Clinical trial NCT02527395: Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Experimental pain
Men
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen Trial Unit, Center for Clinical Intervention Research
name: University of Copenhagen
First posted: 2015-08-19
Enrollment: 121
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this prospective study is to investigate how close Heat Pain Detection Threshold is associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.

Furthermore we wish to investigate how close the clinical pain model: Pain during 1 min. heating of the skin (45 degrees celsius), and the psychological tests, Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale are associated with the area of secondary hyperalgesia, elicited by the clinical pain model Brief Thermal Sensitization.

Detailed description: The study participants will be tested with 3 types of clinical pain models on two separate identical study days. A minimum of 7 days will separate the two study days, thus, the minimum length of the study is 7 days, but can be higher.

The 3 types of pain conditioning consist of 1) Brief thermal sensitisation (BTS), 2) Heat pain detection threshold (HPDT), and pain during 1 min. thermal stimulation (p-TS.

The order of the stimulations (HPDT and BTS) is randomised for each patient and each study day, by a random allocation sequence, computer-generated by Copenhagen Trial Unit and stored in sealed and opaque envelopes to secure adequate allocation concealment. p-TS is conducted subsequent to BTS and HPDT.

The participants will complete the psychological tests Pain Catastrophizing Scale (PCS) and Hospital Anxiety and Depression Scale (HADS) in their private home prior to study day 1. The completed tests will be placed in opaque sealed envelopes to secure blinding of the investigator and outcome assessor.

Eligibility 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

Primary outcomes:
measure: Size of the Area of secondary hyperalgesia following Brief thermal sensitization, evaluated by cm2, and heat pain detection threshold registered by degrees celsius.
timeFrame: 7 days
Secondary outcomes:
measure: Pain during 1 min. thermal stimulation, evaluated by Area Under the Curve of the visual analog scale, 0-100 mm.
timeFrame: Study day 1 and 2. A minimum of 7 days
measure: Pain during 1 min. thermal stimulation, evaluated by maximum on the visual analog scale, 0-100mm.
timeFrame: Study day 1 and 2. A minimum of 7 days.
measure: Score of Pain Catastrophizing Scale
timeFrame: Study day 1 and 2. A minimum of 7 days.
measure: Score of Hospital Anxiety and Depression Scale
timeFrame: Study day 1 and 2. A minimum of 7 days.
measure: Score of Subscales of Pain Catastrophizing Scale and Hospital Anxiety and Depression Scale.
timeFrame: Study day 1 and 2. A minimum of 7 days.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of anaesthesia and surgery, 4231, Rigshospitalet
Study officials:
References:
citation: Hansen MS, Asghar MS, Wetterslev J, Pipper CB, Johan Martensson J, Becerra L, Christensen A, Nybing JD, Havsteen I, Boesen M, Dahl JB. Is the Volume of the Caudate Nuclei Associated With Area of Secondary Hyperalgesia? - Protocol for a 3-Tesla MRI Study of Healthy Volunteers. JMIR Res Protoc. 2016 Jun 17;5(2):e117. doi: 10.2196/resprot.5680.
citation: Hansen MS, Wetterslev J, Pipper CB, Asghar MS, Dahl JB. Is heat pain detection threshold associated with the area of secondary hyperalgesia following brief thermal sensitization? A study of healthy volunteers - design and detailed plan of analysis. BMC Anesthesiol. 2016 May 31;16(1):28. doi: 10.1186/s12871-016-0193-2.