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
- Are there results?
- Not yet: the study is under way
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
Show all 15Show fewer
- 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.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. Oral Steroids in New Injuries
- ClinicalTrials.gov ID
- NCT07393503
- Acronym / sponsor ID
- MOTION / STUDY00009423
- Conditions
- Musculoskeletal Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone | Active comparator | Drug: Methylprednisolone 4Mg TabArm 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) |
| Oral Acetaminophen and Ibuprofen | Active comparator | Drug: Acetaminophen 500Mg Tab, Drug: Ibuprofen 200Mg Oral TabletArm 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- > 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylprednisolone 4Mg TabAlso: MedrolParticipants follow standard 6- day taper dosing schedule. | Drug | Methylprednisolone |
| Acetaminophen 500Mg TabAlso: TylenolParticipants follow a 6- day taper dosing schedule. | Drug | Oral Acetaminophen and Ibuprofen |
| Ibuprofen 200Mg Oral TabletAlso: MotrinParticipants follow a 6- day taper dosing schedule. | Drug | Oral Acetaminophen and Ibuprofen |
Primary outcome
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 secondary outcome
Change in Function
Time frame: 1 week, 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain (time frame: 1 week, 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.