Influence of Propranolol on Conditioned Pain Modulation

Not Applicable

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: Placebo; Drug: propranolol

• Registration Number: NCT02808611
• Lead Sponsor: Kristian Kjær Petersen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-15
• Study First Submitted QC: 2016-06-17
• Study First Posted: 2016-06-22
• Study Start: 2016-07
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-27
• Last Update Posted: 2017-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Propranolol	propranolol	Propranolol is a beta-blocker

Primary Outcome Measures

Name	Time	Method
CPM efficacy	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 Outcome Measures

Name	Time	Method
Temporal summation of pain	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.
Heart-rate variability	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.
Offset analgesia	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.

Trial Locations

Locations (1)

Center for Sensory Motor Interaction, Aalborg University; 🇩🇰 Aalborg East, Denmark

Center for Sensory Motor Interaction, Aalborg University

🇩🇰Aalborg East, Denmark