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Nonsteroidal Anti-inflammatory Drug (NSAID)

Diclofenac Gel + Ibuprofen for Acute Low Back Pain

Phase 4
Waitlist Available
Led By Benjamin Friedman, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights

Study Summary

This trial is comparing two treatments for acute low back pain, oral ibuprofen and topical diclofenac. Participants will be randomly assigned to one of three groups: 1) oral ibuprofen + topical diclofenac; 2) oral ibuprofen + topical placebo; 3) oral placebo + topical diclofenac. Outcomes will be measured 2 days later.

Eligible Conditions
  • Lower Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Improvement in Roland Morris Disability Questionnaire
Secondary outcome measures
Moderate or severe low back pain
Use of medication for low back pain

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Oral ibuprofen + topical diclofenacExperimental Treatment2 Interventions
Oral ibuprofen 400mg Topical diclofenac 2gm
Group II: Oral ibuprofen + topical placeboActive Control1 Intervention
Oral ibuprofen 400mg Topical placebo
Group III: Oral placebo + topical diclofenacActive Control1 Intervention
Oral placebo Topical diclofenac 2gm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical diclofenac
2021
Completed Phase 4
~200
Ibuprofen 400 mg
2021
Completed Phase 4
~1930

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
441 Previous Clinical Trials
581,998 Total Patients Enrolled
Benjamin Friedman, MDPrincipal InvestigatorMontefiore Medical Center
6 Previous Clinical Trials
1,644 Total Patients Enrolled

Media Library

Ibuprofen 400 mg (Nonsteroidal Anti-inflammatory Drug (NSAID)) Clinical Trial Eligibility Overview. Trial Name: NCT04611529 — Phase 4
Lower Back Pain Research Study Groups: Oral ibuprofen + topical placebo, Oral ibuprofen + topical diclofenac, Oral placebo + topical diclofenac
Lower Back Pain Clinical Trial 2023: Ibuprofen 400 mg Highlights & Side Effects. Trial Name: NCT04611529 — Phase 4
Ibuprofen 400 mg (Nonsteroidal Anti-inflammatory Drug (NSAID)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04611529 — Phase 4

Frequently Asked Questions

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

To what maladies is topical diclofenac usually administered?

"Topical diclofenac is an effective solution for managing catarrh, photorefractive keratectomy, and muscular spasms."

Answered by AI

Has Topical diclofenac been given the regulatory green light by the FDA?

"The high level of safety associated with topical diclofenac is indicated by its Phase 4 trial status, which merits a score of 3."

Answered by AI

What prior research has been undertaken to investigate the effects of topical diclofenac?

"Presently, 59 clinical trials concerning Topical diclofenac are underway. Of those studies, 15 have reached the third phase of research. While most experiments take place in Pittsburgh, Pennsylvania, there are 130 locations across the nation running these investigations."

Answered by AI

Are investigators still actively seeking participants for this study?

"Affirmative. The clinicaltrials.gov database confirms that recruitment for this trial is currently taking place, with a first post date of March 2nd 2021 and recent update on February 16th 2022. This study requires 198 participants to be enrolled at one medical centre."

Answered by AI

How many individuals are participants in this trial?

"Indeed, the current data posted on clinicaltrials.gov confirms that this medical experiment is still open for participants. This trial was initiated on March 2nd 2021 and modified most recently on February 16th 2022; it seeks to recruit 198 patients from a single site."

Answered by AI

Are younger individuals within the qualification range for this experiment?

"This clinical trial is exclusively available for patients between the ages of 18 and 69. However, there are separate studies dedicated to younger individuals (32 trials) and seniors (301)."

Answered by AI

What qualifications are necessary to participate in this experiment?

"This clinical trial is accepting 198 persons between the ages 18 and 69, who experience low back pain. Patients must meet multiple requirements in order to be included, such as: suffering from non-radicular discomfort; having had a pain duration of less than two weeks prior to enrollment; not presenting with any substantial or direct trauma to their back within the past month; scoring higher than 5 on the Roland Morris Disability Questionnaire; being discharged home at conclusion of ED visit; and finally, falling under 70 years old due to potential adverse medication effects that may occur with elderly participants."

Answered by AI

Who else is applying?

What site did they apply to?
Montefiore
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.
2021. "Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04611529.
~48 spots leftby Apr 2025
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