Development of a nociceptive test battery - inflammatory and neuropathic pain tests.

Completed

• Conditions: Pain; 10034606

• Registration Number: NL-OMON36524
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

* 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;
* Clinically significant findings as determined by medical history taking, physical examination, ECG and vital signs;
* Hemodynamic status at screening: systolic <100 and >160 mmHg, diastolic <50 and >95 mmHg, heart rate <45 and >100 bpm measured on the non-dominant (non-leading/non-writing hand) arm;
* 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 (disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, etc.);
* Pregnancy;
* Dark skin, wide-spread acne, tattoos or scarring on back or forearm;
* Subjects indicating nociceptive tests intolerable at screening, achieving tolerance at >70% of maximum input intensity for any somatic tasks;
*Non-responders to UVB, determined by a MED > 1321 mJ/cm^2;
* Have a urine drug screen detecting illicit drug of abuse (morphine, benzodiazepines, cocaine, amphetamine, THC, methamphetamines, MDMA) or a positive alcohol breath test at screening;
* Consume, on average, >8 units/day of (methyl)xanthines (e.g. coffee, tea, cola, chocolate) and not able to refrain from use during each stay at the CHDR clinic;
* History or clinical evidence of alcoholism or drug abuse;
* Smoking of >5 cigarettes/day or equivalent and not able to abstain from smoking cigarettes during each stay at the CHDR clinic;
* Sun-bathing or sun-bed use 2 weeks prior to screening and not able to abstain from sun-bathing or sun-bed use from screening until end of last study day;
* 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.
* Participation in a clinical trial within 90 days of screening or more than 4 times in the previous year.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>* UV (sun burn) model<br /><br>- current pain intensity;<br /><br>- erythema<br /><br>- secondary hyperalgesia (allodynia);<br /><br>- primary hyperalgesia:<br /><br>- evoked potentials.<br /><br><br /><br>* Pain threshold and tolerance levels for each nociceptive test: pressure pain<br /><br>(muscle) (kPa), electrical pain (skin) (mA), cold pressor pain (sec).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Continuous VAS of pain intensity.<br /><br>* McGill Pain Questionnaire Scores.<br /><br>* STAI-DY2 scores.</p><br>