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Completed

NCT Number: NCT03752502

Effects of Cerebral and Peripheral Electrical Stimulation on Conditioned Pain Modulation in Healthy Subjects.

The Neuromatrix pain model and new findings on pain chronification process point to a greater efficacy of treatments that address central and peripheral rather than only peripheral structures. Both cerebral and peripheral electrical stimulations can modulate brain areas involved in pain processing. However, their effects on pain modulation systems and clinical outcomes are lacking.

This study aims to investigate the efficacy of transcranial direct current stimulation (tDCS) and peripheral electrical stimulation (PES) alone as well tDCS combined with PES on pressure pain threshold and conditioned pain modulation in healthy subjects.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Physical Therapy. Federal University of Piaui

Parnaíba, Piauí, 64202020, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy subjects without medical complaints.

Exclusion criteria

Concurrent medication likely to affect cognitive performance pregnancy or possible pregnancy history of drug or alcohol abuse or dependence recent head injury (in the last 3 months) history of seizure or stroke.

Treatment and study plan

Transcranial Direct Current Stimulation (tDCS)

Procedure

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.

Peripheral electrical stimulation (PES)

Procedure

Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.

Sham tDCS

Procedure

Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.

Primary outcomes

  1. Pressure pain threshold

    Time frame: Pre and Post-test (immediately after tDCS)

    Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.

  2. Conditioned pain modulation

    Time frame: Pre and Post-test (immediately after tDCS)

    Conditioned pain modulation paradigms consist of the evaluation of a painful test stimulus followed by a second evaluation either at the same time as a distant, painful conditioning stimulus.

    PPT will be evaluated following a conditioning stimulus condition (hand immersion in a cold water).

Other outcomes

  1. Anxiety

    Time frame: Pre-test (before tDCS)

    Visual analogue scale (VAS) for anxiety assesses anxiety symptoms that we tracked as possible confounding factor.

    The VAS for general anxiety is assessed by a horizontal 100-mm-long line. The extreme left end points to no anxiety, and the extreme right end to the worst anxiety possible.

  2. Depression

    Time frame: Pre-test (before tDCS)

    Beck depression inventory (BDI) for depressive symptoms that we tracked as possible confounding factor.

    The BDI is a tool of self-assessment of depression using a questionnaire with 21 items whose intensity varies from 0 to 3 (higher scores indicating more depressive symptoms).

  3. Pain catastrophizing

    Time frame: Pre-test (before tDCS)

    Catastrophizing pain scale that we tracked as possible confounding factor.

    The pain catastrophizing scale consists of 13 sentences describing pain-related thoughts or feelings. These are divided into 3 domains: rumination, magnification and helplessness.

    The total score on the questionnaire can lie between 0 - 52 where a higher score indicates higher levels of pain catastrophizing thoughts.

Sponsors and collaborators

Lead sponsor

Universidade Federal do Piauí

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Nov 26, 2018
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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