- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06231615
Efficacy of Fascia Exercises in Migraine Patients
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Çubuk
-
Ankara, Çubuk, Turkey, 06760
- Ankara Yıldırım Beyazıt University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07.04.2022/06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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