Percutaneous Microelectrolysis (MEP) Versus Ischemic Compression in Miofascial Trigger Points

Short Term Effects in Pressure-pain Threshold of Percutaneous Galvanic Microcurrent Versus Ischemic Compression in the Trapezius Trigger Points

The Percutaneous Microelectrolysis ® (MEP®) is a technique that employs a galvanic current up to 990 uA, which is applied percutaneously with an acupuncture needle connected to the cathode. Although it is used in tendinopathies, trigger points and muscle injuries, among other conditions, its bases are mostly empirical and there is lack of evidence.

Ischemic compression is a manual therapy that is usually applied in muscle pain.

Myofascial Pain Syndrome (MPS) usually presents painful myofascial trigger points (MTrPs). One methodology used to quantify the pain in MPS is the algometry, which measures the pressure pain threshold (PPT).

The aim of this study was to compare the effects of MEP® with ischemic compression on MTrPs with algometry.

Study Overview

• Status: Completed
• Conditions: Myofascial Trigger Point Pain
• Intervention / Treatment: Device: MEP; Other: Ischemic compression

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Caba
    • Ciudad Autónoma de Buenos Aire, Caba, Argentina, 1428
      • Oscar Ronzio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 28 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy volunteers
• Between 18 to 30 years old.
• Who referred MTrP in the upper trapezious.
• PPT equal or less than 3 KgF/cm2

Exclusion Criteria:

• Being pregnant.
• Taking analgesic medication at least 24 hours before the intervention.
• Being in physical therapy treatment.
• Needle phobia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Percutaneous Microelectrolysis (MEP); Principal MTrP will be detected by digital palpation in the upper trapezius. Algometry will be used to determine if the Pain Pressure Threshold (PPT) is equal or less than 3 KgF/cm2. If not, the patient will be not included. A mark will be done in the MTrP. MEP® will be applied with a 0,30 x 25 mm acupuncture needle. The needle will be introduced perpendicularly to the MTrP with 100 uA and then increased up to 600 uA. The current will be paused if the patient feels a burning sensation, pain or oppression, waiting up to the patient feels no discomfort. The procedure will be repeated as many times is necessary until the patient do not feel any discomfort for more than 1 minute. Algometry will be done immediately finished the intervention, after 10 minutes and at 24 hs.	Device: MEP; MEP® will be applied with an acupuncture needle (0,30 x 25 mm). The needle will be introduced perpendicularly to the MTrP with 100 uA and then increased up to 600 uA. The current will be paused if the patient feels a burning sensation, pain or oppression, waiting up to the patient feels no discomfort. The procedure will be repeated as many times is necessary until the patient do not feel any discomfort for more than 1 minute.; Other Names: Percutaneous microelectrolysis; Percutaneous galvanic microcurrent
Experimental: Ischemic compression; Principal MTrP will be detected by digital palpation in the upper trapezius. Algometry will be used to determine if the Pain Pressure Threshold (PPT) is equal or less than 3 KgF/cm2. If not, the patient will be not included. A mark will be done in the MTrP with a marker. Ischemic compression will be applied perpendicularly to the MTrP, increasing gradually the pression until the patient refers the maximum tolerable pain. This pressure will be applied for 1 minute. Algometry will be done immediately finished the intervention, after 10 minutes and at 24 hs.	Other: Ischemic compression; Ischemic compression will be applied perpendicularly to the MTrP, increasing gradually the pression until the patient refers the maximum tolerable pain. This pressure will be applied for 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preasure Pain Threshold (PPT)	Algometry is used to measure the Preasure Pain Threshold (PPT). PPT is defined as the minimum force applied which induces pain. It was applied in the Miofascial Trigger points.	24 hours

Collaborators and Investigators

• Sponsor: Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
• Investigators: Study Director: Oscar Ronzio, I.U. Fundación H.A. Barceló - U. Maimónides - U. Nacional Arturo Jauretche

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): December 10, 2019
• Study Completion (Actual): December 10, 2019

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 15, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): December 23, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: dry needling; myofascial trigger point; ischemic compression; electrolysis; galvanic current; percutaneous microelectrolysis
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Myofascial Pain Syndromes
• Other Study ID Numbers: MKC18G11; U1111-1222-0977 (Registry Identifier: Universal Trial Number (UTN))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at www.mepsport.com
• IPD Sharing Time Frame: After the primary study results have been accepted for publication.
• IPD Sharing Access Criteria: Formal request from qualified scientific and researchers on IPD and clinical study documents from clinical trials supporting products submitted, for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No