The Best Drug for Severe Acute Low Back Pain

Just about everyone suffers from at least one bout of acute low back pain at some point in their lives. Indeed, in any given three-month period, approximately one-quarter of adults report experiencing at least one day of low back pain.[1]

Low back pain is the fifth most common reason for outpatient doctor visits[2] and leads to 2.6 million emergency room visits in the U.S. every year.[3] Patients seeking medical care for severe low back pain routinely are prescribed nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen (TYLENOL), opioid pain relievers, muscle relaxants or, as is often the case, some combination of these drugs.[4] Prior research has shown that when used alone, some of these drugs offer varying degrees of benefit for treating low back pain compared with a placebo. In contrast, studies comparing the risks and benefits of different drugs or drug combinations generally have either yielded mixed results or been poorly designed.

However, a recent well-designed study, published in The Journal of the American Medical Association (JAMA), sheds new light on the safety and effectiveness of three commonly used drug treatments for severe acute low back pain:

• the NSAID naproxen (ALEVE, ANAPROX, NAPRELAN, NAPROSYN);
• naproxen, plus the muscle relaxant cyclobenzaprine (AMRIX); and
• naproxen, plus the opioid oxycodone with acetaminophen (OXYCET, PERCOCET, ROXICET, XARTEMIS XR).[5]

Drugs used for back pain

NSAIDs

Naproxen and other NSAIDs are approved for the treatment of pain and inflammation. These drugs can cause serious harm, and even death, by inducing bleeding in the stomach or intestines. Evidence from numerous randomized clinical trials demonstrates that NSAIDs alone are more effective than a placebo for short-term relief of symptoms in patients with low back pain[6] and offer benefits equivalent to acetaminophen.[7]

Guidelines issued jointly by the American College of Physicians and the American Pain Society recommend NSAIDs or acetaminophen as the first choice for treating most patients with low back pain.[8]

Muscle relaxants

Muscle relaxants such as cyclobenzaprine are approved for the treatment of muscle spasms associated with acute, painful musculoskeletal conditions.[9] Data from several clinical trials have shown that these drugs, when used alone, are more effective than a placebo for short-term relief of acute low back pain.[10] However, the use of muscle relaxants is associated with increased risks of drowsiness, dizziness and other adverse effects.[11]

Three randomized trials have compared NSAIDs alone with NSAIDs combined with cyclobenzaprine for acute back or neck pain. Two studies conducted more than 25 years ago appeared to show better relief of symptoms with the combination therapy, but each had design flaws.[12],[13]

The third, more recent trial was better designed. It showed no significant difference between the effectiveness of NSAIDs and combination therapy.[14] Combination therapy did, however, result in more side effects, such as sedation, lightheadedness, fatigue and confusion.

We have designated cyclobenzaprine as Do Not Use because it has not been definitively shown to be more effective than NSAIDs or painkillers for relieving pain associated with muscle spasms and has greater risks.[15]

Opioids

Opioids affect the central nervous system, producing pain relief and drowsiness. While undoubtedly effective for treating pain, they can be addictive and are associated with many adverse effects, including confusion, hallucinations, nausea and vomiting, and troubled breathing that can lead to death. These drugs should be reserved for severe pain that is not relieved by other painkillers such as acetaminophen or NSAIDs.

Physicians prescribe opioids more frequently than any other drug when treating acute back pain patients in emergency rooms: a whopping 62 percent of cases.[16] However, clinical trials have not shown any significant difference in effectiveness between opioids and NSAIDs for the management of acute low back pain,[17] and there are no published high-quality studies comparing NSAIDs alone with NSAIDs plus opioids for this condition.

The new JAMA study[18]

The study was conducted by researchers in New York at the Montefiore Medical Center emergency room. From 2012 to 2014, they studied 323 adult patients who were seen for severe acute low back pain.

All subjects were prescribed 500 milligrams (mg) of naproxen twice daily for 10 days. The subjects were then randomly assigned to receive one of the following in addition to the naproxen: cyclobenzaprine (5 mg tablets), oxycodone-acetaminophen (5-325 mg tablets) or placebo tablets. The subjects were given 60 of the assigned tablets and were instructed to take one or two every eight hours, as needed, for their back pain symptoms.

