NCT04976725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

7 months

First QC Date

April 9, 2021

Last Update Submit

November 6, 2021

Conditions

Keywords

migraine, osteopathic maniulative treatment, myofascial release, physiotherapy

Outcome Measures

Primary Outcomes (7)

  • 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

    4 weeks , evaluation will be apply at the beginning and after treatment

  • 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.

    4 weeks , evaluation will be apply at the beginning and after treatment

  • 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.

    4 weeks , evaluation will be apply at the beginning and after treatment

  • 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

    4 weeks , evaluation will be apply at the beginning and after treatment

  • 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

    4 weeks , evaluation will be apply at the beginning and after treatment

  • 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.

    4 weeks , evaluation will be apply at the beginning and after treatment

  • Trigger Point Palpation

    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

Study Arms (3)

Ostepathic manipulative treatment

EXPERIMENTAL

The effects of osteopathy treatment method on the migraine

Other: Osteopathic Manipulative Therapy

Myofascial relaxation Treatment

EXPERIMENTAL

The effects of myofascial treatment method on the migraine

Other: Osteopathic Manipulative Therapy

Control treatment

EXPERIMENTAL

Control group will have just medication treatment

Other: Osteopathic Manipulative Therapy

Interventions

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.

Control treatmentMyofascial relaxation TreatmentOstepathic manipulative treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanyaaku

Antalya, Alanya, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Conditions

Migraine Disorders

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physical Therapist, pHd

Study Record Dates

First Submitted

April 9, 2021

First Posted

July 26, 2021

Study Start

February 10, 2021

Primary Completion

September 10, 2021

Study Completion

September 20, 2021

Last Updated

November 9, 2021

Record last verified: 2021-11

Locations