Podcast #4 - Acute Back Pain

Yes, that oh so common complaint that brings patients into the ER.   With acute back pain, everyone seems to have their own cocktail for treatment, but what has been shown to work?  In this reviewed of a trial in JAMA published October 20, 2015 we review a randomized control trial that looked into just this issue.  

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Title: Naproxen with Cyclobenzaprine, Oxycodone/Acetaminophen, or Placebo for Treating Acute Low Back Pain: A Randomized Control Trial
 
Case: A 26 y/o otherwise healthy male comes to your ED complaining of back pain after moving furniture at his home.  He reports pain that is worse with lifting, bending, and twisting that is mostly a dull ache but sharp at times.  At home he has tried ice and heat without relief.  His review of systems is negative for red flag symptoms.  On exam he has tenderness to palpation of the lower back without vertebral point tenderness and occasional muscle spasms are palpated. 
 
Background: Low back pain is a common complaint that is responsible for more than 2.5 million visits annually.  It is treated in a variety of ways ranging NSAIDS to muscle relaxers, and even opiates. 
 
Clinical Question: In patients with acute, nontraumatic, nonradicular low back pain presenting to the ED, does adding cyclobenzaprine or oxycodone/acetaminophen to naproxen improve functional outcomes or pain at one week follow-up?
 
Reference:

• Population: Back pain patients presenting to an urban ED in the Bronx, New York City for nontraumatic, nonradicular back pain present for two weeks or less that had a Roland-Morris Disability Questionnaire (RMDQ) score  greater than 5.   
  • Exclusion Criteria: Patients with radicular pain (defined as radiating below the gluteal folds), direct trauma to the back within the previous month, pain for more than two weeks, or recent history of greater than one episode of lower back pain per month. 
• Intervention: Naproxen paired with either oxycodone/acetaminophen or cyclobenzaprine.
• Comparison: Naproxen with placebo.
• Outcome: Improvement in RMDQ between ED discharge and one week later.

 
Author’s Conclusions: Among patients with acute, nontraumatic, nonradicular low back pain 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.
 
Quality Checklist for Randomized Clinical Trials:

1. The study population included or focused on those in the ED. Yes
2. The patients were adequately randomized. Yes
3. The randomization process was concealed. Yes, this was a double-blinded randomized placebo controlled trial
4. The patients were analyzed in the groups to which they were randomized. Yes, even when lost to follow-up at 7 days or 3 months
5. The study patients were recruited consecutively (i.e. no selection bias). Not completely as research associates staffed ED 16 to 24 hours per day 7 days per week during the 30 month study starting in April 2012
6. The patients in both groups were similar with respect to prognostic factors. Yes
7. All participants (patients, clinicians, outcome assessors) were unaware of group allocation. Yes, with the exception of the pharmacist who did the randomization and made the medications which were done in a concealed manner
8. All groups were treated equally except for the intervention. Unsure
9. Follow-up was complete (i.e. at least 80% for both groups). Yes
10. All patient-important outcomes were considered. Yes
11. The treatment effect was large enough and precise enough to be clinically significant. Yes

 
Key Results: RMDQ at baseline in the placebo group was 20 (interquartile range [IQR] of 17-21), in the cyclobenzaprine group 19 (IQR of 17-21), and oxycodone/acetaminophen group 20 (IQR 17-22).  AT one week follow-up the 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 the mean RMDQ improvement for cyclobenzaprine vs placebo was 0.3 (98.3% CI, -2.6 to 3.2 with a p=0.77), for oxycodone/acetaminophen vs placebo 1.3 (98.3% CI, -2.1 to 3.9 with a p=0.45), and oxycodone/acetaminophen vs cyclobenzaprine was 0.9 (98.3% CI, -2.1 to 3.9 with a p=0.45). 
 
Key Points of Debate:

• As one might expect, the pain persists
  • More than 50% of patients still required medication for their pain which they said continued. 
  • However, at least two-thirds of the patients in each category would want the same medication again if they returned for the same pain.
  • Naproxen use was still continued regularly but the other medications were used much less frequently. 
• Patients could have been unblinded during the trial
  • The placebo versus cyclobenzaprine or oxycodone/acetaminophen could cause certain side-effects which would unblind the patient.
  • To better look for this, researchers could have asked patients what medication they thought they received.
  • This could have potentially led to changes in reporting of pain and functional outcomes. 
• Not all patients are created equally
  • This study was done in an urban ED that served socioeconomically depressed people.
  • Access to treatment can affect back pain outcomes and not all patients have equal access, especially in settings with a larger population that could be considered poor.
  • However, there are most likely many hospitals that do serve such a population and could consider this data helpful
• There were a large number of secondary analyses which could have led to false findings.
  • One such example would be that there were no differences in outcomes from those who had the placebo versus oxycodone/acetaminophen but in secondary analysis found fewer patients reported moderate or severe pain if they took oxycodone/acetaminophen more than once.
  • This should serve as a reminder that too many analyses can lead to false findings or at least ones that require further evaluation separately. 
• Keep in mind how the medications were given
  • Patients received 20 tablets of naproxen 500mg to be taken twice daily no matter their group.
  • They then received 60 tablets of one of the following: placebo, cyclobenzaprine 5mg, of oxycodone/acetaminophen 5/325.  Patients were told to take 1-2 of these pills every 8 hours as needed for pain.
  • More specifically, they were told to take one pill then wait 30 minutes before taking the second. 
  • In addition they were instructed to try certain exercises and stretches, hot or cold packs, physical therapy, massage therapy, and acupuncture. 
  • In general, the dosing of medications is similar to what can be done in many practice settings which may help with generalization. 

 
Comparing Conclusions:
We agree with the conclusion that patients with acute, nontraumatic, nonradicular low back pain presenting to the ED do not benefit from adding cyclobenzaprine or oxycodone/acetaminophen to naproxen to improve functional outcomes or pain at one week.  Routine use of adding these medications do not appear to be useful based on this study.  However, this is a narrow population and cannot be generalized to all back pain patients. 
 
Our Bottom Line:
We agree the addition of cyclobenzaprine or oxycodone/acetaminophen does not show benefit in addition to naproxen for acute, nontraumatic, nonradicular low back pain of less than two weeks duration.
 
Case Resolution:
You discuss with your patient the plan for treatment.  You review how current evidence shows that naproxen alone appears beneficial and medications such as cyclobenzaprine or oxycodone/acetaminophen do not show additional benefit.  You also explain how added these other medications do have increased risks such as drowsiness, nausea/vomiting, and dizziness.  After this shared decision making, the patient agrees to try naproxen along with conservative measures to help with his pain.
 
Clinical Application:
At this time, patients who are appropriate and meet study criteria should be considered for treatment by naproxen alone.  Shared decision making and detailed information about back pain along with the risks/benefits of other potential medications should be discussed.
 
What do I tell my patient?
Although there are many ways to treat back pain, our current evidence shows that naproxen alone is beneficial in treating your pain.  Other medications have been tested with naproxen and do not show benefit.  Back pain can take a long time to recover from and there are many ways to help speed your recovery.  Make sure to follow-up with your PCP so that they can further evaluate your pain with time to see if other things need to be done.

Conclusion:
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