The researchers re-evaluated the subjects one week and three months later, using a standardized questionnaire for measuring back pain symptoms and related disability (how much the pain interfered with normal daily activities). Subjects also were asked to report any symptoms related to their assigned medications and were specifically asked whether they experienced stomach irritation, tiredness or dizziness.

The researchers found no significant differences among the three study groups in terms of pain relief and the ability to resume normal activities at either of the follow-up evaluations. By three months, most subjects had recovered, although nearly one-fourth in each group still had moderate to severe low back pain and were using medication for it.

However, subjects in the oxycodone-acetaminophen group were more likely to experience drowsiness, dizziness, and nausea or vomiting.

These results indicate that there is no benefit to adding cyclobenzaprine or oxycodone-acetaminophen to naproxen in patients with acute, nontraumatic low back pain, and for oxycodone-acetaminophen, there is increased risk.

What You Can Do

If you experience acute low back pain, follow the recommendations summarized in the box below.

If medication is needed to manage acute low back pain, use acetaminophen or an NSAID, and avoid use of muscle relaxants and opioids. Because low-dose ibuprofen and naproxen are least likely to increase cardiovascular risk,[20] we recommend these as first-choice NSAIDs for treating acute low back pain severe enough to require medicine. As with many other drugs for acute conditions, use the lowest effective dose for the shortest amount of time.

Never stop taking any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

References

[1] Deyo RA, Mirza SK, Martin BI. Back pain prevalence and visit rates: Estimates from U.S. national surveys, 2002. Spine. 2006;31(23):2724-2727.

[2] Hart LG, Deyo RA, Cherkin DC. Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine. 1995;20(1):11-19.

[3] Friedman BW, Chilstrom M, Bijur PE, Gallagher EJ. Diagnostic testing and treatment of low back pain in United States emergency departments: A national perspective. Spine (Phila Pa 1976). 2010;35(24):E1406-E1411.

[4] Ibid.

[5] 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. JAMA. 2015;314(15):1572-1580.

[6] Roelofs PD, Deyo RA, Koes BW, et al. Nonsteroidal anti-inflammatory drugs for low back pain: an updated Cochrane review. Spine (Phila Pa 1976). 2008;33(16):1766-1774.

[7] Ibid.

[8] Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: A joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147(7):478-491.

[9] DailyMed. Amrix label. Updated September 21, 2015. http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3902123b-1365-ac3c-0934-afff9eeeb1bd. Accessed February 9, 2016.

[10] Van Tulder MW, Touray T, Furlan AD, et al. Muscle relaxants for nonspecific low back pain: A systematic review within the framework of the Cochrane Collaboration. Spine (Phila Pa 1976). 2003; 28(17):1978-1992.

[11] Ibid.

[12] Basmajian JV. Acute back pain and spasm: A controlled multicenter trial of combined analgesic and antispasm agents. Spine (Phila Pa 1976). 1989;14(4):438-439.

[13] Borenstein DG, Lacks S, Wiesel SW. Cyclobenzaprine and naproxen versus naproxen alone in the treatment of acute low back pain and muscle spasm. Clin Ther. 1990;12(2):125-131.

[14] Turturro MA, Frater CR, D’Amico FJ. Cyclobenzaprine with ibuprofen versus ibuprofen alone in acutemyofascial strain: a randomized, double-blind clinical trial. Ann Emerg Med. 2003;41(6):818-826.

[15] WorstPills.org. Drug profile: Cyclobenzaprine. /monographs/view/57. Accessed January 14, 2016.

[16] Friedman BW, Chilstrom M, Bijur PE, Gallagher EJ. Diagnostic testing and treatment of low back pain in United States emergency departments: A national perspective. Spine (Phila Pa 1976). 2010;35(24):E1406-E1411.

[17] Roelofs PD, Deyo RA, Koes BW, et al. Non-steroidal anti-inflammatory drugs for lowback pain. Cochrane Database Syst Rev. 2008;(1):CD000396.

[18] 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. JAMA. 2015;314(15):1572-1580.

[19] Chou R, Qaseem A, Snow V, et al. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147(7):478-491.

[20] Further evidence that CELEBREX is a Do Not Use drug; new designation of diclofenac (VOLTAREN) as a Do Not Use drug; and other Do Not Use NSAIDs. Worst Pills, Best Pills News. June 2014. /newsletters/view/905. Accessed February 9, 2016.