Healthy Clinical Trial
Official title:
Can Training Increase Reporting Accuracy and Study Power in Human Pain Trials
NCT number | NCT03952715 |
Other study ID # | 016/18 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 17, 2018 |
Est. completion date | July 2019 |
In previous studies, results of both the Focused Analgesia Selection Test (FAST) procedure, a method to assess pain-reporting accuracy, and the Evoked Pain Training (EPT) procedure, aimed to improve pain-reporting accuracy, correlated with the placebo response. The objectives of the current project were to determine if EPT (1) increases pain reporting accuracy and (2) affect the placebo response in experimental pain study.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | July 2019 |
Est. primary completion date | July 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Absence of neurological, psychiatric, or chronic pain disorders. - Have used at list once Ibuprofen, and not sensitive to NSAIDs. - Ability to give informed consent, communicate, and understand the purpose and instructions of this study. Exclusion Criteria: - Presence of diagnosed psychiatric disorders, cognitive and /or neurological deficits. - Use of analgesic, anti-depressant or anti-enxiayoltic medications on a regular basis (except for oral contraceptives). - Pregnancy. - Never used NSAIDs. |
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 drug/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. | Mechanical and thermal stimuli before the drug/placebo (Pre-drug/placebo) until receiving the same stimuli 40 minutes after taking the drug/placebo pill (Post-drug/placebo). | |
Secondary | Evoked pain training | 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. There are 3 training visits, each training consists of 2 FAST procedure and last approximately 1 hour. |
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