Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT07393503
Phase
PHASE4
Status
Enrolling By Invitation

Conditions

  • Musculoskeletal Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Methylprednisolone 4Mg Tab — DRUG
    Participants follow standard 6- day taper dosing schedule.
  • Acetaminophen 500Mg Tab — DRUG
    Participants follow a 6- day taper dosing schedule.
  • Ibuprofen 200Mg Oral Tablet — DRUG
    Participants follow a 6- day taper dosing schedule.

Study Details

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: 1. Methylprednisolone((Medrol)dose pack- standard taper per dose pack instructions 2. Standard of Care (SOC) which includes a combination of Acetaminophen (Tylenol)+Ibuprofen (Motrin) The investigators are interested in studying pain relief regimens for acute injury of any body part among an adult orthopaedic urgent care population.

Key Dates

Start date
Sep 17, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Active Comparator: Methylprednisolone
    Arm 1 dosing scheme: Day 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)
  • Active Comparator: Oral Acetaminophen and Ibuprofen
    Arm 2 dosing scheme: Day 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

Primary Outcome Measure

Change in Pain [ Time Frame: 1 week, 1 month ]

Locations (1)

FacilityCityStateZIPSite coordinators
UBMD Orthopaedics and Sports Medicine (716 Health)BuffaloNew York14221-

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UBMD Orthopaedics and Sports Medicine (716 Health)· Buffalo, NY

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