The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache

Exercise Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05883319
• Other study ID #: SankoMU
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 3, 2024

Study information

• Verified date: March 2024
• Source: Sanko University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 3, 2024
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Headache
• Post-Traumatic Headache
• Therapeutics

Intervention

Other:
• manuel therapy
approaches will be applied for 3 days / week for 6 weeks.
• exercises
approaches will be applied for 3 days / week for 6 weeks.

Locations

Country	Name	City	State
Turkey	SANKO University	Gaziantep	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Meltem Uzun

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of headache	headache intensity by Visual Analogue Scale , headache frequency and analgesic intake	6 week
Primary	Change of muscle stiffness degree	SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro	6 week
Primary	Change of blood flow degree	head-neck artery flow Doppler Ultrasound (US)	6 week
Primary	change of posture	The PostureScreen Mobile® application	6 week
Secondary	neck range of motion	range of motion by Cervical Range of Motion device	6 week
Secondary	deep neck flexor muscle endurance	muscle endurance by Pressure Biofeedback Unit	6 week
Secondary	headache life quality	Migraine Disability Assessment Scale for headache on quality of life.	6 week
Secondary	neck functional status	Neck Disability Index for functional status	6 week