The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache

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

Study Overview

• Status: Completed
• Conditions: Exercise; Therapeutics; Headache, Cervicogenic
• Intervention / Treatment: Other: manuel therapy; Other: exercises

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.

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Meltem Uzun, PhD(c); Phone Number: 05346390534; Email: meuzun@sanko.edu.tr

Study Locations

• Turkey
  • Please Select
    • Gaziantep, Please Select, Turkey, 27060
      • SANKO University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cervical mobilization; Cervical mobilization methods will be applied to 1st group for 3 days / week for 6 weeks.	Other: manuel therapy; approaches will be applied for 3 days / week for 6 weeks.; Other Names: cervical mobilization
Active Comparator: clinical pilates exercises; clinical pilates exercises will be applied to 2nd group,for 3 days / week for 6 weeks.	Other: exercises; approaches will be applied for 3 days / week for 6 weeks.; Other Names: clinical pilates exercises
Active Comparator: cervical mobilization and clinical pilates exercises; cervical mobilization and clinical pilates exercises will be applied to 3rd group,for 3 days / week for 6 weeks.	Other: manuel therapy; approaches will be applied for 3 days / week for 6 weeks.; Other Names: cervical mobilization; Other: exercises; approaches will be applied for 3 days / week for 6 weeks.; Other Names: clinical pilates exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of muscle stiffness degree	SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro	6 week
Change of blood flow degree	head-neck artery flow Doppler Ultrasound (US)	6 week
Change of headache	headache intensity by Visual Analogue Scale , headache frequency and analgesic intake	6 week
change of posture	The PostureScreen Mobile® application	6 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neck functional status	Neck Disability Index for functional status	6 week
headache life quality	Migraine Disability Assessment Scale for headache on quality of life.	6 week
neck range of motion	range of motion by Cervical Range of Motion device	6 week
deep neck flexor muscle endurance	muscle endurance by Pressure Biofeedback Unit	6 week

Collaborators and Investigators

• Sponsor: Meltem Uzun
• Investigators: Study Director: Meltem Uzun, PhD(c), SANKO University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Actual): April 15, 2023
• Study Completion (Actual): January 3, 2024

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: posture; Blood flow; Cervical mobilization; Cervicogenic Headache,; Pilates based exercises; muscle stifness
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: SankoMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No