Generalization of placebo and nocebo effects across pain modalities and from pain to itch.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28928

Enrollment

Registered

2019-10-08

Start date

2019-04-08

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy participants

Interventions

Participants will learn the links between the changes of heat pain intensity with an Electrical Nerve Stimulation (ENS) device ‘ON/OFF’. This ENS device serves as a sham device and does not work in th

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy participants between 18 and 35 years old; 2. Fluent in the English language.

Exclusion criteria

Exclusion criteria: 1.Refusal to give written informed consent 2.Severe morbidity (e.g., multiple sclerosis, heart or lung disease, chronic itch or pain complaints) 3.DSM-IV psychiatric disorders (e.g., depression, autism) 4.Regular use of recreational drugs 5.Current use of medication 6.Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Generalization of placebo and nocebo effects to pressure pain. Following the heat pain conditioning and test, participants will receive 6 medium pressure pain stimuli; 3 stimuli with ENS ‘ON’ and 3 with ENS ‘OFF’. After each stimulus, participants will be asked to rate their pain intensity by using a 0-10 numerical rating scale. Our primary outcome is the comparison of the difference in average pressure pain between ENS ‘ON’ and ‘OFF’ in placebo and nocebo groups, respectively. Additionally, maximum pressure pain ratings between ENS ‘ON’ and ‘OFF’ in these groups will also be compared.	—

Measure

Time frame

Generalization of placebo and nocebo effects to pressure pain. Following the heat pain conditioning and test, participants will receive 6 medium pressure pain stimuli; 3 stimuli with ENS ‘ON’ and 3 with ENS ‘OFF’. After each stimulus, participants will be asked to rate their pain intensity by using a 0-10 numerical rating scale. Our primary outcome is the comparison of the difference in average pressure pain between ENS ‘ON’ and ‘OFF’ in placebo and nocebo groups, respectively. Additionally, maximum pressure pain ratings between ENS ‘ON’ and ‘OFF’ in these groups will also be compared.

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Secondary

Measure	Time frame
Generalization of placebo and nocebo effects to cowhage-evoked itch. Following the heat pain conditioning, participants will receive cowhage twice, once with ENS ‘ON’ and once with ENS ‘OFF’. As soon as participants feel itch for the first time, they will be asked to rate their itch intensity by using a 0-10 numerical rating scale every 10 seconds for 3 minutes. Our primary outcome is the comparison of the difference in average itch ratings between ENS ‘ON’ and ‘OFF’ in placebo and nocebo groups. Additionally, maximum itch ratings between ENS ‘ON’ and ‘OFF’ in these groups will also be compared. Psychological factors: the individual characteristics (e.g.,, anxiety) will be used to investigate possible moderators of placebo and nocebo effects within and across modalities.	—

Measure

Time frame

Generalization of placebo and nocebo effects to cowhage-evoked itch. Following the heat pain conditioning, participants will receive cowhage twice, once with ENS ‘ON’ and once with ENS ‘OFF’. As soon as participants feel itch for the first time, they will be asked to rate their itch intensity by using a 0-10 numerical rating scale every 10 seconds for 3 minutes. Our primary outcome is the comparison of the difference in average itch ratings between ENS ‘ON’ and ‘OFF’ in placebo and nocebo groups. Additionally, maximum itch ratings between ENS ‘ON’ and ‘OFF’ in these groups will also be compared. Psychological factors: the individual characteristics (e.g.,, anxiety) will be used to investigate possible moderators of placebo and nocebo effects within and across modalities.

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Contacts

Public ContactAndrea Evers

Leiden University

a.evers@fsw.leidenuniv.nl+31 71 527 6891

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)