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

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ClinicalTrials.gov Identifier: NCT03708107
Recruitment Status : Not yet recruiting
First Posted : October 17, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Oscar Ronzio, Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló

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.


Condition or disease Intervention/treatment Phase
Myofascial Trigger Point Pain Device: MEP Other: Ischemic compression Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The researcher who did the algometry was masked. The researcher who did the statistical analysis was masked.
Primary Purpose: Treatment
Official Title: Short Term Effects in Pressure-pain Threshold of Percutaneous Galvanic Microcurrent Versus Ischemic Compression in the Trapezius Trigger Points
Estimated Study Start Date : October 22, 2018
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 15, 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Preasure Pain Threshold (PPT) [ Time Frame: 24 hours ]
    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.



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03708107


Contacts
Contact: Oscar Ronzio +541147823575 oronzio@gmail.com

Locations
Argentina
Oscar Ronzio
Ciudad Autónoma de Buenos Aire, Caba, Argentina, 1428
Sponsors and Collaborators
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
Investigators
Study Director: Oscar Ronzio Instituto Universitario Fundación H.A. Barceló - Universidad Maimónides - Universidad Nacional Arturo Jauretche

Responsible Party: Oscar Ronzio, Professor - Researcher, Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
ClinicalTrials.gov Identifier: NCT03708107     History of Changes
Other Study ID Numbers: MKC18G11
U1111-1222-0977 ( Registry Identifier: Universal Trial Number (UTN) )
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at www.mepsport.com
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: After the primary study results have been accepted for publication.
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.
URL: http://www.mepsport.com

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

Keywords provided by Oscar Ronzio, Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló:
galvanic current
electrolysis
myofascial trigger point
percutaneous microelectrolysis
dry needling
ischemic compression

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases