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Completed

NCT Number: NCT04710992

Influence of Percutaneous Electrolysis on Endogenous Pain Modulation

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca

Salamanca, 37007, Spain

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Isolated needling procedure

Procedure

The needle will be inserted into the common extensor tendon of the epicondyle (dominant elbow) for 90 seconds without galvanic current.

Low intensity Percutaneous Electrolysis

Procedure

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.

High intensity percutaneous electrolysis

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Salamanca

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jan 15, 2021
Registry last updated
Jan 26, 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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