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

Primary Purpose

Myofascial Trigger Point Pain

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
MEP
Ischemic compression
Sponsored by
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Trigger Point Pain focused on measuring galvanic current, electrolysis, myofascial trigger point, percutaneous microelectrolysis, dry needling, ischemic compression

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Oscar Ronzio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Percutaneous Microelectrolysis (MEP)

Ischemic compression

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 11, 2018
Last Updated
December 20, 2019
Sponsor
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
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1. Study Identification

Unique Protocol Identification Number
NCT03708107
Brief Title
Percutaneous Microelectrolysis (MEP) Versus Ischemic Compression in Miofascial Trigger Points
Official Title
Short Term Effects in Pressure-pain Threshold of Percutaneous Galvanic Microcurrent Versus Ischemic Compression in the Trapezius Trigger Points
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Trigger Point Pain
Keywords
galvanic current, electrolysis, myofascial trigger point, percutaneous microelectrolysis, dry needling, ischemic compression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The researcher who did the algometry was masked. The researcher who did the statistical analysis was masked.
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Microelectrolysis (MEP)
Arm Type
Experimental
Arm Description
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.
Arm Title
Ischemic compression
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MEP
Other Intervention Name(s)
Percutaneous microelectrolysis, Percutaneous galvanic microcurrent
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Ischemic compression
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preasure Pain Threshold (PPT)
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oscar Ronzio
Organizational Affiliation
I.U. Fundación H.A. Barceló - U. Maimónides - U. Nacional Arturo Jauretche
Official's Role
Study Director
Facility Information:
Facility Name
Oscar Ronzio
City
Ciudad Autónoma de Buenos Aire
State/Province
Caba
ZIP/Postal Code
1428
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.mepsport.com

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

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