Comparative Effect of MEP With or Without Current Emission in the Treatment of Cervical Pain in MTrPs of the Trapezius

April 18, 2023 updated by: Arguello Retamar Verónica Inés, Universidad Nacional de Córdoba

Comparative Effect of Percutaneous Microelectrolysis With or Without Current Emission in the Treatment of Cervical Pain in Myofascial Trigger Points of the Trapezius

Myofascial pain syndrome (MPS) is initial to other pathologies such as neck pain or tension headaches; the symptoms that are located on the area of myofascial trigger points (MTrPs) of specific references in different muscles. MTrPs are palpable, tense bands found in stiff muscle that cause pain and swelling. They affect the disruptive soft tissues, resulting in deterioration of the muscle and fascia; effects that can be transferred further, through the myofascial chain to distant tissues, inducing the referred pain that is the main feature of MPS. MTrPs are treated with stretching, massage, analgesics, acupuncture, dry needling, electrical stimulation, and ultrasound. Percutaneous microelectrolysis (MEP®) is a new technique that uses galvanic current of low intensity and high density. Based on the previous reviews, the investigators consider that the use of MEP in individuals who have MTrPs in the trapezius is more effective than acupuncture treatment. Objectives: To assess the effect of MEP as a technique for treating pain in MTrPs of the trapezius muscle compared to without current emission, analyzing function, pain and strength in MTrPs before and after both treatments.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Myofascial pain syndrome (MPS) is initial to other pathologies such as neck pain or tension headaches; the symptoms that are located on the area of myofascial trigger points (MTrPs) of specific references in different muscles. MTrPs are palpable, tense bands found in stiff muscle that cause pain and swelling. They affect the disruptive soft tissues, resulting in deterioration of the muscle and fascia; effects that can be transferred further, through the myofascial chain to distant tissues, inducing the referred pain that is the main feature of MPS. MTrPs are treated with stretching, massage, analgesics, acupuncture, dry needling, electrical stimulation, and ultrasound. Percutaneous microelectrolysis (MEP®) is a new technique that uses galvanic current of low intensity and high density. Based on the previous reviews, the investigators consider that the use of MEP in individuals who have MTrPs in the trapezius is more effective than acupuncture treatment. Objectives: To assess the effect of MEP as a technique for treating pain in MTrPs of the trapezius muscle compared to without current emission, analyzing function, pain and strength in MTrPs before and after both treatments.

Materials and methods: Randomized controlled clinical research. The study population consists of patients of both sexes between 20 and 60 years of age, with medical referral for neck pain who do not currently receive physiotherapeutic treatment, pain of at least 1 month of evolution, presenting on both sides of the trapezius MTrPs muscle and having signed the informed consent. They will be randomly distributed into: group treated with acupuncture (control) and group treated with MEP. Both will take place over 3 weeks, with one session per week. The evaluation is carried out through the visual analogue scale (VAS), measurement of force with a dynamometer and mobility with a goniometer. The score will be recorded on a validated neck pain questionnaire (NPQ). The Chi-Square test (test) will be implemented for the analysis of categorical data and the "t" test for paired data for quantitative data, based on a significance level of p˂0.05 in all cases.

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Centro de Investigación, Extensión y Capacitación de la Escuela de Kinesiología y Fisioterapia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • with medical referral for pain of at least 1 month of evolution
  • presenting on both sides of the trapezius MTrPs muscle

Exclusion Criteria:

  • neck pain who do currently receive physiotherapeutic treatment of at least 1 month of evolution

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: without current emission in the treatment
percutaneous microelectrolysis without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius. Both will take place over 3 weeks, with one session per week.
Other: percutaneous microelectrolysis in myofascial trigger points of the trapezius
percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius
Other Names:
  • MEP (percutaneous microelectrolysis)
  • Trigger Points
Active Comparator: wit current emission in the treatment
percutaneous microelectrolysis with current emission in the treatment of cervical pain in myofascial trigger points of the trapezius. oth will take place over 3 weeks, with one session per week.
Other: percutaneous microelectrolysis in myofascial trigger points of the trapezius
percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius
Other Names:
  • MEP (percutaneous microelectrolysis)
  • Trigger Points

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Northwick Park Neck Pain Questionnaire
Time Frame: will take place over 3 weeks, with one session per week.
The validated and adapted Northwick Park Neck Pain Questionnaire (NPQ) relates to activities of daily living. The outcome measure is in Points per NPQ protocol. The questionnaire will be completed prior to treatment. Nominal variables were described by of proportions with a confidence interval of 95%; Chi-Square test (Pearson's test), based on a significance level of p˂0.05 in all cases.
will take place over 3 weeks, with one session per week.
Mobility with a goniometer
Time Frame: will take place over 3 weeks, with one session per week.
The range of joint mobility of flexion, extension, inclination and rotation movements will be measured with a goniometer. The outcome measure is in degrees, before and after treatment. Evaluating the comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in trapezius myofascial trigger points.
will take place over 3 weeks, with one session per week.
Objective pain measurement with a dynamometer
Time Frame: will take place over 3 weeks, with one session per week.
It is the objective measurement of pain, through the measurement of results in the Newton (N) unit to perform force measurements and objectively evaluate the pain threshold at strategic points of the trapezius muscle, using the DINATOR® portable dynamometer. It will be measured with the dynamometer before and after treatment with or without current. Evaluated comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius.
will take place over 3 weeks, with one session per week.
visual analogue scale
Time Frame: will take place over 3 weeks, with one session per week.
The evaluation is carried out through the visual analogue scale (VAS) with the outcome measure from 0 to 10 (10 the worst pain experienced and 0 no pain); change from pain level to baseline pain level before and after treatment. The Chi-Square test (Pearson's test) will be implemented for the analysis of categorical data and the "t" test for paired data for quantitative data, based on a significance level of p˂0.05 in all cases. Evaluated comparative effect of percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius.
will take place over 3 weeks, with one session per week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Córdoba

Investigators

  • Study Director: Vilma Campana, Dr, Universidad Nacional de Córdoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 16, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

March 30, 2023

Study Registration Dates

First Submitted

August 13, 2022

First Submitted That Met QC Criteria

August 29, 2022

First Posted (Actual)

September 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3926

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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