Ibuprofen + Dexamethasone for Lower Back Pain

Recruiting at 1 trial location

Overseen By Eddie Irizarry, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Montefiore Medical Center

Must not be taking: Analgesics, Steroids, Anticoagulants, others

Disqualifiers: Pregnant, Chronic pain, Heart failure, others

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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 7 days

132 Participants Needed

Trial Summary

What is the purpose of this trial?

This will be a placebo controlled, randomized, double-blind, comparative effectiveness study, in which we patients are enrolled during an emergency department (ED) visit for acute radicular low back pain (LBP) and followed by telephone two and seven days later. Patients will be randomized to receive an oral dose of dexamethasone for 2 consecutive days or placebo during an ED visit for acute radicular LBP. Every patient will receive a 7 day supply of ibuprofen and a low back pain education session.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you use pain medication daily or have chronic steroid use. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug combination of Ibuprofen and Dexamethasone for lower back pain?

Research shows that ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is effective for treating acute low back pain. While there is no direct evidence for the combination of ibuprofen and dexamethasone, ibuprofen alone is a proven option for pain relief in similar conditions. ^{1 2 3 4 5}

Is the combination of Ibuprofen and Dexamethasone generally safe for humans?

Ibuprofen is generally well-tolerated in humans, with studies showing good safety even at high doses for conditions like rheumatoid arthritis. Dexamethasone, a type of steroid, is also used in various treatments, but specific safety data for the combination of Ibuprofen and Dexamethasone is not provided in the available research. ^{1 6 7 8 9}

How does the drug combination of Ibuprofen and Dexamethasone differ from other treatments for lower back pain?

The combination of Ibuprofen and Dexamethasone for lower back pain is unique because it combines an NSAID (nonsteroidal anti-inflammatory drug) with a glucocorticoid, potentially offering both pain relief and anti-inflammatory benefits. This dual approach may provide more comprehensive relief compared to using NSAIDs or glucocorticoids alone. ^{1 3 10 11 12}

Research Team

Eddie Irizarry, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

This trial is for adults aged 18-70 with acute radicular low back pain, which hasn't lasted more than two weeks and radiates from the lower back to the leg. Participants should have a significant level of disability due to their pain but can't have had frequent back pain in the past three months or direct trauma recently. They must not be pregnant, suffer from chronic pain syndromes, or have conditions that make ibuprofen or dexamethasone risky.

Inclusion Criteria

My pain has lasted less than 2 weeks.

My back pain is not due to a recent injury.

I have severe lower back pain that spreads to my buttock or leg.

Exclusion Criteria

Pregnant

You will be excluded from the study if you have: 1) Stomach ulcers, ongoing stomach discomfort, or history of stomach bleeding 2) Severe heart failure 3) Chronic kidney disease 4) Taking anti-coagulants 5) Liver disease or hepatitis with specific liver enzyme levels.

I take pain medication almost every day for chronic pain.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive an oral dose of dexamethasone or placebo for 2 consecutive days and a 7-day supply of ibuprofen, along with a low back pain education session

7 days

1 visit (in-person), 2 follow-up calls

Follow-up

Participants are monitored for safety and effectiveness after treatment via telephone follow-ups

7 days

2 follow-up calls

Treatment Details

Interventions

• Dexamethasone Oral
• Educational Intervention
• Ibuprofen 400 mg

Trial Overview The study tests if adding dexamethasone to standard care (ibuprofen and education on low back pain) helps improve outcomes for acute radicular low back pain when given during an emergency department visit. Patients are randomly assigned to receive either dexamethasone or a placebo alongside ibuprofen, without knowing which one they're getting.

Participant Groups

Group I: Ibuprofen + dexamethasone + educational intervention Experimental Treatment 3 Interventions

Ibuprofen 400 mg PO every 8 hours as needed for 7 days + dexamethasone 16 mg PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.

