Chronic Pain Clinical Trial
Official title:
Learning Mechanisms in Nocebo Hyperalgesia: the Role of Conditioning and Extinction Processes
Verified date | August 2019 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Aged 18 - 35 years - Good understanding of the Dutch language Exclusion Criteria: - Severe or chronic physical morbidity (e.g., heart and lung diseases, diabetes) - Psychiatric disorders (DSM diagnosis; e.g., depression, autism) - Chronic pain complaints (= 6 months) at present or in the past - Current pain - Current use of analgesic medication - Pregnancy - After inclusion, participants who do not reach a sensation of high pain with the highest temperature administered or participants who appear unable to distinguish between moderate and high pain stimuli will also be excluded |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University | Leiden | South Holland |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Universiteit Leiden |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Possible resistance to extinction of induced nocebo effects on pain (rated on a 0-10 numeric rating scale) after PRF as compared to after CRF. | Exploring whether participants in the PRF group will exhibit higher resistance to extinction during attenuation, as compared to participants in the CRF group. This will be assessed by analyzing the time-course of extinction of the previously induced nocebo effects on pain (rated on a 0-10 numeric rating scale) during the attenuation phase and the 2nd evocation phase | Testing day 1, in the attenuation phase and the 2nd evocation phase | |
Primary | Magnitude of nocebo effects on pain (rated on a 0-10 numeric rating scale) after PRF, CRF, or sham conditioning. | This will be calculated in the first evocation phase, by analysing the pain ratings for the first reinforced trial against the pain ratings for the first control trial. | Testing day 1, in the 1st evocation phase | |
Secondary | Magnitude of nocebo effects on pain (rated on a 0-10 numeric rating scale) still present after counterconditioning or extinction. | This will be calculated by analysing the pain ratings for the first reinforced trial in the second evocation phase against the pain ratings for the first reinforced trial in the first evocation phase. | Testing day 1, in the 2nd evocation phase |
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