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CompletedNCT02808611Updated Jun 28, 2017

Influence of Propranolol on Conditioned Pain Modulation

An interventional study of propranolol and Placebo in Healthy Subjects, sponsored by Kristian Kjær Petersen. Completed at 1 site in Denmark. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-28.

Sponsored by Kristian Kjær Petersen · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Male
01

Study summary

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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Conditions studied

  • Healthy Subjects
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In context

Lead sponsor

Kristian Kjær Petersen is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects

Exclusion criteria

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
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
25 participants (actual)

Study arms

  • Active comparator
    Propranolol

    Propranolol is a beta-blocker

    Drug: propranolol

  • Placebo comparator
    Placebo

    Placebo

    Drug: Placebo

Interventions

  • Drugpropranolol

    Reduction of the ANS response

  • DrugPlacebo
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What researchers measure

Primary outcomes

  1. CPM efficacy

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

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

Secondary outcomes

  1. Temporal summation of pain

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

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

  2. Heart-rate variability

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

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

  3. Offset analgesia

    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.

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

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Study locations

1 site
  • Center for Sensory Motor Interaction, Aalborg University
    Aalborg East, 9220, Denmark
08

References and documents

Publications

  • Petersen KK, Andersen HH, Tsukamoto M, Tracy L, Koenig J, Arendt-Nielsen L. The effects of propranolol on heart rate variability and quantitative, mechanistic, pain profiling: a randomized placebo-controlled crossover study. Scand J Pain. 2018 Jul 26;18(3):479-489. doi: 10.1515/sjpain-2018-0054. PubMed 29858911 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02808611
Lead sponsor
Kristian Kjær Petersen
Responsible party
Kristian Kjær Petersen (M.Sc, Ph.d., Aalborg University) — Sponsor-investigator
First posted
Jun 22, 2016
Start date
Jul 2016
Primary completion
Jan 2017
Completion
Jan 2017
Last update
Jun 28, 2017

Study contacts

KRISTIAN K PETERSEN, Ph.D.
principal investigator · Aalborg University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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