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Effect of Physiotherapy on Cobb Angle in Patients With Cervicogenic HeadacheNCT07168512

Effect of Myofascial Release Technique Alone or Combined With Exercises on Cervical Cobb Angle, Sleep Quality, and Psychological Factors in Patients With Cervicogenic Headache

A study testing Exercises (Endurance and strengthening) and Myofascial release technique in people with Effect of Physiotherapy on Cobb Angle in Patients With Cervicogenic Headache, run by Al-Azhar University at 3 sites in Palestinian Territories.

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Sites and contacts
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Trial summary

This study will investigate whether myofascial release therapy alone or in combination with therapeutic exercises can improve cervical spine alignment, measured by cervical Cobb angle on X-ray, in patients with cervicogenic headache. Read more about this study

Who is it for?
Ages 20 to 55 yearsHealthy volunteers can take part
What is being tested?
Exercises (Endurance and strengthening) and Myofascial release technique
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
3 sitesPalestinian Territories
Study dates
4 Sep 2025to 20 Dec 2026
Phase
Interventional

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 20 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age 20-55 years.
  • Clinical diagnosis of cervicogenic headache according to International Classification of Headache Disorders (ICHD-3) criteria (headache attributed to cervical disorder).

Who cannot join

  • History of major cervical spine pathology such as fracture, dislocation, congenital malformation, tumor, infection, or inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis).
  • Previous cervical spine surgery or fusion at any level.
  • Red flag symptoms indicating serious pathology (e.g., progressive neurological deficit, unexplained weight loss, fever, history of cancer).
  • Systemic or neurological disorders that may affect neck function or headache (e.g., multiple sclerosis, Parkinson's disease).
  • Severe osteoporosis or metabolic bone disease that contraindicates cervical X-ray imaging.
  • Vascular disorders such as vertebrobasilar insufficiency or carotid artery disease.
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  • Pregnancy or breastfeeding (due to radiation exposure during cervical radiography).
  • Unstable psychiatric conditions (e.g., severe depression, psychosis) that may interfere with participation or adherence.
  • Recent physiotherapy or manual therapy targeting the cervical region within the past 6 weeks, or planned during the study outside the protocol.
  • Use of botulinum toxin or steroid injections to the neck or head region in the past 6 months.
  • Contraindications to manual therapy or exercise (e.g., acute cervical disc herniation, severe myelopathy, unstable cardiovascular disease).
  • Inability to understand study procedures, comply with treatment sessions, or provide informed consent.
  • Symptoms of migraine, tension-type headache (TTH), or any other headache apart from cervicogenic headache.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Palestinian Territories3 sites, 3 recruiting
  • Naser Medical Complex

    Gaza, Gaza Strip

    Mosab M Mosab aldabbaa, assistant professor, 00972597451222, mosab.m.aldabbas@gmail.com

    Not yet recruiting
  • Ministry of Health

    Gaza

    NAser medical complex naser medical complex, 00972597451222, mosab.m.aldabbas@gmail.com

    Not yet recruiting
  • Naser medical Complex, Al shifa hospital

    Gaza

    lecturer, 0597451222, matar772015@gmail.com

    Recruiting

Other trials in Palestinian Territories

About this study

Official title: "Myofascial Release With or Without Exercise for Cervicogenic Headache"

This study will investigate whether myofascial release therapy alone or in combination with therapeutic exercises can improve cervical spine alignment, measured by cervical Cobb angle on X-ray, in patients with cervicogenic headache. The research will also examine potential effects on sleep quality and psychological factors."

Being tested
Exercises (Endurance and strengthening), Myofascial release technique
Keywords
cobb angle, sleep, cervicogenic headache, exercise, myofascial release
Medical subject headings
Post-Traumatic Headache, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercises (Endurance and strengthening)Other

    Neck Strengthening and Endurance Exercises with Hot Packs

    Preparation: A moist hot pack will be applied for 10-15 minutes to the cervical region before exercise to reduce stiffness and enhance tissue extensibility.

    Exercise program:

    Deep cervical flexor training: Chin tucks in supine and sitting, progressing to sustained isometric holds.

    Extensor and scapular stabilizer training: Prone head lifts and shoulder retraction exercises with light resistance.

    Endurance training: Low-load, high-repetition exercises focusing on maintaining cervical posture against gravity.

    Progression: Intensity and duration will gradually increase, emphasizing endurance over maximal strength to correct postural deficits.

