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NCT Number: NCT07657377

The Effects of Physiotherapy in Migraine

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital

Ankara, 06560, Turkey (Türkiye)

Location status: Recruiting

Location contact

Nuriye Kayalı Şendur

CONTACT

[email protected]

+90 312 212 66 66

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physiotherapy program

Other

A physiotherapy program including taVNS and cervical muscle exercises

Primary outcomes

  1. Pain Assessment

    Time frame: Baseline, 8th week (after treatment)

    Individuals' pain parameters will be assessed using a pain diary.

Secondary outcomes

  1. Assessment of Functional Status

    Time frame: 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)

  2. Quality of Life Assessment

    Time frame: 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.

  3. Assessment of Psychological State

    Time frame: 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.

  4. Sleep Quality Assessment

    Time frame: 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) .

Sponsors and collaborators

Lead sponsor

Ankara Yildirim Beyazıt University

Other

Registry information

Official study title

The Effects of Physiotherapy Applications in Individuals With Migraine

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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