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NCT Number: NCT02808611

Influence of Propranolol on Conditioned Pain Modulation

An extensive amount of studies indicate that conditioned pain modulation (CPM) test paradigms can be of use to evaluate the efficacy of the endogenous pain inhibition pathway in healthy controls and pain patients. A number of studies indicate that the autonomic nervous system (ANS) responds to painful stimulation by parasympathetic activity withdrawal and up-regulation of sympathetic activity (flight-or-fight mode), but it remains unknown whether these responses predict individual pain susceptibility or CPM efficacy and whether different pain modalities evoke different physiological stress responses, i.e. do individuals with low pain tolerance exhibit more vigorous ANS responses when subjected to controlled acute pain stimuli, and do high ANS responsiveness to pain coincide with altered psychophysical pain levels/CPM efficacy.

This study aims to investigate the effect of ANS responsiveness on CPM paradigms and to investigate if an exogenous, pharmaceutically induced decrease in the sympathetic drive of the ANS will yield decreased CPM efficacy.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Sensory Motor Interaction, Aalborg University

Aalborg East, 9220, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subjects

Exclusion criteria

  • Drug addiction defined as the use of cannabis, opioids or other drugs
  • Previous history of neurologic, musculoskeletal, mental illnesses or a chronic pain condition
  • Lack of ability to cooperate
  • Current use of medications that may affect the trial, e.g., analgesics, anti-inflammatory drugs
  • Consumption of alcohol, caffeine, nicotine or painkillers the morning and until termination of the study on the study day
  • Recent history of acute pain affecting the lower limb
  • Participation in other pain trials throughout the study period
  • Known diagnosis of cardio vascular diseases (low blood pressure, heart conditions)
  • Asthma
  • Decreased function of liver and kidneys
  • Diabetes

Treatment and study plan

Propranolol

Drug

Reduction of the ANS response

Placebo

Drug

Primary outcomes

  1. CPM efficacy

    Time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.

    A test stimuli will be applied and compared with a test stimuli simultaneous a condition stimuli.

Secondary outcomes

  1. Temporal summation of pain

    Time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.

    10 stimuli will be applied and subjects will back asked to rate the pain for each individual stimuli.

  2. Heart-rate variability

    Time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.

    Two-point Heart-rate variability recording will be conducted using the Polar RS800CX heart rate monitor.

  3. Offset analgesia

    Time frame: 1-2 hours after propranolol/placebo and after 10 minutes break.

    Temperatures ranging from 45-48°C will be applied to the forearm in three phases (phase 1: 5 seconds, phase 2: 5 seconds, and phase 3: 20 seconds). The subjects will be asked to assess the pain of the thermal stimuli using the electronic VAS scale.

Sponsors and collaborators

Lead sponsor

Kristian Kjær Petersen

Other

Registry information

Official study title

Konditionerende Smertestimuli - Sammenligning af Forskellige Test og Konditioneringsmodaliteter

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 22, 2016
Registry last updated
Jun 28, 2017

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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