Chronic MigraineNCT07762690
Mechanism-Based Cervical Rehabilitation for Chronic Migraine
A study testing cervical sensorimotor rehabilitation and conventional physiotherapy programme in people with Chronic Migraine, run by Beni-Suef University at 1 site in Egypt.
Trial summary
To investigate the effectiveness of mechanism-based cervical sensorimotor rehabilitation on cervical muscle activation, cervical proprioception, and migraine burden. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- cervical sensorimotor rehabilitation and conventional physiotherapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Oct 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
To investigate the effectiveness of mechanism-based cervical sensorimotor rehabilitation on cervical muscle activation, cervical proprioception, and migraine burden.
Read the detailed description
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.
- Conditions
- Chronic Migraine
- Being tested
- cervical sensorimotor rehabilitation, conventional physiotherapy programme
- Keywords
- Cervical Sensorimotor Rehabilitation, Joint Position Error, Cervical Muscle Activation, EMG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical sensorimotor rehabilitationOther
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 programmeOther
Describe the conventional physiotherapy programme in the same level of detail as the experimental intervention, including exercise dosage, repetitions, duration, progression, and home programme.
| Study group | Role | What they receive |
|---|---|---|
| expermintal | Experimental | 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. Receives: Other: cervical sensorimotor rehabilitation; Other: conventional physiotherapy programme |
| control group | Active comparator | The control group will receive conventional physiotherapy, including cervical range of motion exercises, stretching exercises, postural education, and a home exercise programme, with the same treatment frequency and duration as the experimental group. Receives: Other: conventional physiotherapy programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
cervical joint position error
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
Measured: after the 8-week intervention, and at the 3-month follow-up
Secondary outcomes (2)
Headache Impact Test (HIT-6)
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.
Measured: after the 8-week intervention (Week 8), and at the 3-month follow-up
Surface electromyographic (sEMG)
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
Measured: baseline of 8-week intervention, and at the 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start25 Oct 2026 (estimated)
- Primary completion25 Feb 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Following baseline assessment, participants will be randomly assigned in a 1:1 ratio to either the expermential group or control group. An independent researcher will use a machine-generated random order to ensure a random distribution
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed naeem, Beni-Suef University
- Investigators
- mohamed naeem, Study chair, BeniSuef
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07762690
- Sponsor's protocol ID
- BSUPT/05012025/naeem
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07762690
- Acronym / sponsor ID
- BSUPT/05012025/naeem
- Conditions
- Chronic Migraine
- Keywords
- Cervical Sensorimotor Rehabilitation, Joint Position Error, Cervical Muscle Activation, EMG
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 25 Oct 2026 (estimated)
- Primary completion
- 25 Feb 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effectiveness of mechanism-based cervical sensorimotor rehabilitation on cervical muscle activation, cervical proprioception, and migraine burden.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Following baseline assessment, participants will be randomly assigned in a 1:1 ratio to either the expermential group or control group. An independent researcher will use a machine-generated random order to ensure a random distribution
| Arm | Type | Receives |
|---|---|---|
| expermintal | Experimental | Other: cervical sensorimotor rehabilitation, Other: conventional physiotherapy programmehe 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. |
| control group | Active comparator | Other: conventional physiotherapy programmeThe control group will receive conventional physiotherapy, including cervical range of motion exercises, stretching exercises, postural education, and a home exercise programme, with the same treatment frequency and duration as the experimental group. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- • 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical sensorimotor rehabilitationhe 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. | Other | expermintal |
| conventional physiotherapy programmeDescribe the conventional physiotherapy programme in the same level of detail as the experimental intervention, including exercise dosage, repetitions, duration, progression, and home programme. | Other | control group, expermintal |
Primary outcome
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
2 secondary outcomes
Headache Impact Test (HIT-6)
Time frame: after the 8-week intervention (Week 8), and at the 3-month follow-up
Surface electromyographic (sEMG)
Time frame: baseline of 8-week intervention, and at the 3-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
mohamed naeem study chair
BeniSuef
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical sensorimotor rehabilitation and conventional physiotherapy programme in people with Chronic Migraine, run by Beni-Suef University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cervical joint position error (time frame: after the 8-week intervention, and at the 3-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.