MigraineNCT05292599
Effect of a Home-based Versus Supervised Exercise Program in Patients With Migraine
A study testing Experimental in people with Migraine and Exercises, run by University of Gran Rosario at 1 site in Argentina.
Trial summary
Migraine is a common primary headache with documented impacts on the patient, the economy, and society. A growing number of studies have reported that people with migraines are more likely to experience neck pain and neck dysfunction. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteArgentina
- Study dates
- 13 Jun 2022to 20 Jun 2023
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a diagnosis of migraine according to the beta version of the third edition of the International Classification of Headache Disorders (ICHD), with or without pharmacological treatment.
- Age ranging between 18 to 55 years, both genders
Who cannot join
- Patients with neurological disorders (neuropathic pain or neurodegenerative disease),
- Whiplash associated disorders,
- Specific neck pain (radicular pain),
- Recent dental or physical therapy.
- If patients are taking medication to relieve pain during the study, they will be encouraged to report it.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Cuadi- Universidad Gran Rosario
Rosario, Santa Fe Province, 2000
About this study
Official title: Effect of a Home-based Versus Supervised Exercise Program in Patients With Migraine: a Randomized Clinical Trial
Migraine is a common primary headache with documented impacts on the patient, the economy, and society. A growing number of studies have reported that people with migraines are more likely to experience neck pain and neck dysfunction. The coexistence of migraine and neck pain is also associated with a higher frequency of migraine attacks, greater susceptibility to certification. It has been reported that they present decreased cervical mobility, as well as decreased strength, resistance, and coordination of the cervical musculature of the skull. The objective of this study is to evaluate the possible clinical effects in migraineurs of supervised craniocervical and axioscapular exercises versus home-based exercises.
Read the detailed description
This study will aim to verify the effect of home versus supervised exercise programs in migraine patients. The primary outcomes will be changes in the Visual Analog Scale (VAS) (0-10) and Migraine Disability Assessment Scores (MIDAS). Secondary outcomes will be changes in cervical range of motion; change in muscle endurance test; neck disability index (NDI), Headache Impact Test (HIT-6) score, Patient Health Questionnaire (PHQ-9) scores, Generalized Anxiety Disorder (GAD-7) scores.
Volunteers for the study will be included if they are between 18 and 55 years old, are of either sex, have been diagnosed with migraine according to the third edition of the International Classification of Headache, and have exhibited at least 3 days with migraine attacks in the previous month, then will be randomly assigned into two groups. A single therapist will administer the interventions twice a week for 8 weeks. The experimental group (supervised) will carry out a supervised exercises program twice a week in comparison with the control group (no supervised) and will carry out a home-based exercise program twice a week. These volunteers will be recruited at the University of Gran Rosario, (Rosario, Argentina). Primary and secondary outcomes will be measured at both groups' baseline and the end of the treatment. All the evaluations will be performed by a blinded physiotherapist
- Being tested
- Experimental, Control
- Keywords
- Craniocervical flexion exercises, Neck exercises, Axioscapular exercises
- Medical subject headings
- Migraine Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
CCFE will be performed with the patient in a supine position with both knees flexed at 45°. This exercise involves a craniocervical movement. The IFE will be performed with the patient in a supine position while the IEE will be performed in a prone position. Both exercises will activate cervical muscles. RFE and RRE will be performed with the patient in a sitting or standing position at the same time he resists with his hands on his head. ME the function of these exercises is to depress and stabilize the scapula.
