Effect of Manual Therapy on Migraine in Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pressure Pain Threshold (PPT)
研究概览
简要总结
The purpose of the study is to determine the effect of manual therapy on migraine in postmenopausal women.
详细描述
Menopause is a period of great changes to women's bodies and minds. Alterations to body image and emotions, psychological adjustment to a new phase of life and worries about the higher prevalence of severe diseases and cognitive dysfunction all contribute towards negatively affecting the quality of life of menopausal patients. Symptoms that are typical of hormonal deprivation and aging are prevalent and distressful to many, often requiring individual counseling and specific therapies. Some of the symptoms are manageable and headache is certainly a modifiable parameter if given the appropriate treatment. About one third of the women had experienced worsening of their primary headaches after their last menstrual period, which contradicts the popular belief that "after menopause the headache gets better.
Migraine is a severe headache often felt as a throbbing pain - and usually occurring on one side of the head. It often comes with nausea or vomiting, and a heightened sensitivity to light or sound. The headache is such that it stops doing what is normally do and can last from four to 72 hours .
Soft tissue massage of the paraspinal muscles, jaw muscles will all help decrease the muscle spasm of tension headaches. Joint Manipulation: this can be done with manipulative techniques or gentle articulation techniques to encourage joint release and movement By manipulating the bones of skull and the dura mater that is a membrane just below the skull, craniosacral therapy also relieves arterial pressure to ease pain.
There is dearth of knowledge regarding the effect of manual therapy on migraine in postmenopausal women. This study, therefore, contributes valuable insights to a relatively unexplored area of
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women are postmenopausal at least one year following last menstruation.
- •They are suffering from migraine.
- •Their ages will range from 50 to 60 years old.
- •Their body mass index (BMI) will not exceed 30 Kg/m
- •Women with regular or irregular attacks of migraine.
排除标准
- •Artificial or premature menopause
- •Recent head trauma.
- •Cerebral aneurysm or rupture.
- •Acute intracerebral bleeding.
- •Hormonal replacement therapy.
研究组 & 干预措施
Non-steroidal anti-inflammatory drugs (NSAIDs) group
The participants will receive non-steroidal anti-inflammatory drugs (NSAIDs) to relieve the pain and symptoms of a migraine attack and help prevent further migraine attacks
干预措施: Non-steroidal anti-inflammatory drugs (NSAIDs) (Drug)
Manual therapy group and non-steroidal anti-inflammatory drugs (NSAIDs) group
The participants will receive the same medical treatment (non-steroidal anti-inflammatory drugs (NSAIDs)) plus manual therapy techniques for 3 times per week for 8 weeks.
干预措施: Non-steroidal anti-inflammatory drugs (NSAIDs) (Drug)
Manual therapy group and non-steroidal anti-inflammatory drugs (NSAIDs) group
The participants will receive the same medical treatment (non-steroidal anti-inflammatory drugs (NSAIDs)) plus manual therapy techniques for 3 times per week for 8 weeks.
干预措施: Manual therapy techniques (Other)
结局指标
主要结局
Pressure Pain Threshold (PPT)
时间窗: 8 weeks
Pressure algometry (PA) is a method described to objectify pressure pain threshold PPT. Application: * Frontal muscle (2 cm above the surfacing of the supra orbital branch of the trigeminal nerve) Medium temporalis muscle (located 2 cm to the lateral rim of the eyebrow) * Masseter muscle (origin: anterior rim of the surface portion of the muscle; insertion: lower most prominent region identified by manual palpation during maximal dental clenching, and belly: the mid-point between the origin and the insertion) ; * Trapezius (insertion: the point immediately below the occipital bone, located in the sub-occipital region; upper fibers: mid-point between the spinous process of seventh cervical vertebrae (C 7) and the acromion); * Sternocleidomastoid muscle (upper portion: fibers below the mastoid process) * PPT levels were obtained in three consecutive series bilaterally
Migraine disability assessment Questionnaire :
时间窗: 8 weeks
Migraine Disability Assessment (MIDAS) questionnaire was designed to be brief, self-administered, and easy to score. It assesses not only missed days of activity, but also days in which productivity is reduced by at least half. The MIDAS score is derived as the sum of missed days and days when productivity was reduced by at least half for work outside the home and household work, as well as missed days of nonwork activities (family, social, and leisure) during a 3-month period. The score, therefore, has units of lost days. Physicians graded each patient for pain level (mild, moderate, or severe), level of disability (none, mild, moderate, or severe), and need for medical care (from 0 \[lowest\] to 100 \[highest\]).
The blink reflexometer
时间窗: 8 weeks
It is an electrodiagnostic test that evokes the corneal reflex. It evaluates the integrity of the trigeminal and facial nerve. The supraorbital branch of the ophthalmic division of the trigeminal nerve constitutes the afferent arm, while the motor fibers of the facial nerve form the efferent arm of this reflex.Normally, as with the corneal reflex, the ipsilateral electrical stimulation of the trigeminal nerve will produce an eye blink bilaterally. The subject is supine and asked to stay relaxed with their eyes open or gently closed. The active electrode (A) is placed over the inferior aspect of the orbicularis oculus while the reference electrode (R) is placed either over the bony prominence of the zygomatic arch or the nose. The ground electrode (G) can be placed over the forehead or under the chin. Using a prong stimulator, each supraorbital nerve is stimulated and the response from the orbicularis oculus is recorded bilaterally.
次要结局
- Migraine-Specific Quality of Life Questionnaire (MSQv2.1)(8 weeks)
研究者
Marwa Mohamed Mohamed Yassen
Principal investigator
Cairo University