Effect of High Power Laser Therapy on Myoelectrical Activities of Suboccipital Muscles and Quality of Life in Patients With Cervicogenic Headache
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
- Myoelectrical activity of suboccipital muscle
研究概览
简要总结
The study will be conducted:
To investigate the effect of high-power laser on myoelectrical activities of suboccipital muscles in patients with cervicogenic headache.
- To investigate the effect of high-power laser on pain in patients with cervicogenic headache.
- To investigate the effect of high-power laser on quality of life in patients with cervicogenic headache.
详细描述
Cervicogenic headache is a classification of headache in which pain is referred from the cervical spine. This category of headache is typically chronic, presented as unilateral cephalgia, spreading over the occipital, temporal, and frontal regions and is believed to be caused by musculoskeletal dysfunction of the neck.
In high-power laser therapy (HPLT) there is an increase in mitochondrial oxidative reaction and adenosine phosphate (photobiology effect). The pain-releasing effect of HPLT is provided by reducing the transmission of painful stimuli and increased morphine mimetic factors. It has rapidly induced photochemical and photothermal effects, increasing blood flow, cell metabolism, and vascular permeability.
In a recent study on exercise for cervicogenic headache, Subjects reported significant decreases in the frequency, intensity, and duration of their headaches.
To our knowledge there is no study was found to investigate the effect of high-power laser therapy (HPLT) on myoelectrical activities of suboccipital muscles, pain and functional activities in patients with cervicogenic headache.
So, this study aimed to determine the effect of high power laser therapy (HPLT) on myoelectrical activities of suboccipital muscles , pain and quality of life in patients with cervicogenic headache.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from cervicogenic headache based on international headache society "IHS" criteria for cervicogenic headache.
- •Unilateral cervical radiculopathy (Upper cervical C1 -C4).
- •Age ranged from 30 to 50 years.
- •Neck pain referring unilaterally to suboccipital region.
- •The pain and restriction in C1-C2 rotation by Cervical Flexion-Rotation Test (FRT )
- •Intensifying headache by manual pressure to upper cervical muscles and joints.
- •Experiencing headache at least once per week for the last 6 months.
- •Patients will be referred by neurological consultants.
- •Body mass index (18.5 -
- •Moderate (45-74) to severe (75-100) neck pain on the visual analogue scale.
排除标准
- •Cervical myelopathy, cervical instability, cervical fracture cervical surgery with evidence of pyramidal, posterior column disorders.
- •History of any neurologic disease ( stroke, MS , cerebellar disorders , vestibular dysfunction and neuropathy )Pregnant or breastfeeding women
- •Other types of headaches (migraine - cluster headaches- tension headache)
- •Patients of systemic diseases such as rheumatoid arthritis
- •contraindication to high-power Laser such as:
- •Wounds or skin changes in the neck or shoulder region (such as psoriasis, scars, or burns).
- •Photosensitivity diagnosis.
- •Tumors of some type have been diagnosed in the last 5 years.
- •Presence of solar urticaria or adverse reactions to sunlight.
研究组 & 干预措施
High power laser therapy and conventional physical therapy program
The participants will receive high power laser therapy (HPLT) for 15 minutes in addition to a conventional physical therapy program (therapeutic exercise) for 45 minutes three a week for six weeks.
干预措施: High-power laser therapy (Device)
Placebo high power laser therapy and conventional physical therapy program
The participants will receive placebo high power laser therapy (HPLT) for 15 minutes in addition to a conventional physical therapy program (therapeutic exercise) for 45 minutes three a week for six weeks.
干预措施: Placebo (PL) high power laser (Device)
High power laser therapy and conventional physical therapy program
The participants will receive high power laser therapy (HPLT) for 15 minutes in addition to a conventional physical therapy program (therapeutic exercise) for 45 minutes three a week for six weeks.
干预措施: Conventional physical therapy program (Other)
Placebo high power laser therapy and conventional physical therapy program
The participants will receive placebo high power laser therapy (HPLT) for 15 minutes in addition to a conventional physical therapy program (therapeutic exercise) for 45 minutes three a week for six weeks.
干预措施: Conventional physical therapy program (Other)
结局指标
主要结局
Myoelectrical activity of suboccipital muscle
时间窗: 6 weeks
Needle electromyography (EMG, Micromed, made in Italy) is a definitive invasive technique that allows an objective evaluation of muscle activity. Activation pattern of the suboccipital muscle mainly the rectus capitis posterior muscles will be recorded and analyzed. The skin is cleaned with alcohol to reduce skin impedance. A Concentric needle is inserted in the rectus capitis posterior muscles, positioned caudad, at a point 1-2cm lateral to the midline at the level of the approximation of the posterior arch of C1. at approximately 80 degrees from an imaginary line drawn parallel to the surface of the skin in the mid-sagital plane. The patient performed extension delivering maximum voluntary contraction against therapist hand. Reference electrode is placed just above the middle of the spine of the right scapula or over the forehead. Data will be represented as interference patterns (graphics), analyzed and compared before and after the intervention for all participants in the study.
Neck Disability Index (NDI)
时间窗: 6 weeks
The NDI will be used to assess neck pain and quality of life for all participants before and after the treatment program. It is consisted of 10 items with six potential responses per item relating to pain severity, headache, attention, and various physical activities (lifting, personal care, recreation, work, driving, reading, and sleeping). Each item's score ranges from 0 to 5. The maximum possible total score is 50, which is translated to a percentage. Higher scores indicate a greater degree of impairment. The NDI has been demonstrated to be a valid, had stable psychometric characteristics and accurate questionnaire for people suffering from neck pain
Quality of life (QoL) assessment
时间窗: 6 weeks
The SF-36 questionnaire will be used to assess QoL for all participants before and after the end of the study program. It is a self-administered questionnaire containing 36 items which takes about five minutes to complete. It measures health on eight multi-item dimensions, covering physical functioning, role limitation due to physical health, bodily pain, general health perception, vitality, social functioning, role limitation due to emotional problems and perceived mental health. Each domain contains number of items. The answers to each question are extrapolated to a standardized set of answers, and the results are transferred to a scale of 0-100, where 0 represents the worst state of health measured, and 100 represents the best state of health measured. It has good validity and reliability and can be used as a general questionnaire to assess quality of life.
次要结局
- Pain intensity(6 weeks)
- Headache impact test-6 (The HIT-6)(6 weeks)
研究者
Ahmed Karem Youssef Tawfik
Principal investigator
Cairo University