Efficacy of Fascia Exercises in Migraine Patients

January 26, 2024 updated by: Ankara Yildirim Beyazıt University

Efficacy of Fascia Exercises in Migraine Patients: A Randomized Controlled Trial

Migraine, which is characterized by attacks and many accompanying symptoms, negatively affects the quality of life of patients. Although different methods have been tried for migraine, there is no definitive treatment approach yet. The aim of this study is to examine the effect of fascia exercises as a new approach on the symptoms and complaints of migraine patients.

The study was completed with 30 volunteer migraine patients. Participants were divided into two groups in a randomized controlled manner. While head-neck and breathing exercises were applied to the control group, fascial pattern exercises were performed in the study group in addition to these exercises. This protocol was applied 2 days a week for 6 weeks. Pain intensity, quality of life and sleep, heart rate changes, depression and anxiety levels and satisfaction levels were evaluated before and after the treatment.

Fascial pattern exercises are an effective approach on the symptoms and complaints of migraine patients and can be adopted as a complementary application in migraine treatment. Since this is the first study in this field, it needs to be supported by other studies in order to increase the provability of the effectiveness of the exercises.

Study Overview

Detailed Description

Migraine, which is characterized by attacks and many accompanying symptoms, negatively affects the quality of life of patients. Although different methods have been tried for migraine, there is no definitive treatment approach yet. The aim of this study is to examine the effect of fascia exercises as a new approach on the symptoms and complaints of migraine patients.

The study was completed with 30 volunteer migraine patients. Participants were divided into two groups in a randomized controlled manner. While head-neck and breathing exercises were applied to the control group, fascial pattern exercises were performed in the study group in addition to these exercises. This protocol was applied 2 days a week for 6 weeks. Pain intensity, quality of life and sleep, heart rate changes, depression and anxiety levels and satisfaction levels were evaluated before and after the treatment.

Demographic and descriptive characteristics of the participants were similar (p>0.05). In both groups, the number of attacks, duration of attacks, pain intensity, migraine-related disability and anxiety levels decreased and sleep quality improved after treatment (p<0.05). There was no significant difference in heart rate change parameters within and between the groups (p>0.05). There was no significant difference between the groups in terms of treatment efficacy (p>0.05). Patient satisfaction was higher in the fascia exercises group (p<0.05).

Fascial pattern exercises are an effective approach on the symptoms and complaints of migraine patients and can be adopted as a complementary application in migraine treatment. Since this is the first study in this field, it needs to be supported by other studies in order to increase the provability of the effectiveness of the exercises.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Çubuk
      • Ankara, Çubuk, Turkey, 06760
        • Ankara Yıldırım Beyazıt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • having a diagnosis of migraine for at least one year
  • between the ages of 18-65 years,
  • having migraine attacks at least 5 days a month,
  • having a history of migraine starting under the age of 50,
  • giving informed written consent to participate in the study

Exclusion Criteria:

  • headache due to organic or secondary causes (history of subarachnoid or cerebral hemorrhage, hypertension, cerebral embolism or thrombosis),
  • receiving acupuncture treatment in the last 6 months,
  • history of bleeding diathesis or receiving anticoagulant treatment,
  • being pregnant or lactating,
  • history of malignancy,
  • having a diagnosis of depression or receiving antidepressant treatment,
  • caffeine consumption in the last 4 hours,
  • tobacco use in the last 48 hours,
  • drug and alcohol use in the last week,
  • eating within 2 hours prior to the test,
  • being unable to move independently,
  • having an uncontrolled medical condition,
  • chronic cardiovascular disease,
  • recent surgery,
  • symptoms of somatic dysfunction,
  • musculoskeletal injuries,
  • any medication that interferes with the autonomic nervous system or immune system (e.g., beta blockers, steroids, or TNF-a inhibitors)
  • any medical condition that affects the autonomic nervous system or immune system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Patients in this group are the group to which fascia exercises are applied.
Fascia exercises are slow and calm movements similar to yoga performed by the person herself/himself.
Head and neck exercises and breathing exercises
Other: Control group
Patients in this group are the group to which conventional physiotherapy and breathing exercises are applied.
Head and neck exercises and breathing exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability
Time Frame: Change from baseline at 6 weeks treatment program
Heart rate variability is a tool that allows the investigation of cardiovascular autonomic function through the measurement of variations in RR intervals and provides valuable information about the control of the autonomic nervous system
Change from baseline at 6 weeks treatment program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain level
Time Frame: Change from baseline at 6 weeks treatment program
Visual analog scale was used to examine pain levels of participants.Individuals are presented with a line numbered evenly from 1 to 10 and asked to mark the point corresponding to their pain intensity. A higher score indicates that the severity of pain is increasing.
Change from baseline at 6 weeks treatment program
Level of disability due to migraine
Time Frame: Change from baseline at 6 weeks treatment program
The Migraine Disability Scale was used to evaluate the level of disability due to headache.Patients answer the questions by reflecting on their last 3 months. The total score is examined in 4 stages. 0-5 points means stage 1, 6-10 points means stage 2, 11-20 points means stage 3, 21 points and above means stage 4. 21 points and above means serious disability.
Change from baseline at 6 weeks treatment program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2022

Primary Completion (Actual)

August 5, 2023

Study Completion (Actual)

September 10, 2023

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 26, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will be available to the responsible researcher.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe