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Clinical Trials/NCT06604637
NCT06604637
Completed
N/A

Effectiveness of Vagus Nerve Stimulation in Individuals With Tension-Type Headache

Bitlis Eren University1 site in 1 country30 target enrollmentSeptember 30, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Tension-Type Headache
Sponsor
Bitlis Eren University
Enrollment
30
Locations
1
Primary Endpoint
Pain intensity
Status
Completed
Last Updated
last year

Overview

Brief Summary

It is planned to examine the effect of Vagus Nerve Stimulation on headache symptoms in individuals with tension-type headache.

Detailed Description

Tension-type headache is the most common primary headache, usually bilateral, characterized by oppressive and squeezing pain of mild or moderate intensity, unchanged by physical activity. It affects approximately 80% of the population and has a point prevalence of 42% in the general population. There are various pharmacological and non-pharmacological treatment methods for tension-type headache. One of the non-pharmacological treatment methods may be Vagus Nerve Stimulation (VNS). VNS can affect healing processes by regulating the autonomic nervous system and reduce symptoms in tension-type headache.

Registry
clinicaltrials.gov
Start Date
September 30, 2024
End Date
March 5, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bitlis Eren University
Responsible Party
Principal Investigator
Principal Investigator

Mesut Arslan

Assistant Professor

Bitlis Eren University

Eligibility Criteria

Inclusion Criteria

  • Individuals with tension-type headache according to the International Classification of Headache Disorders (ICHD-3) criteria,
  • Individuals between the ages of 18-65,

Exclusion Criteria

  • History of trauma or surgery to the head and neck region,
  • Presence of lesions or metal implants in the application area,
  • Uncontrolled hypertension/abnormal ECG results/history of myocardial infarction/pacemaker and similar cardiovascular disease history/suspicion,
  • Pregnancy or suspicion,
  • Other primary and secondary headache types,
  • Individuals who received physiotherapy in the last 6 months,

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Change from baseline at 4 weeks

In the headache diary, the severity of the pain will be questioned with a numerical pain scale.

Pain duration

Time Frame: Change from baseline at 4 weeks

The duration of pain will be questioned in the headache diary.

Number of days of pain for 1 month

Time Frame: Change from baseline at 4 weeks

The number of days of pain during a month will be questioned in the headache diary.

Heart rate variability

Time Frame: Change from baseline at 4 weeks

Heart rate variability will be measured with an automatic device.

Secondary Outcomes

  • Headache Impact Scale(Change from baseline at 4 weeks)
  • Depression Anxiety Stress Scale (DASS-21)(Change from baseline at 4 weeks)

Study Sites (1)

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