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The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache

Primary Purpose

Headache, Cervicogenic, Exercise, Therapeutics

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
manuel therapy
exercises
Sponsored by
Meltem Uzun
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Headache, Cervicogenic focused on measuring Cervicogenic Headache,, Pilates based exercises, Cervical mobilization, Blood flow, posture, muscle stifness

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • SANKO UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

cervical mobilization

clinical pilates exercises

cervical mobilization and clinical pilates exercises

Arm Description

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

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

cervical mobilization and clinical pilates exercises will be applied to 3rd group,for 3 days / week for 6 weeks.

Outcomes

Primary Outcome Measures

Change of muscle stiffness degree
SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro
Change of blood flow degree
head-neck artery flow Doppler Ultrasound (US)
Change intensity of pain
Visual Analogue Scale for pain, frequency, duration, and characteristics of pain

Secondary Outcome Measures

neck functional status
Neck Disability Index for functional status
deep neck flexor muscle strength
Biofeedback Stabilizer Pressure deep neck flexor muscle strength
headache life quality
Migraine Disability Assessment Scale for headache on quality of life.

Full Information

First Posted
March 22, 2022
Last Updated
May 22, 2023
Sponsor
Meltem Uzun
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1. Study Identification

Unique Protocol Identification Number
NCT05883319
Brief Title
The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache
Official Title
The Effect Of Cervical Mobilization And Clinical Pilates Exercises On Pain, Muscle Hardness, Head-Neck Blood Flow in Cervicogenic Headache
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Meltem Uzun

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Cervicogenic, Exercise, Therapeutics
Keywords
Cervicogenic Headache,, Pilates based exercises, Cervical mobilization, Blood flow, posture, muscle stifness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cervical mobilization
Arm Type
Active Comparator
Arm Description
Cervical mobilization methods will be applied to 1st group for 3 days / week for 6 weeks.
Arm Title
clinical pilates exercises
Arm Type
Active Comparator
Arm Description
clinical pilates exercises will be applied to 2nd group,for 3 days / week for 6 weeks.
Arm Title
cervical mobilization and clinical pilates exercises
Arm Type
Active Comparator
Arm Description
cervical mobilization and clinical pilates exercises will be applied to 3rd group,for 3 days / week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
manuel therapy
Other Intervention Name(s)
cervical mobilization
Intervention Description
approaches will be applied for 3 days / week for 6 weeks.
Intervention Type
Other
Intervention Name(s)
exercises
Other Intervention Name(s)
clinical pilates exercises
Intervention Description
approaches will be applied for 3 days / week for 6 weeks.
Primary Outcome Measure Information:
Title
Change of muscle stiffness degree
Description
SKM,suboccipital and upper trapezoidal muscle stiffness with Myoton Pro
Time Frame
6 week
Title
Change of blood flow degree
Description
head-neck artery flow Doppler Ultrasound (US)
Time Frame
6 week
Title
Change intensity of pain
Description
Visual Analogue Scale for pain, frequency, duration, and characteristics of pain
Time Frame
6 week
Secondary Outcome Measure Information:
Title
neck functional status
Description
Neck Disability Index for functional status
Time Frame
6 week
Title
deep neck flexor muscle strength
Description
Biofeedback Stabilizer Pressure deep neck flexor muscle strength
Time Frame
6 week
Title
headache life quality
Description
Migraine Disability Assessment Scale for headache on quality of life.
Time Frame
6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meltem Uzun, PhD(c)
Phone
05346390534
Email
meuzun@sanko.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meltem Uzun, PhD(c)
Organizational Affiliation
Sanko University
Official's Role
Study Director
Facility Information:
Facility Name
SANKO University
City
Gaziantep
State/Province
Please Select
ZIP/Postal Code
27060
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MELTEM UZUN, Ph.D(c)
Phone
05346390534
Email
meuzun@sanko.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect Of Cervical Mobilization And Clinical Pilates in Cervicogenic Headache

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