Clinical trial NCT05741775: Physiotherapy Intervention for Migraine Symptoms
Official title: Efficacy of Physiotherapy Intervention Among University Students With Migraine Symptoms
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine symptoms
Aerobic exercise
Biofeedback training
University students
Lead sponsor: Universiti Tunku Abdul Rahman
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: resting-state EEG
timeFrame: 20 minutes
Secondary outcomes:
measure: Pittsburgh Sleep index
timeFrame: 10 minutes
measure: Migraine Specific Quality of life
timeFrame: 10 minutes
measure: Health survey questionnaire
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Kajang
country: Malaysia
facility: UTAR
state: Selangor
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: Puledda F, Shields K. Non-Pharmacological Approaches for Migraine. Neurotherapeutics. 2018 Apr;15(2):336-345. doi: 10.1007/s13311-018-0623-6.
citation: 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.
citation: 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.
citation: 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.