Hyperalgesia Clinical Trial
— LFSOfficial title:
Pain-related Fear as a Facilitator of Nocebo Hyperalgesia: An Experimental Study
Verified date | February 2020 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Nocebo hyperalgesia is characterized by adverse pain outcomes, induced by patients' expectations. In the lab, nocebo effects are commonly studied via classical conditioning, a method that employs pairings of neutral cues/treatments with different pain intensities to install differential pain-related expectations. In such conditioning experiments, participants are typically taught that a (sham) treatment exaggerates their pain, by surreptitiously administering high intensity (e.g. pain) stimuli in combination with this treatment. Verbal suggestions are also often used to inform participants of the supposed adverse effects of such treatments. In nocebo studies, higher pain levels and suggestions that are of more threatening nature may induce fear, thereby adding a crucial element to the experimental manipulation. Since nocebo effects are hypothesized to arise in clinical settings due to a combination of several psychological and cognitive mechanisms, it is important to study the role that factors such as higher pain levels, conditioned pain-related fear, or more threatening verbal suggestions may play in the formation of nocebo hyperalgesia. To date, no studies have focused on the fear-inducing effect that different pain intensities or verbal threat suggestions may have and how this fear, in turn, may strengthen the acquisition of nocebo effects. This study aims to investigate whether higher pain intensity or higher pain-related fear induced via threatening suggestions facilitate the acquisition and hinder subsequent extinction of nocebo hyperalgesia. This study will be conducted at Leiden University.
Status | Completed |
Enrollment | 72 |
Est. completion date | February 14, 2020 |
Est. primary completion date | February 14, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Aged 17 - 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), - Experiencing acute physical pain (e.g., headache; above 3 on a 10-point NRS scale), 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 who appear unable to distinguish between moderate and high pain stimuli (reporting at least a mean difference of 1.5 NRS points between nocebo and control trials during induction) will also be excluded. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University | Leiden | South Holland |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | KU Leuven, Maastricht University, Universiteit Leiden |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Fear levels | Fear levels (for mediation analyses) are measured via eye-blink startle modulation | On the testing day, in both experimental phases | |
Other | Fear self report levels | Fear levels (for mediation analyses) are also measured via self-reported fear during nocebo trials (relative to control trials). | On the testing day, in both experimental phases | |
Primary | Magnitude of nocebo hyperalgesia | The magnitude of induced nocebo hyperalgesia is defined as the difference in pain ratings for the first nocebo trial compared to the first control trial of the extinction phase. | On the testing day, in the first trials of the extinction phase | |
Secondary | Reduction of nocebo hyperalgesia | The reduction of nocebo hyperalgesia is defined as the change in reported pain between the first and last nocebo trial of the extinction phase. | On the testing day, in the extinction phase |
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