Conditioned Pain Modulation Using Painful Cutaneous Electrical Stimulation or Simply Habituation?

July 30, 2017 updated by: Christoph Maier, Prof. Dr., Ruhr University of Bochum
Painful cutaneous electrical stimulation (PCES) and corresponding evoked potentials led to a significant pain relief and decrease of evoked potentials and has been used to analyze conditioned pain modulation (CPM). However, it is unknown whether the pain relief results from habituation to the repeated painful electric stimulation. We compared the effects of CPM and habituation on PCES-induced pain and PCES-evoked potentials and analyzed whether increased attention by a random change of electric intensities amplifies the habituation effects.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

33

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 35 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

healthy subjects

Description

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • any kind of disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain relief
Time Frame: during the measurement
pain intensity of painful cutaneous electrical stimulation on a numeric rating scale (NRS 0-100)
during the measurement
N1P1-amplitude
Time Frame: during the measurement
Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV
during the measurement

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
N1-latency
Time Frame: during the measurement
Latency of the peak N1 of painful cutaneous electrical stimulation evoked potentials in msec
during the measurement
P0N1-amplitude
Time Frame: during the measurement
Amplitudes of painful cutaneous electrical stimulation evoked potentials in µV
during the measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruhr University of Bochum

Investigators

  • Principal Investigator: Christoph Maier, Prof Dr med, University clinic Bergmannsheil Bochum gGmbH, Department of pain medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2016

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

July 30, 2017

First Submitted That Met QC Criteria

July 30, 2017

First Posted (ACTUAL)

August 2, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 30, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCES-Hab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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