Podcast: Play in new window | Download

Subscribe: RSS

[display_podcast]

Date: June 20th, 2018

Reference: Fox LM et al. Battlefield acupuncture to treat low back pain in the emergency department. Am J  EM 2018

Guest Skeptics: Dr. Robert Edmonds is an emergency physician in the US Air Force in Virginia. This is Bob’s seventh visit to the SGEM, and his first since returning from deployment. 

DISCLAIMER: The views and opinions of this podcast do not represent the United States Government or the US Air Force.

Case: A 48-year-old male presents to your emergency department with seven hours of gradual onset lower back pain that feels identical to prior flares of his chronic lower back pain.  He’s been previously worked up by his primary physician and found to not have a concerning cause of his pain.  During your encounter, he asks if there’s anything he can do for his pain that won’t make him drowsy.

Background: Lower back pain is one of the most common emergency department (ED) complaints, comprising approximately 2.6 million visits per year in the US [1]. Opioids are frequently used in the ED to treat pain and ED physicians are among the most frequent prescribers of opioids [2].

Given the opioid crisis, there is great demand for other methods of treatment for back pain and other painful conditions. One such alternative treatment under recent investigation is Battlefield Acupuncture (BFA), where five semi-permanent ASP needles are inserted into auricular acupuncture points.

Proponents of BFA cite the relative safety of the technique in comparison with opioids.  The needles may be left inserted for several days and patients may engage in their regular activities, removing the needles at any time they choose by grasping the end of the needle and lightly pulling.

Acupuncture has been covered on three different episodes of the SGEM. The first time was with Dr. Al Sacchetti. This reviewed a study investigation acupuncture compared to pharmacologic treatment for the treatment of pain the ED

SGEM#187: There is no high-quality evidence that acupuncture works for patients presenting to the emergency department with back pain, ankle sprains or migraines.

Al was brought back for a second time looking at using electro-acupuncture for migraine prophylaxis.

SGEM#211: This study does not provide any evidence of the efficacy of acupuncture to prevent the re-occurrence of migraine headache in patients without aura.

The most recent time was looking at acupuncture vs. morphine for renal colic.

SGEM#220: This trial does not support the claim that acupuncture works or is superior to morphine for adult patients presenting to the emergency department.

Clinical Question: Can patients with low back pain be effectively treated with Battlefield Acupuncture in the Emergency Department?

Reference: Fox LM et al. Battlefield acupuncture to treat low back pain in the emergency department. Am J  EM 2018

  • Population: Patients over 18-years-old with a chief complaint of “low back pain”
  • Intervention: Standard care at the discretion of the treating physician plus Battlefield Acupuncture. BFA involved the placement of ASP indwelling semi-permanent needles in up to five pre-specified points on the ear, corresponding with established auricular acupuncture points. This was according to the protocol described in the US Air Force Acupuncture Center’s Battlefield Acupuncture Protocol Book.
  • Comparison: Standard care at the discretion of the treating physician
  • Outcomes:
    • Primary Outcomes:
      • Timed get up and go test (GUGT)
      • Numeric rating scale (NRS) for back pain
    • Secondary Outcomes:
      • NRS for pain radiating to leg
      • Range of motion (ROM) of lumbar spine
      • Length of stay (LOS)
      • Medications before and after the visit
      • Safety outcomes-including if the placement of the needles was too painful to tolerate

Authors’ Conclusions: “This pilot study demonstrates that BFA is feasible as a therapy for LBP in the ED. Furthermore, our data suggest that BFA may be efficacious to improve LBP symptoms, and thus further efficacy studies are warranted.”

Quality Checklist for Randomized Clinical Trials:

  1. The study population included or focused on those in the emergency department. Yes
  2. The patients were adequately randomized. Yes
  3. The randomization process was concealed. Yes
  4. The patients were analyzed in the groups to which they were randomized. No
  5. The study patients were recruited consecutively (i.e. no selection bias). No
  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. No
  8. All groups were treated equally except for the intervention. Yes
  9. Follow-up was complete (i.e. at least 80% for both groups). No
  10. All patient-important outcomes were considered. Yes
  11. The treatment effect was large enough and precise enough to be clinically significant. No

Key Results: They enrolled 30 patients and 25 were available for analysis.

