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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03752502
• Other study ID #: 1.584.966
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: December 1, 2018
• Est. completion date: November 27, 2021

Study information

• Verified date: November 2023
• Source: Universidade Federal do Piauí
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 27, 2021
• Est. primary completion date: November 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Procedure:
• Transcranial direct current stimulation (tDCS)
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)
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
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.

Locations

Country	Name	City	State
Brazil	Department of Physical Therapy. Federal University of Piaui	Parnaíba	Piauí

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal do Piauí

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anxiety	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.	Pre-test (before tDCS)
Other	Depression	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).	Pre-test (before tDCS)
Other	Pain catastrophizing	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.	Pre-test (before tDCS)
Primary	Pressure pain threshold	Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.	Pre and Post-test (immediately after tDCS)
Primary	Conditioned pain modulation	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).	Pre and Post-test (immediately after tDCS)