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Comparison of Craniosacral Therapy and Myofacial Relaxation Techniques in People Diagnosed With Migraine

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Osteopathic Manipulative Therapy
Sponsored by
Alanya Alaaddin Keykubat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring migraine, osteopathic maniulative treatment, myofascial release, physiotherapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-65 Diagnosed with chronic migraine Patients who have recently been diagnosed with chronic migraine who have not taken any medications so far for migraines.

Exclusion Criteria:

Those in the drug group had a decommissioning of drug use for 4 weeks Suspicion or presence of pregnancy

Sites / Locations

  • Alanyaaku

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ostepathic manipulative treatment

Myofascial relaxation Treatment

Control treatment

Arm Description

The effects of osteopathy treatment method on the migraine

The effects of myofascial treatment method on the migraine

Control group will have just medication treatment

Outcomes

Primary Outcome Measures

Pain Severity
Pain severity: the visual Analog scale (VAS) will be used to determine the pain severity of cases during rest and activity, the cases will be divided into 10 equal parts of 100 mm and the number values placed between 0 and 10 on the horizontal line will be described. "I don't have any pain" was announced as 0 points, "unbearable pain" was announced as 10 points, "moderate pain" was announced as 5 points. They will be asked to mark one of the values in accordance with these descriptions
24-Hour Daily Life Scale In Migraines
The validity and reliability of the "24-hour migraine quality of life scale", developed to determine changes in their quality of life within 24 hours after the first dose of the migraine drug they received after the onset of migraine headache, was examined for Turkish society.
Migraine Disability Index
MIDAS is a scale that has been developed to measure headache-related yeti loss and to improve patient-doctor communication about the functional consequences of migraine.
Corbin Posture Analysis
Anterior, posterior and lateral posture analysis of individuals Corbin posture analysis will be performed. Anterior tilt of the head, rounded back, shoulder protraction, kyphosis, lordosis, abdominal sagging, Genu recurvatum, lateral tilt of the head, protrusion of the scapula and scoliosis will be evaluated
Cranial Analysis
The presence of asymmetry on the face will be evaluated together with parallel lines passing through the eyes, nose and lip on the face
Cervikal Range of Motion
Cervical region normal joint movement (NEH), cervical region extension, rotation, flexion and lateral flexion motion angles will be measured with universal goniometer.
Trigger Point Palpation
The trigger point in the chewing and neck muscles will be investigated by fingertip palpation in a stretched muscle.

Secondary Outcome Measures

Full Information

First Posted
April 9, 2021
Last Updated
November 6, 2021
Sponsor
Alanya Alaaddin Keykubat University
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1. Study Identification

