Influence of Propranolol on Conditioned Pain Modulation

NCT ID: NCT02808611

Last Updated: 2017-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propranolol

Propranolol is a beta-blocker

Group Type ACTIVE_COMPARATOR

propranolol

Intervention Type DRUG

Reduction of the ANS response

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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propranolol

Reduction of the ANS response

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kristian Kjær Petersen

OTHER

Sponsor Role lead

Responsible Party

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Kristian Kjær Petersen

M.Sc, Ph.d.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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KRISTIAN K PETERSEN, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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Center for Sensory Motor Interaction, Aalborg University

Aalborg East, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 29858911 (View on PubMed)

Other Identifiers

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N-20150055

Identifier Type: -

Identifier Source: org_study_id

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