Aaron Nethercott, Mercer University College of Pharmacy
According to the American College of Physicians Clinical Practice Guideline for low back pain (LBP), LBP is the fifth most common cause for doctor visits in the United States. The most commonly prescribed medications for LPB are considered to be acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), benzodiazepines, antiepileptic drugs, and antidepressants. The evidence supporting the combined use of different pain medications is conflicting. 
A review article suggested that the steps to treat patients with acute LPB are patient education, heat, exercises, medications, and return to normal activities. The recommended first-line agents for acute LBP are NSIADs. 
|Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain A Randomized Clinical Trial |
|Design||This was a randomized, double blinded, three group study (N = 2588). Of the initial patients, 2198 patients meet exclusion criteria or refused to participate. A total of 323 patients were randomized.|
|Objective||To compare functional outcomes and pain at one week and three months after an emergency department (ED) visit for acute LBP among patients randomized to a 10-day course study therapy|
|Study groups||Placebo + naproxen (n = 107), Cyclobenzaprine + naproxen (n = 108), oxycodone/acetaminophen (n = 108)|
|Methods||Patients were randomized to receive naproxen 500 mg twice daily + placebo; naproxen 500 mg twice daily + cyclobenzaprine five mg; or naproxen 500 mg twice daily + oxycodone/acetaminophen five mg/325 mg. Patients were instructed to take placebo/cyclobenzaprine/oxycodone and acetaminophen one to two tablets every eight hours as needed for LBP. Follow ups were made on week one and month three from ED discharge|
|Duration||April 2012 through December 2014|
|Primary Outcome Measure||Improvement on the Roland-Morris Disability Questionnaire (RMDQ) between ED discharge and one week post discharge|
|Mean age in years (SD)||39 (11)||38 (11)||39 (11)|
|Mean RMDQ at discharge (SD)||18.7 (4.0)||18.4 (4.1)||18.9 (3.7)|
|Duration of LBP prior to ED in hours (IQR)||48 (24 – 96)||48 (18 – 96)||72 (33 – 139)|
|Improvement in RMDQ at one week follow up (CI)||9.8 (7.9 – 11.7)||10.1 (7.9 – 12.3)||11.1 (9.0 – 13.2)|
|Adverse Events||Common Adverse Events:|
|Drowsiness, n (%)||4 (4)||7 (7)||16 (15)|
|Dizziness, n (%)||3 (3)||3 (3)||16 (15)|
|Nausea or vomiting, n (%)||6 (6)||4 (4)||19 (18)|
|Serious Adverse Events: Not applicable|
|Percentage that Discontinued due to Adverse Events: Not applicable|
|Study Author Conclusions||Among patients with acute, nontraumatic, nonradicular LBP presenting to the ED, adding cyclobenzaprine or oxycodone/acetaminophen to naproxen did not improve functional outcomes or pain at one-week follow-up. These findings do not support use of these additional medications in this setting.|
The study found that supplementing naproxen with other medications had no statistical significance in the reduction of pain or improvement of function. This suggests that NSAID therapy alone may be a sufficient prescribing practice for acute LBP. In practice this could help reduce the misuse and abuse of scheduled pain medications. Pharmaceutical pain management should only be considered part of complete patient care. Physical therapy is often needed to prevent acute LBP from progressing to chronic LBP.
- Chou R, Huffman LH. Medications for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007;147(7):505-14.
- Casazza BA. Diagnosis and treatment of acute low back pain. Am Fam Physician. 2012;85(4):343-50.
- Friedman BW, Dym AA, Davitt M, et al. Naproxen With Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Clinical Trial.2015;314(15):1572-1580. doi:10.1001/jama.2015.13043.