Patient Education vs Placebo

Traeger AC et al. Effect of Intensive Patient Education vs Placebo Patient Education on Outcomes in Patients with Acute Low Back Pain. JAMA Neurology: 2018
  • Study is first randomized placebo-controlled trial to investigate formal patient education compared to placebo in patients with acute low back pain. Primary outcome measure was mean pain intensity during the first week assessed at 3 months after the onset of low back pain.
  • Participants aged 18 to 75 years who were seeking care for acute low back pain with or without referred leg pain. Participants with signs of radiculopathy were included.
  • Exclusion criteria included chronic low back pain (> 1/10 on VAS) for the past 3 months, <3/10 on VAS over the past week, clinical features of serious spinal pathology (eg, cauda equina syndrome, infection, fracture, or cancer) assessed by a clinician, poor command of the English language, previous spinal surgery, or a mental health condition that would preclude study participation.
  • 202 total participants were included and had similar demographic and clinical characteristics at baseline.
  • Education sessions consisted of 2, 1 hour one on one sessions. Intensive Patient Education intervention was adapted information and advice provided in book Explain Pain. It included detailed explanation about the biopsychosocial nature of pain in the format of diagrams, metaphors, and stories.
  • Placebo patient education was matched for time and consisted of clinician active listening and interest but without any actual education or advice provided. 
  • Primary analysis indicated that patient education was not more effective than placebo education at reducing pain intensity at 3 months for people with acute low back pain.
  • Certain between group differences did exist including a reduction in disability at 1 week and 3 months in the education group but no differences at 6 and 12 months.
  • The odds of recurrence of LBP at 12 months were lower in the education group compared to placebo as well as pain interference and odds of seeking healthcare at 3 months but also no significant differences at 6 or 12 months.
  • Causal mediation analysis confirmed that pt education reduced catastrophizing and unhelpful beliefs, but that did not necessarily reduce pain intensity.