Tylenol/Ibuprofen vs Oral Steroids for Musculoskeletal Pain
(MOTION Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of two treatments for short-term relief of acute musculoskeletal (MSK) pain, which is sudden pain in muscles, bones, or joints. One group of participants will receive a steroid medication called Methylprednisolone, while the other group will take a combination of Acetaminophen (Tylenol) and Ibuprofen (Motrin). The goal is to determine which treatment provides better pain relief. Adults who have experienced sudden MSK pain for less than two weeks and can speak English may be suitable for this study. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, and this research aims to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as anti-platelet agents, oral anti-coagulants, daily prednisone, and chronic pain medications like gabapentin, Lyrica, or narcotics.
What is the safety track record for these treatments?
Research shows that acetaminophen and ibuprofen are generally safe when taken as directed. Acetaminophen is commonly used and considered very safe up to 4 grams per day. Studies indicate that combining ibuprofen and acetaminophen can provide pain relief similar to or better than other pain medications, including opioids, without increasing side effects.
Methylprednisolone, a type of steroid, has been used safely in various treatments and effectively reduces pain. However, long-term steroid use can lead to side effects like weaker bones (osteoporosis) and other muscle and bone issues. These side effects are less common with short-term use, such as the six-day treatment in this trial.
Both treatment options in this trial have been used safely before, but it's important to consider the benefits and possible risks. Always consult a healthcare provider about any concerns before joining a trial.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for musculoskeletal pain because they offer two distinct approaches. The combination of acetaminophen and ibuprofen, both well-known pain relievers, is being tested together to see if their combined effect offers enhanced pain relief compared to when used separately. Meanwhile, the use of methylprednisolone, an oral steroid, is being explored for its anti-inflammatory properties, which might provide quicker and more substantial relief by directly reducing inflammation, unlike standard over-the-counter pain meds. By comparing these two methods, researchers hope to identify a more effective and faster-acting pain management strategy.
What evidence suggests that this trial's treatments could be effective for acute musculoskeletal pain?
This trial will compare the effectiveness of methylprednisolone with a combination of acetaminophen and ibuprofen for musculoskeletal pain. Research has shown that methylprednisolone, a type of steroid, can reduce pain and improve mobility. In one study, patients experienced more pain relief than those who took a placebo, which contains no active medicine. Another study found that injections of methylprednisolone reduced hand pain, with effects lasting up to 12 weeks.
In contrast, the results are less clear for using acetaminophen (Tylenol) and ibuprofen (Motrin) together for pain relief. Research indicates that taking these two common painkillers together does not significantly reduce pain more than taking either one alone. While a fixed-dose combination of these drugs has shown some promise, the results remain mixed. Participants in this trial will receive either methylprednisolone or the combination of acetaminophen and ibuprofen to assess their effectiveness in managing pain.678910Are 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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Methylprednisolone or a combination of Acetaminophen and Ibuprofen for pain relief over 6 days
Follow-up
Participants are monitored for changes in pain and function after treatment
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?
2
Treatment groups
Active Control
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)
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
State University of New York at Buffalo
Lead Sponsor
Citations
Ibuprofen vs acetaminophen vs their combination in the ...
In summary our study did not find that an oral combination of acetaminophen ibuprofen was more effective at relieving the pain associated with acute ...
Ibuprofen vs acetaminophen vs their combination in the ...
We conclude that the combination of ibuprofen and acetaminophen did not reduce pain scores or the need for rescue analgesics compared with either agent alone ...
Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for ...
Among ED patients with acute, nontraumatic, nonradicular LBP, adding acetaminophen to ibuprofen does not improve outcomes within 1 week.
Ibuprofen vs acetaminophen vs their combination...
We tested the hypothesis that the reduction in pain scores with the combination of ibuprofen and acetaminophen would be at least 15 mm greater than with either ...
Ibuprofen/acetaminophen fixed-dose combination as an ...
A fixed-dose combination (FDC) of ibuprofen and acetaminophen (IBU/APAP) has shown promise as an alternative to opioids in a range of pain management scenarios.
Combined acetaminophen and ibuprofen for pain relief after ...
Acetaminophen is widely used and is very safe at the recommended dose of 4 g per day, but does not always provide adequate pain relief on its own. Combining ...
232 Ibuprofen versus Acetaminophen versus Their ...
Conclusion. The combination of ibuprofen and acetaminophen did not reduce pain scores or the need for rescue analgesics compared with either agent alone in ED ...
8.
haleonhealthpartner.com
haleonhealthpartner.com/content/dam/cf-consumer-healthcare/health-professionals/en_US/pdf/Ibuprofen-Acetaminophen-Combo-for-Pain-Management-Study.pdfIbuprofen/acetaminophen fixed-dose combination as an ...
Across studies, IBU/APAP. FDCs consistently demonstrated pain relief similar to or better than opioid and nonopioid comparators and reliably ...
Musculoskeletal Outcomes Using Tylenol/Ibuprofen vs. ...
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 ...
Adding acetaminophen (paracetamol) or hydromorphone ...
Simply stated: there wasn't an added benefit of adding oral acetaminophen or hydromorphone to ibuprofen in non-operative musculoskeletal pain.
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