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The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine

Primary Purpose

Migraine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cervical Stabilization Exercise
Standard treatment
Sponsored by
Ankara Yildirim Beyazıt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being between the ages of 18-55,
  • To be diagnosed with migraine by a neurologist according to International Headache Society criteria,
  • Having at least 3 migraine attacks per month,
  • Volunteering to participate in the study,
  • Having the opportunity to access devices such as computers, phones and tablets with internet connection,
  • Not having any problems that prevent cooperation and understanding

Exclusion Criteria:

  • Having other accompanying headache types,
  • Being pregnant,
  • Being in the breastfeeding period,
  • Having a history of trauma, fracture or surgery in the craniocervical region,
  • Presence of concomitant neurological and/or inflammatory rheumatic disease
  • Presence of serious psychiatric problems,
  • History of malignancy,
  • Changes in medical treatment during the study period,
  • Receiving physiotherapy for the cervical region in the last 6 months

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Exercise group

    Standard treatment group

    Arm Description

    Exercise group will be performed cervical stabilization exercise training applied with telerehabilitation and standard treatment ( preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine) for 8 weeks

    Standard treatment group will be given preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks.

    Outcomes

    Primary Outcome Measures

    The characteristic of the migraine
    The characteristic of the migraine will be evaluated with the "Headache Diary".

    Secondary Outcome Measures

    Cervical range of motion
    Cervical range of motion was evaluated using the goniometer
    Upper cervical region movements
    Upper cervical region movements will be evaluated with a Cervical Range of Motion device
    Performance of the deep neck flexor muscles
    Performance of the deep neck flexor muscles will be evaluated with a Stabilizer Pressure Biofeedback Unit
    Cranio-vertebral angle
    The cranio-vertebral angle will be measured with a goniometer
    Disability Status
    The Turkish version of Migraine Disability Assessment Scale will be used to determine the disability status in daily activities of individuals due to migraine
    Sleep quality
    Sleep quality will be evaluated with the Turkish version of Jenkins Sleep Scale
    Life quality
    Life quality will be evaluated with the Turkish version of Headache Impact Test

    Full Information

    First Posted
    January 10, 2022
    Last Updated
    January 10, 2022
    Sponsor
    Ankara Yildirim Beyazıt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05202171
    Brief Title
    The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine
    Official Title
    The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 2022 (Anticipated)
    Primary Completion Date
    February 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ankara Yildirim Beyazıt University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.
    Detailed Description
    Cervical muscles are adversely affected in individuals with migraine. It is important to investigate the effects of cervical muscle training in these individuals. Telerehabilitation applications have been used frequently in many patients in recent years. It is necessary to examine the effects of cervical stabilization exercises applied with telerehabilitation in individuals with migraine.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise group
    Arm Type
    Experimental
    Arm Description
    Exercise group will be performed cervical stabilization exercise training applied with telerehabilitation and standard treatment ( preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine) for 8 weeks
    Arm Title
    Standard treatment group
    Arm Type
    Active Comparator
    Arm Description
    Standard treatment group will be given preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks.
    Intervention Type
    Other
    Intervention Name(s)
    Cervical Stabilization Exercise
    Intervention Description
    Exercise group will be performed cervical stabilization exercise training applied with telerehabilitation and standard treatment ( preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine) for 8 weeks
    Intervention Type
    Other
    Intervention Name(s)
    Standard treatment
    Intervention Description
    standard treatment will include preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks
    Primary Outcome Measure Information:
    Title
    The characteristic of the migraine
    Description
    The characteristic of the migraine will be evaluated with the "Headache Diary".
    Time Frame
    change from baseline at 8 weeks
    Secondary Outcome Measure Information:
    Title
    Cervical range of motion
    Description
    Cervical range of motion was evaluated using the goniometer
    Time Frame
    change from baseline at 8 weeks
    Title
    Upper cervical region movements
    Description
    Upper cervical region movements will be evaluated with a Cervical Range of Motion device
    Time Frame
    change from baseline at 8 weeks
    Title
    Performance of the deep neck flexor muscles
    Description
    Performance of the deep neck flexor muscles will be evaluated with a Stabilizer Pressure Biofeedback Unit
    Time Frame
    change from baseline at 8 weeks
    Title
    Cranio-vertebral angle
    Description
    The cranio-vertebral angle will be measured with a goniometer
    Time Frame
    change from baseline at 8 weeks
    Title
    Disability Status
    Description
    The Turkish version of Migraine Disability Assessment Scale will be used to determine the disability status in daily activities of individuals due to migraine
    Time Frame
    change from baseline at 8 weeks
    Title
    Sleep quality
    Description
    Sleep quality will be evaluated with the Turkish version of Jenkins Sleep Scale
    Time Frame
    change from baseline at 8 weeks
    Title
    Life quality
    Description
    Life quality will be evaluated with the Turkish version of Headache Impact Test
    Time Frame
    change from baseline at 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being between the ages of 18-55, To be diagnosed with migraine by a neurologist according to International Headache Society criteria, Having at least 3 migraine attacks per month, Volunteering to participate in the study, Having the opportunity to access devices such as computers, phones and tablets with internet connection, Not having any problems that prevent cooperation and understanding Exclusion Criteria: Having other accompanying headache types, Being pregnant, Being in the breastfeeding period, Having a history of trauma, fracture or surgery in the craniocervical region, Presence of concomitant neurological and/or inflammatory rheumatic disease Presence of serious psychiatric problems, History of malignancy, Changes in medical treatment during the study period, Receiving physiotherapy for the cervical region in the last 6 months
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Seyda Toprak Celenay
    Phone
    +90312 906 1000
    Email
    sydtoprak@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Seyda Toprak Celenay
    Organizational Affiliation
    Ankara Yildirim Beyazıt University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    The Effects of Cervical Stabilization Exercise Training With Telerehabilitation in Individuals With Migraine

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