ControlOther
CCFE will be performed with the patient in a supine position with both knees flexed at 45°. This exercise involves a craniocervical movement. The IFE will be performed with the patient in a supine position while the IEE will be performed in a prone position. Both exercises will activate cervical muscles. RFE and RRE will be performed with the patient in a sitting or standing position at the same time he resists with his hands on his head. ME the function of these exercises is to depress and stabilize the scapula.
| Study group | Role | What they receive |
|---|---|---|
| Supervised | Experimental | All participants in this arm will receive physiotherapy treatment that includes craniocervical flexion exercise (CCFE), isometric flexion exercises (IFE), isometric extension exercises (IEE), self-resistance exercise for neck flexion and extension (RFE), self-resistance exercise for neck rotation (RRE), midscapular exercise (ME) in 2 sessions for week, 60 minutes each, for 8 weeks. CCFE will focus on the recruitment of the deep cervical flexor muscles and will be performed from lower to higher complexity. Each of the exercises will be for 3 sets of 10 repetitions with 10 seconds of isometric contraction during the 8 weeks. IFE and IEE consist of 3 sets of 8 repetitions with 6 seconds of isometric contraction, for 6 weeks. For self-resistance exercises, the patient performs RFE and RRE. These exercises will be performed with 3 sets of 8 repetitions with 6 seconds of isometric contraction during the 8 weeks. The ME will be performed in 3 sets of 8 repetitions during the 5 weeks. Receives: Other: Experimental |
| No supervised | Active comparator | The participants will perform the same exercises as the supervised group. However, in this arm will be instructed to perform the same exercises as the experimental group at home, without any supervision. These instructions will be given by the physiotherapist through videos and/or photos. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale (VAS)
VAS is a straight horizontal line of fixed length, usually 100mm. It is a tool to assess the intensity of pain. Patients should mark their pain assessment on a scale indicated by a straight line from 0 (no pain) to 100 (pain of greatest intensity). The values will be recorded in millimeters, taken with a ruler hidden from the patient.
Measured: At baseline and eighth weeks
Change in MIDAS Scale (Migraine Disability Assessment Scale)
The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over 3 months. Is the most widely used instrument to assess the degree of disability of patients. The disability that causes the headache is measured based on 5 questions that cover both the workplace and the domestic and family partner. Your score is obtained from the sum of the days lost by headache recorded in each of these activities, which translates into an explicit measure of time lost due to illness. This scale has shown that it is highly reliable, reproducible (regardless of the population groups evaluated), disease-specific and easy to rate, in addition to showing good internal consistency, high reliability and validity.
Measured: At baseline and eighth weeks
Secondary outcomes (7)
The Cervical Disability Index (IDC)
Patient-completed, condition-specific functional status questionnaire with 10 items including pain, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. It is made up of 10 elements that measure the influence of neck pain on daily activities. Individual items are scored and the total score can range from 0 to 50. Neck disability is classified as follows, based on the NDI score: 0-4 = no disability; 5-14 = mild; 15-24 = moderate; 25-34 = severe; 35 or higher = complete
Measured: At baseline and eighth weeks
The Headache Impact Test-6 (HIT-6)
The Headache Impact Test-6 (HIT-6) was developed to measure a broad spectrum of factors that contribute to headache burden and is useful in generating quantitative and relevant information on the impact of headache. The HIT -6 is a self-reported questionnaire consisting of six items: pain, social functioning, role functioning, vitality, cognitive functioning, and psychological distress. The patient answers each of the six related questions using one of the following five answers: "never", "rarely", "sometimes", "very often" or "always".
Measured: At baseline and eighth weeks
Neck muscle strength
will be measured with a hand dynamometer in conjunction with a non-elastic belt to resist movement of the head, rather than the examiner's hand, to avoid any additional force from the examiner's stabilization. Neck movements included flexion, extension, and right and left lateral flexion.
Measured: At baseline and eighth weeks
Cervical flexion rotation test (FRT)
The cervical rotation flexion test will be performed through the Easy Angle, this is an electronic goniometer, an innovative device that allows cervical mobility to be measured. This provides accurate measurements of joint mobility, is easy to use and can also save measurement results.
Measured: At baseline and eighth weeks
Patient Health Questionnaire (PHQ-9)
This easy-to-use patient questionnaire is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which rates each of the nine criteria. Where "0" (nothing) to "3" (almost every day). It has been validated for use in primary care. It is not a screening tool for depression but is used to monitor the severity of depression and response to treatment. However, it can be used to make a tentative diagnosis of depression in populations at risk.
