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NCT Number: NCT02527395

Association Between Heat Pain Detection Threshold and Area of Secondary Hyperalgesia

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.

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Key information

Conditions

Healthy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of anaesthesia and surgery, 4231, Rigshospitalet

Copenhagen, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brief thermal sensitization

Other

A small area of the skin of the study participants are heated to 45 degree celsius for 3 minutes, followed by evaluation of secondary hyperalgesia.

Other names: Clinical pain model

Pain during 1 min. thermal stimulation

Other

A small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute. During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.

Other names: Clinical pain model

Heat pain detection threshold

Other

The threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered. 4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements.

Other names: Clinical pain model

Primary outcomes

  1. 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

    How close is the Heat Pain Detection Threshold associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization? Area of secondary hyperalgesia will be investigated on two separate study days separated with a minimum of 7 days. The association will be expressed in R2 and prediction intervals for the area of BTS given fixed values of HPDT.

Secondary outcomes

  1. 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

    How close is the Visual analog scale (VAS)-AUC (area under the curve) following pain during 1 min. thermal stimulation associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?

  2. 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.

    How close is the max. VAS-score following pain during 1 min. thermal stimulation associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?

  3. Score of Pain Catastrophizing Scale

    Time frame: Study day 1 and 2. A minimum of 7 days.

    How close is the scores of Pain Catastrophizing Scale associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?

  4. Score of Hospital Anxiety and Depression Scale

    Time frame: Study day 1 and 2. A minimum of 7 days.

    How close is the scores of Hospital Anxiety and Depression Scale associated with the size of the area of secondary hyperalgesia induced by Brief thermal sensitization?

  5. 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.

    How close are the subscales in the two psychological tests (PCS-rumination, PCS-magnification, PCS-helplessness, and HADS-Anxiety, HADS-Depression) associated with the size of the area of secondary hyperalgesia?

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen Trial Unit, Center for Clinical Intervention Research
  • University of Copenhagen

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 19, 2015
Registry last updated
Aug 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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