    Frequency: 40 minutes per session, 3 times per week for 6 weeks

    Rationale: The combined use of heat and targeted exercises improves neuromuscular control, enhances cervical stability, and supports better cervical curvature correction. Myofascial Release Technique

  • Myofascial release techniqueOther

    Myofascial Release Technique

    Target areas: Suboccipital muscles, upper trapezius, levator scapulae, and deep cervical fascia.

    Method: A physiotherapist will perform gentle, sustained manual pressure and low-load, long-duration stretching on restricted cervical and upper thoracic fascia to reduce tension and improve soft tissue mobility.

    Duration and frequency: Each session will include 30'to 50 minutes of myofascial release, delivered 3 times per week for the study period for 6 weeks.

    Rationale: This technique aims to decrease myofascial restrictions contributing to abnormal cervical alignment and pain, thereby facilitating improved posture and muscle activation.

Study groups in NCT07168512
Study groupRoleWhat they receive
One group will receive exercisesExperimentalThe intervention will include targeted neck strengthening and endurance exercises combined with the application of hot packs
Receives: Other: Exercises (Endurance and strengthening)
Exercises and Myofascial release techniqueExperimentalThe intervention will include targeted neck strengthening and endurance exercises combined with the application of hot packs in addition to myofasical release technique
Receives: Other: Exercises (Endurance and strengthening); Other: Myofascial release technique
ControlNo interventioncontrol ; only advices

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cervical cobb angle

    Measured: pre and post (6 weeks)

  2. Cobb angle of cervical spine assessed by X Ray (Lateral)

    Landmarks \& angle construction (C2-C7 Cobb)

    Draw a line along the inferior endplate of C2.

    Draw a line along the inferior endplate of C7.

    Erect perpendiculars to each line and measure the angle at their intersection (alternatively, measure the acute angle between the two endplate lines and subtract from 180°).

    Record the angle in degrees of lordosis (greater positive values = greater lordosis). Note the sign convention in your CRF and keep it consistent pre/post.

    Normal value is between 20_40

    Measured: pre , and 8 weeks post physiotherapy intervention

  3. Hospital Anxiety and depression scale

    The Hospital Anxiety and Depression Scale (HADS) is a validated self-report screening tool developed to assess levels of anxiety and depression in patients, particularly in non-psychiatric hospital settings. It contains 14 items divided into two subscales: seven items for anxiety (HADS-A) and seven for depression (HADS-D). Each item is scored on a 4-point Likert scale ranging from 0 to 3, giving a maximum score of 21 for each subscale. Higher scores indicate greater symptom severity. Scores of 0-7 are generally considered normal, 8-10 suggest borderline (possible) anxiety or depression, and 11-21 indicate clinically significant levels. The HADS is widely used in clinical and research contexts due to its brevity, ease of administration, and ability to distinguish between anxiety and depression symptoms without being confounded by physical illness.

    Measured: pre and 8 weeks post physiotherapy interventions

Secondary outcomes (2)
  1. sleep quality

    The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire designed to assess sleep quality and disturbances over a one-month period. It consists of 19 items grouped into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction. Each component is scored from 0 (no difficulty) to 3 (severe difficulty), and the component scores are summed to yield a global score ranging from 0 to 21. A higher score indicates poorer sleep quality, with a global score greater than 5 commonly used to differentiate between good and poor sleepers. The PSQI is valued for its reliability, validity, and practicality in both clinical and research settings for evaluating sleep problems across diverse populations.

    Measured: pre, and 8 weeks post physiotherapy

  2. neck disability

    The Neck Disability Index (NDI) is a self-administered questionnaire designed to measure a patient's level of neck pain-related disability. It consists of 10 items covering domains such as pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation. Each item is scored on a 6-point scale ranging from 0 (no disability) to 5 (complete disability), resulting in a total possible score of 50. The raw score is often expressed as a percentage by multiplying by two. Higher scores indicate greater disability, with common interpretation ranges being: 0-4 (no disability), 5-14 (mild), 15-24 (moderate), 25-34 (severe), and ≥35 (complete disability). The NDI is one of the most widely used tools for assessing functional status in patients with neck pain, demonstrating strong reliability, validity, and responsiveness to clinical change.

    Measured: pre and 8 weeks post physiotherapy interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2025
  2. Study start4 Sep 2025
  3. Primary completion12 Dec 2026 (estimated)
  4. Study completion20 Dec 2026 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07168512
Sponsor's protocol ID
Al Azhar university, Palestine
Status last verified
Sep 2026
First submitted
27 Aug 2025
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cervical Cobb angle, sleep quality and psychological factors in patients with chronic neck pain with and without cervicogenic headache

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