Naproxen Alone Wins for Relieving Lower Back Pain

This is for our providers who treat back pain.

• Opioids, when combined with naproxen, are not more effective than naproxen alone for the majority of patients with acute, nontraumatic, nonradicular low back pain.
• Pain, functional impairment, and use of healthcare resources were similar among treatment groups at 7 days or 3 months, and almost two-thirds of patients had clinically significant improvement regardless of treatment group.

Among patients with acute, nontraumatic, nonradicular lower back pain (LBP) presenting to the emergency department (ED), adding cyclobenzaprine or oxycodone/acetaminophen (Percocet) to naproxen alone did not improve functional outcomes or pain at 1-week follow-up, a randomized, double-blind, three-group study has shown.

“These findings do not support the use of these additional medications in this setting,” Benjamin W. Friedman MD MS, of Montefiore Medical Center, Albert Einstein School of Medicine in New York City, and colleagues reported in the JAMA.

“Opioids, when combined with naproxen, are not more effective than naproxen alone for the majority of patients with low back pain,” Friedman said in an interview. “We demonstrated that adding cyclobenzaprine or oxycodone/acetaminophen to naproxen is unlikely to benefit the patient. Emergency physicians should counsel their patients that passage of time will bring improvement and eventual relief to most patients,” he told MedPage Today.

Measures of pain, functional impairment and use of healthcare resources were not different between the study groups at 7 days or at 3 months after the ED visit, reported the investigators. One week later, almost two-thirds of the patients demonstrated clinically significant improvement in LBP and function regardless of treatment group.

On the other hand, 40% of the cohort reported pain that was moderate or severe and half reported functional impairment 1 week after the ED visit. In addition, 60% of the study participants said they were still using medication after 1 week.

Three months after the initial ED visit, opioid use for LBP was uncommon regardless of which group patients were in, and fewer than 3% of patients in the opioid group reported taking medication in the previous 72 hours, said the investigators.

LBP is responsible for more than 2.7 million visits to U.S. EDs annually, pointed out Friedman and colleagues. In most cases, patients are treated with nonsteroidal anti-inflammatory drugs, acetaminophen, opioids, or skeletal muscle relaxants, often in combination, they said.

“Pain outcomes for these patients are generally poor,” wrote the authors. One week after an ED visit, 70% of patients reported persistent back pain-related functional impairment and 69% reported continued use of analgesics, they noted. After 3 months, some 48% reported functional impairment and 46% reported persistent analgesic use. This included 19% who still required opioids.

“Our data leave clinicians and patients in a difficult position,” Friedman told MedPage Today. “Many patients have already taken NSAIDs for LBP before they arrive in the ED. Some patients may have taken insufficient doses at incorrect intervals and could be instructed to optimize their NSAID regimen. But for those patients who have already optimized their NSAID regimen, there are no additional evidence-based medical therapies available.”

Remaining active leads to a better outcomes than bed rest, said the investigators, although they acknowledged that complementary therapies such as acupuncture, yoga, and massage have been inadequately studied in an acute LBP population.

In the study (April 2012-December 2014), a total of 323 patients who presented to the Montefiore Medical Center in New York City with nontraumatic, nonradicular LBP of 2 weeks’ duration or less were enrolled. All had a score of greater than 5 on the Roland-Morris Disability Questionnaire (RMDQ). (Zero indicates no functional impairment and 24 indicates maximum impairment.)

Patients were randomized 1:1:1 to one of three groups for 10-day courses of naproxen + placebo, naproxen + cyclobenzaprine, or naproxen + oxycodone/acetaminophen.

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, 5 mg cyclobenzaprine, or 5 mg oxycodone/ 325 mg acetaminophen.

Participants were instructed to take one or two of these tablets every 8 hours, as needed. Prior to discharge, they received a standardized 10-minute educational session on LBP.

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

Demographic characteristics were comparable among the three groups, said the investigators. At baseline, median RMDQ score in:

• 20 in the placebo group 0 (interquartile range [IQR] 17-21);
• 19 in the cyclobenzaprine group (IQR 17-21); and
• 20 in the oxycodone/acetaminophen group (IQR 17-22).

These scores were cut approximately in half in all three groups at the end of treatment. Specific between-group differences in score change at follow-up (using a stringent 98.3% confidence interval) were:

• 3 for cyclobenzaprine versus placebo (98.3% CI −2.6 to 3.2; P=0.77);
• 3 for oxycodone/acetaminophen versus placebo (98.3% CI −1.5 to 4.1; P=0.28); and
• 9 for oxycodone/acetaminophen versus cyclobenzaprine (98.3% CI −2.1 to 3.9; P=0.45).

Acute low back pain is a frustrating condition, acknowledged Friedman in an interview. “In general, a majority of patients with acute onset LBP report persistent suffering 1 week later. By 3 months, however, the majority has improved.”

Still, even though the study selected for patients at low risk of a poor outcome at 3 months by excluding those with chronic LBP, radicular symptoms, or regular use of analgesics, more than 20% of the cohort reported poor outcomes 3 months after the ED visit, he pointed out.