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NCT Number: NCT05372796

The Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization on Patients With Chronic Migraine

In this study, it was aimed to examine the effects of two different treatments applied to the neck region, which have been popular in recent years, on migraine.The study included 45 female patients aged 20-50 years with migraine complaints. The patients were divided into 3 randomized groups: control group (n=15), Instrument-Assisted Soft tissue Mobilization (EDYDM) group (n=15) and on Occipital nerve TENS (OTES) group(n=15).Each group was given home exercise to their treatment. Home exercises applied 1 time per day for 5 weeks. Each exercise in the exercise program was performed with 10 repetitions

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Emine Atıcı

Tuzla, Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Be between the ages of 20-50
  • International Classification of headache disorders, Third Edition (beta), using the criteria to be diagnosed with migraine without aura,
  • migraine with a history of being at least an annual,
  • VAS neck pain to be on Level 4,
  • the hit-6 score is greater than 56

Exclusion criteria

  • receiving pharmacological or non-pharmacological treatment regularly in the last three months,
  • using a pacemaker,
  • being an epileptic or severely psychiatric patient,
  • conducting a surgical operation from the neck region,
  • cervical disc degeneration or prolapse, the presence of different diagnoses of headaches

Treatment and study plan

IASTM

Other

instrument-assisted soft tissue mobilization

Home exercise

Other

home exercise

Chattanooga direct Tens device (DJO UK Ltd, Guildford Surrey, United Kingdom)

Device

OTES (Occipital Transcutenous Electric Stimulation)

Primary outcomes

  1. Visuel Analog Skale

    Time frame: Change from Baseline Pain at 5 weeks

    VAS is a one-dimensional scale used to determine the severity of pain. The patient is asked to mark the pain he feels on a straight line of 10 cm. the value '0" means that there is no pain at all, and the value "10" means the most severe pain

Secondary outcomes

  1. Headache effect test (HIT-6)

    Time frame: Change from baseline headache at 5 weeks

    The Headache Impact Test-6 (HIT-6) has been developed to measure the factors contributing to headache and provides quantitative information about the impact of headache. HIT-6 consists of 6 items: pain, social functioning, role function, vitality, cognitive function and psychological distress. Scores ranging from 36 to 78 are obtained from the test Dec High scores indicate that the patient's headache negatively affects his daily life

  2. Pittsburgh sleep quality index (PQI)

    Time frame: change from baseline sleep at 5 weeks

    The Pittsburgh sleep quality index (PQI) consists of 24 questions in total. The individual himself answers 19 of these questions. The remaining five questions are answered by the person staying with him, if the person is left alone, they are evaluated for informational purposes and are not added as scoring. There are seven dimensions in the index, namely subjective sleep quality, sleep latency, sleep duration, habitual sleep pattern, sleep disorder status, drug use to fall asleep, daytime dysfunction. The question of each dimension Dec a score between 0 and 3. A total score of 7 dimensions in total gives a sleep quality score. The total score is the range from 0 to 21. The sleep quality of people with a score total below 5 is 'good'; for those with more than 5, their sleep quality is interpreted as 'bad

  3. SF 36

    Time frame: Change from baseline quality of life at 5 weeks

    The SF-36 quality of life index is a scale that evaluates a person's general health status. 2 basic parameters (mental and physical) and 8 sub-parameter (emotional function, physical function, physical role, social function, mental health, general health, vitality, and pain) to rate on the total consists of 36 questions. From 0 to 100 points can be obtained from each parameter. High scores indicate that a person's quality of life is good

Sponsors and collaborators

Lead sponsor

Emine Atıcı

Other

Collaborators

  • KTO Karatay University

Registry information

Official study title

Effects of Transcutaneous Occipital Nerve Stimulation and Instrument-Assisted Soft Tissue Mobilization in Chronic Migraine

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 13, 2022
Registry last updated
May 13, 2022

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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