The Effects of Physiotherapy in Migraine
ConditionMigraine
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAnkara Yildirim Beyazıt University
About this trial
The aim of this study is to investigate the effects of a physiotherapy program including cervical muscle training and transcutaneous auricular vagus nerve stimulation (taVNS) on pain, functional status, quality of life, psychological status, and sleep quality in individuals with migraine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Volunteering to participate in the study
Being between 18 and 55 years of age
Being diagnosed with migraine by a neurologist according to the International Classification of Headache Disorders 3 (ICHD-3) criteria
Disqualifiers
Diagnosis of other primary and/or secondary headaches in addition to migraine,
Coexisting neurological and/or rheumatological diseases,
Severe psychiatric disorders (bipolar disorder, schizophrenia, psychosis, etc.),
Pregnancy or lactation,
Trial design
Design model
Parallel
Treatments tested in this trial
Physiotherapy program
Other interventionA physiotherapy program including taVNS and cervical muscle exercises
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Pain Assessment
Individuals' pain parameters will be assessed using a pain diary.
Time frame
Baseline, 8th week (after treatment)Secondary outcomes
1
Assessment of Functional Status
The Migraine Disability Assessment Scale will be used to determine the functional status associated with migraine. This scale aims to evaluate headache-related disability and the functionality of individuals diagnosed with migraine in daily and social activities. Score ranges are calculated as follows: Grade I: no loss or very little loss (0-5 days); Grade II: mild loss (6-10 days); Grade III: moderate loss (11-20 days); Grade IV: severe loss (21 days or more)
Time frame
Baseline, 8th week (after treatment)2
Quality of Life Assessment
The Migraine-Specific Quality of Life Scale (Version 2.1) will be used to assess quality of life. The 14-item scale comprises three sections: role-limiting, role-preventing, and emotional function. Scores for each subsection range from 0 to 100. Higher scores indicate better health-related quality of life.
Time frame
Baseline, 8th week (after treatment)3
Assessment of Psychological State
The Hospital Anxiety and Depression Scale will be used to assess psychological status. Of the 14 items comprising the scale, the 7 odd-numbered items assess anxiety disorder, while the 7 even-numbered items assess depression. The minimum and maximum scores patients can obtain on either subscale are 0 and 21, respectively. Higher scores indicate higher levels of depression and anxiety.
Time frame
Baseline, 8th week (after treatment)4
Sleep Quality Assessment
The Single-Item Sleep Quality Scale will be used to assess sleep quality.In this scale, participants are asked the question, "How would you rate your sleep quality overall over the past 7 days?" Responses are obtained using a numerical rating ranging from 0 (Terrible) to 10 (Excellent) .
Time frame
Baseline, 8th week (after treatment)Sponsors and contacts
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Source ClinicalTrials.gov