Unique Protocol Identification Number
NCT04976725
Brief Title
Comparison of Craniosacral Therapy and Myofacial Relaxation Techniques in People Diagnosed With Migraine
Official Title
Comparison of the Effectiveness of Craniosacral Therapy and Myofacial Relaxation Techniques in People Diagnosed With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
September 10, 2021 (Actual)
Study Completion Date
September 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alanya Alaaddin Keykubat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Headache is a neurological condition that is very common all over the world and is observed at some time in life in more than 90% of society. Migraine headache, known for thousands of years, is one of the oldest diseases of humanity. The word 'hemicrania', meaning 'half of a head', is used due to unilateral pain. Approaches to treating migraine include medication, relaxation, biofeedback, living a regular life, adequate sleep, exercise, and stress management. Neck pain is especially common in migraine patients. Exercise, manual practices, electrop novelties are used to reduce musculoskeletal problems, thus reducing the effects of migraine. Myofascial relaxation techniques, which are included in the manipulative techniques in the literature, are relaxation methods performed on myofascial trigger points.Osteopathic manual therapy (OMT) , which has recently entered the literature, 19. osteopathy, developed by Andrew Taylor STILL at the end of the century, is a treatment system characterized by focusing on integrity and using it by hand to heal diseases.The study of cranial OMM kraniyum first anatomical and physiological mechanisms for the prevention and treatment of disease as a whole is concerned with the relationship of the body, including diagnostic and therapeutic methods.It is used in the treatment of somatic dysfunction of the head and other body parts. An important component of cranial Omm is the primary respiratory mechanism, which occurs as movement of the head bones, sacrum, dural membranes, central nervous system and cerebrospinal fluid. The primary respiratory mechanism is synchronous with the cranial rhythmic impulse, a 2-phase rhythmic cycle that represents a dynamic metabolic exchange with each stage of the body. This cycle is indicated as loops between 7 and 14 per minute.Fascial mobilization therapy increases energy use in segments implemented by mechanical changes.Accordingly, it helps to reduce the spasm of these layers extending fascially, to dissolve adhesions, and to increase the range of motion of the joint. H0: Osteopathic Manipulative Therapy has no effect on migraine symptoms. H1: Osteopathic Manipulative Therapy has an effect on migraine symptoms. H2: myofascial relaxation techniques have no effect on migraine symptoms. H3: methods of Osteopathic Manipulative Therapy have an effect on migraine symptoms. H4: myofascial relaxation techniques and osteopathic manipulative treatment methods have no superiority over each other. H5: myofascial relaxation techniques and osteopathic manipulative treatment methods have superiority over each other.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
migraine, osteopathic maniulative treatment, myofascial release, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
75 individuals will be included in our study, including 3 groups: control group (N= 25), osteopathic manipulative technique (n= 25), myofascial relaxation group (n=25). Which group of individuals will be determined by randomizing them with closed envelope method. Osteopathic Manipulative Therapy and myofascial relaxation treatment applications will be applied 2 days a week, for periods of 30 min for 4 weeks.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ostepathic manipulative treatment
Arm Type
Experimental
Arm Description
The effects of osteopathy treatment method on the migraine
Arm Title
Myofascial relaxation Treatment
Arm Type
Experimental
Arm Description
The effects of myofascial treatment method on the migraine
Arm Title
Control treatment
Arm Type
Experimental
Arm Description
Control group will have just medication treatment
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Therapy
Intervention Description
75 individuals will be included in our study, including 3 groups: control group (N= 25), osteopathic manipulative technique (n= 25), myofascial relaxation group (n=25). Which group of individuals will be determined by randomizing them with closed envelope method. Osteopathic Manipulative Therapy and myofascial relaxation treatment applications will be applied 2 days a week, for periods of 30 min for 4 weeks.
Primary Outcome Measure Information:
Title
Pain Severity
Description
Pain severity: the visual Analog scale (VAS) will be used to determine the pain severity of cases during rest and activity, the cases will be divided into 10 equal parts of 100 mm and the number values placed between 0 and 10 on the horizontal line will be described. "I don't have any pain" was announced as 0 points, "unbearable pain" was announced as 10 points, "moderate pain" was announced as 5 points. They will be asked to mark one of the values in accordance with these descriptions
Time Frame
4 weeks , evaluation will be apply at the beginning and after treatment
Title
24-Hour Daily Life Scale In Migraines
Description
The validity and reliability of the "24-hour migraine quality of life scale", developed to determine changes in their quality of life within 24 hours after the first dose of the migraine drug they received after the onset of migraine headache, was examined for Turkish society.
Time Frame
4 weeks , evaluation will be apply at the beginning and after treatment
Title
Migraine Disability Index
Description
MIDAS is a scale that has been developed to measure headache-related yeti loss and to improve patient-doctor communication about the functional consequences of migraine.
Time Frame
4 weeks , evaluation will be apply at the beginning and after treatment
Title
Corbin Posture Analysis
Description
Anterior, posterior and lateral posture analysis of individuals Corbin posture analysis will be performed. Anterior tilt of the head, rounded back, shoulder protraction, kyphosis, lordosis, abdominal sagging, Genu recurvatum, lateral tilt of the head, protrusion of the scapula and scoliosis will be evaluated
Time Frame
4 weeks , evaluation will be apply at the beginning and after treatment
Title
Cranial Analysis
Description
The presence of asymmetry on the face will be evaluated together with parallel lines passing through the eyes, nose and lip on the face
Time Frame
4 weeks , evaluation will be apply at the beginning and after treatment
Title
Cervikal Range of Motion
Description
Cervical region normal joint movement (NEH), cervical region extension, rotation, flexion and lateral flexion motion angles will be measured with universal goniometer.
Time Frame
4 weeks , evaluation will be apply at the beginning and after treatment
Title
Trigger Point Palpation
Description
The trigger point in the chewing and neck muscles will be investigated by fingertip palpation in a stretched muscle.
Time Frame
4 weeks , evaluation will be apply at the beginning and after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-65 Diagnosed with chronic migraine Patients who have recently been diagnosed with chronic migraine who have not taken any medications so far for migraines. Exclusion Criteria: Those in the drug group had a decommissioning of drug use for 4 weeks Suspicion or presence of pregnancy
Facility Information:
Facility Name
Alanyaaku
City
Antalya
State/Province
Alanya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
YES
Links:
URL
https://doi.org/10.1016/J.JCM.2019.12.001
Description
Related Info
URL
http://www.biomedcentral.com/1472-6882/8/28
Description
Related Info
Available IPD and Supporting Information:
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://doi.org/10.1016/J.JCM.2019.12.001

Learn more about this trial

Comparison of Craniosacral Therapy and Myofacial Relaxation Techniques in People Diagnosed With Migraine

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