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

November 6, 2021 updated by: Ayça Araci, Alanya Alaaddin Keykubat University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Alanya
      • Antalya, Alanya, Turkey
        • Alanyaaku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ostepathic manipulative treatment
The effects of osteopathy treatment method on the migraine
Other: Osteopathic Manipulative Therapy

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.
EXPERIMENTAL: Myofascial relaxation Treatment
The effects of myofascial treatment method on the migraine
Other: Osteopathic Manipulative Therapy

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.
EXPERIMENTAL: Control treatment
Control group will have just medication treatment
Other: Osteopathic Manipulative Therapy

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Severity
Time Frame: 4 weeks , evaluation will be apply at the beginning and after treatment
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
4 weeks , evaluation will be apply at the beginning and after treatment
24-Hour Daily Life Scale In Migraines
Time Frame: 4 weeks , evaluation will be apply at the beginning and after treatment
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.
4 weeks , evaluation will be apply at the beginning and after treatment
Migraine Disability Index
Time Frame: 4 weeks , evaluation will be apply at the beginning and after treatment
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.
4 weeks , evaluation will be apply at the beginning and after treatment
Corbin Posture Analysis
Time Frame: 4 weeks , evaluation will be apply at the beginning and after treatment
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
4 weeks , evaluation will be apply at the beginning and after treatment
Cranial Analysis
Time Frame: 4 weeks , evaluation will be apply at the beginning and after treatment
The presence of asymmetry on the face will be evaluated together with parallel lines passing through the eyes, nose and lip on the face
4 weeks , evaluation will be apply at the beginning and after treatment
Cervikal Range of Motion
Time Frame: 4 weeks , evaluation will be apply at the beginning and after treatment
Cervical region normal joint movement (NEH), cervical region extension, rotation, flexion and lateral flexion motion angles will be measured with universal goniometer.
4 weeks , evaluation will be apply at the beginning and after treatment
Trigger Point Palpation
Time Frame: 4 weeks , evaluation will be apply at the beginning and after treatment
The trigger point in the chewing and neck muscles will be investigated by fingertip palpation in a stretched muscle.
4 weeks , evaluation will be apply at the beginning and after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alanya Alaaddin Keykubat University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 10, 2021

Primary Completion (ACTUAL)

September 10, 2021

Study Completion (ACTUAL)

September 20, 2021

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (ACTUAL)

July 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2021

Last Update Submitted That Met QC Criteria

November 6, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10354421-2021/03-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

YES

Study Data/Documents

  1. Statistical Analysis Plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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