Pain Sensitivity in Acute Inflammatory Pain (PASORI)

University of Copenhagen

Status: Completed

Conditions: Healthy Volunteers Are Studied

Treatments: Procedure: first degree cutaneous burn injury

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01345877

H-1-2009-132

Details and patient eligibility

About

Pain is a complex experience influenced by gender and genetics, and, by psychosocial and sensory experiences. Pain sensitivity is thus highly variable between individuals.

In the present study we evaluate individuals´ pain perception in response to a number of different pain stimuli in 100 healthy volunteers (50 females and 50 males).

The data will allow us to assess pain sensitivity, to predict pain responses and to investigate gender related differences in pain perception.

A second aim is to evaluate the robustness of the different pain-tests since the tests are repeated with an interval of 2-4 weeks.

Full description

Pain perception is affected by physiological, psychological, existential and demographic factors.

In the present study psychophysiological, psychological, genetic and demographic components in pain perception are evaluated in healthy volunteers (n = 100).

Psychophysical assessments following induction of a first degree burn injury (47.0 C, 420 s, 12.5 sq.cm, lower leg) include:

• pain during induction of burn injury
• thermal thresholds
• tactile thresholds
• electrical thresholds
• areas of secondary hyperalgesia
• pressure algometric assessments
• assessment of Diffuse Noxious Inhibitory Control (DNIC) efficiency
• assessment of (DNIC) using cold pressor test

Psychological assessments include:

• HADS (Hospital Anxiety and Depression Scale)
• PCS (Pain Catastrophizing Scale)
• vulnerability score

Genetics include:

• A118G SNP

Demographics include:

• gender
• height
• weight

Enrollment: 100 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy
• psychomotor ability to perform the tests
• cognitive ability to perform the tests

Exclusion criteria

• smoker
• Body Mass Index > 28
• participation in drug studies < 4 weeks prior to inclusion
• chronic pain
• chronic intake of analgesics
• drug or alcohol abuse
• intake of analgesics < 48 hours prior to study
• females not on contraceptive therapy (intra-uterine device or p-pill)
• lesion in the assessment area

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

gender

Other group

Treatment:

Procedure: first degree cutaneous burn injury