The Effects of Physiotherapy in Migraine

NCT07657377 — Not applicable, Recruiting, 50 participants, Ankara Yildirim Beyazıt University

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The Effects of Physiotherapy Applications in Individuals With Migraine

RegistryNCT07657377
StatusRecruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment50 (Estimated)
SponsorAnkara Yildirim Beyazıt University (Other)
ConditionsMigraine
InterventionsPhysiotherapy program (Other)
Datesstart 2026-08-10, primary completion 2027-08-01 (estimated), completion 2027-08-01 (estimated), first posted 2026-06-18, last updated 2026-09-22
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Migraine All trials of Physiotherapy program

-Summary

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.

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+Arms and interventions

ArmTypeInterventionsDescription
Control GroupNo interventionThe control group will receive no intervention and will continue with their routine treatment.
Treatment GroupExperimentalOther: Physiotherapy programIn addition to routine treatments, a physiotherapy program including transcutaneous auricular vagus nerve stimulation and cervical muscle exercises will be implemented.
  • Physiotherapy program (Other): A physiotherapy program including taVNS and cervical muscle exercises

+Outcome measures

Primary outcomes

  • Pain Assessment [Baseline, 8th week (after treatment)]: Individuals' pain parameters will be assessed using a pain diary.

Secondary outcomes

  • Assessment of Functional Status [Baseline, 8th week (after treatment)]: 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)
  • Quality of Life Assessment [Baseline, 8th week (after treatment)]: 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.
  • Assessment of Psychological State [Baseline, 8th week (after treatment)]: 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.
  • Sleep Quality Assessment [Baseline, 8th week (after treatment)]: 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) .

+Eligibility

Sex: All, ages: 18 Years to 55 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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,
* Malignancy,
* Known arrhythmia or presence of any implanted electronic device,
* Presence of sensory loss in the application area,
* Having received physiotherapy or any other treatment in the head/neck region within the last 12 months,
* History of head/neck trauma or surgery within the last 12 months.

+Locations (1)

FacilityCityCountryStatus
Gazi Mustafa Kemal Occupational and Environmental Diseases HospitalAnkaraTurkey (Türkiye)Recruiting