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临床试验/NCT05646160
NCT05646160Unknown不适用

Effects of Myofascial Trigger Points Therapy in Migraine.

Józef Piłsudski University of Physical Education2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Health-related quality of life

研究概览

简要总结

Case series, repeated-measures design, pilot study.

Adult, female, migraine patients underwent seven Ischemic Compression Myofascial Trigger Points (IC-MTrPs) therapy sessions.

The aim of the study is to investigate whether therapy of the shoulder girdle and neck muscles by deactivating MTrPs causes modification of biomechanical and biochemical variables in the blood and reduces headache in people with migraine, improving their quality of life by improving their health.

People qualified for the study were divided into 3 groups according to the type of migraine:

  1. CM group - patients with chronic migraine
  2. EMa group - patients with paroxysmal migraine with aura
  3. EMb group - patients with paroxysmal migraine without an aura.

All patients underwent 7 interventions in the area of the muscles of the shoulder girdle and neck (by deactivating trigger points) performed every 2 or 3 days. They did not take any headache medications during the treatment period. However, during a migraine attack, they could undergo treatments and research measurements. Biomechanical measurements of the cervical spine, shoulder girdle muscles and blood chemistry were performed before, during and after the patients' therapy.

All treatments were performed on the following muscles:

  • m. trapesius pars descendent (trapezius upper),
  • m. sternocleidomastoideus (sternocleidomastoid),
  • m. temporalis (temporal),
  • m. legator scapulae (levator scapula),
  • m. supraspinatus (supraspinatus),
  • m. suboccipitales (suboccipital).

详细描述

Detailed Description:

I. The specific objectives were to investigate whether the therapy of the shoulder girdle and neck had an effect on:

  1. the range of mobility of the cervical spine
  2. myometric variables (stiffness, flexibility and tension) of the muscle (trapezius upper part)
  3. concentration of selected biochemical factors (S100 beta protein, substance P (SP), calcitonin gene-related peptide (CGRP), brain-derived neurotrophic factor (BDNF) in patients with migraine
  4. feel headache
  5. feel pain in the muscles of the shoulder girdle
  6. feel the quality of life related to health.

II. Hypotheses

  1. Inactivation of MTrPs by IC-MTRPs therapy improves biomechanical properties of the cervical spine (increases the range of mobility of the cervical spine - lateral inclination, rotation and forward inclination) in people with migraine.
  2. Inactivation of MTrPs by IC-MTRPs therapy improves the resting biomechanical properties (reduction of tension, stiffness and increased flexibility) of the muscles of the shoulder girdle.
  3. Inactivation of MTrPs by IC-MTRPs therapy reduces the concentration of biochemicals in the blood responsible for the aggravation of migraine pain.
  4. TOBS therapy through IC-MTrPs therapy improves biomechanical and biochemical variables, reducing the sensations of headache and muscle pain, improving health-related quality of life in people with migraine.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • age: 18 to 65 years of age, female gender, migraine diagnosed by a specialist neurologist for at least 12 months, no metabolic, cardiological, neurological and orthopedic diseases within the shoulder girdle, and cervical spine, voluntary written consent for examination; criteria according to ICHD-3 allowing to classify the symptoms as migraines.

排除标准

  • minors or over 65 years of age, male gender, patients undergoing pharmacological treatment that cannot be discontinued; people with other headaches; past injuries of the musculoskeletal system in the cervical spine and shoulder girdle; skin diseases and other conditions such as deep vein thrombosis, osteoporosis; criteria for excluding migraine according to ICHD-3.

结局指标

主要结局

Health-related quality of life

时间窗: 1 month after intervention completion, the subject completed the WHOQoL-BREF questionnaire again.

Health-related quality of life will be expressed as points of the WHOQoL-BREF scale \[point\]. The subject completed the WHOQoL-BREF questionnaire.

Muscle pain perception

时间窗: Day 7

The subjects were assessed on a scale of 1 to 10 (VAS scale), immediately after the therapy of the muscles of the neck and shoulder girdle. Muscle pain perception will be expressed in \[cm\] as the distance between the two end points (between value 1 and 10) of visual analog scale.

Headache pain perception

时间窗: 1 month after the end of treatment.

The VAS scale also determined the intensity of the perceived headache during the last migraine attack. Headache pain perception will be expressed in \[cm\] as the distance between the two end points (between value 1 and 10) of visual analog scale (VAS).

ROM cervical spine

时间窗: Described data was collected for 1 month after the last intervention.

The measuring device allowed to assess the range of movement of the cervical spine with the motor control of the patient in the movement of the lateral to the right bend and left side, right and left rotations and forward bends. The ROM values will be expressed in degrees \[°\].

次要结局

  • Myomentric parameter - Frequency(1 month after the last intervention.)
  • Blood parameter S100beta(24 hours after the sixth treatment.)
  • Blood parameter CGRP(24 hours after the sixth treatment.)
  • Myomentric parameter - Stiffness(1 month after the last intervention.)
  • Blood parameter - SP(24 hours after the sixth treatment.)
  • Myomentric parameter - Decrement(1 month after the last intervention.)
  • Blood parameter BNDF(24 hours after the sixth treatment.)

研究者

发起方
Józef Piłsudski University of Physical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Maciej Olesiejuk

Principal Investigator, PhD

Józef Piłsudski University of Physical Education

研究点 (2)

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