CompletedPhase 4

Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

United States198 participantsStarted 2021-03-02

Plain-language summary

This is a randomized, double-blind placebo-controlled study comparing two different treatments for acute low back pain: oral ibuprofen and topical diclofenac. Participants will be randomized to one of three study arms: 1) Oral ibuprofen + topical diclofenac; 2) Oral ibuprofen + topical placebo; 3) Oral placebo + topical diclofenac. Outcomes will be determined at 48 hours (2 days) and 7 days later.

Who can participate

Age range

18 Years – 69 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Present to Emergency Department (ED) primary for management of Low Back Pain (LBP), defined as pain originating between the lower border of the scapulae and the upper gluteal folds. Flank pain, that is pain originating from tissues lateral to the paraspinal muscles, will not be included. * Musculoskeletal etiology of low back. Patients with non-musculoskeletal etiologies such as urinary tract infection, ovarian cysts, or influenza like illness will be excluded. The primary clinical diagnosis, at the conclusion of the ED visit, must be a diagnosis consistent with non-traumatic, non-radicular, musculoskeletal LBP. * Patient is to be discharged home. * Age 18-69. Enrollment will be limited to adults younger than 70 years because of the increased risk of adverse medication effects in the elderly. * Non-radicular pain. Patients will be excluded if the pain radiates below the gluteal folds in a radicular pattern. * Pain duration \<2 weeks (336 hours). * Prior to the acute attack of LBP, back pain must occur less frequently than once per month. * Non-traumatic LBP: no substantial and direct trauma to the back within the previous month * Functionally impairing back pain: A baseline score of \> 5 on the Roland-Morris Disability Questionnaire Exclusion Criteria: * Not available for follow-up * Pregnant * Any analgesic medication use on a daily or near-daily basis * Allergic to or intolerant of investigational medications * Open wounds or skin breakdown of the l…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial compared topical diclofenac gel with oral ibuprofen for acute low back pain — since it's a Phase 4 study using medications already approved for general use, does that mean we have a clearer safety picture than we would with an experimental drug, and how does that affect what we know about risks for someone in my situation?
2The trial measured improvement using the Roland Morris Disability Questionnaire, which tracks how back pain affects daily functioning — can you help me understand what a meaningful improvement in that score would actually look like in terms of my day-to-day life?
3Since this trial is now completed, has the results data been published, and if so, did one treatment — the topical gel or the oral ibuprofen — show a notably better effect on pain-related disability that might be relevant to my care?
4I currently take other medications or have stomach sensitivities — given that this trial was specifically comparing a topical option to an oral anti-inflammatory, is one of these approaches safer or more practical for me personally?
5Given that this study focused on acute low back pain, and my situation may be similar, would you recommend trying one of these existing approved treatments first before considering anything more involved, like physical therapy add-ons or other interventions?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Pain Disability - Roland Morris Disability Questionnaire (RMDQ) Score

Timeframe: Baseline to 48 hours

Trial details

NCT IDNCT04611529

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

Results submitted2024-08-14

View on ClinicalTrials.gov More Low Back Pain trials