Analgesic Mechanisms of Percutaneous Electrolysis

NCT ID: NCT05097937

Last Updated: 2022-02-16

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

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2022-02-11

Brief Summary

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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.

Detailed Description

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Conditions

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Percutaneous Electrolysis Pain Analgesia Pain Modulation Endogenous Analgesia System

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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Sham intervention

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

Group Type SHAM_COMPARATOR

Sham intervention

Intervention Type OTHER

The needle will be inserted into the right common extensor tendon of the epicondyle for 90 seconds without galvanic current.

Low intensity percutaneous electrolysis

Galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.

Group Type EXPERIMENTAL

Low intensity percutaneous electrolysis

Intervention Type OTHER

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.

High intensity percutaneous electrolysis

Participants will receive three impacts of galvanic current with an intensity of 3 mA for 3 seconds each.

Group Type EXPERIMENTAL

High intensity percutaneous electrolysis

Intervention Type OTHER

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.

Interventions

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Sham intervention

The needle will be inserted into the right common extensor tendon of the epicondyle for 90 seconds without galvanic current.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
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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de Miguel Valtierra L, Salom Moreno J, Fernandez-de-Las-Penas C, Cleland JA, Arias-Buria JL. Ultrasound-Guided Application of Percutaneous Electrolysis as an Adjunct to Exercise and Manual Therapy for Subacromial Pain Syndrome: A Randomized Clinical Trial. J Pain. 2018 Oct;19(10):1201-1210. doi: 10.1016/j.jpain.2018.04.017. Epub 2018 May 16.

Reference Type BACKGROUND
PMID: 29777953 (View on PubMed)

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)

Cagnie B, Dewitte V, Barbe T, Timmermans F, Delrue N, Meeus M. Physiologic effects of dry needling. Curr Pain Headache Rep. 2013 Aug;17(8):348. doi: 10.1007/s11916-013-0348-5.

Reference Type BACKGROUND
PMID: 23801002 (View on PubMed)

Abat F, Valles SL, Gelber PE, Polidori F, Stitik TP, Garcia-Herreros S, Monllau JC, Sanchez-Ibanez JM. [Molecular repair mechanisms using the Intratissue Percutaneous Electrolysis technique in patellar tendonitis]. Rev Esp Cir Ortop Traumatol. 2014 Jul-Aug;58(4):201-5. doi: 10.1016/j.recot.2014.01.002. Epub 2014 May 10. Spanish.

Reference Type BACKGROUND
PMID: 24821478 (View on PubMed)

Abat F, Gelber PE, Polidori F, Monllau JC, Sanchez-Ibanez JM. Clinical results after ultrasound-guided intratissue percutaneous electrolysis (EPI(R)) and eccentric exercise in the treatment of patellar tendinopathy. Knee Surg Sports Traumatol Arthrosc. 2015 Apr;23(4):1046-52. doi: 10.1007/s00167-014-2855-2. Epub 2014 Jan 30.

Reference Type BACKGROUND
PMID: 24477495 (View on PubMed)

Yarnitsky D, Bouhassira D, Drewes AM, Fillingim RB, Granot M, Hansson P, Landau R, Marchand S, Matre D, Nilsen KB, Stubhaug A, Treede RD, Wilder-Smith OH. Recommendations on practice of conditioned pain modulation (CPM) testing. Eur J Pain. 2015 Jul;19(6):805-6. doi: 10.1002/ejp.605. Epub 2014 Oct 20.

Reference Type BACKGROUND
PMID: 25330039 (View on PubMed)

Other Identifiers

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EP550

Identifier Type: -

Identifier Source: org_study_id

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