Craniocervical Flexion Training for Reducing Migraine Headaches and Disability

NCT ID: NCT06751732

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-15
• Study Completion Date: 2025-02-01

Brief Summary

Migraine, a leading cause of disability globally, necessitates effective interventions beyond pharmacotherapy due to the associated risks. This project addresses the literature gap by focusing on physiotherapy, particularly novel craniocervical flexion training (CCFT), for managing migraine headache. The prevalence of migraines, coupled with their economic burden, underscores the urgency for non-pharmacological alternatives. Current pharmacological treatments pose challenges, making nonpharmacological modalities like exercise physiotherapy and manual therapy promising migraine management. Despite limited research, these interventions show potential benefits in addressing peri-cranial muscle tenderness and cervical dysfunction. This study aims to assess the effects of a comprehensive physiotherapy protocol, including the CCFT, shedding light on its impact on migraine frequency, onset, and intensity.

This Randomized Clinical Trial will be conducted at Riphah Rehab Training and Research Center, spans 8 months. The sample size of 38 individuals will undergo a comprehensive physiotherapy protocol, either with or without the CCFT. Data collection, occurring at baseline, 2 weeks, and 4 weeks, includes primary outcomes (headache frequency, intensity, HIT-6 scores) and secondary outcomes (MSQ. V2.1). Participants will receive a minimum of 2 sessions per week, maintaining confidentiality. Randomization, conducted by computer-generated stratified randomization, ensures unbiased allocation to the two groups. The single-blind study incorporates rigorous statistical analysis, utilizing SPSS software for descriptive statistics, change over time assessments, and intergroup differences via t-tests and f-tests.

Detailed Description

Migraine along with tension-type headache and cluster-headache are three major types of primary headaches. Through the Global Burden of Disease (GBD) study, headache disorders are revealed as one of the major public-health concerns globally in all countries and world regions. In the 2019 iteration (GBD2019), migraine alone was second among the causes of disability, and first among women under 50 years of age. The data indicated that the worldwide prevalence of migraine was approximately 14.0% (8.6% in males, 17.0% in females), while tension-type headache (TTH) had a prevalence of 26.0% (23.4% in males, 27.1% in females). The International Classification of Headache Disorders version 3 (ICHD-3) defines primary headache as a headache disorder not caused by or attributed to another disorder. Primary headaches are disorders by themselves. They are caused by independent Patho-mechanisms and not by other disorders. Using economic loss due to migraine and working population data from the Statistics Bureau of Japan, the annual economic loss due to presenteeism is US $3.3 billion, calculated from the number of days when work efficiency has fallen to less than half due to headaches using Migraine Disability Assessment Questionnaire (MIDAS).

The pharmacological approach is one of the first-line treatments within the international guidelines for treating primary headaches. The main classes of drugs to treat migraine headaches include: Beta-blockers, Anticonvulsants, Antidepressants, and other prophylactic medications. Medication overuse cause a significant bad effect to those with primary headaches, potentially leading to a shift from episodic headache attacks to chronic headache episodes. Therefore, guidelines already implement nonpharmacological modalities in the management of primary headaches as main treatments within the physical therapy practice. Manual Therapy is one of the most common nonpharmacological treatments used for the management of common recurrent headaches.

Limited research exists on physical therapy for treating migraines, but it can still offer benefits. Migraine sufferers may experience tender peri-cranial muscles and altered muscle tone and cervical dysfunction between episodes. Physical therapy interventions, including manual therapy, targeted exercises, education, and modalities, can help reduce attack frequency, onset, and intensity. There are many MT interventions available for headache disorders which are mostly applied on cervical region. A study on the treatment of neck pain for migraine patients showed better response to physiotherapy as compared to aerobic exercises.

The prevalence of migraines globally, as indicated by the Global Burden of Disease study, underscores the urgent need for effective interventions. Migraine not only ranks among the leading causes of disability but also imposes a substantial economic burden. Current pharmacological approaches, while commonly employed, carry the risk of medication overuse and the transition from episodic to chronic headaches. Recognizing the limitations of pharmacotherapy, nonpharmacological modalities, particularly exercise physiotherapy and manual therapy (MT), emerge as promising avenues for managing migraines. Although research on physical therapy for migraines is limited, its potential benefits, such as addressing peri-cranial muscle tenderness and cervical dysfunction, make it a valuable area of exploration. This research seeks to evaluate the efficacy of a novel CCFT am within the context of manual therapy, providing insights into its impact on migraine frequency, onset, and intensity.

Conditions

Episodic Migraine Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT)

The physiotherapy protocol will consist of the following components:

Diaphragm Respiratory Training (15 minutes), Cervical Mobilization and Traction (5 minutes), Digital Compression on Muscle Trigger Points (6 minutes), Passive Stretching of Neck Muscles, Passive Stretching of Neck Muscles, Instruction on Postural Correction and Specialized Craniocervical Flexion Training (CCFT) Protocol.

Group Type: EXPERIMENTAL

Craniocervical Flexion Training (CCFT)

Intervention Type: OTHER

CCFT is a targeted intervention aimed at improving neuromuscular control in the cervicoscapular and craniocervical regions through low-load endurance exercises. A pressure biofeedback unit placed behind the neck sets a baseline at 20 mmHg, ensuring relaxed neck muscles. Participants open the mouth 20 mm to activate deep cervical flexors and minimize superficial muscle use, maintaining head contact with the surface while gazing 45 degrees below the horizontal. Pressure is increased in 5 mmHg steps (20 to 40 mmHg), with each level held for 10 seconds, followed by a 10-second rest. CCFT can also be performed seated, reducing sternocleidomastoid activity and promoting longus colli thickness for functional training.

