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

Primary Purpose

Neck Pain, Posterior, Myofascial Pain Syndromes

Status
Completed
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
percutaneous microelectrolysis in myofascial trigger points of the trapezius
Sponsored by
Universidad Nacional de Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain, Posterior focused on measuring neck, pain, muscles, needles, Electrolysis, electrotherapy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

without current emission in the treatment

wit current emission in the treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Northwick Park Neck Pain Questionnaire
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.
Mobility with a goniometer
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.
Objective pain measurement with a dynamometer
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.
visual analogue scale
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.

Secondary Outcome Measures

Full Information

First Posted
August 13, 2022
Last Updated
April 18, 2023
Sponsor
Universidad Nacional de Córdoba
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1. Study Identification

Unique Protocol Identification Number
NCT05524623
Brief Title
Comparative Effect of MEP With or Without Current Emission in the Treatment of Cervical Pain in MTrPs of the Trapezius
Official Title
Comparative Effect of Percutaneous Microelectrolysis With or Without Current Emission in the Treatment of Cervical Pain in Myofascial Trigger Points of the Trapezius
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
March 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional de Córdoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Posterior, Myofascial Pain Syndromes
Keywords
neck, pain, muscles, needles, Electrolysis, electrotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
percutaneous microelectrolysis with or 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. 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).
Masking
Participant
Masking Description
Both groups do not know if the treatment has emission or not while the sessions are carried out.
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
without current emission in the treatment
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
wit current emission in the treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
percutaneous microelectrolysis in myofascial trigger points of the trapezius
Other Intervention Name(s)
MEP (percutaneous microelectrolysis), Trigger Points
Intervention Description
percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius
Primary Outcome Measure Information:
Title
Northwick Park Neck Pain Questionnaire
Description
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.
Time Frame
will take place over 3 weeks, with one session per week.
Title
Mobility with a goniometer
Description
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.
Time Frame
will take place over 3 weeks, with one session per week.
Title
Objective pain measurement with a dynamometer
Description
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.
Time Frame
will take place over 3 weeks, with one session per week.
Title
visual analogue scale
Description
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.
Time Frame
will take place over 3 weeks, with one session per week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vilma Campana, Dr
Organizational Affiliation
Universidad Nacional de Córdoba
Official's Role
Study Director
Facility Information:
Facility Name
Centro de Investigación, Extensión y Capacitación de la Escuela de Kinesiología y Fisioterapia
City
Córdoba
ZIP/Postal Code
5000
Country
Argentina

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32565858
Citation
Margalef R, Bosque M, Monclus P, Flores P, Minaya-Munoz F, Valera-Garrido F, Santafe MM. Percutaneous Application of Galvanic Current in Rodents Reverses Signs of Myofascial Trigger Points. Evid Based Complement Alternat Med. 2020 May 28;2020:4173218. doi: 10.1155/2020/4173218. eCollection 2020.
Results Reference
result
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/32565858/
Description
Percutaneous Application of Galvanic Current in Rodents Reverses Signs of Myofascial Trigger Points

Learn more about this trial

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

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