Measured: At baseline and eighth weeks
Generalized Anxiety Disorder Assessment (GAD-7)
This easy-to-use self-administered patient questionnaire is used as a screening tool and severity measure for generalized anxiety disorder (GAD). The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all, 'several days', 'more than half the days', and 'nearly every day, respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate, and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater.
Measured: At baseline and eighth weeks
Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NPRS) (an outcome measure) that is a unidimensional measure of pain intensity in adults, including those with chronic pain due to rheumatic diseases. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: At baseline and eighth weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start13 Jun 2022
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Gran Rosario
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Imaz, University of Gran Rosario
- Investigators
- Fernando Imaz, PT/MSc, Principal investigator, University of Gran Rosario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292599
- Sponsor's protocol ID
- HE versus SE in Migraine
- Status last verified
- Jul 2023
- First submitted
- 14 Mar 2022
- Last updated
- 11 Jul 2023
- Results posted
- 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 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Home-based Versus Supervised Exercise Program in Patients With Migraine: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05292599
- Acronym / sponsor ID
- HE versus SE in Migraine
- Keywords
- Craniocervical flexion exercises, Neck exercises, Axioscapular exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Gran RosarioUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 23 Mar 2022 (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 is a common primary headache with documented impacts on the patient, the economy, and society. A growing number of studies have reported that people with migraines are more likely to experience neck pain and neck dysfunction. The coexistence of migraine and neck pain is also associated with a higher frequency of migraine attacks, greater susceptibility to certification. It has been reported that they present decreased cervical mobility, as well as decreased strength, resistance, and coordination of the cervical musculature of the skull. The objective of this study is to evaluate the possible clinical effects in migraineurs of supervised craniocervical and axioscapular exercises versus home-based exercises.
Detailed description
This study will aim to verify the effect of home versus supervised exercise programs in migraine patients. The primary outcomes will be changes in the Visual Analog Scale (VAS) (0-10) and Migraine Disability Assessment Scores (MIDAS). Secondary outcomes will be changes in cervical range of motion; change in muscle endurance test; neck disability index (NDI), Headache Impact Test (HIT-6) score, Patient Health Questionnaire (PHQ-9) scores, Generalized Anxiety Disorder (GAD-7) scores.
Volunteers for the study will be included if they are between 18 and 55 years old, are of either sex, have been diagnosed with migraine according to the third edition of the International Classification of Headache, and have exhibited at least 3 days with migraine attacks in the previous month, then will be randomly assigned into two groups. A single therapist will administer the interventions twice a week for 8 weeks. The experimental group (supervised) will carry out a supervised exercises program twice a week in comparison with the control group (no supervised) and will carry out a home-based exercise program twice a week. These volunteers will be recruited at the University of Gran Rosario, (Rosario, Argentina). Primary and secondary outcomes will be measured at both groups' baseline and the end of the treatment. All the evaluations will be performed by a blinded physiotherapist
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised | Experimental | Other: ExperimentalAll participants in this arm will receive physiotherapy treatment that includes craniocervical flexion exercise (CCFE), isometric flexion exercises (IFE), isometric extension exercises (IEE), self-resistance exercise for neck flexion and extension (RFE), self-resistance exercise for neck rotation (RRE), midscapular exercise (ME) in 2 sessions for week, 60 minutes each, for 8 weeks. CCFE will focus on the recruitment of the deep cervical flexor muscles and will be performed from lower to higher complexity. Each of the exercises will be for 3 sets of 10 repetitions with 10 seconds of isometric contraction during the 8 weeks. IFE and IEE consist of 3 sets of 8 repetitions with 6 seconds of isometric contraction, for 6 weeks. For self-resistance exercises, the patient performs RFE and RRE. These exercises will be performed with 3 sets of 8 repetitions with 6 seconds of isometric contraction during the 8 weeks. The ME will be performed in 3 sets of 8 repetitions during the 5 weeks. |
| No supervised | Active comparator | Other: ControlThe participants will perform the same exercises as the supervised group. However, in this arm will be instructed to perform the same exercises as the experimental group at home, without any supervision. These instructions will be given by the physiotherapist through videos and/or photos. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients with a diagnosis of migraine according to the beta version of the third edition of the International Classification of Headache Disorders (ICHD), with or without pharmacological treatment.
