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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03708107
Other study ID # MKC18G11
Secondary ID U1111-1222-0977
Status Completed
Phase N/A
First received
Last updated
Start date October 22, 2018
Est. completion date December 10, 2019

Study information

Verified date December 2019
Source Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 10, 2019
Est. primary completion date December 10, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Intervention

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:
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.

Locations

Country Name City State
Argentina Oscar Ronzio Ciudad Autónoma de Buenos Aire Caba

Sponsors (1)

Lead Sponsor Collaborator
Instituto Universitario de Ciencias de la Salud Fundación H.A. Barceló

Country where clinical trial is conducted

Argentina, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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