Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:24 AM
Study NCT ID:
NCT07393503
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2026-02-18
First Post:
2026-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059352', 'term': 'Musculoskeletal Pain'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'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': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2026-01-30', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain', 'timeFrame': '1 week, 1 month', 'description': 'Pain as self-reported by the patient, following pain medication treatment for an acute musculoskeletal (MSK) injury as measured with the Visual Analog Scale (VAS) where 0 is no pain at all and 10 is the worst pain imaginable. Lower scores indicate less pain.'}], 'secondaryOutcomes': [{'measure': 'Change in Function', 'timeFrame': '1 week, 1 month', 'description': 'Function as self-reported by the patient following pain medication treatment for an acute musculoskeletal (MSK) injury as measured with the musculoskeletal health questionnaire (MSK-HQ) scale which sums 14 health domains on a 5-point scale from 4 being not at all and 0 to very severe. Higher scores indicate better overall MSK health.'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Musculoskeletal Pain']}, 'descriptionModule': {'briefSummary': 'In this pilot study, the investigators aim to compare two short-term pain relief methods administered over the course of 6 days in the setting of acute musculoskeletal (MSK) pain:\n\n1. Methylprednisolone((Medrol)dose pack- standard taper per dose pack instructions\n2. Standard of Care (SOC) which includes a combination of Acetaminophen (Tylenol)+Ibuprofen (Motrin)\n\nThe investigators are interested in studying pain relief regimens for acute injury of any body part among an adult orthopaedic urgent care population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults 18+\n* Able to answer survey questions in English\n* MSK pain \\> 3 on the VAS scale in any body part\n* Invited to participate by and enrolling clinician\n\nExclusion Criteria:\n\n* \\> 2 weeks from pain onset\n* Fractures\n* Active infections\n* Anaphylactic reaction to either medication (Oral Steroids, Ibuprofen, and/or Acetaminophen)\n* Currently taking anti-platelet agents (aspirin \\</= 100/mg a day, clopidogrel, etc.)\n* Chronic Kidney Disease Stage 3 or worse\n* Uncontrolled diabetes (A1C above 9)\n* Currently taking oral anti-coagulants\n* History of bleeding ulcer\n* Cirrhosis\n* Taking daily prednisone\n* Chronic pain syndrome\n* Chronic pain medication (gabapentin, Lyrica, narcotics, etc.)\n* Pregnant Patients\n* Worker's Compensation Patients"}, 'identificationModule': {'nctId': 'NCT07393503', 'acronym': 'MOTION', 'briefTitle': 'Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries', 'orgStudyIdInfo': {'id': 'STUDY00009423'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone', 'description': 'Arm 1 dosing scheme:\n\nDay 1: 2 tabs (8mg) before breakfast, 1 tab (4mg) at lunch and dinner, 2 tabs (8mg) at bedtime (6 tabs total) Day 2: 1 tab (4mg) before breakfast, lunch and dinner and 2 tabs (8mg) at bedtime (5 tabs total) Day 3: 1 tab (4mg) before breakfast, lunch and dinner and 1 tab (4mg) at bedtime (4 tabs total) Day 4: 1 tab (4mg) before breakfast, lunch and dinner (3 tabs total) Day 5: 1 tab (4mg) before breakfast and at bedtime (2 tabs total) Day 6: 1 tab (4mg) before breakfast (1 tab total)', 'interventionNames': ['Drug: Methylprednisolone 4Mg Tab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral Acetaminophen and Ibuprofen', 'description': 'Arm 2 dosing scheme:\n\nDay 1: day of consent: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol Extra- Strength (ES)(1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 2: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 3: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen at dinner, and 2 tabs Tylenol ES (1000mg) at bedtime Day 4: 3 tabs ibuprofen (600mg) with breakfast, 2 tabs Tylenol ES (1000mg) at lunch, 3 tabs ibuprofen (600mg) at dinner Day 5: 3 tabs ibuprofen (600mg) at breakfast and 2 tabs Tylenol ES (1000mg) at bedtime Day 6: 3 tabs ibuprofen (600mg) at breakfast', 'interventionNames': ['Drug: Acetaminophen 500Mg Tab', 'Drug: Ibuprofen 200Mg Oral Tablet']}], 'interventions': [{'name': 'Methylprednisolone 4Mg Tab', 'type': 'DRUG', 'otherNames': ['Medrol'], 'description': 'Participants follow standard 6- day taper dosing schedule.', 'armGroupLabels': ['Methylprednisolone']}, {'name': 'Acetaminophen 500Mg Tab', 'type': 'DRUG', 'otherNames': ['Tylenol'], 'description': 'Participants follow a 6- day taper dosing schedule.', 'armGroupLabels': ['Oral Acetaminophen and Ibuprofen']}, {'name': 'Ibuprofen 200Mg Oral Tablet', 'type': 'DRUG', 'otherNames': ['Motrin'], 'description': 'Participants follow a 6- day taper dosing schedule.', 'armGroupLabels': ['Oral Acetaminophen and Ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14221', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'UBMD Orthopaedics and Sports Medicine (716 Health)', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rajiv Jain, MD', 'investigatorFullName': 'Rajiv Jain', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}