Influence of Percutaneous Electrolysis on Endogenous Pain Modulation

January 23, 2023 updated by: Sergio Varela Rodríguez, University of Salamanca

Influence of Percutaneous Electrolysis on Endogenous Pain Modulation: A Randomized Clinical Trial

Percutaneous electrolysis is a minimally invasive approach that consists in the application of a galvanic current through an acupuncture needle. Although several mechanisms and effects are attributed to percutaneous electrolysis, currently there are only a few publications that delve into this topic. The aim of this study is to investigate the influence of percutaneous electrolysis on the endogenous pain modulation. Four groups of intervention will be involved: no-intervention, isolated needling procedure, low intensity percutaneous electrolysis and high intensity percutaneous electrolysis. The effects on the pain modulation system will be evaluated before and immediately after the intervention, through pressure pain thresholds, conditioned pain modulation and temporal summation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Salamanca, Spain, 37007
        • Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca

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

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy asymptomatic subjects
  • Aged 18 to 40 years
  • Both genders

Exclusion Criteria:

  • Belonephobia or fear of needles
  • Neurological, cardiovascular or metabolic diseases
  • Any pathology or process that causes pain
  • Cutaneous alterations
  • Pregnancy
  • Cognitive and sensitivity disorders
  • Fibromyalgia
  • Frequent or recent (24 hours before) intake of alcohol and other drugs
  • Have received pharmacological, physiotherapeutic or other treatment in the last week
  • Intake of caffeine in the two hours prior to measurement
  • Vigorous physical activity on the day of testing

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

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Needling Group
The needle will be inserted for 90 seconds without galvanic current.
Procedure: Isolated needling procedure
The needle will be inserted into the common extensor tendon of the epicondyle (dominant elbow) for 90 seconds without galvanic current.
Experimental: Low intensity percutaneous electrolysis
A single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.
Procedure: Low intensity percutaneous electrolysis
Once the needle is located in the common extensor tendon of the epicondyle (dominant elbow), a single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.
Experimental: High intensity percutaneous electrolysis
Three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each.
Procedure: High intensity percutaneous electrolysis
The needle will be inserted in the target position during the same time as in the other groups (90 seconds). During the first stage of intervention the needle will be imbedded without galvanic current and when the end of the application time approaches (approximately 75 seconds) three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Conditioned Pain Modulation (evaluated by pressure algometry) immediately after the intervention
Time Frame: Baseline and immediately after the intervention
Assessed by algometry. Conditioning stimulus: pressure cuff on the arm. Measured at three locations (bilaterally): common extensor tendon of the epicondyle, cervical spine and tibialis anterior muscle.
Baseline and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Pressure Pain Thresholds immediately after the intervention
Time Frame: Baseline and immediately after the intervention
Assessed by algometry. Measured at three locations (bilaterally): common extensor tendon of the epicondyle, cervical spine and tibialis anterior muscle.
Baseline and immediately after the intervention
Change from baseline Temporal Summation (evaluated by VNRS) immediately after the intervention
Time Frame: Baseline and immediately after the intervention
Assessed by Verbal Numeric Rating Scale (11-point). Temporary stimuli: 10 consecutive pressures with the algometer at the intensity of the pressure pain threshold. Three locations (bilaterally): common extensor tendon of the epicondyle, cervical spine and tibialis anterior muscle.
Baseline and immediately after the intervention

Collaborators and Investigators

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

Sponsor

University of Salamanca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 3, 2022

Primary Completion (Actual)

December 23, 2022

Study Completion (Actual)

December 23, 2022

Study Registration Dates

First Submitted

January 10, 2021

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Electrolysis550

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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