Cervicogenic HeadacheNCT06803186
High Power Laser on Suboccipital Myoelectrical Activities and Quality of Life in Patients With Cervicogenic Headache
A study testing High-power laser therapy and Conventional physical therapy program in people with Cervicogenic Headache, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- High-power laser therapy and Conventional physical therapy program
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 31 Jan 2025to 15 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- Photosensitivity diagnosis.
- Tumors of some type have been diagnosed in the last 5 years.
- Presence of solar urticaria or adverse reactions to sunlight.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of High Power Laser Therapy on Myoelectrical Activities of Suboccipital Muscles and Quality of Life in Patients With Cervicogenic Headache
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.
Read the 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.
- Conditions
- Cervicogenic Headache
- Being tested
- High-power laser therapy, Placebo (PL) high power laser, Conventional physical therapy program
- Medical subject headings
- Post-Traumatic Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-power laser therapyDevice
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 laserDevice
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 programOther
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
| Study group | Role | What they receive |
|---|---|---|
| High power laser therapy and conventional physical therapy program | Experimental | 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. Receives: Device: High-power laser therapy; Other: Conventional physical therapy program |
| Placebo high power laser therapy and conventional physical therapy program | Active comparator | 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. Receives: Device: Placebo (PL) high power laser; Other: Conventional physical therapy program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoelectrical activity of suboccipital muscle
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.
Measured: 6 weeks
Neck Disability Index (NDI)
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
Measured: 6 weeks
Quality of life (QoL) assessment
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.
Measured: 6 weeks
Secondary outcomes (2)
Pain intensity
Visual analogue scale (VAS) will be used to assess pain intensity for all participants before and after the treatment program. It is a straight line, and its length is 10 cm, ranging from no pain or discomfort (zero), to the worst pain (10) that the patient could feel. it is a valid scale and has good validity and reliability.
Measured: 6 weeks
Headache impact test-6 (The HIT-6)
The six-item Headache Impact Test (HIT-6) from Quality Metric is a patient-reported outcome (PRO) tool used to capture the impact of headaches and headache treatments on functional health and wellbeing. The HIT-6 addresses six core domains affected by headaches: pain. social Functioning, role Functioning, cognitive Functioning, vitality and psychological Stress.
Each item is answered on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The final score is obtained from a simple summation of the six items. The HIT-6 total score ranges between 36 and 78, with larger scores reflecting greater impact. Four categories have been derived to aid in the interpretation of HIT-6 scores: scores ≤49 represent little or no impact; scores between 50 and 55 represent mild impact; scores between 56 and 59 represent moderate impact; and scores ≥60 indicate severe impact.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start31 Jan 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Karem Youssef Tawfik, Cairo University
- Investigators
- Shehab Khadrawy, Professor, Study director, Al-Azhar UniversityAsharaf A. Abdelmoneim, Professor, Study director, Cairo UniversityAbd El-Aleem A Attia, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803186
- Sponsor's protocol ID
- P.T.REC/012/005470
- Status last verified
- Jan 2025
- First submitted
- 27 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Power Laser Therapy on Myoelectrical Activities of Suboccipital Muscles and Quality of Life in Patients With Cervicogenic Headache
- ClinicalTrials.gov ID
- NCT06803186
- Acronym / sponsor ID
- P.T.REC/012/005470
- Conditions
- Cervicogenic Headache
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 31 Jan 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 31 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High power laser therapy and conventional physical therapy program | Experimental | Device: High-power laser therapy, Other: Conventional physical therapy programThe 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. |
| Placebo high power laser therapy and conventional physical therapy program | Active comparator | Device: Placebo (PL) high power laser, Other: Conventional physical therapy programThe 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. |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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 )
Key exclusion criteria (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-power laser therapyHigh 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 | Device | High power laser therapy and conventional physical therapy program |
| Placebo (PL) high power laserlaser 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). | Device | Placebo high power laser therapy and conventional physical therapy program |
| Conventional physical therapy programA 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 | Other | High power laser therapy and conventional physical therapy program, Placebo high power laser therapy and conventional physical therapy program |
Primary outcome
Myoelectrical activity of suboccipital muscle
Time frame: 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)
Time frame: 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
Time frame: 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.
2 secondary outcomes
Pain intensity
Time frame: 6 weeks
Headache impact test-6 (The HIT-6)
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shehab Khadrawy, Professor study director
Al-Azhar University
Asharaf A. Abdelmoneim, Professor study director
Cairo University
Abd El-Aleem A Attia, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-power laser therapy and Conventional physical therapy program in people with Cervicogenic Headache, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed K youssef, PHD (+201060638274, ahmed.karem41570@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myoelectrical activity of suboccipital muscle (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2025.