NCT07657377

Brief Summary

The aim of this study is to investigate the effects of a physiotherapy program including cervical muscle training and transcutaneous vagus nerve stimulation on pain, functional status, quality of life, psychological status, and sleep quality in individuals with migraine.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 13, 2026

Last Update Submit

June 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Assessment

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

    Baseline, 8th week (after treatment)

Secondary Outcomes (4)

  • Assessment of Functional Status

    Baseline, 8th week (after treatment)

  • Quality of Life Assessment

    Baseline, 8th week (after treatment)

  • Assessment of Psychological State

    Baseline, 8th week (after treatment)

  • Sleep Quality Assessment

    Baseline, 8th week (after treatment)

Study Arms (2)

Control Group

NO INTERVENTION

The control group will receive no intervention and will continue with their routine treatment.

Treatment Group

EXPERIMENTAL

In addition to routine treatments, a physiotherapy program including taVSS and cervical muscle exercises will be implemented.

Other: Physiotherapy program

Interventions

A physiotherapy program including taVSS and cervical muscle exercises

Treatment Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi Mustafa Kemal Occupational and Environmental Diseases Hospital

Ankara, 06560, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physiotherapist and PhD Candidate

Study Record Dates

First Submitted

June 13, 2026

First Posted

June 18, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

June 18, 2026

Record last verified: 2026-06

Locations