Group II: Ibuprofen + placebo + educational intervention Placebo Group 2 Interventions

Ibuprofen 400 mg PO every 8 hours as needed for 7 days + placebo PO for day 1 and day 2. Research personnel will provide each participant with a 15-minute educational intervention.

Ibuprofen 400 mg is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

Approved in United States as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation
• Menstrual cramps
• Arthritis

Approved in European Union as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation
• Rheumatoid arthritis
• Osteoarthritis

Approved in Canada as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation
• Menstrual cramps
• Arthritis

Approved in Japan as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation
• Rheumatoid arthritis
• Osteoarthritis

Approved in China as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation
• Menstrual cramps
• Arthritis

Approved in Switzerland as Ibuprofen for:

• Pain relief
• Fever reduction
• Inflammation
• Rheumatoid arthritis
• Osteoarthritis

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Findings from Research

Diflunisal and acetaminophen with codeine both provided effective pain relief for patients with mild to moderate acute low back strain, showing similar levels of analgesic efficacy.

Diflunisal was found to be better tolerated and more acceptable to patients compared to acetaminophen with codeine, making it a preferable option for outpatient pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of diflunisal and acetaminophen with codeine in the treatment of initial or recurrent acute low back strain. Brown, FL., Bodison, S., Dixon, J., et al.[2020]

In a study of 56 patients with acute low back strain, diflunisal was found to be significantly more effective than naproxen in relieving pain, with 81% of patients reporting relief compared to only 41% for naproxen.

Both medications were well tolerated, with no withdrawals due to side effects, but diflunisal also offered a longer duration of action, allowing for less frequent dosing compared to naproxen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of diflunisal and naproxen in the management of acute low back strain. Aghababian, RV., Volturo, GA., Heifetz, IN.[2013]

In a crossover trial involving 60 out-patients with acute low back pain, mefenamic acid (1500 mg) and phenylbutazone (300 mg) were found to be the most effective analgesics, significantly reducing pain scores compared to other treatments.

Patients preferred mefenamic acid and phenylbutazone over aspirin and dextropropoxyphene plus paracetamol, indicating higher satisfaction and adherence to these medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicines of choice in low back pain. Evans, DP., Burke, MS., Newcombe, RG.[2019]

In a study involving 37 patients with chronic back pain, naproxen sodium (550 mg twice daily) was found to be significantly more effective than placebo in reducing overall pain, night pain, and pain during movement over a 14-day treatment period.

Diflunisal (500 mg twice daily) did not show significant pain relief compared to placebo, indicating that naproxen sodium may be a more effective option for managing chronic back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naproxen sodium, diflunisal, and placebo in the treatment of chronic back pain. Berry, H., Bloom, B., Hamilton, EB., et al.[2019]

In a study involving 198 patients with acute low back pain, ketorolac showed a trend towards better pain relief and less stomach irritation compared to ibuprofen, with 80% of ketorolac patients reporting mild or no pain by day 5.

While there were no significant differences in overall functional improvement (measured by the Roland-Morris Disability Questionnaire) among the three NSAIDs, ibuprofen was associated with a higher rate of stomach irritation (26%) compared to ketorolac (5%) and diclofenac (9%).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of ibuprofen versus ketorolac versus diclofenac for acute, nonradicular low back pain. Irizarry, E., Restivo, A., Salama, M., et al.[2022]

In treating osteo-articular pathologies, particularly vertebral issues, ibuprofen (Brufen 400) shows a significant and rapid positive effect in 75% of cases when administered at a sufficient dosage of 1,600 mg to 2,400 mg per day.

The study indicates that the tolerance for ibuprofen at these dosages is quite satisfactory, suggesting it is a safe option for managing pain in these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ibuprofen in osteo-articular (author's transl)]. Maigne, R., Le Corre, F., Juvin, P., et al.[2013]

In a study of 59 rheumatoid arthritis patients treated with up to 1,600 mg of ibuprofen daily for six months, significant improvements were observed in all clinical parameters, demonstrating its efficacy in managing symptoms.

