Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia

• Register: ClinicalTrials.gov
• Last refreshed on: 5 September 2016
• Main ID: NCT02527395
• Date of registration: 14/08/2015
• Prospective Registration: Yes
• Primary sponsor: Rigshospitalet, Denmark
• Public title: Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia
• Scientific title: To Determine the Degree of Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia Following Brief Thermal Sensitization in Healthy Male Volunteers
• Date of first enrolment: October 2015
• Target sample size: 121
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02527395
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science
• Phase: N/A

Countries of recruitment

Denmark

Key inclusion & exclusion criteria

Inclusion Criteria:

- Age >18 years and <35 years

- Speak and understand Danish

- Male gender

- Study participants who have understood and signed the informed consent

- No prescription medicine during the last 30 days.

Exclusion Criteria:

- Study participants that cannot cooperate to the test.

- Study participants who have a weekly intake of >21 units of alcohol, or a have
consumed >3 units of alcohol within 24 hours before experimental day.

- Study participants with a substance abuse, assessed by the investigator.

- Study participants, who have consumed analgesics less than 3 days before experimental
day.

- Study participants, who have consumed antihistamines less than 48 hours before
experimental day.

- Study participants, who have consumed antidepressant medication during the last 30
days before experimental day.

- Study participants with chronic pain.

- Study participants with neurological illnesses.

- Study participants with psychiatric diagnoses.

- Study participants with tattoos on the extremities.

- Study participants with eczema, wounds or sunburns on the sites of stimulation.

- Study participants with a Body Mass Index of >30 kg/m2 or <18 kg/m2



Age minimum: 18 Years
Age maximum: 35 Years
Gender: Male

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Other: Brief thermal sensitization

Other: Heat pain detection threshold

Other: Pain during 1 min. thermal stimulation

Primary Outcome(s)

Size of the Area of secondary hyperalgesia following Brief thermal sensitization, evaluated by cm2, and heat pain detection threshold registered by degrees celsius. [Time Frame: 7 days]

Secondary Outcome(s)

Pain during 1 min. thermal stimulation, evaluated by Area Under the Curve of the visual analog scale, 0-100 mm. [Time Frame: Study day 1 and 2. A minimum of 7 days]

Pain during 1 min. thermal stimulation, evaluated by maximum on the visual analog scale, 0-100mm. [Time Frame: Study day 1 and 2. A minimum of 7 days.]

Score of Pain Catastrophizing Scale [Time Frame: Study day 1 and 2. A minimum of 7 days.]

Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale. [Time Frame: Study day 1 and 2. A minimum of 7 days.]

Score of Hospital Anxiety and Depression Scale [Time Frame: Study day 1 and 2. A minimum of 7 days.]

Secondary ID(s)

SM2-MSH-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Copenhagen

Copenhagen Trial Unit, Center for Clinical Intervention Research