No difference in Get Up and Go Test (GUGT) but decrease in pain scale at one hour.

  • Primary Outcomes:
    • Timed Get Up and Go Test (GUGT) – No difference
      • 21.3 seconds treatment group vs 19.0 seconds control, p=0.33
    • Numeric Rating Scale for Back Pain – 
      • 5.2 (95% CI 4.2-6.2) treatment group vs 6.9 (95% CI 5.7-8.3) control, p=0.04
  • Secondary Outcomes:
    • Numeric rating scale for pain radiating to leg – No difference
    • 4 treatment vs. 2.2 control, p=0.43
    • Range of motion of lumbar spine – No difference
      • Flexion-49.8 degrees treatment vs 48.2 degrees control, p=0.82
      • Extension-22.8 degrees treatment vs 18.1 degrees control, p=0.28
    • Length of Stay (LOS)
      • Mentioned to be not significant difference but no data given
    • Medications before and after the visit
      • Before-Opioids given 2/15 treatment vs 4/15 control
      • After-Opioids given 7/15 treatment vs 7/15 control
    • Safety Outcomes 
      • Two treatment patients complained of discomfort at needle insertion site, but there were no serious adverse events from acupuncture

 

1)  P Values and Power: This study did detect a statistically significant difference in the treatment vs. control groups.  However, the authors comment on how the study lacks significant power to definitively detect clinical outcomes.  Given the small number of patients in the study and the fairly high dropout rate in the control group, single patients had a large effect on the findings, and caution should be applied to the p value.  Just because a difference in two groups is less than 0.05 doesn’t mean it’s infallible.

2)  Outcomes: They had two primary outcomes, GUGT and pain. As SGEMers know there can only be one primary outcome. This got me curious, so I went and check out their a priori primary and secondary outcomes on www.clinicalTrials.gov. Their original primary outcome was GUGT (NCT02399969). To remind everyone this was NEGATIVE (no difference).

Pain on the NRS was not listed as a primary outcome but rather listed as one of their secondary outcomes. The difference in NRS showed a small statistical difference of 1.7. Previous research has shown the difference needs to be greater than 1.3 to be clinically significant. But this was an unblinded trial with no sham group, so we would expect a strong placebo effect. This only became a primary outcome when published? No explanation was given on why the change. Perhaps it was decided post hoc after the data was reviewed? The original primary outcome of GUGT was negative but one of the secondary outcomes was statistically positive so it was elevated to a primary outcome.

Note that length of stay, medication administered, and adverse events were also added later as secondary outcomes.

3) Bias: The lack of blinding in this trial introduces bias into the study that would favor the acupuncture group in the form of a placebo effect. There could also be selection bias because these were not consecutive patients. Acupuncture was available during “limited hours” per the authors but this is not further described.  They do acknowledge that there was selection bias and lack of blinding in their limitation section.

4) Fallacies and Evidence: Acupuncture has been used to treat pain for thousands of years. This is a fallacious argument (appeal to antiquity). Just because something has been around for a long time does not means it works. In addition, ear acupuncture has not been around for thousands of years but dates back less than one-hundred years.

  • Appeal to tradition (also known as argumentum ad antiquitatem, appeal to antiquity, or appeal to common practice) is an argument in which a thesis is deemed correct on the basis that it is correlated with some past or present tradition (Wikipedia)

Another logical fallacy is the argument from popularity. Just because BFA has been taught to military physicians and is widely implemented does not mean it works.

