flags"(tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)\n* cervical spine injections (steroidal) in the past two weeks\n* current use of steroidal medication prescribed for their radiculopathy symptoms'}, 'identificationModule': {'nctId': 'NCT00695006', 'briefTitle': 'Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT', 'organization': {'class': 'OTHER', 'fullName': 'Rocky Mountain University of Health Professions'}, 'officialTitle': 'Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT', 'orgStudyIdInfo': {'id': '5388642'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'II', 'description': 'Sham Traction', 'interventionNames': ['Other: Sham Traction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'I', 'description': 'Traction', 'interventionNames': ['Other: Traction']}], 'interventions': [{'name': 'Sham Traction', 'type': 'OTHER', 'description': 'Traction \\<5lbs', 'armGroupLabels': ['II']}, {'name': 'Traction', 'type': 'OTHER', 'description': 'Standard supine intermittent traction', 'armGroupLabels': ['I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22401', 'city': 'Fredericksburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Advance Rehab at Fredericksburg Orthopaedics', 'geoPoint': {'lat': 38.30318, 'lon': -77.46054}}], 'overallOfficials': [{'name': 'Ian A Young, PT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Advance Rehab at Fredericksburg Orthopaedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rocky Mountain University of Health Professions', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Ian Young', 'oldOrganization': 'Advance Rehab'}}}}