Experimental Pain Reporting Accuracy and Placebo Response
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|ClinicalTrials.gov Identifier: NCT03950999|
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Healthy Placebo Effect Pain||Other: Placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pain and Placebo - a Study to Examine Relations Between Pain Reporting Accuracy and the Response to Experimental Placebo Model|
|Actual Study Start Date :||August 13, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: Study arm
Each subject underwent baseline assessment of pain reporting accuracy (FAST). Thereafter, the placebo response was assessed using tonic heat stimuli delivered at fixed temperature of 44, 46.5, and 48°C which evoke mild, moderate and severe pain sensations (in accordance). The stimuli were given in a pseudo-random order twice, once before receiving the placebo pill (a sugar pill) and once after, maintaining the same order as before.
- Pain reporting accuracy [ Time Frame: Fast procedure itself (49 heat stimuli, from 7 designated heat temperatures, given in a random block-order design) lasting approximately 20 minutes. ]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".
- Change in experimental pain perception due to placebo pill intake [ Time Frame: Tonic stimuli before the placebo (Pre-placebo) until receiving the same stimuli 20 minutes after taking the placebo pill (Post-placebo). ]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 (Δ) will be calculated as the difference between the mean NPS.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950999
|Contact: Roi Treister, PhD||972-(0)firstname.lastname@example.org|
|Contact: Liat Honigman, PhD||972-(0)email@example.com|
|University of Haifa, The Clinical Pain Innovation Lab||Recruiting|
|Haifa, Israel, 3498838|
|Contact: Roi Treister, PhD 972-(0)4-6146214 firstname.lastname@example.org|