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Enrolling by Invitation

NCT Number: NCT07168512

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

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Key information

Conditions

Effect of Physiotherapy on Cobb Angle in Patients With Cervicogenic Headache Behavior Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Motor Activity Nervous System Diseases Post-Traumatic Headache

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naser Medical Complex, Gaza, Gaza Strip, Palestinian Territories

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

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 Technique

Other

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.

Primary outcomes

  1. Cervical cobb angle

    Time frame: pre and post (6 weeks)

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

    Time frame: pre , and 8 weeks post physiotherapy intervention

    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

  3. Hospital Anxiety and depression scale

    Time frame: pre and 8 weeks post physiotherapy interventions

    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.

Secondary outcomes

  1. sleep quality

    Time frame: pre, and 8 weeks post physiotherapy

    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.

  2. neck disability

    Time frame: pre and 8 weeks post physiotherapy interventions

    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.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

"Myofascial Release With or Without Exercise for Cervicogenic Headache"

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 11, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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