Efficacy of Fascia Exercises in Migraine Patients

NCT06231615 | Completed

• 1 other identifier: 07.04.2022/06
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Migraine

Keywords

migraine; pain; exercise; fascia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pain level

  Change from baseline at 6 weeks treatment program

• Level of disability due to migraine

  Change from baseline at 6 weeks treatment program

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients in this group are the group to which fascia exercises are applied.

Other: Fascia exercises; Other: Conventional physiotherapy and breathing exercises

Control group

OTHER

Patients in this group are the group to which conventional physiotherapy and breathing exercises are applied.

Other: Conventional physiotherapy and breathing exercises

Interventions

Fascia exercises OTHER

Fascia exercises are slow and calm movements similar to yoga performed by the person herself/himself.

Treatment group

Conventional physiotherapy and breathing exercises OTHER

Head and neck exercises and breathing exercises

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University

Ankara, Çubuk, 06760, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Migraine Disorders; Pain; Motor Activity

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation of the patients was carried out by a blinded investigator, and the treatment was carried out by a different investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: dual parallel group design

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 30, 2024
• Study Start: October 10, 2022
• Primary Completion: August 5, 2023
• Study Completion: September 10, 2023
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)