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NCT Number: NCT07762690

Mechanism-Based Cervical Rehabilitation for Chronic Migraine

To investigate the effectiveness of mechanism-based cervical sensorimotor rehabilitation on cervical muscle activation, cervical proprioception, and migraine burden.

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Key information

Conditions

Chronic Migraine

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Chronic migraine is a disabling neurological disorder characterised by headache occurring on at least 15 days per month for more than three months, with migraine features on at least eight days per month according to the International Classification of Headache Disorders (ICHD-3). In addition to headache symptoms, individuals with chronic migraine frequently exhibit cervical musculoskeletal impairments, including reduced cervical range of motion, impaired cervical proprioception, altered neuromuscular control, and increased activity of superficial cervical muscles. These impairments are thought to be associated with altered sensorimotor integration and dysfunction of the trigeminocervical complex, potentially contributing to headache persistence and disability.

Although several studies have reported beneficial effects of cervical rehabilitation in patients with migraine, the underlying neuromuscular mechanisms remain insufficiently understood. In particular, few randomized controlled trials have simultaneously investigated changes in cervical muscle activation, cervical joint position error, and migraine-related outcomes following a structured cervical sensorimotor rehabilitation programme. Understanding these mechanisms may improve clinical decision-making and facilitate the development of targeted rehabilitation strategies. This study is a prospective, assessor-blinded, parallel-group randomized controlled trial designed to investigate the effectiveness of a mechanism-based cervical sensorimotor rehabilitation programme in patients with chronic migraine.

A total of 80 participants diagnosed with chronic migraine according to the International Classification of Headache Disorders, Third Edition (ICHD-3) will be recruited from the outpatient clinics of the Faculty of Physical Therapy, Beni-Suef University. Participants will be randomly allocated in a 1:1 ratio to either an experimental group or a control group using a computer-generated randomization sequence with concealed allocation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male or female adults aged 18-55 years. Diagnosed with chronic migraine according to the International Classification of Headache Disorders, Third Edition (ICHD-3), defined as headache occurring on ≥15 days per month for more than 3 months, with migraine features present on at least 8 days per month.

History of migraine for at least 12 months prior to enrolment. Experiencing chronic migraine during the previous three months, confirmed through clinical history and/or headache diary.

Presence of cervical sensorimotor impairment, demonstrated by at least one of the following:

Increased cervical joint position error. Reduced cervical range of motion. Impaired cervical motor control. Neck pain or cervical dysfunction associated with migraine.

Exclusion criteria

  • • Diagnosis of headache disorders other than chronic migraine (e.g., cervicogenic headache, cluster headache, or medication-overuse headache).

Previous cervical spine surgery, fracture, or significant cervical trauma. Cervical radiculopathy, myelopathy, or severe cervical spine pathology. Neurological disorders other than migraine (e.g., stroke, multiple sclerosis, Parkinson's disease).

Vestibular disorders affecting balance or proprioception. Inflammatory or systemic musculoskeletal diseases (e.g., rheumatoid arthritis, ankylosing spondylitis).

Pregnancy or breastfeeding. Physiotherapy, chiropractic treatment, acupuncture, or cervical rehabilitation within the previous 3 months.

Botulinum toxin injections or cervical pain interventions within the previous 3-4 months.

Changes in migraine preventive medication within the previous 4 weeks. Skin conditions preventing surface EMG electrode placement. Inability to comply with the study protocol or provide informed consent.

Treatment and study plan

cervical sensorimotor rehabilitation

Other

he experimental group will receive an eight-week mechanism-based cervical sensorimotor rehabilitation programme consisting of deep cervical flexor training, cervical motor control exercises, laser-guided cervical joint position error retraining, eye-head coordination exercises, scapular neuromuscular stabilization exercises, and a structured home exercise programme. Treatment will be delivered three sessions per week, with each session lasting approximately 40 minutes.

Conventional physiotherapy programme

Other

Describe the conventional physiotherapy programme in the same level of detail as the experimental intervention, including exercise dosage, repetitions, duration, progression, and home programme.

Primary outcomes

  1. cervical joint position error

    Time frame: after the 8-week intervention, and at the 3-month follow-up

    Cervical Joint Position Error (JPE) will be assessed to evaluate cervical proprioception using the Head Repositioning Accuracy Test. A lightweight laser pointer will be securely attached to the participant's head using an adjustable headband. Participants will be seated comfortably at a distance of 90 cm from a target grid mounted on a wall at eye level.

    At the beginning of each trial, participants will be instructed to identify and memorise their neutral head position while visually focusing on the centre of the target. They will then close their eyes and actively move their head to the end range of the required movement (flexion, extension, right rotation, left rotation, right lateral flexion, or left lateral flexion, depending on the testing protocol) before attempting to return to the original neutral position without visual feedback.The distance between the original target position and the repositioned laser point will be recorded and converted into angular error (degrees). Thre

Secondary outcomes

  1. Headache Impact Test (HIT-6)

    Time frame: after the 8-week intervention (Week 8), and at the 3-month follow-up

    The Headache Impact Test (HIT-6) will be used to assess the impact of headaches on participants' daily functioning and health-related quality of life. The HIT-6 is a validated, self-administered questionnaire consisting of six items that evaluate headache-related limitations in pain severity, social functioning, role functioning, vitality, cognitive functioning, and psychological distress over the previous four weeks.

    Each item is scored using a five-point Likert scale with the following response options:

    Never = 6 points Rarely = 8 points Sometimes = 10 points Very Often = 11 points Always = 13 points

    The total score ranges from 36 to 78 points, with higher scores indicating a greater negative impact of headaches on daily life.

  2. Surface electromyographic (sEMG)

    Time frame: baseline of 8-week intervention, and at the 3-month follow-up

    Surface electromyography (sEMG) will be used to assess the neuromuscular activity of the bilateral sternocleidomastoid (SCM) and upper trapezius (UT) muscles. Disposable Ag/AgCl bipolar surface electrodes will be placed over each muscle according to the Surface Electromyography for the Non-Invasive Assessment of Muscles (SENIAM) recommendations following skin preparation (shaving if necessary, light abrasion, and cleaning with alcohol). The primary sEMG variables will include the root mean square (RMS) amplitude (µV) of the muscle activation during each task. If maximal voluntary isometric contraction (MVIC) testing is feasible, RMS values will be normalized and expressed as a percentage of MVIC (%MVIC) to facilitate comparisons between participants. If MVIC normalization is not performed, RMS values will be reported in microvolts (µV).

    The mean value of the three trials will be used for statistical analysis. Surface EMG measurements will be obtained at baseline (Week 0), immediately

Study contacts

Contact information is provided by the study sponsor or research team.

mohamed naeem, assistant professor

CONTACT

[email protected]

+201006739576 ext. 01006739576

mohmoud hamada, assistant professor

CONTACT

[email protected]

01111750888

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

Effect of Mechanism-Based Cervical Sensorimotor Rehabilitation on Cervical Muscle Activation, Joint Position Error, and Migraine Burden in Patients With Chronic Migraine: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 13, 2026
Registry last updated
Aug 18, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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