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临床试验/NCT05976399
NCT05976399已完成不适用

The Investigation of The Effectiveness Of Manual Lymph Drainage in Individuals With Migraine

Izmir Democracy University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年6月6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
40
试验地点
2
主要终点
Pressure algometer (Dolorimeter)

研究概览

简要总结

In the literature, research into the examination of the effect of MLD on migraine is quite limited. Our study aimed to examine the effectiveness of manual lymph drainage and connective tissue massage treatments on neck pain and disability, sleep quality, pain threshold and severity, depression and quality of life.

详细描述

Although there are evidence-based guidelines for clinical decision-making and reporting the care of patients with migraine, migraine management for the population is inadequate. Even among individuals who are correctly diagnosed, almost more than half of patients are not administered any acute or preventive treatment. Various invasive and non-invasive treatment options are available in the treatment of migraine. Relaxation training, exercise, cold application, massage, transcutaneous electrical nerve stimulation (TENS), biofeedback, manipulation and mobilization techniques, and trigger point therapy are some of the non-invasive treatment options used in migraine treatment. These treatments, which can be applied independently, can also be applied in combination with pharmacological treatments in some patients. In addition, the patient's knowledge about the disease makes it easier to manage the process and cope with the pain better.

Connective tissue massage (CTM) is a manipulative therapy method that is different from traditional massages in terms of both technical and physiological effects and has been used for diagnosis or treatment since 1928. Although the manipulative procedures applied target superficial connective and subcutaneous tissues, they also have effects on organs far from the local stimulation area. Another approach to migraine prophylaxis includes manual lymph drainage (MLD). It is considered that MLD causes sympathetic and parasympathetic effects and is similar to therapeutically effective relaxation therapy by reducing the hyperexcitability of the central system. With the parasympathetic effect it creates, it helps to reduce muscle pain and spasm, making it easier to cope with tension and stress. Reduction of the tension and stress factors may reduce the triggering of migraine and make it easier to cope with the current migraine. Recent studies have shown that the meningeal lymphatic system is located in the brain and that this system is a new way for the drainage of the cerebrospinal fluid.

In the literature, research into the examination of the effect of MLD on migraine is quite limited. We planned this randomized controlled trial to contribute to the reduction of pain and increase the quality of life of individuals with migraine by increasing the awareness of individuals working in this field in our country.

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

The individuals to be included in the study were listed on the computer according to their application order, and then a randomization process was employed to divide them into two groups: the manual lymph drainage group and the connective tissue massage group. Individuals with odd-numbered positions were assigned to the manual lymph drainage group, while individuals with even-numbered positions were assigned to the connective tissue massage group.

入排标准

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

入选标准

  • To be able to read and write
  • Diagnosis of migraine by a neurologist according to IHS criteria
  • Be willing to participate in the study voluntarily signing an informed consent form
  • Have good cognitive functioning
  • Between the ages of 18 and 65
  • Reported pain intensity of 40 mm or more according to VAS
  • Headache (without allodynia) <15 days per month

排除标准

  • Had any of the contraindications of MLD for the general and neck region
  • Had a history of neuromuscular disease,
  • Had communication problems to the extent that prevented evaluation methods,
  • Had headaches lasting >15 days a month, were diagnosed with other types of headaches (cervicogenic type headache, tension-type headache),
  • Were diagnosed with fibromyalgia or myofascial pain syndrome, exhibited whiplash and similar traumas
  • Had severe depression symptoms according to the Beck depression inventory,
  • Had a congenital musculoskeletal anomaly, received non-pharmacological migraine treatment (acupuncture, dry needling, etc.),

结局指标

主要结局

Pressure algometer (Dolorimeter)

时间窗: All individuals participating in the study were evaluated before and after the 6-week-long treatment

The pressure algometer was developed by Fischer to determine the perception of pressure and assess pain sensitivity. in our study, measurements with a dolorimeter were made from a total of 12 regions, including 6 on the right and 6 on the left. Selected 6 muscles were M. Temporalis anterior, M. Sternocleidomastoid, M. Scalenous anterior, M. Suboccipital, M. Levator scapula, and M. Trapezius (Upper).

次要结局

  • Back Depression Inventory(All individuals participating in the study were evaluated before and after the 6-week-long treatment)
  • The Pittsburgh Sleep Quality Index(All individuals participating in the study were evaluated before and after the 6-week-long treatment)
  • Short Form-36(All individuals participating in the study were evaluated before and after the 6-week-long treatment)
  • Neck Pain and Disability Scale(All individuals participating in the study were evaluated before and after the 6-week-long treatment)
  • Visual Analog Scale(All individuals participating in the study were evaluated before and after the 6-week-long treatment)
  • Pain diary(in the study a pain diary were given 2 weeks before the initiation of treatment and after the 6-week-long treatment was completed)

研究者

发起方
Izmir Democracy University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Özlem Çınar Özdemir

Assoc. prof

Izmir Democracy University

研究点 (2)

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