Chronic Pain Clinical Trial
Official title:
Learning Mechanisms in Nocebo Hyperalgesia: the Role of Conditioning and Extinction Processes
Nocebo effects are adverse effects induced by patients' expectations. Nocebo effects on pain may underlie several clinical conditions, such as chronic pain. These effects can be learned via classical conditioning mechanisms. In the lab, nocebo effects are commonly studied via conditioning with continuous reinforcement (CRF) during which 100 percent of unconditioned pain stimuli are paired to conditioned stimuli (i.e., the activation of a mock medical device). Partial reinforcement (PRF) provides a more uncertain pairing during conditioning, where less than 100 percent of unconditioned pain stimuli are paired to conditioned stimuli. This method provides a potentially more clinically relevant learning platform to study how nocebo effects on pain are induced. In this study, the efficacy of conditioning with PRF, CRF, and sham-conditioning in inducing nocebo effects on pain will be compared. Furthermore, a counterconditioning method will be compared to an extinction method for the attenuation of nocebo effects on pain. Given the relevance of nocebo effects for patients, it is important to ascertain effective & clinically relevant methods to understand how nocebo effects may be formed and attenuated. This study is conducted by Leiden University.
Main planned analyses:
Primary Outcome; Comparing the effectivity of conditioning with PRF, conditioning with CRF,
and sham conditioning, in inducing nocebo effects on pain:
The magnitude of the induced nocebo effect during the first evocation phase (dependent
variable), will be compared between induction groups (independent variable). The pain ratings
for the first control trial will be measured against the pain ratings for the first
reinforced trial, yielding the magnitude of the nocebo effect. A 3x2 mixed model Analysis of
Variance (ANOVA) will be used, treating group as the between-subjects factor with three
levels (PRF, CRF, sham) and magnitude of the nocebo effect on pain as a within-subjects
measure with two levels (first control and first reinforced trial). Planned contrasts will be
conducted.
Secondary Outcome; Comparing the effectivity of counterconditioning and extinction in
attenuating nocebo effects on pain:
The nocebo effect still present in the second evocation phase (dependent variable) will be
compared between attenuation groups (independent variable). This effect will be measured as
the change in pain ratings reported in the first reinforced trial of the first evocation
phase (after induction) and pain ratings reported in the first reinforced trial of the second
evocation phase (after attenuation). This effect will be further analysed by measuring any
change in pain reports for the control trials (second dependent variable) in the same way.
The effect of induction group will also be further explored. A 2x2 mixed model ANOVA will be
conducted, with attenuation group as the between-subjects factor (counterconditioning and
extinction) and the degree to which the nocebo effect has been attenuated as the
within-subjects measure with two levels (first and second evocation phase for the first
reinforced trials). Further secondary analyses will be conducted.
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