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Physiotherapy Intervention for Migraine Symptoms

Primary Purpose

Migraine

Status
Recruiting
Phase
Early Phase 1
Locations
Malaysia
Study Type
Interventional
Intervention
Aerobic training
Biofeedback Training
Sponsored by
Universiti Tunku Abdul Rahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine symptoms, Aerobic exercise, Biofeedback training, University students

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UTARRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Aerobic training

Biofeedback training

Waitlist Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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,

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
February 3, 2023
Last Updated
February 14, 2023
Sponsor
Universiti Tunku Abdul Rahman
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1. Study Identification

Unique Protocol Identification Number
NCT05741775
Brief Title
Physiotherapy Intervention for Migraine Symptoms
Official Title
Efficacy of Physiotherapy Intervention Among University Students With Migraine Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2022 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Tunku Abdul Rahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine symptoms, Aerobic exercise, Biofeedback training, University students

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aerobic training
Arm Type
Experimental
Arm Description
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.
Arm Title
Biofeedback training
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Aerobic training
Other Intervention Name(s)
Group 1
Intervention Description
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
Intervention Name(s)
Biofeedback Training
Other Intervention Name(s)
Group 2
Intervention Description
Neurotrac myoplus 4 pro instrument will be used for EMG biofeedback training.
Primary Outcome Measure Information:
Title
resting-state EEG
Description
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 minutes
Secondary Outcome Measure Information:
Title
Pittsburgh Sleep index
Description
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 minutes
Title
Migraine Specific Quality of life
Description
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 minutes
Title
Health survey questionnaire
Description
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 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kiruthika Selvakumar
Phone
0139441606
Email
kiruthika@utar.edu.my
Facility Information:
Facility Name
UTAR
City
Kajang
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kiruthika Selvakumar
Phone
0139441606
Email
kiruthika@utar.edu.my
First Name & Middle Initial & Last Name & Degree
Kiruthika Selvakumar, MPT

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Study protocol may be shared
Citations:
PubMed Identifier
25410451
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.
Results Reference
background
PubMed Identifier
21890526
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.
Results Reference
background
PubMed Identifier
22790281
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.
Results Reference
background
PubMed Identifier
29616493
Citation
Puledda F, Shields K. Non-Pharmacological Approaches for Migraine. Neurotherapeutics. 2018 Apr;15(2):336-345. doi: 10.1007/s13311-018-0623-6.
Results Reference
background
PubMed Identifier
15361327
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.
Results Reference
background
PubMed Identifier
32259398
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.
Results Reference
background
PubMed Identifier
26643584
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.
Results Reference
result
Links:
URL
http://doi.org/10.1186/s10194-018-0902-y
Description
The association between migraine and physical exercise.

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Physiotherapy Intervention for Migraine Symptoms

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