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

February 13, 2026 updated by: Rajiv Jain, State University of New York at Buffalo

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • > 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Participants follow standard 6- day taper dosing schedule.
Other Names:
  • Medrol
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
Participants follow a 6- day taper dosing schedule.
Other Names:
  • Tylenol
Drug: Ibuprofen 200Mg Oral Tablet
Participants follow a 6- day taper dosing schedule.
Other Names:
  • Motrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain
Time Frame: 1 week, 1 month
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.
1 week, 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Function
Time Frame: 1 week, 1 month
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.
1 week, 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State University of New York at Buffalo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 30, 2026

First Submitted That Met QC Criteria

January 30, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00009423

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Musculoskeletal Pain

Clinical Trials on Methylprednisolone 4Mg Tab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe