Physiotherapy Intervention for Migraine Symptoms

NCT05741775 | Recruiting Phase 3

• 1 other identifier: U/SERC/188/2022
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Migraine

Keywords

Migraine symptoms; Aerobic exercise; Biofeedback training; University students

Outcome Measures

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,

  20 minutes

Secondary Outcomes (3)

• Pittsburgh Sleep index

  10 minutes

• Migraine Specific Quality of life

  10 minutes

• Health survey questionnaire

  5 minutes

Study Arms (3)

Aerobic training

EXPERIMENTAL

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.

Other: Aerobic training

Biofeedback training

EXPERIMENTAL

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.

Other: Biofeedback Training

Waitlist Control group

NO INTERVENTION

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.

Interventions

Aerobic training 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.

Also known as: Group 1

Aerobic training

Biofeedback Training OTHER

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

Also known as: Group 2

Biofeedback training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Tunku Abdul Rahman: lead

Study Sites (1)

UTAR

Kajang, Selangor, 43000, Malaysia

RECRUITING

Related Publications (7)

• 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.

  PMID: 25410451 BACKGROUND

• 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.

  PMID: 21890526 BACKGROUND

• 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.

  PMID: 22790281 BACKGROUND

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

  PMID: 29616493 BACKGROUND

• 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.

  PMID: 15361327 BACKGROUND

• 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.

  PMID: 32259398 BACKGROUND

• 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.

  PMID: 26643584 RESULT

Related Links

• The association between migraine and physical exercise.

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Kiruthika Selvakumar

CONTACT

0139441606; kiruthika@utar.edu.my

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator (Lecturer)

Model Details: 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.

Study Record Dates

• First Submitted: February 3, 2023
• First Posted: February 23, 2023
• Study Start: September 18, 2022
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

MY (1)