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

NCT07393503 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: STUDY00009423
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Methylprednisolone((Medrol)dose pack- standard taper per dose pack instructions
2. 2.Standard of Care (SOC) which includes a combination of Acetaminophen (Tylenol)+Ibuprofen (Motrin)

Conditions

Musculoskeletal Pain

Outcome Measures

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.

  1 week, 1 month

Secondary Outcomes (1)

• Change in Function

  1 week, 1 month

Study Arms (2)

Methylprednisolone

ACTIVE COMPARATOR

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

Oral Acetaminophen and Ibuprofen

ACTIVE COMPARATOR

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

Acetaminophen 500Mg Tab DRUG

Participants follow a 6- day taper dosing schedule.

Also known as: Tylenol

Oral Acetaminophen and Ibuprofen

Ibuprofen 200Mg Oral Tablet DRUG

Participants follow a 6- day taper dosing schedule.

Also known as: Motrin

Oral Acetaminophen and Ibuprofen

Methylprednisolone 4Mg Tab DRUG

Participants follow standard 6- day taper dosing schedule.

Also known as: Medrol

Methylprednisolone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

UBMD Orthopaedics and Sports Medicine (716 Health)

Buffalo, New York, 14221, United States

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Interventions

Methylprednisolone; Acetaminophen; Ibuprofen; Tablets

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rajiv Jain, MD

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 6, 2026
• Study Start: September 17, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)