MigraineNCT06231615
Efficacy of Fascia Exercises in Migraine Patients
A study testing Fascia exercises and Conventional physiotherapy and breathing exercises in people with Migraine, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Migraine
- What is being tested?
- Fascia exercises and Conventional physiotherapy and breathing exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2022to 10 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Yıldırım Beyazıt University
Ankara, Çubuk, 06760
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Fascia exercises, Conventional physiotherapy and breathing exercises
- Keywords
- migraine, pain, exercise, fascia
- Medical subject headings
- Migraine Disorders, Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fascia exercisesOther
Fascia exercises are slow and calm movements similar to yoga performed by the person herself/himself.
Conventional physiotherapy and breathing exercisesOther
Head and neck exercises and breathing exercises
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients in this group are the group to which fascia exercises are applied. Receives: 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. Receives: Other: Conventional physiotherapy and breathing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline at 6 weeks treatment program
Secondary outcomes (2)
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.
Measured: Change from baseline at 6 weeks treatment program
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.
Measured: Change from baseline at 6 weeks treatment program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start10 Oct 2022
- Primary completion5 Aug 2023
- Study completion10 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Ankara Yildirim Beyazıt UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- dual parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231615
- Sponsor's protocol ID
- 07.04.2022/06
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be available to the responsible researcher.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Fascia Exercises in Migraine Patients: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06231615
- Acronym / sponsor ID
- 07.04.2022/06
- Conditions
- Migraine
- Keywords
- migraine, pain, exercise, fascia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 5 Aug 2023 (actual)
- Study completion
- 10 Sep 2023 (actual)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- dual parallel group design
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Other: Fascia exercises, Other: Conventional physiotherapy and breathing exercisesPatients in this group are the group to which fascia exercises are applied. |
| Control group | Other | Other: Conventional physiotherapy and breathing exercisesPatients in this group are the group to which conventional physiotherapy and breathing exercises are applied. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (18 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fascia exercisesFascia exercises are slow and calm movements similar to yoga performed by the person herself/himself. | Other | Treatment group |
| Conventional physiotherapy and breathing exercisesHead and neck exercises and breathing exercises | Other | Control group, Treatment group |
Primary outcome
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
2 secondary outcomes
Pain level
Time frame: Change from baseline at 6 weeks treatment program
Level of disability due to migraine
Time frame: Change from baseline at 6 weeks treatment program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: No. Individual participant data will be available to the responsible researcher.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fascia exercises and Conventional physiotherapy and breathing exercises in people with Migraine, run by Ankara Yildirim Beyazıt University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (time frame: Change from baseline at 6 weeks treatment program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.