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.
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
- Conditions the study is for
- Effect of Physiotherapy on Cobb Angle in Patients With Cervicogenic Headache
- 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
- Not yet 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
- Recruiting
Naser medical Complex, Al shifa hospital
Gaza
lecturer, 0597451222, matar772015@gmail.com
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 group | Role | What they receive |
|---|---|---|
| One group will receive exercises | Experimental | The 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 technique | Experimental | The 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 |
| Control | No intervention | control ; only advices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical cobb angle
Measured: pre and post (6 weeks)
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
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)
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
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.
- First posted11 Sep 2025
- Study start4 Sep 2025
- Primary completion12 Dec 2026 (estimated)
- Study completion20 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of Physiotherapy on Cobb Angle in Patients With Cervicogenic HeadacheStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mosab ALdabbas, Al-Azhar University
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