NCT05202171

Brief Summary

The aim of our study is to investigate the effects of cervical stabilization exercise training applied with telerehabilitation in individuals with migraine.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Status
unknown

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

January 10, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 21, 2022

Status Verified

January 1, 2022

Enrollment Period

1 year

First QC Date

January 10, 2022

Last Update Submit

January 10, 2022

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

  • The characteristic of the migraine

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

    change from baseline at 8 weeks

Secondary Outcomes (7)

  • Cervical range of motion

    change from baseline at 8 weeks

  • Upper cervical region movements

    change from baseline at 8 weeks

  • Performance of the deep neck flexor muscles

    change from baseline at 8 weeks

  • Cranio-vertebral angle

    change from baseline at 8 weeks

  • Disability Status

    change from baseline at 8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Other: Cervical Stabilization Exercise

Standard treatment group

ACTIVE COMPARATOR

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.

Other: Standard treatment

Interventions

Cervical Stabilization ExerciseOTHER

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

Exercise group
Standard treatmentOTHER

standard treatment will include preventive/symptomatic oral drug therapy routinely in the clinic and suggestions for triggering factors in migraine for 8 weeks

Standard treatment group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Seyda Toprak Celenay

    Ankara Yildirim Beyazıt University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seyda Toprak Celenay

CONTACT

+90312 906 1000sydtoprak@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 10, 2022

First Posted

January 21, 2022

Study Start

February 1, 2022

Primary Completion

February 1, 2023

Study Completion

June 1, 2023

Last Updated

January 21, 2022

Record last verified: 2022-01