Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial.
OBJECTIVE
Low back pain (LBP) is responsible for more than 2.5 million visits to US emergency departments (EDs) annually. These patients are usually treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination.


OBJECTIVE
To compare functional outcomes and pain at 1 week and 3 months after an ED visit for acute LBP among patients randomized to a 10-day course of (1) naproxen + placebo; (2) naproxen + cyclobenzaprine; or (3) naproxen + oxycodone/acetaminophen.


METHODS
This randomized, double-blind, 3-group study was conducted at one urban ED in the Bronx, New York City. 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). 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. Beginning in April 2012, a total of 2588 patients were approached for enrollment. Of the 323 deemed eligible for participation, 107 were randomized to receive placebo and 108 each to cyclobenzaprine and to oxycodone/acetaminophen. Follow-up was completed in December 2014.


METHODS
All participants were given 20 tablets of naproxen, 500 mg, to be taken twice a day. They were randomized to receive either 60 tablets of placebo; cyclobenzaprine, 5 mg; or oxycodone, 5 mg/acetaminophen, 325 mg. Participants were instructed to take 1 or 2 of these tablets every 8 hours, as needed for LBP. They also received a standardized 10-minute LBP educational session prior to discharge.


METHODS
The primary outcome was improvement in RMDQ between ED discharge and 1 week later.


RESULTS
Demographic characteristics were comparable among the 3 groups. 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 in the placebo group, 10.1 in the cyclobenzaprine group, and 11.1 in the oxycodone/acetaminophen group. Between-group difference in mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 (98.3% CI, -2.6 to 3.2; P = .77), for oxycodone/acetaminophen vs placebo, 1.3 (98.3% CI, -1.5 to 4.1; P = .28), and for oxycodone/acetaminophen vs cyclobenzaprine, 0.9 (98.3% CI, -2.1 to 3.9; P = .45).


CONCLUSIONS
Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen alone did not improve functional outcomes or pain at 1-week follow-up. These findings do not support use of these additional medications in this setting.


BACKGROUND
clinicaltrials.gov Identifier: NCT01587274.
Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
Benjamin W
BW
Friedman
Medical College, Albert Einstein College of Medicine, Bronx, New York.
Andrew A
AA
Dym
Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
Michelle
M
Davitt
Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
Lynne
L
Holden
Pharmacy Department, Montefiore Medical Center, Bronx, New York.
Clemencia
C
Solorzano
Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
David
D
Esses
Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
Polly E
PE
Bijur
Department of Emergency Medicine, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
E John
EJ
Gallagher
D000082:Acetaminophen / Q000627:therapeutic use*; D000208:Acute Disease; D000328:Adult; D000368:Aged; D000639:Amitriptyline / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D004636:Emergency Service, Hospital; D005260:Female; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009125:Muscle Relaxants, Central / Q000627:therapeutic use*; D009288:Naproxen / Q000627:therapeutic use*; D010098:Oxycodone / Q000627:therapeutic use*; D010147:Pain Measurement; D016896:Treatment Outcome
D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal; D004338:Drug Combinations; D009125:Muscle Relaxants, Central; C514822:oxycodone-acetaminophen; D000639:Amitriptyline; D000082:Acetaminophen; D009288:Naproxen; C004704:cyclobenzaprine; D010098:Oxycodone