Clinical trial NCT06803186: High Power Laser on Suboccipital Myoelectrical Activities and Quality of Life in Patients With Cervicogenic Headache
Official title: Effect of High Power Laser Therapy on Myoelectrical Activities of Suboccipital Muscles and Quality of Life in Patients With Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervicogenic Headache
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Myoelectrical activity of suboccipital muscle
timeFrame: 6 weeks
measure: Neck Disability Index (NDI)
timeFrame: 6 weeks
measure: Quality of life (QoL) assessment
timeFrame: 6 weeks
Secondary outcomes:
measure: Pain intensity
timeFrame: 6 weeks
measure: Headache impact test-6 (The HIT-6)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Karem Youssef Tawfik
Study officials:
affiliation: Al-Azhar University
name: Shehab Khadrawy, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Asharaf A. Abdelmoneim, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Abd El-Aleem A Attia, professor
role: STUDY_CHAIR
References: