Physiotherapy Intervention for Migraine Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-18

Study Completion Date

2024-12-31

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:

1. 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.
2. 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.

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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.

Conditions

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Migraine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

A single blinding method will be used. The participant will not know whether he or she belongs to experimental group. Only the primary researcher performing the study will know if the participants are into aerobic training, biofeedback training or control group. Single blinding will be used in this study because the results produced are less likely to be biased.

Study Groups

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Waitlist Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Aerobic training

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.

Group Type EXPERIMENTAL

Aerobic training

Intervention Type OTHER

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.

Biofeedback training

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.

Group Type EXPERIMENTAL

Biofeedback Training

Intervention Type OTHER

Neurotrac myoplus 4 pro instrument will be used for EMG biofeedback training.

Interventions

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Aerobic training

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.

Intervention Type OTHER

Biofeedback Training

Neurotrac myoplus 4 pro instrument will be used for EMG biofeedback training.

Intervention Type OTHER

Other Intervention Names

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Group 1 Group 2

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No