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

NCT05524623 | Completed DMC

• 1 other identifier: 3926
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Neck Pain, Posterior; Myofascial Pain Syndromes

Keywords

neck; pain; muscles; needles; Electrolysis; electrotherapy

Outcome Measures

Primary Outcomes (4)

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

without current emission in the treatment

SHAM COMPARATOR

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

wit current emission in the treatment

ACTIVE COMPARATOR

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

Interventions

percutaneous microelectrolysis in myofascial trigger points of the trapezius OTHER

percutaneous microelectrolysis with or without current emission in the treatment of cervical pain in myofascial trigger points of the trapezius

Also known as: MEP (percutaneous microelectrolysis), Trigger Points

wit current emission in the treatment; without current emission in the treatment

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Nacional de Córdoba: lead

Study Sites (1)

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

Córdoba, 5000, Argentina

Location

Related 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: 10.1155/2020/4173218. eCollection 2020.

  PMID: 32565858 RESULT

Related Links

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

MeSH Terms

Conditions

Neck Pain; Myofascial Pain Syndromes; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Officials

• Vilma Campana, Dr

  Universidad Nacional de Córdoba

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Both groups do not know if the treatment has emission or not while the sessions are carried out.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (Bachelor of Kinesiology and Physiotherapy)

Model Details: 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).

Study Record Dates

• First Submitted: August 13, 2022
• First Posted: September 1, 2022
• Study Start: August 16, 2022
• Primary Completion: November 30, 2022
• Study Completion: March 30, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)