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Enrolling by invitation NCT07393503

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

Phase IV Interventional Musculoskeletal Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methylprednisolone 4Mg Tab, Acetaminophen 500Mg Tab, Ibuprofen 200Mg Oral Tablet.
Who it may be relevant to
Registry conditions: Musculoskeletal Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

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

Primary outcome measures

  • Change in Pain [Time frame: 1 week, 1 month]
Secondary outcome measures (1)
  • Change in Function [Time frame: 1 week, 1 month]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Other

Study locations

United States · 1 center
  • UBMD Orthopaedics and Sports Medicine (716 Health) — Buffalo

Identifiers

NCT: NCT07393503 · STUDY00009423

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