Development of a nociceptive test battery - acute pain tests

Completed

Conditions: Pain
10034606

Registration Number: NL-OMON34385

Lead Sponsor: Centre for Human Drug Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

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

* 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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoints<br /><br>* Pain threshold and tolerance levels for each nociceptive test: pressure<br /><br>pain (muscle) (kPa), electrical pain (skin) (mA), cold pressor pain (sec).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study endpoints<br /><br>* Continuous VAS of pain intensity.<br /><br>* McGill Pain Questionnaire Scores.<br /><br>* STAI-DY1 scores.</p><br>