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

NCT03708107 | Completed

• 2 other identifiers: MKC18G11U1111-1222-0977
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofascial Trigger Point Pain

Keywords

galvanic current; electrolysis; myofascial trigger point; percutaneous microelectrolysis; dry needling; ischemic compression

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Percutaneous Microelectrolysis (MEP)

EXPERIMENTAL

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

Ischemic compression

EXPERIMENTAL

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

Interventions

MEP DEVICE

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.

Also known as: Percutaneous microelectrolysis, Percutaneous galvanic microcurrent

Percutaneous Microelectrolysis (MEP)

Ischemic compression OTHER

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.

Ischemic compression

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló: lead

Study Sites (1)

Oscar Ronzio

Ciudad Autónoma de Buenos Aire, Buenos Aires F.D., 1428, Argentina

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Oscar Ronzio

  I.U. Fundación H.A. Barceló - U. Maimónides - U. Nacional Arturo Jauretche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who did the algometry was masked. The researcher who did the statistical analysis was masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor - Researcher

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 17, 2018
• Study Start: October 22, 2018
• Primary Completion: December 10, 2019
• Study Completion: December 10, 2019
• Last Updated: December 23, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

AR (1)