Tylenol/Ibuprofen vs Oral Steroids for Musculoskeletal Pain

(MOTION Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: State University of New York at Buffalo

Must not be taking: Anti-platelets, Anti-coagulants, Prednisone, others

Disqualifiers: Fractures, Infections, Diabetes, Cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

In our pilot study, we 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)

We are interested in studying pain relief regimens for acute injury of any body part among an adult orthopaedic urgent care population.

Are You a Good Fit for This Trial?

Adults over 18 with musculoskeletal pain scoring more than 3 on the VAS scale, who can answer surveys in English and are seen by an enrolling clinician. It's not for those with specific exclusions as determined by the study.

Inclusion Criteria

I was invited by a doctor to join this study.

I am 18 years old or older.

I can answer survey questions in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either Methylprednisolone or a combination of Acetaminophen and Ibuprofen for pain relief over 6 days

1 week

1 visit (in-person) on day of consent

Follow-up

Participants are monitored for changes in pain and function after treatment

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Acetaminophen + Ibuprofen
• Methylprednisolone

Trial Overview

The trial is testing two pain relief methods for acute musculoskeletal injuries: a Methylprednisolone dose pack versus a combination of Acetaminophen (Tylenol) and Ibuprofen (Motrin), taken over six days.

How Is the Trial Designed?

Group I: Methylprednisolone Active Control 1 Intervention

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)

Group II: Oral Acetaminophen and Ibuprofen Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+