High Power Laser on Suboccipital Myoelectrical Activities and Quality of Life in Patients With Cervicogenic Headache

Официальное название

Effect of High Power Laser Therapy on Myoelectrical Activities of Suboccipital Muscles and Quality of Life in Patients With Cervicogenic Headache

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство High-power laser therapy
  High power laser therapy (HPLT) with a neodymium-yttrium aluminum garnet laser with a pulsating waveform produced by a ( Hilterapia device , ASA, Arcugnano, Vicenza, Italy). It will be set at the following parameters: Nd:YAG laser with pulsed emission (1064 nm), very high peak powers with average power 6 W, high levels of fluency (760 mJ/cm energy density), short pulse duration (250 μs), low frequency (10-40 Hz), and 5-cm probe diameter for 15 minutes. The scanning will be performed longitudina
• Устройство Placebo (PL) high power laser
  laser probe scanning will be applied to the same areas as that applied in the HPLT procedure. PL will be applied while the lights of the device will be on, with no current flowing through the device. Placebo therapy will be applied at the same frequency as HPLT (Three sessions a week for six weeks for a total of 18 sessions; one session will be lasted 15 minutes).
• Другое Conventional physical therapy program
  A specific program of 45-min exercise of three sessions a week for six weeks for a total of 18 sessions. Corrective exercises will be performed initially by stretching exercises for(suboccipital, upper trapezeius, scalene, levator scapulae, sternocleidomastoid, pectoralis major/minor muscles) will be given four repetitions with 30 second hold. each with 3 seconds rest between each stretch Then, strengthening exercises will be performed initially in an isometric manner for weak muscles (deep cerv

Первичные конечные точки

• Myoelectrical activity of suboccipital muscle [Срок оценки: 6 weeks]
• Neck Disability Index (NDI) [Срок оценки: 6 weeks]
• Quality of life (QoL) assessment [Срок оценки: 6 weeks]

Вторичные конечные точки (2)

• Pain intensity [Срок оценки: 6 weeks]
• Headache impact test-6 (The HIT-6) [Срок оценки: 6 weeks]

Критерии участия

Критерии включения

• 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 - 29. 9 Kg/m2).
• Moderate (45-74) to severe (75-100) neck pain on the visual analogue scale.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Ahmed Karem Youssef Tawfik — Cairo

Идентификаторы

NCT: NCT06803186 · P.T.REC/012/005470

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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