Acute Low Back Pain. Topical Diclofenac and Oral Ibuprofen.

Phase 4 Completed 198 enrolled Montefiore Medical Center

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2021-03-02
Primary completion: 2023-06-30
Completion: 2023-06-30

Publications

Khankhel N, Friedman BW, Baer J, Lopez L, Feliciano C, Lee S, Irizarry E. Topical Diclofenac Versus Oral Ibuprofen Versus Diclofenac + Ibuprofen for Emergency Department Patients With Acute Low Back Pain: A Randomized Study. Ann Emerg Med. 2024 Jun;83(6):542-551. doi: 10.1016/j.annemergmed.2024.01.037. Epub 2024 Mar 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Diclofenac	Other / unclassified	4 g	Topical
Subject	Ibuprofen	Small molecule	400 mg	Oral

Indications

No indication recorded.