NCT07168512

Brief 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. The research will also examine potential effects on sleep quality and psychological factors."

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

September 4, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2026

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

7 months

First QC Date

August 27, 2025

Last Update Submit

September 4, 2025

Conditions

Keywords

cobb anglesleepcervicogenic headacheexercisemyofascial release

Outcome Measures

Primary Outcomes (3)

  • Cervical cobb angle

    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

    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.

    pre and 8 weeks post physiotherapy interventions

Secondary Outcomes (2)

  • sleep quality

    pre, and 8 weeks post physiotherapy

  • neck disability

    pre and 8 weeks post physiotherapy interventions

Study Arms (3)

One group will receive exercises

EXPERIMENTAL

The intervention will include targeted neck strengthening and endurance exercises combined with the application of hot packs

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

Other: Exercises (Endurance and strengthening)Other: Myofascial release technique

Control

NO INTERVENTION

control ; only advices

Interventions

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

Exercises and Myofascial release techniqueOne group will receive exercises

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.

Exercises and Myofascial release technique

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Naser Medical Complex

Gaza, Gaza Strip, Palestinian Territories

Location

Ministry of Health

Gaza, Palestinian Territories

Location

Related Publications (1)

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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Post-Traumatic HeadacheMotor Activity

Interventions

ExerciseMyofascial Release Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaMassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
mosab aldabbas

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 11, 2025

Study Start

September 4, 2025

Primary Completion

April 1, 2026

Study Completion

April 3, 2026

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations