Analgesic Mechanisms of Percutaneous Electrolysis

NCT05097937 | Completed

• 1 other identifier: EP550
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Percutaneous Electrolysis; Pain; Analgesia; Pain Modulation; Endogenous Analgesia System

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in Pressure Pain Thresholds (PPT)

  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 Outcomes (2)

• Changes from baseline in Conditioned Pain Modulation (CPM)

  Baseline and immediately after the intervention

• Changes from baseline in Temporal Summation (TS)

  Baseline and immediately after the intervention

Study Arms (3)

Sham intervention

SHAM COMPARATOR

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

Other: Sham intervention

Low intensity percutaneous electrolysis

EXPERIMENTAL

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

Other: Low intensity percutaneous electrolysis

High intensity percutaneous electrolysis

EXPERIMENTAL

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

Other: High intensity percutaneous electrolysis

Interventions

Sham intervention OTHER

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

Sham intervention

Low intensity percutaneous electrolysis 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.

Low intensity percutaneous electrolysis

High intensity percutaneous electrolysis 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.

High intensity percutaneous electrolysis

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Asymptomatic subjects
• Signature of the informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Salamanca: lead

Study Sites (1)

Facultad de Enfermería y Fisioterapia de la Universidad de Salamanca

Salamanca, 37007, Spain

Location

Related Publications (6)

• 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.

  PMID: 29777953 BACKGROUND

• 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.

  PMID: 28135129 BACKGROUND

• 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.

  PMID: 23801002 BACKGROUND

• 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.

  PMID: 24821478 BACKGROUND

• 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.

  PMID: 24477495 BACKGROUND

• 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.

  PMID: 25330039 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate

Study Record Dates

• First Submitted: October 16, 2021
• First Posted: October 28, 2021
• Study Start: November 22, 2021
• Primary Completion: February 11, 2022
• Study Completion: February 11, 2022
• Last Updated: February 16, 2022

Record last verified: 2022-02

Locations

ES (1)