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临床试验/NCT05524623
NCT05524623已完成不适用

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

Universidad Nacional de Córdoba2 个研究点 分布在 1 个国家目标入组 95 人开始时间: 2022年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
试验地点
2
主要终点
Northwick Park Neck Pain Questionnaire

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Both groups do not know if the treatment has emission or not while the sessions are carried out.

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Northwick Park Neck Pain Questionnaire

时间窗: 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.

Mobility with a goniometer

时间窗: 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.

visual analogue scale

时间窗: 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.

Objective pain measurement with a dynamometer

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Universidad Nacional de Córdoba
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arguello Retamar Verónica Inés

Principal Investigator (Bachelor of Kinesiology and Physiotherapy)

Universidad Nacional de Córdoba

研究点 (2)

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