Diaphragm Respiratory Training

Intervention Type: OTHER

Patients will undergo a 15-minute diaphragmatic respiratory training session, focusing on smooth diaphragmatic breathing with gentle expirations.

Cervical Mobilization and Traction

Intervention Type: OTHER

A physiotherapist will perform a low-velocity, passive cervical joint mobilization technique (Oscillation technique) based on the regimen described by Maitland.(17) This will be followed by cervical spine traction while patients continue diaphragmatic breathing.

Digital Compression on Muscle Trigger Points

Intervention Type: OTHER

Digital compression will be applied for 90 seconds on identified trigger points in the craniocervical muscles, not exceeding eight trigger points in each session.

Passive Stretching of Neck Muscles

Intervention Type: OTHER

Passive stretching will be performed three times for neck flexion and rotation associated with ipsilateral flexion directions, using moderate force within the patient's pain limits, and maintained for 30 seconds.

Instruction on Postural Correction

Intervention Type: OTHER

Physiotherapists will provide instructions on postural correction, addressing craniocervical extension, cervicothoracic flexion, protraction of shoulders, increased thoracic kyphosis, and flattened lumbar lordosis. Patients will be guided on correcting these postural abnormalities through craniocervical flexion, cervicothoracic extension, shoulder retraction, thoracic spine extension, and normalization of lumbar lordosis.

Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT)

Participants in Group B will receive the same comprehensive physiotherapy protocol as Group A, excluding the specialized CCFT.

Group Type: ACTIVE_COMPARATOR

Diaphragm Respiratory Training

Intervention Type: OTHER

Patients will undergo a 15-minute diaphragmatic respiratory training session, focusing on smooth diaphragmatic breathing with gentle expirations.

Cervical Mobilization and Traction

Intervention Type: OTHER

A physiotherapist will perform a low-velocity, passive cervical joint mobilization technique (Oscillation technique) based on the regimen described by Maitland.(17) This will be followed by cervical spine traction while patients continue diaphragmatic breathing.

Digital Compression on Muscle Trigger Points

Intervention Type: OTHER

Digital compression will be applied for 90 seconds on identified trigger points in the craniocervical muscles, not exceeding eight trigger points in each session.

Passive Stretching of Neck Muscles

Intervention Type: OTHER

Passive stretching will be performed three times for neck flexion and rotation associated with ipsilateral flexion directions, using moderate force within the patient's pain limits, and maintained for 30 seconds.

Instruction on Postural Correction

Intervention Type: OTHER

Physiotherapists will provide instructions on postural correction, addressing craniocervical extension, cervicothoracic flexion, protraction of shoulders, increased thoracic kyphosis, and flattened lumbar lordosis. Patients will be guided on correcting these postural abnormalities through craniocervical flexion, cervicothoracic extension, shoulder retraction, thoracic spine extension, and normalization of lumbar lordosis.

Interventions

Craniocervical Flexion Training (CCFT)

CCFT is a targeted intervention aimed at improving neuromuscular control in the cervicoscapular and craniocervical regions through low-load endurance exercises. A pressure biofeedback unit placed behind the neck sets a baseline at 20 mmHg, ensuring relaxed neck muscles. Participants open the mouth 20 mm to activate deep cervical flexors and minimize superficial muscle use, maintaining head contact with the surface while gazing 45 degrees below the horizontal. Pressure is increased in 5 mmHg steps (20 to 40 mmHg), with each level held for 10 seconds, followed by a 10-second rest. CCFT can also be performed seated, reducing sternocleidomastoid activity and promoting longus colli thickness for functional training.

Intervention Type: OTHER

Diaphragm Respiratory Training

Patients will undergo a 15-minute diaphragmatic respiratory training session, focusing on smooth diaphragmatic breathing with gentle expirations.

Intervention Type: OTHER

Cervical Mobilization and Traction

A physiotherapist will perform a low-velocity, passive cervical joint mobilization technique (Oscillation technique) based on the regimen described by Maitland.(17) This will be followed by cervical spine traction while patients continue diaphragmatic breathing.

Intervention Type: OTHER

Digital Compression on Muscle Trigger Points

Digital compression will be applied for 90 seconds on identified trigger points in the craniocervical muscles, not exceeding eight trigger points in each session.

Intervention Type: OTHER

Passive Stretching of Neck Muscles

Passive stretching will be performed three times for neck flexion and rotation associated with ipsilateral flexion directions, using moderate force within the patient's pain limits, and maintained for 30 seconds.

Intervention Type: OTHER

Instruction on Postural Correction

Physiotherapists will provide instructions on postural correction, addressing craniocervical extension, cervicothoracic flexion, protraction of shoulders, increased thoracic kyphosis, and flattened lumbar lordosis. Patients will be guided on correcting these postural abnormalities through craniocervical flexion, cervicothoracic extension, shoulder retraction, thoracic spine extension, and normalization of lumbar lordosis.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with episodic Migraine. A diagnosis of episodic migraine will be made by the primary investigator under the guidance of a medical practitioner as per the ICHD-3. An episodic migraine is that which occurs on less than 15 days per month for at least 3 months.(4)

Exclusion Criteria

• Headache diagnosis: Other than migraine according to ICHD-3
• Upper cervical spine instability.(21)
• Cervical arterial insufficiency.
• Vertigo or dizziness history.
• Rheumatoid arthritis, ankylosing spondylosis, cervical spine fractures.
• Pregnancy.
• Cognitive compromise.
• Contraindications to manual therapy.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Husnain Irshad, DPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University, Lahore

Syed Shakil ur Rehman, PhD

Role: STUDY_DIRECTOR

Riphah International University, Lahore

Locations

Riphah Rehab Training and Research Center

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

Muhammad Husnain

Identifier Type: -

Identifier Source: org_study_id