Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-06-25 @ 6:14 AM
Study NCT ID:
NCT03301766
Status:
WITHDRAWN
Last Update Posted:
2023-06-29
First Post:
2017-09-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'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': 'D057968', 'term': 'Transdermal Patch'}, {'id': 'D059039', 'term': 'Standard of Care'}], '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': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Delay for subject recruitment and then not feasible with COVID\\>', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2017-09-29', 'studyFirstSubmitQcDate': '2017-09-29', 'lastUpdatePostDateStruct': {'date': '2023-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Repeat visits', 'timeFrame': '1 week and 1 month', 'description': 'Repeat visits to an emergency department'}], 'primaryOutcomes': [{'measure': 'Numerical Pain Rating Scale (NRS)', 'timeFrame': '1 week', 'description': 'Patient description of pain on a scale of 0-10'}], 'secondaryOutcomes': [{'measure': 'Roland-Morris-24 back pain disability scale', 'timeFrame': '1 week and 1 month', 'description': '24 point back pain disability scale'}, {'measure': 'Numerical Pain Rating Scale (NRS)', 'timeFrame': '1 month', 'description': 'Patient description of pain on a scale of 0-10'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lidocaine'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the addition of lidocaine % transdermal patches to standard therapy in the treatment of acute non-radicular low back pain in patients discharged from the Emergency Department. In addition to standard therapy, half of the participants will receive medicated patches while the other half will receive non-medicated patches.', 'detailedDescription': 'Low back pain is a common emergency department (ED) chief complaint. Multiple therapies have been evaluated in the treatment of ED patients with low back pain including acetaminophen, NSAIDS, opioids, steroids, and muscle relaxants.\n\nLidocaine is a local anesthetic that can be administered by various routes. It is used in a transdermal patch for the treatment of pain. It is commonly used for focal causes of pain, including low back pain. The addition of lidocaine 5% patches to standard low back pain therapy has not been rigorously evaluated, although it is frequently used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '24 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pain originating between the lower border of the scapulae and the upper gluteal folds\n* treating ED physician plan for discharge of the patient\n\nExclusion Criteria:\n\n* radicular pain defined as pain radiating below the gluteal folds\n* direct trauma to the back within previous month\n* pain of greater than 2 weeks duration or greater than 1 LBP episode per month in the past 3 months\n* patient being pregnant or lactating; no access to phone or ability to participate in follow-up phone calls\n* known allergy to lidocaine or skin breakdown over site of pain\n* treating physician plan for opioid prescription (tramadol, codeine, hydrocodone)\n* personal history of malignancy, fever (temperature greater than 37.9ºC), or previous spinal surgery\n* patients who are detainees\n* previous enrollment in the study'}, 'identificationModule': {'nctId': 'NCT03301766', 'briefTitle': 'Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Cook County Health'}, 'officialTitle': 'Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department', 'orgStudyIdInfo': {'id': '17-510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine 5% patch', 'description': 'Patients will receive a 7 day supply (21 patches) of lidocaine 5% patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.', 'interventionNames': ['Drug: lidocaine 5% patch', 'Drug: standard therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-medicated patch', 'description': 'Patients will receive a 7 day supply (21 patches) of non-medicated patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician.', 'interventionNames': ['Drug: standard therapy', 'Drug: Non-medicated patch']}], 'interventions': [{'name': 'lidocaine 5% patch', 'type': 'DRUG', 'description': 'transdermal patch', 'armGroupLabels': ['Lidocaine 5% patch']}, {'name': 'standard therapy', 'type': 'DRUG', 'description': 'Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)', 'armGroupLabels': ['Lidocaine 5% patch', 'Non-medicated patch']}, {'name': 'Non-medicated patch', 'type': 'DRUG', 'description': 'non-medicated patch', 'armGroupLabels': ['Non-medicated patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'John H Stroger Jr Hospital of Cook County', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook County Health', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Department of Emergency Medicine, Principal Investigator', 'investigatorFullName': 'Neeraj Chhabra', 'investigatorAffiliation': 'Cook County Health'}}}}