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Open-Label Placebo Injection for Chronic Back Pain With Functional Neuroimaging: A Randomized Clinical Trial.

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Open-label placebos (OLPs) reduced chronic back pain intensity for one month and improved mood and sleep for a year. Neuroimaging revealed OLP engagement of brain pain-modulatory pathways, offering a non-deceptive therapeutic option.

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Area of Science:

  • Pain Medicine
  • Neuroscience
  • Clinical Trials

Background:

  • Chronic back pain (CBP) is a major cause of disability, with placebos often showing efficacy comparable to active treatments.
  • Open-label placebos (OLPs), administered without deception, present a potential avenue for CBP relief, but their mechanisms require further investigation.

Purpose of the Study:

  • To evaluate the long-term effectiveness of OLPs for CBP.
  • To explore the neurobiological underpinnings of OLP treatment in CBP patients.

Main Methods:

  • A randomized clinical trial involving 101 adults with CBP, comparing OLP (saline injection with placebo information) to usual care.
  • Longitudinal functional magnetic resonance imaging (fMRI) was used to assess brain activity and connectivity before and after treatment.
  • Follow-up extended to 1 year, with primary outcome as pain intensity at 1 month.

Main Results:

  • OLP significantly reduced CBP intensity at 1 month post-treatment compared to usual care (P=.02).
  • While immediate pain relief from OLP did not persist long-term, significant improvements were noted in depression, anxiety, anger, and sleep quality up to 1 year.
  • fMRI revealed OLP altered brain responses to pain, engaging prefrontal-brainstem pain modulatory pathways.

Conclusions:

  • A single OLP injection can effectively reduce CBP intensity in the short term and offer sustained psychological and sleep benefits.
  • The neurobiological effects of OLPs in CBP patients involve established pain-modulatory brain networks, similar to deceptive placebos.
  • OLPs represent a promising non-deceptive therapeutic strategy for chronic pain management.