The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache

NCT ID: NCT05883319

Last Updated: 2024-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-01-03

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.

Conditions

Headache, Cervicogenic; Exercise; Therapeutics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

cervical mobilization

Cervical mobilization methods will be applied to 1st group for 3 days / week for 6 weeks.

Group Type: ACTIVE_COMPARATOR

manuel therapy

Intervention Type: OTHER

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

clinical pilates exercises

clinical pilates exercises will be applied to 2nd group,for 3 days / week for 6 weeks.

Group Type: ACTIVE_COMPARATOR

exercises

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

manuel therapy

Intervention Type: OTHER

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

exercises

Intervention Type: OTHER

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

Interventions

manuel therapy

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

Intervention Type: OTHER

exercises

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

Intervention Type: OTHER

Other Intervention Names

cervical mobilization; clinical pilates exercises

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Meltem Uzun

OTHER

Sponsor Role: lead

Responsible Party

Meltem Uzun

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Meltem Uzun, PhD(c)

Role: STUDY_DIRECTOR

Sanko University

Locations

SANKO University

Gaziantep, Please Select, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SankoMU

Identifier Type: -

Identifier Source: org_study_id