NCT02808611

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
9 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

June 28, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 15, 2016

Last Update Submit

June 27, 2017

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • CPM efficacy

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

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

Secondary Outcomes (3)

  • Temporal summation of pain

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

  • Heart-rate variability

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

  • Offset analgesia

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

Study Arms (2)

Propranolol

ACTIVE COMPARATOR

Propranolol is a beta-blocker

Drug: propranolol

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

propranololDRUG

Reduction of the ANS response

Propranolol
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Sensory Motor Interaction, Aalborg University

Aalborg East, 9220, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 29858911DERIVED

MeSH Terms

Interventions

Propranolol

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • KRISTIAN K PETERSEN, Ph.D.

    Aalborg University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.Sc, Ph.d.

Study Record Dates

First Submitted

June 15, 2016

First Posted

June 22, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

June 28, 2017

Record last verified: 2017-06

Locations

DK(1)