Influence of Propranolol on Conditioned Pain Modulation

Healthy Subjects Clinical Trial

Official title:

Konditionerende Smertestimuli - Sammenligning af Forskellige Test og Konditioneringsmodaliteter

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808611
• Other study ID #: N-20150055
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: June 27, 2017
• Start date: July 2016
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Aalborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• propranolol
Reduction of the ANS response
• Placebo

Locations

Country	Name	City	State
Denmark	Center for Sensory Motor Interaction, Aalborg University	Aalborg East

Sponsors (1)

Lead Sponsor	Collaborator
Kristian Kjær Petersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Temporal summation of pain	10 stimuli will be applied and subjects will back asked to rate the pain for each individual stimuli.	1-2 hours after propranolol/placebo and after 10 minutes break.
Secondary	Heart-rate variability	Two-point Heart-rate variability recording will be conducted using the Polar RS800CX heart rate monitor.	1-2 hours after propranolol/placebo and after 10 minutes break.
Secondary	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.	1-2 hours after propranolol/placebo and after 10 minutes break.