Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for aLBP

[101N]

October 20, 2015, Vol 314, No. 15 >

< Previous Article
Full content is available to subscribers
Subscribe/Learn MoreNext Article >
Original Investigation | October 20, 2015
Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back PainA Randomized Clinical Trial
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
[+] Author Affiliations
JAMA. 2015;314(15):1572-1580. doi:10.1001/jama.2015.13043.

Importance 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.

Design, Setting, and Participants 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.

Interventions 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.

Main Outcomes and Measures 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 and Relevance 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.

---

Members don't see this ad.

 

[drusso]

Inner city ED in the Bronx @ Montefiore Medical Center: They should have added a "Vico-Soma-Xanax" arm to that study and used cannabis as an comparator/"active placebo." The effect size for that intervention would have been amazing...

 

[ampaphb]

Flexeril (or Robaxin, or Balcofen, or Parafon Forte, etc.) are not pain meds.

If they do anything, they reduce muscle spasm. The study's outcome measures are imprecise, and thus that arm of the conclusions is unreliable.

Additionally, lumping all LBP together, and then looking for a 'one size fits all' solution, strikes me as GIGO methodology.

 

[Ducttape]

you are missing the whole purpose of the study.

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.

the original purpose of ER medicine is a triage platform, not a diagnostic center. note that - purposefully - no diagnosis is given.

in other words, for these patients, no emergent condition found, patient can be discharged to follow up with primary care provider/specialist for definitive diagnosis and treatment.

now, this study suggests that it may be appropriate to send patients home without opioids (and ER is one of the identified areas where patients may be receiving unnecessary opioids) or muscle relaxants.

this study should help reduce unnecessary opioid prescribing. is that GIGO?

 

[ampaphb]

Any study that can't distinguish pain from a vertebral fracture and pain from a soft tissue injury is, indeed, GIGO.

 

[Ducttape]

you are stating that ER care is irrelevant.

if that is indeed your standpoint, then it is pointless discussing this study - or your overall perspective on anything related to ER medicine.

fyi, if you are going to be nit-picky - you mention vertebral fracture. what do you mean, traumatic or non-traumatic?

(traumatic fractures and traumatic low back pain was an exclusion criteria)

 

[ampaphb]

I don't think it is nit-picking to hope that investigators evaluating low back pain be capable of distinguishing pain from spasm

 

[Fiveoboy11]

Some of you guys are full of it. Negative findings with implications for my practice = nonsense. Same thing for a different profession = makes total sense. Nice double standard. Way to be "leaders" and "patient centered."

 

[ampaphb]

Really. False negatives are nonsense? Your results may be perfect. For those of us who can admit we are fallible, false negatives are a reason to repeat procedures that may not have provided relief the first time around.

 

[Fiveoboy11]

No. What I'm saying is you need to be consistent in what you call nonsense and why you call it nonsense. I see lots of bias infecting the interpretation of studies by people on this forum. Never said "my" results are perfect, read my posts and you'll see I'm very critical of "my" studies including when non members with a bias and agenda pretend they know how to interpret results. I'm all for repetition of studies when they contradict practice pattern or prevailing belief, with modifications if they don't hold up to critique for 2 seoncds.