Friedman BW et al. Naproxen with cyclobenzaprine, oxycodone/acetaminophen, or placebo for treating acute low back pain: A randomized clinical trial. JAMA 2015 Oct 20; 314:1572.
Benjamin W. Friedman, MD, MS1; Andrew A. Dym, BS2; Michelle Davitt, MD1; Lynne Holden, MD1; Clemencia Solorzano, PharmD3; David Esses, MD1; Polly E. Bijur, PhD1; E. John Gallagher, MD1
1Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York
2Medical College, Albert Einstein College of Medicine, Bronx, New York
3Pharmacy Department, Montefiore Medical Center, Bronx, New York
Relevance of the Study: Low back ache is one of the commonest clinical problems presenting to the emergency department. A variety of drugs like NSAIDs, Paracetamol, Opioids and Muscle relaxants are used routinely. Recently the AAOS released a mission statement to curtail the use of opioids in orthopaedic practice due to problems of dependence and addiction. This study is a level 1 Randomised Control trial comparing the efficacy of (1) naproxen(NSAID)+placebo; (2) naproxen+cyclobenzaprine; or (3) naproxen+oxycodone/acetaminophen. The study compares the functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP. Cyclobenzaprine is a tricyclic antidepressant considered to have “muscle relaxant” properties, even though it has no effect on skeletal muscles or motor neurons
Materials and Methods:
Design: randomized, double-blind, 3-group study
Population: Patients who presented with nontraumatic, nonradicular LBP of 2 weeks’ duration or less were eligible for enrollment upon ED discharge if they had a score greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). 2588 participants were approached for enrollment, They also received a standardized 10-minute LBP educational session prior to discharge.
323 patients were randomized into 3 groups. Patients included were those with acute nontraumatic, nonradicular low back pain
All participants were given 20 tablets of naproxen, 500 mg, to be taken twice a day along with placebo
Group A: cyclobenzaprine, 5 mg
Group B: oxycodone, 5 mg/acetaminophen, 325 mg
Outcome Measurement: Roland-Morris Disability Questionnaire (RMDQ)- The RMDQ is a 24-item questionnaire commonly used to measure LBP and related functional impairment on which 0 indicates no functional impairment and 24 indicates maximum impairment
- At baseline, median RMDQ score in the placebo group was 20 (interquartile range [IQR],17-21), in the cyclobenzaprine group-19 (IQR,17-21), and in the oxycodone/acetaminophen group- 20 (IQR,17-22).
- At 1-week follow-up, the mean RMDQ improvement was 9.8- placebo group, 10.1 – cyclobenzaprine group, and 11.1- oxycodone/acetaminophen group.
- Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 , for oxycodone/acetaminophen vs placebo, 1.3 , and for oxycodone/acetaminophen vs cyclobenzaprine, 0.9
Conclusions: Multiple earlier studies(Turturro et al.., Khwaja SM et al..) have demonstrated that the evidence for addition of opioids, muscle relaxants and paracetamol in acute low back pain is limited. This study too demonstrated that after 1 week, improvement in scores on the Roland-Morris Disability Questionnaire (the primary outcome) was similar in all three groups. The authors also state that almost 20% patients had worse outcomes at 3 months.
Trial Registration clinicaltrials.gov Identifier: NCT01587274