Healthy Clinical Trial
Official title:
Pain and Placebo - a Study to Examine Relations Between Pain Reporting Accuracy and the Response to Experimental Placebo Model
NCT number | NCT03950999 |
Other study ID # | 273/17 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 13, 2017 |
Est. completion date | June 2019 |
Good clinical care relies on precise evaluation of patients' conditions. Chronic pain and other neurological and psychiatric diagnoses pose challenges because their assessment depends on subjective patient-reported outcome measures (PROs). The investigators have recently developed the Focused Analgesia Selection Task (FAST), a method that allows assessing pain reporting accuracy. Preliminary results suggest that those who more accurately report their pain show diminished placebo response. The underlying mechanisms for this observation cannot be explained by current theories. Therefore, the investigators have conducted a pilot study to further characterize this relation in healthy population.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 2019 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - absence of acute or chronic pain disorders; - no reports of psychiatric, cognitive and /or neurological disorders; - no drugs including, analgesics or anti-anxiety medications on regular use (except for oral contraceptives). Exclusion Criteria: - pregnant or breast-feeding; - unable to give informed consent, communicate and understand the purpose and the instructions of the study. |
Country | Name | City | State |
---|---|---|---|
Israel | University of Haifa, The Clinical Pain Innovation Lab | Haifa |
Lead Sponsor | Collaborator |
---|---|
University of Haifa |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain reporting accuracy | Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable". | Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes. | |
Primary | Change in experimental pain perception due to placebo pill intake | Subjects will be asked to report their pain on numerical pain scale (NPS) ranging from 0, denoting "no pain", to 10, denoting "the worst pain imaginable". The placebo effect (?) will be calculated as the difference between the mean NPS. | Tonic stimuli before the placebo (Pre-placebo) until receiving the same stimuli 20 minutes after taking the placebo pill (Post-placebo). |
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