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MigrainePhase 3NCT05741775

Physiotherapy Intervention for Migraine Symptoms

A Phase 3 study testing Aerobic training and Biofeedback Training in people with Migraine, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Migraine
What is being tested?
Aerobic training and Biofeedback Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteMalaysia
Study dates
18 Sep 2022to Dec 2024
Phase
Phase 3
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 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Undergraduate, and postgraduate students from Universiti Tunku Abdul Rahman
  • 4 of 5 on the Migraine Screen Questionnaire

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Kiruthika Selvakumar contact

0139441606

kiruthika@utar.edu.my

Malaysia1 site, 1 recruiting

  • UTAR

    Kajang, Selangor, 43000

    Kiruthika Selvakumar, 0139441606, kiruthika@utar.edu.my

    Kiruthika Selvakumar, MPT

    Recruiting

Other trials in Malaysia

About this study

Official title: Efficacy of Physiotherapy Intervention Among University Students With Migraine Symptoms

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.

Read the detailed description

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
Migraine
Being tested
Aerobic training, Biofeedback Training
Keywords
Migraine symptoms, Aerobic exercise, Biofeedback training, University students
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic trainingOther

    Also called Group 1

    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 TrainingOther

    Also called Group 2

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

Study groups in NCT05741775
Study groupRoleWhat they receive
Aerobic trainingExperimentalParticipants 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.
Receives: Other: Aerobic training
Biofeedback trainingExperimentalParticipants 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.
Receives: Other: Biofeedback Training
Waitlist Control groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  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,

    Measured: 20 minutes

Secondary outcomes (3)

  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.

    Measured: 10 minutes

  2. 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.

    Measured: 10 minutes

  3. 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.

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2023
  2. Study start18 Sep 2022
  3. Primary completionJun 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant
Enrolment
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05741775
Sponsor's protocol ID
U/SERC/188/2022
Status last verified
Jun 2024
First submitted
3 Feb 2023
Last updated
1 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Study protocol may be shared

Publications

  • Santiago MD, Carvalho Dde S, Gabbai AA, Pinto MM, Moutran AR, Villa TR. Amitriptyline and aerobic exercise or amitriptyline alone in the treatment of chronic migraine: a randomized comparative study. Arq Neuropsiquiatr. 2014 Nov;72(11):851-5. doi: 10.1590/0004-282x20140148.

    PubMed 25410451

  • Varkey E, Cider A, Carlsson J, Linde M. Exercise as migraine prophylaxis: a randomized study using relaxation and topiramate as controls. Cephalalgia. 2011 Oct;31(14):1428-38. doi: 10.1177/0333102411419681. Epub 2011 Sep 2.

    PubMed 21890526

  • Wallasch TM, Kropp P. Multidisciplinary integrated headache care: a prospective 12-month follow-up observational study. J Headache Pain. 2012 Oct;13(7):521-9. doi: 10.1007/s10194-012-0469-y. Epub 2012 Jul 12.

    PubMed 22790281

  • Puledda F, Shields K. Non-Pharmacological Approaches for Migraine. Neurotherapeutics. 2018 Apr;15(2):336-345. doi: 10.1007/s13311-018-0623-6.

    PubMed 29616493

  • Parsons AA. Cortical spreading depression: its role in migraine pathogenesis and possible therapeutic intervention strategies. Curr Pain Headache Rep. 2004 Oct;8(5):410-6. doi: 10.1007/s11916-996-0016-0.

    PubMed 15361327

  • Ouyang CS, Chiang CT, Yang RC, Wu RC, Lin LC. Quantitative electroencephalogram analysis of frontal cortex functional changes in patients with migraine. Kaohsiung J Med Sci. 2020 Jul;36(7):543-551. doi: 10.1002/kjm2.12213. Epub 2020 Apr 7.

    PubMed 32259398

  • Irby MB, Bond DS, Lipton RB, Nicklas B, Houle TT, Penzien DB. Aerobic Exercise for Reducing Migraine Burden: Mechanisms, Markers, and Models of Change Processes. Headache. 2016 Feb;56(2):357-69. doi: 10.1111/head.12738. Epub 2015 Dec 8.

    PubMed 26643584

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aerobic training and Biofeedback Training in people with Migraine, run by Universiti Tunku Abdul Rahman at 1 site in Malaysia.

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 6 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: status not confirmed, as of the sponsor's last update on 1 Jul 2024. 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 Malaysia. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kiruthika Selvakumar (0139441606, kiruthika@utar.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

resting-state EEG (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05741775, which also lists 7 linked publications.

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 1 Jul 2024.

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