Influence of Percutaneous Electrolysis on Endogenous Pain Modulation

NCT ID: NCT04710992

Last Updated: 2023-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2022-12-23

Brief Summary

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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

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Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Needling Group

The needle will be inserted for 90 seconds without galvanic current.

Group Type SHAM_COMPARATOR

Isolated needling procedure

Intervention Type 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

A single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.

Group Type EXPERIMENTAL

Low intensity percutaneous electrolysis

Intervention Type 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

Three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each.

Group Type EXPERIMENTAL

High intensity percutaneous electrolysis

Intervention Type 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.

Interventions

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Isolated needling procedure

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

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Salamanca

OTHER

Sponsor Role lead

Responsible Party

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Sergio Varela Rodríguez

PhD candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca

Salamanca, , Spain

Site Status

Countries

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Spain

References

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Garcia Bermejo P, De La Cruz Torres B, Naranjo Orellana J, Albornoz Cabello M. Autonomic Responses to Ultrasound-Guided Percutaneous Needle Electrolysis: Effect of Needle Puncture or Electrical Current? J Altern Complement Med. 2018 Jan;24(1):69-75. doi: 10.1089/acm.2016.0339. Epub 2017 Jan 30.

Reference Type BACKGROUND
PMID: 28135129 (View on PubMed)

Valera-Garrido F, Minaya-Munoz F, Medina-Mirapeix F. Ultrasound-guided percutaneous needle electrolysis in chronic lateral epicondylitis: short-term and long-term results. Acupunct Med. 2014 Dec;32(6):446-54. doi: 10.1136/acupmed-2014-010619. Epub 2014 Aug 13.

Reference Type BACKGROUND
PMID: 25122629 (View on PubMed)

Abat F, Diesel WJ, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Effectiveness of the Intratissue Percutaneous Electrolysis (EPI(R)) technique and isoinertial eccentric exercise in the treatment of patellar tendinopathy at two years follow-up. Muscles Ligaments Tendons J. 2014 Jul 14;4(2):188-93. eCollection 2014 Apr.

Reference Type BACKGROUND
PMID: 25332934 (View on PubMed)

Nir RR, Yarnitsky D. Conditioned pain modulation. Curr Opin Support Palliat Care. 2015 Jun;9(2):131-7. doi: 10.1097/SPC.0000000000000126.

Reference Type BACKGROUND
PMID: 25699686 (View on PubMed)

Fernandez-de-Las-Penas C, Nijs J. Trigger point dry needling for the treatment of myofascial pain syndrome: current perspectives within a pain neuroscience paradigm. J Pain Res. 2019 Jun 18;12:1899-1911. doi: 10.2147/JPR.S154728. eCollection 2019.

Reference Type BACKGROUND
PMID: 31354339 (View on PubMed)

Damien J, Colloca L, Bellei-Rodriguez CE, Marchand S. Pain Modulation: From Conditioned Pain Modulation to Placebo and Nocebo Effects in Experimental and Clinical Pain. Int Rev Neurobiol. 2018;139:255-296. doi: 10.1016/bs.irn.2018.07.024. Epub 2018 Aug 14.

Reference Type BACKGROUND
PMID: 30146050 (View on PubMed)

Sanchez-Gonzalez JL, Navarro-Lopez V, Calderon-Diez L, Varela-Rodriguez S, Fernandez-de-Las-Penas C, Sanchez-Sanchez JL. Effectiveness of different percutaneous electrolysis protocols in the endogenous modulation of pain: A Double-Blinded Randomized Clinical Trial. Musculoskelet Sci Pract. 2023 Nov;68:102872. doi: 10.1016/j.msksp.2023.102872. Epub 2023 Oct 11.

Reference Type DERIVED
PMID: 37847947 (View on PubMed)

Other Identifiers

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Electrolysis550

Identifier Type: -

Identifier Source: org_study_id

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