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Clinical Question
Is treatment for acute low back pain more effective with a combination of ibuprofen and a muscle relaxant as compared with ibuprofen alone to improve functional outcomes and reduce pain?
Bottom line
Adding a muscle relaxant to treatment with ibuprofen does not improve functional outcomes or pain, or lessen the number of people reporting moderate to severe back pain one week after starting treatment. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Emergency department
Synopsis
These researchers enrolled 320 patients who presented to 1 of 2 emergency departments with nonradicular low back pain of 2 weeks' duration or less (average 72 hours) with a score of at least 6 of a possible 24 on the Roland-Morris Disability Questionnaire, a self-rated measure of disability due to low back pain. More than 90% of patients had a score of 10 or higher. All patients were given ibuprofen 600 mg to be taken up to 3 times a day, as needed. They were also randomized, concealed allocation unknown, to receive identical-appearing capsules containing placebo, baclofen 10 mg, metaxalone 400 mg, or tizanidine 2 mg, and were instructed to take 1 or 2 capsules up to 3 times a day, as needed. One week later, using intention-to-treat analysis, questionnaire scores improved in all groups, with improvement ranging from an average 10.1 points to 11.2 points across the groups compared with baseline. At this time, approximately 34% of patients across the groups reported moderate to severe back pain. The study had a power of 80% to find a difference of 5 points on the questionnaire if one existed.
Reviewer
Allen F. Shaughnessy, PharmD, MMedEd
Professor of Family Medicine
Tufts University
Boston, MA