Objective:
To evaluate the effectiveness of a single subcutaneous saline injection, openly disclosed as a placebo, in reducing chronic back pain intensity compared to usual care.
Approach:
- Study Design: A randomized clinical trial involving 101 adults with chronic back pain, utilizing functional magnetic resonance imaging (fMRI) to assess brain activity.
- Participants: Adults aged 21-70 years with chronic back pain for at least half the days in the past 6 months and a 1-week average pain intensity of ≥4/10.
- Intervention: Participants received either an open-label placebo (OLP) injection or usual care.
- Outcome Measures: Pain intensity reduction, pain interference, anxiety, and neuroimaging results were assessed.
Key Findings:
- At one month post-treatment, 45.4% of OLP patients reported at least a 30% pain reduction compared to 38.3% in the usual care group.
- 24.4% of OLP patients reported at least a 50% reduction in pain compared to 14.9% in the usual care group.
- Improvements in pain interference and marginal improvements in anxiety were observed in the OLP group.
- Long-term benefits were noted for depression, anger, anxiety, and sleep disruption, despite pain relief not persisting at one-year follow-up.
- Neuroimaging showed increased activity in pain-regulating brain regions and decreased activity in pain-processing areas.
Interpretation:
Limitations:
- Small sample size and low racial and ethnic diversity.
- Baseline differences in exercise levels and pain duration between groups.
- Higher missing data in the usual care group at 12-month follow-up.
- Recruitment materials may have biased participant selection towards those more open to placebo treatments.
Conclusion:
Sources:
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