Electrophysiological Correlates of Nocebo Effects on Pain
CompletedNot applicableNCT04199858
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Pain is a nociceptive somatosensory process that can arise as a debilitating and chronic symptom in various diseases or following an injury. How pain is experienced can vary widely within and across individuals, and can be shaped by cognitive processes such as learning. Nocebo effects, negative changes in symptom severity attributed to learned outcome-expectations, demonstrate how learning processes can be detrimental for the experience of pain. Research to date has produced inconclusive findings regarding the electrophysiological correlates on nocebo effects. The few studies that have applied electroencephalography (EEG) in this field have pointed towards a potential involvement of alpha-band activity, but the direction of this involvement remains unclear. For example, an EEG study of conditioned nocebo hyperalgesia found a pre to post increase in resting state alpha band power that was correlated with pain catastrophizing scores and not with the magnitude of the nocebo effect. Later, other studies also found pre to post changes in alpha band power, however, these changes were correlated with the magnitude of nocebo effects and not pain catastrophizing. Given the discrepancy in findings, in this study the investigators plan to primarily investigate whether EEG components predict the magnitude of nocebo responses to thermal-pain stimuli. The investigators will also explore electrophysiological correlates during pain anticipation and whether nocebo responses would be significantly related to spectral and temporal EEG biomarkers. This study will utilize a validated model of instructional and associative learning methods (i.e., negative suggestions and classical conditioning, respectively) to experimentally induce nocebo effects on heat-evoked pain. Developing objective, brain-derived markers for nocebo responses, or the detection of individuals most susceptible to nocebo hyperalgesia, will aid in the comprehensive management of pain. This study is conducted at Leiden …
Study details
- Official title
- Electrophysiological Correlates of Nocebo Effects on Pain
- Conditions
- Chronic Pain Syndrome
- Chronic Pain, Psychogenic
- Chronic Pain
- Hyperalgesia
- Interventions
- Behavioral: Baseline pain stimulations
- Behavioral: Conditioning
- Behavioral: Evocation
- Other: Electroencephalography (EEG)
- Sponsor
- Leiden University Medical Center
- Collaborators
- Universiteit Leiden; VU University of Amsterdam
- Start date
- 2019-10-21
- Primary completion
- 2020-01-07
- Sex
- All
- Age range
- from 18 Years to 35 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Netherlands
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Aged 18 - 35 years * Good understanding of the English language * Normal or corrected to normal vision Exclusion Criteria: * Ever having experienced serious medical or psychiatric conditions (e.g., heart or lung disease, panic attacks, drug addiction, clinical depression), * Ever having experienced chronic pain complaints (pain for more than 6 months), * Having experienced persisting painful health problems in the last 6 months, * Experiencing acute physical pain (e.g., headache, or having used pain medication on the day of testing, * Pregnancy or breastfeeding, * Having recent injuries to the wrists or arms on the day of testing, * Previous participation in this or similar studies (e.g., using conditioning or thermal pain). * Having consumed psychotropic medication, recreational drugs, analgesic medication, or more than 3 units of alcohol, in the 24 hours prior to the study appointment. * After inclusion, participants who do not reach a sensation of high pain (at least 6 on the NRS) with the highest administered temperature or participants will also be excluded. * After inclusion, participants who do not reliably report a difference (a mean of at least 1,5 on the NRS) between the administered temperatures for control and nocebo trials in the induction phase will also be excluded. Nocebo conditioning relies upon the pairing of high-pain stimuli to the nocebo stimulus and lower pain to the control stimulus, therefore it is deemed that participants who do not experience this difference do not receive the necessary conditioning manipulation.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04199858