Episodic Migraine HeadacheNCT06751732
Craniocervical Flexion Training for Reducing Migraine Headaches and Disability
A study testing Craniocervical Flexion Training (CCFT), Diaphragm Respiratory Training and Cervical Mobilization and Traction in people with Episodic Migraine Headache, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Episodic Migraine Headache
- What is being tested?
- Craniocervical Flexion Training (CCFT), Diaphragm Respiratory Training and Cervical Mobilization and Traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jul 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah Rehab Training and Research Center
Lahore, Punjab Province, 54770
About this study
Official title: Effects of Craniocervical Flexion Training on Headache Frequency, Intensity, and Functional Disability in Patients With Migraine
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.
Read the 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
- Being tested
- Craniocervical Flexion Training (CCFT), Diaphragm Respiratory Training, Cervical Mobilization and Traction, Digital Compression on Muscle Trigger Points, Passive Stretching of Neck Muscles
- Keywords
- Migraine, Non-Pharmacological Interventions, Physiotherapy, Craniocervical Flexion Training, Craniocervical Flexion Exercises
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Craniocervical Flexion Training (CCFT)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 TrainingOther
Patients will undergo a 15-minute diaphragmatic respiratory training session, focusing on smooth diaphragmatic breathing with gentle expirations.
Cervical Mobilization and TractionOther
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 PointsOther
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 MusclesOther
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 CorrectionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT) | Experimental | 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. Receives: Other: Craniocervical Flexion Training (CCFT); Other: Diaphragm Respiratory Training; Other: Cervical Mobilization and Traction; Other: Digital Compression on Muscle Trigger Points; Other: Passive Stretching of Neck Muscles; Other: Instruction on Postural Correction |
| Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT) | Active comparator | Participants in Group B will receive the same comprehensive physiotherapy protocol as Group A, excluding the specialized CCFT. Receives: Other: Diaphragm Respiratory Training; Other: Cervical Mobilization and Traction; Other: Digital Compression on Muscle Trigger Points; Other: Passive Stretching of Neck Muscles; Other: Instruction on Postural Correction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale
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.
Measured: baseline, after 4 weeks, and after 3 months
The Migraine Disability Assessment Test
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.
Measured: baseline, after 4 weeks, and after 3 months
A headache diary
A headache diary by the national headache foundation will be used to keep track of the headache episodes, intensity, and other parameters.
Measured: baseline, after 4 weeks, and after 3 months
Secondary outcomes (1)
Headache Impact Test questionnaire (HIT-6)
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.
Measured: baseline, after 4 weeks, and after 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2024
- Study start15 Jul 2024
- Primary completion1 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Episodic Migraine HeadacheStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Husnain Irshad, DPT, Principal investigator, Riphah International University, LahoreSyed Shakil ur Rehman, PhD, Study director, Riphah International University, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751732
- Sponsor's protocol ID
- Muhammad Husnain
- Status last verified
- Mar 2025
- First submitted
- 20 Dec 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Craniocervical Flexion Training on Headache Frequency, Intensity, and Functional Disability in Patients With Migraine
- ClinicalTrials.gov ID
- NCT06751732
- Acronym / sponsor ID
- Muhammad Husnain
- Conditions
- Episodic Migraine Headache
- Keywords
- Migraine, Non-Pharmacological Interventions, Physiotherapy, Craniocervical Flexion Training, Craniocervical Flexion Exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 30 Dec 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT) | Experimental | Other: Craniocervical Flexion Training (CCFT), Other: Diaphragm Respiratory Training, Other: Cervical Mobilization and Traction, Other: Digital Compression on Muscle Trigger Points, Other: Passive Stretching of Neck Muscles, Other: Instruction on Postural CorrectionThe 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 B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT) | Active comparator | Other: Diaphragm Respiratory Training, Other: Cervical Mobilization and Traction, Other: Digital Compression on Muscle Trigger Points, Other: Passive Stretching of Neck Muscles, Other: Instruction on Postural CorrectionParticipants in Group B will receive the same comprehensive physiotherapy protocol as Group A, excluding the specialized CCFT. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| 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. | Other | Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT) |
| Diaphragm Respiratory TrainingPatients will undergo a 15-minute diaphragmatic respiratory training session, focusing on smooth diaphragmatic breathing with gentle expirations. | Other | Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT), Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT) |
| Cervical Mobilization and TractionA 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. | Other | Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT), Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT) |
| Digital Compression on Muscle Trigger PointsDigital compression will be applied for 90 seconds on identified trigger points in the craniocervical muscles, not exceeding eight trigger points in each session. | Other | Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT), Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT) |
| Passive Stretching of Neck MusclesPassive 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. | Other | Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT), Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT) |
| Instruction on Postural CorrectionPhysiotherapists 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. | Other | Group A: Comprehensive Physiotherapy Protocol with Craniocervical Flexion Training (CCFT), Group B: Comprehensive Physiotherapy Protocol without Craniocervical Flexion Training (CCFT) |
Primary outcome
Numerical Pain Rating Scale
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Headache Impact Test questionnaire (HIT-6)
Time frame: baseline, after 4 weeks, and after 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Muhammad Husnain Irshad, DPT principal investigator
Riphah International University, Lahore
Syed Shakil ur Rehman, PhD study director
Riphah International University, Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Craniocervical Flexion Training (CCFT), Diaphragm Respiratory Training and Cervical Mobilization and Traction in people with Episodic Migraine Headache, run by Riphah International University at 1 site in Pakistan.
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 11 Mar 2025. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical Pain Rating Scale (time frame: baseline, after 4 weeks, and after 3 months). The study lists 3 primary outcomes in all. 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 11 Mar 2025.