Physiotherapy Intervention for Migraine Symptoms
ConditionMigraine
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversiti Tunku Abdul Rahman
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergraduate, and postgraduate students from Universiti Tunku Abdul Rahman
4 of 5 on the Migraine Screen Questionnaire
Disqualifiers
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,
Trial design
Design model
Parallel
Treatments tested in this trial
Aerobic training
Other interventionThe 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
Other interventionNeurotrac myoplus 4 pro instrument will be used for EMG biofeedback training.
Treatment groups
87 Participants
are divided into 3 treatment groupsGroup A: Aerobic trainingExperimental treatment 1 intervention
Group B: Biofeedback trainingExperimental treatment 1 intervention
Group C: Waitlist Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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,
Time frame
20 minutesSecondary outcomes
1
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.
Time frame
10 minutes2
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.
Time frame
10 minutes3
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.
Time frame
5 minutesSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov