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Influence of Propranolol on Conditioned Pain Modulation

Konditionerende Smertestimuli - Sammenligning af Forskellige Test og Konditioneringsmodaliteter

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02808611
Enrollment
25
Registered
2016-06-22
Start date
2016-07-31
Completion date
2017-01-31
Last updated
2017-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Brief 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.

Interventions

DRUGpropranolol

Reduction of the ANS response

DRUGPlacebo

Sponsors

Kristian Kjær Petersen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
CPM efficacy1-2 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

MeasureTime frameDescription
Temporal summation of pain1-2 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.
Heart-rate variability1-2 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.
Offset analgesia1-2 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026