Pain Perception
Conditions
Interventions
This is a randomized, crossover, placebo-controlled and double-blind clinical trial, which will be conducted with a convenience sample of 41 participants, with the sample size calculated statistically
Sponsors
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo FMRP - USP
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo HCFMRP - USP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants aged at least 18 years; both genders; absence of current or previous history (self-reported) of substance abuse, psychiatric disorders and/or neurological disorders, cardiovascular diseases, pulmonary diseases, high blood pressure; absence of painful disorders and complaints of chronic or acute pain; score less than ten on the Patient Health Questionnaire (PHQ-9), on the Generalized Anxiety Instrument (GAD-7); absence of experience of pain of any kind in the seven days prior to the experimental session, assessed by means of a checklist questionnaire of pre-existing painful conditions and the perception of present pain (Visual Analog Pain Scale)
Exclusion criteria
Exclusion criteria: Adverse reactions of any nature after the use of cannabis extract; failure to complete the experimental tasks that make up the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Threshold, evaluated through an ascending method of thermal stimuli (fixation of a contact thermode in the arm, coupled to an electronic system, which provides a gradual increase in temperature, every 5 seconds, with an initial temperature of 30 and a final temperature of 53 degrees Celsius The temperature reached when the participant indicates the initial perception of the thermal stimulus as being painful will be manually recorded;Pain Tolerance, evaluated through an ascending method of thermal stimuli (fixation of a contact thermode on the arm, coupled to an electronic system, which provides a gradual increase in temperature, every 5 seconds, with an initial temperature of 30 and a final temperature of 53 degrees Celsius The maximum temperature tolerated by the participant will be recorded manually, with a maximum limit of 53 degrees Celsius;Perceived pain intensity, assessed by the Visual Analog Pain Scale, which consists of a limited range of 10 cm in length, which represents the continuum of the painful experience and has at its ends anchor words such as: “No Pain” (score 0 ) and “Worst Possible Pain” (score 10);Degree of subjective displeasure, assessed using a 10 cm visual analogue scale to record the intensity of pain discomfort, with the anchor words “No Unpleasant Feeling” (score 0) and “Worst Possible Unpleasant Feeling” at its ends ” (score 10);Pain Cognitive Processing, assessed by a computerized task, in which a series of 128 color digital photographs are presented, depicting the right hand and right foot in everyday painful (64 photos) and non-painful (64 photos) situations. Participants must assess the intensity of pain experienced, using a visual numerical scale from 0 (no pain) to 10 (most painful) | — |
Secondary
| Measure | Time frame |
|---|---|
| State of Anxiety, assessed through the State-Trait Anxiety Inventory – State Version (STAI-E), whose higher scores are indicative of a higher level of anxiety;Mood State, assessed by the Visual Analog Mood Scale, which is composed of 16 pairs of verbal adjectives with opposite senses of mood states, which the participant must mark according to how they feel at the moment;Safety and tolerability of cannabis extract, assessed by the "Scale for side effects and psychotropic drugs of the Scandinavian Society of Psychopharmacology (UKU) clinical investigation committee", comprising 48 items that assess both symptom severity and side effect perception, divided into picture dimensions of symptoms (psychiatric, neurological, autonomic, others) | — |
Countries
Brazil
Contacts
Public ContactFlavia Osório
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo FMRP - USP
Outcome results
None listed