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Completed

NCT Number: NCT05883319

The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache

Cervicogenic headache (CH) arises from cervical region problems. Various physiotherapy methods such as manual therapy approaches and exercise training are used in the treatment of CH. The aim of our study is to investigate cervical mobilization and clinical Pilates exercises on pain, muscle stiffness, head and neck blood flow in CH. Including individuals diagnosed with CH in the study. Those to be included in the study will be divided into 3 groups by a simple method. Demographic information of the individuals, age, height, weight, Body Mass Index (BMI), gender, educational status, occupation, marital status, smoking, alcohol use will be recorded. In evaluations about pain before treatment; pain intensity, pain frequency, duration and characteristics will be evaluated with Visual Analog Scale (VAS). In addition, analgesic use (frequency, amount) in headache situations will be recorded. Migraine Disability Assessment Scale (MIDAS) will be used to determine the effect of headache on quality of life. Disability Index will be used in the assessment of functional desire, and Postur Screen mobile application will be used in the assessment of posture. Range of motion(ROM) of all neck joint movements will be evaluated by CROM goniometer, deep neck flexor muscle strength by Pressure Biofeedback Unit (PBU), sternocleidomastoid(SKM), suboccipital and upper trapezius muscle stiffness myotonometer, and head-neck artery flow volume will be evaluated by Doppler ultrasound. Cervical mobilization methods will be applied to the 1st group, clinical pilates applications to the 2nd group, clinical pilates with cervical mobilization will be applied to the 3rd group for 3 days / week for 6 weeks. All evaluations were completed again after the 3rd week and after the treatment. After the obtained results are obtained, the literature will be discussed.

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Key information

Conditions

Headache, Cervicogenic Behavior Brain Diseases Central Nervous System Diseases Exercise Headache Disorders Headache Disorders, Secondary Motor Activity Nervous System Diseases Post-Traumatic Headache Therapeutics

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SANKO University

Gaziantep, Please Select, 27060, Turkey (Türkiye)

About this study

The scope of the study, including patients over 18 years of age who applied to the Neurology outpatient clinic of Sani Konukoğlu Application and Research Hospital and presented with cervicogenic headache by a specialist. The sometimes headache frequency variable in the reference result was 5% Power analysis calculated 9 patients per group. It was decided to recruit 15 patients for the group. Inclusion criteria: CH was diagnosed, aged 18-65, had not received medical (except analgesic) treatment or physiotherapy for CH in the previous few months. Exclusion criteria: Individuals who have undergone CH surgery, history of serious heart or surgery, history of ongoing malignancy, diagnosed with epilepsy. Individuals for whom the Voluntary Consent form will be obtained will be randomly divided into groups using the minimalization method given age, gender and duration of illness.Patients will be asked not to use analgesics as much as possible during the treatment period. In the case of analgesic use, the amount and frequency will be recorded. The change in the frequency of analgesic use will also be used to evaluate the effectiveness of the applications.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with Cervicogenic Headache
  • aged 18-65
  • did not receive medical (except analgesic) treatment or physiotherapy for bit Cervicogenic Headache in the previous few months

Exclusion criteria

  • Individuals who have undergone Cervicogenic Headache surgery
  • have had a serious cardiac history or surgery
  • a history of ongoing or previous malignancy
  • a diagnosis of epilepsy.

Treatment and study plan

Manuel therapy

Other

approaches will be applied for 3 days / week for 6 weeks.

Other names: cervical mobilization

Exercises

Other

approaches will be applied for 3 days / week for 6 weeks.

Other names: clinical pilates exercises

Primary outcomes

  1. Change of headache

    Time frame: 6 week

    headache intensity by Visual Analogue Scale , headache frequency and analgesic intake

  2. Change of muscle stiffness degree

    Time frame: 6 week

    SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro

  3. Change of blood flow degree

    Time frame: 6 week

    head-neck artery flow Doppler Ultrasound (US)

  4. change of posture

    Time frame: 6 week

    The PostureScreen Mobile® application

Secondary outcomes

  1. neck range of motion

    Time frame: 6 week

    range of motion by Cervical Range of Motion device

  2. deep neck flexor muscle endurance

    Time frame: 6 week

    muscle endurance by Pressure Biofeedback Unit

  3. headache life quality

    Time frame: 6 week

    Migraine Disability Assessment Scale for headache on quality of life.

  4. neck functional status

    Time frame: 6 week

    Neck Disability Index for functional status

Sponsors and collaborators

Lead sponsor

Meltem Uzun

Other

Registry information

Official study title

The Effect Of Cervical Mobilization And Clinical Pilates Exercises On Pain, Muscle Hardness, Head-Neck Blood Flow in Cervicogenic Headache

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 31, 2023
Registry last updated
Mar 27, 2024

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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