Craniocervical Flexion Training for Reducing Migraine Headaches and Disability

Not Applicable

Recruiting

• Conditions: Episodic Migraine Headache

• Registration Number: NCT06751732
• Lead Sponsor: Riphah International University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-07-15
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Primary Completion: 2024-12-30
• Study First Posted: 2024-12-30
• Last Update Posted: 2024-12-30
• Study Completion: 2025-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numerical Pain Rating Scale	baseline, after 4 weeks, and after 3 months	The Numeric Pain Rating Scale (NPRS) is a pain assessment tool where patients rate their current pain intensity on an 11-point numeric scale, ranging from 0 ("absence of pain") to 10 ("most severe pain imaginable"). While the Minimal Clinically Important Difference (MCID) is established as 1.3 in individuals with mechanical neck pain12, this specific value hasn't been documented for patients with cervical radiculopathy (CR). Recent findings indicate moderate test-retest reliability (ICC = 0.63) in individuals with CR.
The Migraine Disability Assessment Test	baseline, after 4 weeks, and after 3 months	The Migraine Disability Assessment Test (MIDAS) is a widely used, standardized tool designed to measure the impact of migraines on an individual's daily life. It assesses the degree of disability caused by migraines over the previous three months, focusing on areas such as work, household activities, and social or leisure engagements. The test consists of five key questions addressing the number of days migraines affected productivity or routine activities, along with an additional question on headache frequency. Scores are categorized into disability levels, ranging from minimal to severe, to guide clinical decisions and treatment planning.
A headache diary	baseline, after 4 weeks, and after 3 months	A headache diary by the national headache foundation will be used to keep track of the headache episodes, intensity, and other parameters.

Secondary Outcome Measures

Name	Time	Method
Headache Impact Test questionnaire (HIT-6)	baseline, after 4 weeks, and after 3 months	The Head Impact Test (HIT-6) exhibited high internal consistency reliability (0.82-0.90) and test-retest reliability (0.77) among migraine sufferers. Construct validity was supported by correlations with Migraine Disability Assessment Questionnaire (MIDAS) and negative correlations with SF-8 scales. Discriminant validity was observed across headache stages. Score for HIT-6 ranges from 36 to 78. Greater score means greater impact on life. The HIT-6's smaller difference between chronic and episodic migraine scores (2.3) compared to MIDAS (21.6) underscores its effectiveness in evaluating subjective impact. Both instruments assess different aspects of headache-related disability. The HIT-6's one-month recall offers a more accurate evaluation than the MIDAS's three-month recall.

Trial Locations

Locations (1)

Riphah Rehab Training and Research Center; 🇵🇰 Lahore, Punjab, Pakistan