The treatment was well-tolerated, with only two patients experiencing gastrointestinal upset leading to discontinuation, and no biochemical abnormalities were reported, highlighting the safety of high-dose ibuprofen in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience with high doses of ibuprofen in the long-term treatment of rheumatoid arthritis. Pavelka, K., Vojtisek, O., Susta, A., et al.[2017]

A study involving 6 healthy volunteers compared different formulations of ibuprofen, showing that both coated tablets and granules provide similar availability and absorption of the drug.

The new formulations allow for easier dosage adjustments, and the short half-life of ibuprofen, along with its established safety profile, supports their use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of two new oral formulations of ibuprofen. Benvenuti, C., Cancellieri, V., Gambaro, V., et al.[2013]

Dexibuprofen is at least as effective as racemic ibuprofen and shows comparable efficacy to diclofenac at lower doses, making it a strong option for treating conditions like rheumatoid arthritis and osteoarthritis.

Dexibuprofen has a better safety profile than other NSAIDs, with significantly lower rates of adverse drug reactions compared to racemic ibuprofen and diclofenac, indicating good tolerability for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overview on clinical data of dexibuprofen. Phleps, W.[2019]

Lower back pain (LBP) is a common issue, ranking fifth among reasons for seeking medical treatment, highlighting the need for effective pain relief options.

Dexketoprofen, a fast-acting NSAID, has been shown to have high analgesic activity and efficacy in treating acute musculoskeletal pain, making it a valuable option for managing LBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Dexketoprofen trometamol in dorsalgia treatment]. Shavlovskaya, OA.[2018]

In a study of 160 patients undergoing lumbar disk surgery, preoperative dexamethasone significantly reduced acute pain during mobilization compared to placebo, with a notable decrease in pain scores (33 mm vs 43 mm on a visual analog scale).

Dexamethasone also reduced the incidence of postoperative vomiting (17 episodes vs 51 episodes in the placebo group), indicating its potential benefits in managing acute postoperative symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. Nielsen, RV., Siegel, H., Fomsgaard, JS., et al.[2022]

In a study involving 370 outpatients with acute low back pain, dexketoprofen 50mg twice daily was found to be non-inferior to diclofenac 75mg twice daily in terms of pain relief, demonstrating similar efficacy in reducing pain intensity.

Dexketoprofen was well tolerated, with a safety profile comparable to diclofenac, and no serious adverse events were reported, indicating it is a safe option for managing acute low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicentre, randomised, double-blind study comparing the efficacy and tolerability of intramuscular dexketoprofen versus diclofenac in the symptomatic treatment of acute low back pain. Zippel, H., Wagenitz, A.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of diflunisal and acetaminophen with codeine in the treatment of initial or recurrent acute low back strain. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of diflunisal and naproxen in the management of acute low back strain. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Medicines of choice in low back pain. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Naproxen sodium, diflunisal, and placebo in the treatment of chronic back pain. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of ibuprofen versus ketorolac versus diclofenac for acute, nonradicular low back pain. [2022]

6. France pubmed.ncbi.nlm.nih.gov

[Ibuprofen in osteo-articular (author's transl)]. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Experience with high doses of ibuprofen in the long-term treatment of rheumatoid arthritis. [2017]

8. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of two new oral formulations of ibuprofen. [2013]

9. Germany pubmed.ncbi.nlm.nih.gov

Overview on clinical data of dexibuprofen. [2019]

10. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Dexketoprofen trometamol in dorsalgia treatment]. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Preoperative dexamethasone reduces acute but not sustained pain after lumbar disk surgery: a randomized, blinded, placebo-controlled trial. [2022]

12. New Zealand pubmed.ncbi.nlm.nih.gov

A multicentre, randomised, double-blind study comparing the efficacy and tolerability of intramuscular dexketoprofen versus diclofenac in the symptomatic treatment of acute low back pain. [2018]