- Age ranging between 18 to 55 years, both genders
Key exclusion criteria (5 listed)
- Patients with neurological disorders (neuropathic pain or neurodegenerative disease),
- Whiplash associated disorders,
- Specific neck pain (radicular pain),
- Recent dental or physical therapy.
- If patients are taking medication to relieve pain during the study, they will be encouraged to report it.
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 |
|---|---|---|
| ExperimentalCCFE will be performed with the patient in a supine position with both knees flexed at 45°. This exercise involves a craniocervical movement. The IFE will be performed with the patient in a supine position while the IEE will be performed in a prone position. Both exercises will activate cervical muscles. RFE and RRE will be performed with the patient in a sitting or standing position at the same time he resists with his hands on his head. ME the function of these exercises is to depress and stabilize the scapula. | Other | Supervised |
| ControlCCFE will be performed with the patient in a supine position with both knees flexed at 45°. This exercise involves a craniocervical movement. The IFE will be performed with the patient in a supine position while the IEE will be performed in a prone position. Both exercises will activate cervical muscles. RFE and RRE will be performed with the patient in a sitting or standing position at the same time he resists with his hands on his head. ME the function of these exercises is to depress and stabilize the scapula. | Other | No supervised |
Primary outcome
Change in Visual Analog Scale (VAS)
Time frame: At baseline and eighth weeks
VAS is a straight horizontal line of fixed length, usually 100mm. It is a tool to assess the intensity of pain. Patients should mark their pain assessment on a scale indicated by a straight line from 0 (no pain) to 100 (pain of greatest intensity). The values will be recorded in millimeters, taken with a ruler hidden from the patient.
Change in MIDAS Scale (Migraine Disability Assessment Scale)
Time frame: At baseline and eighth weeks
The Migraine Disability Assessment (MIDAS) questionnaire is a brief, self-administered questionnaire designed to quantify headache-related disability over 3 months. Is the most widely used instrument to assess the degree of disability of patients. The disability that causes the headache is measured based on 5 questions that cover both the workplace and the domestic and family partner. Your score is obtained from the sum of the days lost by headache recorded in each of these activities, which translates into an explicit measure of time lost due to illness. This scale has shown that it is highly reliable, reproducible (regardless of the population groups evaluated), disease-specific and easy to rate, in addition to showing good internal consistency, high reliability and validity.
7 secondary outcomes
The Cervical Disability Index (IDC)
Time frame: At baseline and eighth weeks
The Headache Impact Test-6 (HIT-6)
Time frame: At baseline and eighth weeks
Neck muscle strength
Time frame: At baseline and eighth weeks
Cervical flexion rotation test (FRT)
Time frame: At baseline and eighth weeks
Patient Health Questionnaire (PHQ-9)
Time frame: At baseline and eighth weeks
Generalized Anxiety Disorder Assessment (GAD-7)
Time frame: At baseline and eighth weeks
Numeric Pain Rating Scale
Time frame: At baseline and eighth weeks
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 Jul 2023.
- 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.
Fernando Imaz, PT/MSc principal investigator
University of Gran Rosario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental in people with Migraine and Exercises, run by University of Gran Rosario at 1 site in Argentina.
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 2 inclusion and 5 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 Jul 2023. 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 Argentina. 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?
Change in Visual Analog Scale (VAS) (time frame: At baseline and eighth weeks). The study lists 2 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 Jul 2023.