Influence of Percutaneous Electrolysis on Endogenous Pain Modulation

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: Isolated needling procedure; Procedure: Low intensity percutaneous electrolysis; Procedure: High intensity percutaneous electrolysis

• Registration Number: NCT04710992
• Lead Sponsor: University of Salamanca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-12
• Study First Posted: 2021-01-15
• Study Start: 2022-10-03
• Primary Completion: 2022-12-23
• Study Completion: 2022-12-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Needling Group	Isolated needling procedure	The needle will be inserted for 90 seconds without galvanic current.
Low intensity percutaneous electrolysis	Low intensity percutaneous electrolysis	A single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.
High intensity percutaneous electrolysis	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline Conditioned Pain Modulation (evaluated by pressure algometry) immediately after the intervention	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 Outcome Measures

Name	Time	Method
Change from baseline Pressure Pain Thresholds immediately after the intervention	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.
Change from baseline Temporal Summation (evaluated by VNRS) immediately after the intervention	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.

Trial Locations

Locations (1)

Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca; 🇪🇸 Salamanca, Spain