Efficacy of Fascia Exercises in Migraine Patients

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06231615
• Other study ID #: 07.04.2022/06
• Status: Completed
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: September 10, 2023

Study information

• Verified date: January 2024
• Source: Ankara Yildirim Beyazit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 10, 2023
• Est. primary completion date: August 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Other:
• Fascia exercises
Fascia exercises are slow and calm movements similar to yoga performed by the person herself/himself.
• Conventional physiotherapy and breathing exercises
Head and neck exercises and breathing exercises

Locations

Country	Name	City	State
Turkey	Ankara Yildirim Beyazit University	Ankara	Çubuk

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Yildirim Beyazit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability	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	Pain level	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
Secondary	Level of disability due to migraine	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