Physiotherapy Intervention for Migraine Symptoms

Study Overview
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Brief Summary
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The goal of this randomized control trial is to analyse the effectiveness of Physiotherapy intervention among university students with migraine symptoms. The main objective is: To determine the effect of aerobic exercise on the resting-state brainwaves among university students in UTAR with migraine symptoms compared with biofeedback and control exercise. To analyse the influence of aerobic exercise on the sleep quality and quality of life among the cohort compared with biofeedback and control exercise. Although the Migraine Research Foundation listed three main types of non-drug treatments for migraine are lifestyle advice, therapies, and exercises. Some common aerobic exercises such as walking, jogging, a behavioral weight loss program, cycling, and a combination of cross-training, walking, jogging, and cycling are suggested to be beneficial to the migraine patients but there remains no specific protocol established till now. Hence the other main objective of this is to establish a aerobic exercise protocol for patients with migraine symptoms.

Detailed Description
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Habitual aerobic exercise has a major advantage of preventing or reducing symptoms of several chronic diseases and medical conditions. Aerobic or cardiovascular exercise by definition is a form of bodily movement that is fueled by aerobic energy-generating processes, where the energy demands of the exercise performed do not exceed the rate at which the cardiovascular system can supply oxygen to working muscles. Aerobic exercises have already proven to reduce frequency, duration, severity or associated disability in migraine. The physiology is that when one exercises, the body releases endorphins, which are the body's natural painkillers and natural anti-depressants chemicals called enkephalins. According to Centre of Disease Control and Prevention (CDC), adult should exercise 150 minutes of moderate intensity aerobic exercise and 2 or more days a week of muscle strengthening each week for relief of migraine or primary headaches. Similarly, a study conducted comparing neck treatment and aerobic exercise concluded that 5 weeks of intervention for migraine patient responded with better outcomes. According to American migraine foundation the exercise program, should include the cardiorespiratory fitness, flexibility exercises and muscular strengthening. For this reason, several studies encourage a multidisciplinary and tailored treatment approach for these patients. Hence the study aim to assess the efficacy of physiotherapy intervention especially aerobic exercise among university students with migraine symptoms.

Official Title
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Efficacy of Physiotherapy Intervention Among University Students With Migraine Symptoms

Conditions
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Migraine

Intervention / Treatment
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* Other: Aerobic training
* Other: Biofeedback Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergraduate, and postgraduate students from Universiti Tunku Abdul Rahman 4 of 5 on the Migraine Screen Questionnaire Exclusion Criteria: Score of more than or equal to 5 on the visual aura rating scale, Diagnosed to have a secondary headache (headache attributed to the causative disorder example: infection, trauma, injury to head/ or neck) Pregnancy, Took medication for neurological conditions like stroke, multiple sclerosis and took medications for cardiorespiratory conditions like asthma, Took medications for headache and Unwilling to participate will be excluded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three groups will be present. One group receives aerobic training, second group receives biofeedback training and the last group receives patient education. So during the trial, participants in one group receive aerobic intervention in parallel to participants in the other group, who receive biofeedback training and patient education.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic training<br>Participants in the aerobic group will undergo a training that includes walking, static bicycle, and neck exercise. The participants start the session with a warm-up for 5 minutes followed by 30 minutes of aerobic exercise and end with 5 minutes of cool-down exercise. 40 minutes/ session, 3 times per week for 6 weeks. | Other: Aerobic training<br>* The warm-up exercise will include light aerobic activity and some dynamic stretching movements. Similarly, the cool down exercises will include buttock stretch, hamstring stretch, inner thigh stretch, calf stretch and thigh stretch. Each stretch to be performed for 5 repetitions with a hold time of 15 seconds for each. An elastic band secured around the head will be used to apply local pressure over the area. Kettler Computeranleitung Advanced display will be used to train static cycling. ProAction BH Treadmill G6700 instrument will be used for aerobic training.<br>* Other names: Group 1;|
| Experimental: Biofeedback training<br>Participants in this group will undergo an electromyography (EMG) biofeedback training for trapezius and frontalis using rose for relaxation 3 times per week for 6 weeks. Each session will be for 30 minutes with a 5-minute resting period between each muscle session. | Other: Biofeedback Training<br>* Neurotrac myoplus 4 pro instrument will be used for EMG biofeedback training.<br>* Other names: Group 2;|
| No Intervention: Waitlist Control group<br>The control group will receive the patient education sheet with the basic information about migraine in terms of symptoms, triggers, and prevention tips. This group is also called as waitlist control group who will receive intervention after the active treatment group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resting-state EEG | Recording of resting-state EEG will be performed using MUSE 2 a portable EEG recording device. The headset has four dry sensors (two mastoid and two forehead sensors) and fits over the ears and extends at an angle over the middle of the forehead when properly fitted with 3 reference electrodes. Once the headband is fitted, the mind monitor app will be used for data acquisition. The data obtained will be imported to MATLAB using EEGLAB function plugins (muse monitor app) CSV file. Once imported the pre-processing steps will be done to run Independent Component Analysis (ICA). Amplitude and frequency, frequency band ratio, power spectrum density and coherence will be the primary measurement analyzed for the resting-state EEG recording, | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburgh Sleep index | Pittsburgh Sleep index is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. 19 individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality. | 10 minutes | 
| Migraine Specific Quality of life | Migraine Specific Quality of life is a 14-item instrument that measures the impact of migraine across three essential aspects of a patient's health-related quality of life over the past 4 weeks: role function-restrictive (RR), role function-preventive (RP), and emotional function (EF). Raw dimension scores are computed as a sum of item response and rescaled from a 0 to 100 scale. The higher the score better is the quality of life. | 10 minutes | 
| Health survey questionnaire | Characteristics like frequency, severity and duration of migraine. Level of pain scored on a four-point numerical rating scale (0-3) equivalent to no, mild, moderate, and severe pain: 0 no pain. 1 mild pain, does not interfere with usual activities 2 moderate pain, inhibits but does not wholly prevent usual activities 3 severe pain, prevents all activities. The other components are expressed as either decreased/ increased/ remains the same/ unable to recall. | 5 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine symptoms, Aerobic exercise, Biofeedback training, University students