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Nonsteroidal Anti-inflammatory Drug (NSAID)

Ibuprofen + Dexamethasone for Lower Back Pain

Q: Is enrollment in this experiment currently open?

According to the details listed on clinicaltrials.gov, this trial is actively searching for participants; it was initially uploaded on July 1st 2023 and last updated June 24th of that same year.

Q: Is this trial available to individuals who are younger than 55 years old?

The eligibility criteria for this trial demand that patient participants are younger than 70 and have surpassed their 18th birthday.

Q: Who meets the criteria for enrolling in this experiment?

This clinical trial is currently accepting 132 participants who have been suffering from radiating <a href="https://www.withpower.com/clinical-trials/back-pain">back pain</a> for less than two weeks and are between 18-70 years of age. To be eligible, patients must not have experienced substantial or direct trauma to the lower back in the past month, experience a baseline score greater than 5 on the Roland-Morris Disability Questionnaire, and report that their recurrent low back pain has occurred no more frequently than half of days in the last three months.

Q: Is combining Ibuprofen, dexamethasone and educational intervention an effective yet safe regimen for patients?

With Phase 4 trials indicating that this combination of Ibuprofen, dexamethasone and education is approved, it receives a rating of 3 for safety.

Q: What is the total participant count for this clinical experiment?

Affirmative, the information available on clinicaltrials.gov specifies that this research is actively searching for participants. The trial was first announced on July 1st 2023 and recently edited on June 24th of the same year. This study aims to recruit 132 individuals from 2 separate locations.

Phase 4

Recruiting

Led By Eddie Irizarry, MD

Research Sponsored by Montefiore Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pain duration <2 week

Age 18-70 Enrollment will be limited to adults <70 years because of the increased risk of adverse medication effects in older adults.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 days (48 hours)

Awards & highlights

Study Summary

This trial studies how well a 2-day dose of dexamethasone and ibuprofen help patients with acute low back pain. Patients will get a low back pain education session too.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Possible side effects include stomach issues like ulcers and bleeding for ibuprofen; while dexamethasone may cause mood changes, increased blood sugar levels, insomnia, and weakened immunity among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pain has lasted less than 2 weeks.

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I am between 18 and 70 years old.

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My back pain severely affects my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 days (48 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 days (48 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 days (48 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Roland Morris Disability Questionnaire (RMDQ) score

Secondary outcome measures

Absolute Roland Morris Disability Questionnaire (RMDQ) score

Analgesic or LBP medication within the previous 24 hours

Frequency of Radicular LBP

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ibuprofen + dexamethasone + educational interventionExperimental Treatment3 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 interventionPlacebo Group2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Educational Intervention

2013

N/A

~7220

Dexamethasone Oral

2020

N/A

~14110

Ibuprofen 400 mg

2021

Completed Phase 4

~1930

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor

444 Previous Clinical Trials

582,428 Total Patients Enrolled

Eddie Irizarry, MDPrincipal InvestigatorMontefiore Medical Center

1 Previous Clinical Trials

198 Total Patients Enrolled

Media Library

Ibuprofen 400 mg (Nonsteroidal Anti-inflammatory Drug (NSAID)) Clinical Trial Eligibility Overview. Trial Name: NCT05721027 — Phase 4

Lower Back Pain Research Study Groups: Ibuprofen + dexamethasone + educational intervention, Ibuprofen + placebo + educational intervention

Lower Back Pain Clinical Trial 2023: Ibuprofen 400 mg Highlights & Side Effects. Trial Name: NCT05721027 — Phase 4

Ibuprofen 400 mg (Nonsteroidal Anti-inflammatory Drug (NSAID)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05721027 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this experiment currently open?

"According to the details listed on clinicaltrials.gov, this trial is actively searching for participants; it was initially uploaded on July 1st 2023 and last updated June 24th of that same year."

Answered by AI

Is this trial available to individuals who are younger than 55 years old?

"The eligibility criteria for this trial demand that patient participants are younger than 70 and have surpassed their 18th birthday."

Answered by AI

Who meets the criteria for enrolling in this experiment?

"This clinical trial is currently accepting 132 participants who have been suffering from radiating back pain for less than two weeks and are between 18-70 years of age. To be eligible, patients must not have experienced substantial or direct trauma to the lower back in the past month, experience a baseline score greater than 5 on the Roland-Morris Disability Questionnaire, and report that their recurrent low back pain has occurred no more frequently than half of days in the last three months."

Answered by AI

Is combining Ibuprofen, dexamethasone and educational intervention an effective yet safe regimen for patients?

"With Phase 4 trials indicating that this combination of Ibuprofen, dexamethasone and education is approved, it receives a rating of 3 for safety."

Answered by AI

What is the total participant count for this clinical experiment?

"Affirmative, the information available on clinicaltrials.gov specifies that this research is actively searching for participants. The trial was first announced on July 1st 2023 and recently edited on June 24th of the same year. This study aims to recruit 132 individuals from 2 separate locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.

2023. "Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05721027.

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