Analgesic Mechanisms of Percutaneous Electrolysis

February 14, 2022 updated by: Sergio Varela Rodríguez, University of Salamanca

Neurophysiological Effects of Percutaneous Electrolysis Related to Endogenous Pain Modulation

Percutaneous electrolysis is based on the application of a galvanic current through an acupuncture needle. The underlying mechanisms that explain the efficacy of this technique are not completely well understood. The objective is to delve into the neurophysiological analgesic effects of percutaneous electrolysis. Participants will be assigned to one of three intervention groups. The analgesic effects of the technique will be evaluated by means of variables related to endogenous pain modulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Asymptomatic subjects
  • Signature of the informed consent

Exclusion Criteria:

  • Fear of needles
  • Any pathology or process that causes pain
  • Neurological, rheumatologic, cardiovascular or metabolic diseases
  • Cutaneous alterations and cognitive or sensitivity disorders
  • Pregnancy
  • Recent intake of alcohol or caffeine
  • 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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Sham intervention
The needle will be inserted for 90 seconds without galvanic current.
Other: Sham intervention
The needle will be inserted into the right common extensor tendon of the epicondyle for 90 seconds without galvanic current.
EXPERIMENTAL: Low intensity percutaneous electrolysis
Galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.
Other: Low intensity percutaneous electrolysis
A single impact of galvanic current will be applied in the common extensor tendon of the epicondyle (right side) with an intensity of 0.3 mA for 90 seconds.
EXPERIMENTAL: High intensity percutaneous electrolysis
Participants will receive three impacts of galvanic current with an intensity of 3 mA for 3 seconds each.
Other: High intensity percutaneous electrolysis
Three impacts of galvanic current will be applied in the common extensor tendon of the epicondyle (right side) 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
Changes from baseline in Pressure Pain Thresholds (PPT)
Time Frame: Baseline and immediately after the intervention
PPTs will be measure by algometry in the common extensor tendon of the epicondyle, bicipital groove and tibialis anterior muscle (all of the right side).
Baseline and immediately after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline in Conditioned Pain Modulation (CPM)
Time Frame: Baseline and immediately after the intervention
CPM will be assess by upper extremity submaximal effort tourniquet test with algometric measures in the common extensor tendon of the epicondyle, bicipital groove and tibialis anterior muscle (all of the right side).
Baseline and immediately after the intervention
Changes from baseline in Temporal Summation (TS)
Time Frame: Baseline and immediately after the intervention
Assessed by Verbal Numeric Rating Scale (11-point). 10 consecutive pressures will be applied in the three previous locations (epicondyle, bicipital groove and tibialis anterior) with the algometer at the intensity of the pressure pain threshold
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)

November 22, 2021

Primary Completion (ACTUAL)

February 11, 2022

Study Completion (ACTUAL)

February 11, 2022

Study Registration Dates

First Submitted

October 16, 2021

First Submitted That Met QC Criteria

October 16, 2021

First Posted (ACTUAL)

October 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 14, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP550

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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