Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT02060734
Status:
WITHDRAWN
Last Update Posted:
2017-02-23
First Post:
2014-02-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014911', 'term': 'Whiplash Injuries'}, {'id': 'D019547', 'term': 'Neck Pain'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no participant recruited', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2014-02-07', 'studyFirstSubmitQcDate': '2014-02-10', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain', 'timeFrame': '2 weeks following injection', 'description': '10 cm Visual Analog Scale'}], 'secondaryOutcomes': [{'measure': 'cervical range of motion', 'timeFrame': 'Immediately, 2 and 6 weeks after injection'}, {'measure': 'self-report neck disability', 'timeFrame': 'Immediately, 2 and 6 weeks after injection'}, {'measure': 'globe perceived effects', 'timeFrame': 'Immediately, 2 and 6 weeks after injection', 'description': 'The Short Form-12'}, {'measure': 'work performance', 'timeFrame': 'Immediately, 2 and 6 weeks after injection', 'description': 'questionnaire'}, {'measure': 'pain', 'timeFrame': '5 minutes following injection', 'description': '10 cm Visual Analog Scale'}, {'measure': 'pain', 'timeFrame': '6 weeks following injection', 'description': '10 cm Visual Analog Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Whiplash,', 'injection,', 'lidocaine,', 'sham needling'], 'conditions': ['Whiplash Injuries', 'Neck Pain']}, 'descriptionModule': {'briefSummary': 'To determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury.', 'detailedDescription': 'This is a double-blind, randomized controlled trial to determine the efficacy of lidocaine injection of trigger points versus subcutaneous injection in patients with subacute whiplash associated disorder following injury. Outcomes include pain, objective assessment, self-report function recovery, impact on work performance and globe perceived effects which will be assessed 5 minutes, 2 and 6 weeks following injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fulfill the Grade II Quebec Task Force classification of WAD,\n* with identifiable myofascial trigger points ( which occur with or without a taut band),\n* reproduction of recognizable pain with sustained pressure ( up to 10 seconds) on trigger points\n* aged 18 to 70\n* a good understanding of informed consent and willing to attend this trial.\n\nExclusion Criteria:\n\n* have serious injury such as fracture and internal bleeding\n* suspicion of upper cervical instability or neurological deficits\n* clinical evidence of radiculopathy\n* a history of active cancer, central nerve disorder, blood clotting disorders, needle phobia\n* anticoagulant medication user\n* previous experience with any type of needling for myofascial pain'}, 'identificationModule': {'nctId': 'NCT02060734', 'briefTitle': 'Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated Disorder', 'organization': {'class': 'OTHER', 'fullName': 'Hamilton Health Sciences Corporation'}, 'officialTitle': 'Lidocaine Injection Versus Sham Needling in Treating Whiplash Associated disorder-a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HHSCTRIGGERINJ1402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine', 'description': 'The treatment group will receive a 25 gauge, 40mm long needle, pre-filled with 1% lidocaine inserting into the site of the trigger point. Three to five points injection.', 'interventionNames': ['Procedure: Lidocaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saline', 'description': 'The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'PROCEDURE', 'description': 'Lidocaine injection 3-5 points in experimental group( using 25 gauge, 40mm long needle, pre-filled with 1% lidocaine inserting into the site of the trigger point).', 'armGroupLabels': ['lidocaine']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.', 'armGroupLabels': ['Saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Department of physical medicine and rehabilitation, McMaster University', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L8V 1C3', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'HHS (Juravinski Hospital Site)', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Joy MacDermid, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate student, Western University', 'investigatorFullName': 'Maggie Qiyun Shi', 'investigatorAffiliation': 'Hamilton Health Sciences Corporation'}}}}