High Power Laser on Suboccipital Myoelectrical Activities and Quality of Life in Patients With Cervicogenic Headache
NCT ID: NCT06803186
Last Updated: 2025-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2025-01-31
2025-05-15
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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 longitudinally \&transversely from the C3 to C7 posterior neck in the paraspinal region, upper back, inter-scapular area, trapezius, sternocleidomastoid muscles, and posterior \& lateral shoulder areas
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 cervical flexors, rhomboidus, and lower trapezeius muscles) will be done initially without weight and afterward by using Theraband and dumbells. All patients will be instructed to achieve three sets of 12 repetitions of the strengthening exercises (isometrics exercises) with 1 to 2 minutes rest in between each set. Contraction will be held for 5 seconds/repetitions. 10-20 repetitions for strengthening exercises and 3 sets of 30 repetitions for endurance exercise
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.
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).
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 cervical flexors, rhomboidus, and lower trapezeius muscles) will be done initially without weight and afterward by using Theraband and dumbells. All patients will be instructed to achieve three sets of 12 repetitions of the strengthening exercises (isometrics exercises) with 1 to 2 minutes rest in between each set. Contraction will be held for 5 seconds/repetitions. 10-20 repetitions for strengthening exercises and 3 sets of 30 repetitions for endurance exercise
Interventions
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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 longitudinally \&transversely from the C3 to C7 posterior neck in the paraspinal region, upper back, inter-scapular area, trapezius, sternocleidomastoid muscles, and posterior \& lateral shoulder areas
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).
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 cervical flexors, rhomboidus, and lower trapezeius muscles) will be done initially without weight and afterward by using Theraband and dumbells. All patients will be instructed to achieve three sets of 12 repetitions of the strengthening exercises (isometrics exercises) with 1 to 2 minutes rest in between each set. Contraction will be held for 5 seconds/repetitions. 10-20 repetitions for strengthening exercises and 3 sets of 30 repetitions for endurance exercise
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
50 Years
ALL
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Karem Youssef Tawfik
Principal investigator
Principal Investigators
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Shehab Khadrawy, Professor
Role: STUDY_DIRECTOR
Al-Azhar University
Asharaf A. Abdelmoneim, Professor
Role: STUDY_DIRECTOR
Cairo University
Abd El-Aleem A Attia, professor
Role: STUDY_CHAIR
Cairo University
Locations
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Ahmed Karem Youssef Tawfik
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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P.T.REC/012/005470
Identifier Type: -
Identifier Source: org_study_id
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