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Clinical Trials/NCT05883319
NCT05883319
Completed
Not Applicable

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

Meltem Uzun1 site in 1 country45 target enrollmentApril 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Headache, Cervicogenic
Sponsor
Meltem Uzun
Enrollment
45
Locations
1
Primary Endpoint
Change of headache
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
January 3, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Meltem Uzun

Director

Sanko University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change of headache

Time Frame: 6 week

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

Change of muscle stiffness degree

Time Frame: 6 week

SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro

Change of blood flow degree

Time Frame: 6 week

head-neck artery flow Doppler Ultrasound (US)

change of posture

Time Frame: 6 week

The PostureScreen Mobile® application

Secondary Outcomes

  • deep neck flexor muscle endurance(6 week)
  • neck functional status(6 week)
  • headache life quality(6 week)
  • neck range of motion(6 week)

Study Sites (1)

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