Pain
Conditions
Interventions
None listed
Sponsors
Centre for Human Drug Research
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Subject: * Agree to and be capable of signing an informed consent form. * Healthy male and female subjects; * Age: 18 to 65 years at screening (inclusive); * Body mass index between 18-30 kg*m-2 (inclusive); * Able to refrain from strenuous physical exercise from 48 hours prior to each nociceptive test until dismissal from the CHDR clinic; * Able to refrain from alcohol use from 24 hours prior to and for the duration of every stay at the CHDR clinic; * Ability to communicate well with the investigator in the Dutch language. * Ability for female subjects to attend study days while in the follicular phase (3-13 days after onset of menstruation).
Exclusion criteria
Exclusion criteria: * Legal incapacity or inability to understand or comply with the requirements of the study; * Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud*s disease, urticaria, hypothyroidism) or pain (paraesthesia, etc.); * Pregnancy * History or clinical evidence of alcoholism or drug abuse; * Use of prescription, illicit or herbal medication within 7 days of nociceptive assessments; * Use of over-the-counter medications within 3 days of nociceptive assessments.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study endpoints * Pain threshold and tolerance levels for each nociceptive test: pressure pain (muscle) (kPa), electrical pain (skin) (mA), cold pressor pain (sec). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study endpoints * Continuous VAS of pain intensity. * McGill Pain Questionnaire Scores. * STAI-DY1 scores. | — |
Countries
Netherlands
Outcome results
None listed