A third fallacy is an appeal to emotion. They justify the study due to wounded soldiers and the opioid epidemic. That is another fallacious argument (appeal to emotion)

  • Appeal to emotion or argumentum ad passiones is a logical fallacy characterized by the manipulation of the recipient’s emotions in order to win an argument, especially in the absence of factual evidence. (Wikipedia)

There is also a lack of good evidence of efficacy. They claim in their introduction that ear acupuncture has positive results for treating pain a variety of settings. However, when you pull the references they are not very enthusiastic endorsements.

The evidence they cite for positive results is a systematic review and meta-analysis of ten studies (five without a sham group and therefore not blinded) showing a small mean difference of statistical efficacy [3].

The authors were not too sure of the results and concluded that ear acupuncture may (MAY NOT) be a promising modality and state that rigorous research is needed to establish definitive evidence of clinical significance. Their weak evidence dampens their enthusiasm for the treatment.

Ear acupuncture may be a promising modality to be used for pain reduction within 48 hours, with a low side effect profile. Rigorous re- search is needed to establish definitive evidence of a clinically significant difference from controls or from other pain treatments.

The evidence for efficacy in the emergency department is also very weak. One study was a case series of four patients (non-blinded) that concluded a potential use of ear acupuncture [4]. The second was a pilot study, unblinded, showed 23% reduction pain compared to control at ED discharge but no difference at 24hrs [5]. This most likely represents a placebo effect.

5) How Long Does It Take? One of their outcomes mentioned was LOS in the ED that they said was not different between groups but provided no data. An important aspect is how long does it take to perform the procedure? This is an important aspect and could affect the flow of other patients through the ED. Did it impact the LOS of other patients in the department? The flip side of that is that since it does not demonstrate efficacy beyond a placebo effect then it does not matter if it takes very little time.

Comment on Authors’ Conclusion Compared to SGEM Conclusion: We disagree with the authors’ conclusions and do not believe further efficacy studies are warranted.

SGEM Bottom Line: Based on this study, Battlefield Acupuncture cannot be recommended to treat pain in the emergency department.

Case Resolution: You discuss treatment options with your patient and refer them to their primary physician for continued outpatient management and non-pharmaceutical options.  After some toradol in the ED, your patient is discharged and ambulates to the exit.

Dr. Robert Edmonds

Clinical Application: This is another small, poorly designed, unblinded acupuncture study with a lack of a sham control group. Using Bayesian thinking, the pre-test probability of Battlefield acupuncture having efficacy is very low. It would take a very large effect size to demonstrate clinical efficacy.  It is wrong to use the serious opioid problem to justify a therapy which has not been proven to work.

What do I tell my patient?  Some centers are starting to use BFA to help people with low back pain.  There is no good evidence that this works, and I do not feel comfortable recommending this treatment for your pain.

Keener Kontest: Last weeks’ winner was Dr. Szabolcs Gaál-Weisinger from Semmelweis University in Budapest, Hungary. They knew World Cup soccer star Cristiano Ronaldo recently agreed to pay 18.8 million euros in fines for a tax evasion case.

Listen to the SGEM podcast on iTunes to hear this weeks’ question. If you know the answer send an email to TheSGEM@gmail.com with “keener” in the subject line. The first correct answer will receive a cool skeptical prize.

Remember to be skeptical of anything you learn, even if you heard it on the Skeptics’ Guide to Emergency Medicine.

  1. Friedman BW, Chilstrom M, Bijur PE, Gallagher EJ. “Diagnostic testing and treatment of low back pain in US emergency departments. A national perspective”.  Spine (Phila Pa 1976) November 2010
  2. Volkow ND et al. Characteristics of Opioid Prescriptions in 2009. JAMA 2011
  3. Murakami M et al. Ear Acupuncture for Immediate Pain Relief— A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Medicine 2017
  4. Tsai S et al. Auricular Acupuncture in Emergency Department Treatment of Acute Pain. Annals if EM. November 2016
  5. Goertz CMH et al. Auricular Acupuncture in the Treatment of Acute Pain Syndromes: A Pilot Study. Military Medicine. October 2006