NCT05883319

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2024

Completed
Last Updated

March 27, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 22, 2022

Last Update Submit

March 26, 2024

Conditions

Keywords

Cervicogenic Headache,Pilates based exercisesCervical mobilizationBlood flowposturemuscle stifness

Outcome Measures

Primary Outcomes (4)

  • Change of headache

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

    6 week

  • 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 posture

    The PostureScreen Mobile® application

    6 week

Secondary Outcomes (4)

  • neck range of motion

    6 week

  • deep neck flexor muscle endurance

    6 week

  • headache life quality

    6 week

  • neck functional status

    6 week

Study Arms (3)

cervical mobilization

ACTIVE COMPARATOR

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

Other: manuel therapy

clinical pilates exercises

ACTIVE COMPARATOR

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

Other: exercises

cervical mobilization and clinical pilates exercises

ACTIVE COMPARATOR

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

Other: manuel therapyOther: exercises

Interventions

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

Also known as: cervical mobilization
cervical mobilizationcervical mobilization and clinical pilates exercises

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

Also known as: clinical pilates exercises
cervical mobilization and clinical pilates exercisesclinical pilates exercises

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SANKO University

Gaziantep, Please Select, 27060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Post-Traumatic HeadacheMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Meltem Uzun, PhD(c)

    Sanko University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 22, 2022

First Posted

May 31, 2023

Study Start

April 1, 2022

Primary Completion

April 15, 2023

Study Completion

January 3, 2024

Last Updated

March 27, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations