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

Myofascial Pain Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05524623
• Other study ID #: 3926
• Status: Completed
• Phase: N/A
• Start date: August 16, 2022
• Est. completion date: March 30, 2023

Study information

• Verified date: April 2023
• Source: Universidad Nacional de Córdoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: March 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Neck Pain
• Neck Pain, Posterior

Intervention

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

Locations

Country	Name	City	State
Argentina	Centro de Investigación, Extensión y Capacitación de la Escuela de Kinesiología y Fisioterapia	Córdoba

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Nacional de Córdoba

Country where clinical trial is conducted

Argentina, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	will take place over 3 weeks, with one session per week.
Primary	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.	will take place over 3 weeks, with one session per week.
Primary	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.	will take place over 3 weeks, with one session per week.
Primary	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.	will take place over 3 weeks, with one session per week.

External Links

•   Percutaneous Application of Galvanic Current in Rodents Reverses Signs of Myofascial Trigger Points