Musculoskeletal PainPhase 4MOTIONNCT07393503
Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries
A Phase 4 study testing Methylprednisolone 4Mg Tab, Acetaminophen 500Mg Tab and Ibuprofen 200Mg Oral Tablet in people with Musculoskeletal Pain, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Methylprednisolone 4Mg Tab, Acetaminophen 500Mg Tab and Ibuprofen 200Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2025to Jan 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- > 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UBMD Orthopaedics and Sports Medicine (716 Health)
Buffalo, New York, 14221
About this study
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:
- Methylprednisolone((Medrol)dose pack- standard taper per dose pack instructions
- 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.
- Conditions
- Musculoskeletal Pain
- Being tested
- Methylprednisolone 4Mg Tab, Acetaminophen 500Mg Tab, Ibuprofen 200Mg Oral Tablet
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone 4Mg TabDrug
Also called Medrol
Participants follow standard 6- day taper dosing schedule.
Acetaminophen 500Mg TabDrug
Also called Tylenol
Participants follow a 6- day taper dosing schedule.
Ibuprofen 200Mg Oral TabletDrug
Also called Motrin
Participants follow a 6- day taper dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Acetaminophen 500Mg Tab; Drug: Ibuprofen 200Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 week, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start17 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajiv Jain, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07393503
- Sponsor's protocol ID
- STUDY00009423
- Acronym
- MOTION
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No