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Enrolling by invitationNCT07393503MOTIONUpdated Feb 18, 2026

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

A Phase 4 interventional study of Methylprednisolone 4Mg Tab and Acetaminophen 500Mg Tab in Musculoskeletal Pain, sponsored by State University of New York at Buffalo. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-18.

Sponsored by State University of New York at Buffalo · Phase 4, Interventional, and Other

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Sep 2025, registered Jan 2026).
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Musculoskeletal Pain

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03

In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's planned enrollment of 60 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

State University of New York at Buffalo is the lead sponsor of 287 studies on the registry; 65 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 15 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults 18+
  • Able to answer survey questions in English
  • MSK pain > 3 on the VAS scale in any body part
  • Invited to participate by and enrolling clinician

Exclusion criteria

Exclusion Criteria:

  • > 2 weeks from pain onset
  • Fractures
  • Active infections
  • Anaphylactic reaction to either medication (Oral Steroids, Ibuprofen, and/or Acetaminophen)
  • Currently taking anti-platelet agents (aspirin \</= 100/mg a day, clopidogrel, etc.)
  • Chronic Kidney Disease Stage 3 or worse
  • Uncontrolled diabetes (A1C above 9)
  • Currently taking oral anti-coagulants
  • History of bleeding ulcer
  • Cirrhosis
  • Taking daily prednisone
  • Chronic pain syndrome
  • Chronic pain medication (gabapentin, Lyrica, narcotics, etc.)
  • Pregnant Patients
  • Worker's Compensation Patients
05

Study design

Phase
Phase 4
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study 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)

    Drug: Methylprednisolone 4Mg Tab

  • 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

    Drug: Acetaminophen 500Mg Tab · Drug: Ibuprofen 200Mg Oral Tablet

Interventions

  • DrugMethylprednisolone 4Mg Tab

    Participants follow standard 6- day taper dosing schedule.

    Also known as: Medrol

  • DrugAcetaminophen 500Mg Tab

    Participants follow a 6- day taper dosing schedule.

    Also known as: Tylenol

  • DrugIbuprofen 200Mg Oral Tablet

    Participants follow a 6- day taper dosing schedule.

    Also known as: Motrin

06

What researchers measure

Primary outcomes

  1. Change in Pain

    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.

    Time frame: 1 week, 1 month

Secondary outcomes

  1. Change in Function

    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.

    Time frame: 1 week, 1 month

07

Study locations

1 site
  • UBMD Orthopaedics and Sports Medicine (716 Health)
    Buffalo, New York 14221, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07393503
Lead sponsor
State University of New York at Buffalo
Responsible party
Rajiv Jain (Rajiv Jain, MD, State University of New York at Buffalo) — Principal investigator
First posted
Feb 6, 2026
Start date
Sep 17, 2025
Primary completion
Aug 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Feb 18, 2026

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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