• Postgrad Med J · Sep 2024

    Randomized Controlled Trial Multicenter Study Comparative Study

    Comparison of diclofenac with tramadol, tizanidine or placebo in the treatment of acute low back pain and sciatica: multi-center randomized controlled trial.

    • HungKevin K CKKCAccident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, 2/F, Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, Hong Kong.Accident & Emergency Department, Prince of Wales, Rex P K Lam, Herman K H Lee, Yu Fai Choi, Justin Tenney, Zhong Zuo, ChongMarc K CMKCJockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, Hong Kong., Theresa S I Hui, Tak Kan Wong, Tsz Ying Yiu, Suet Yi Chan, Catherine P Y Mok, Ling Yan Leung, Wai Kit Mak, David T F Sun, Chi Hung Cheng, and Colin A Graham.
    • Accident and Emergency Medicine Academic Unit, The Chinese University of Hong Kong, 2/F, Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, Hong Kong.
    • Postgrad Med J. 2024 Sep 22; 100 (1188): 741750741-750.

    BackgroundLow back pain (LBP) is a leading cause of disability worldwide and has posed numerous health and socioeconomic challenges. This study compared whether nonsteroidal anti-inflammatory drugs (NSAIDs) in combination with tramadol, tizanidine or placebo would be the best treatment regime to improve the Roland Morris Disability Questionnaire (RMDQ) scores at 1 week.MethodsThis was a multi-center, double-blind, randomized, and placebo-controlled trial including adult patients with acute LBP and sciatica in three emergency departments in Hong Kong. Patients were randomized to the receive tramadol 50 mg, tizanidine 2 mg, or placebo every 6 hours for 2 weeks in a 1:1:1 ratio. The RMDQ and other secondary outcomes were measured at baseline, Day 2, 7, 14, 21, and 28. Data were analyzed on an intention to treat basis. Crude and adjusted mean differences in the changes of RMDQ and NRS scores from baseline to Day 7 between tizanidine/tramadol and placebo were determined with 95% confidence intervals.ResultsTwo hundred and ninety-one patients were analyzed with the mean age of 47.4 years and 57.7% were male. The primary outcome of mean difference in RMDQs on Day 7 (compared with baseline) was non-significant for tizanidine compared with placebo (adjusted mean difference - 0.56, 95% CI -2.48 to 1.37) and tramadol compared with placebo (adjusted mean difference - 0.85, 95% CI -2.80 to 1.10). Only 23.7% were fully compliant to the treatment allocated. Complier Average Causal Effect analysis also showed no difference in the primary outcome for the tizanidine and tramadol versus placebo.ConclusionAmong patients with acute LBP and sciatica presenting to the ED, adding tramadol or tizanidine to diclofenac did not improve functional recovery.© The Author(s) 2024. Published by Oxford University Press on behalf of Fellowship of Postgraduate Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

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