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IRCT20170524034119N3 IRCT 2022-07-03 Tarbiat Modares University "Investigation of the Effect of cervical Mobilization on Migraine by functional Magnetic Resonance Imaging (fMRI) findings" Investigation of the Effect of upper cervical Mobilization on Migraine headaches by functional Magnetic Resonance Imaging (fMRI) findings with Trigeminal nerve stimulation 2022-04-04 anticipated 30 Complete https://irct.ir/trial/64207 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: The effect of cervical spines mobilization on fMRI findings, Randomization description: The Randomization method will be Simple, Classified and Limited in such a way that: first the individuals are selected according to the inclusion and exclusion criteria, then a total volume of closed envelopes allocation concealment containing numbers 1 and 2 including 15 numbers 1 related to the intervention group and 15 numbers 2 related to the sham group are placed in a lottery container and then the envelopes are removed from the container without replacement, Blinding description: In this study: Patients, Radiologist and Researcher analyzing the fMRI data will be blind to group assignments. N/A Migraine. Intervention 1: Intervention group: Mobilization of the first and second and third cervical spine in the form of extension, rotation and lateral flexion glides to both sides, which is done by the radial side of the index finger. A total of 15 movements. Each movement is repeated 30 times with a frequency of 1 to 2 Hz. The duration of each treatment session is approximately 20 to 30 minutes, which will be done twice a week, a total of 10 sessions (5 weeks). Intervention 2: Control group: The intervention is sham (the therapist holds the patient's head in his hands for 30 minutes and applies a very gentle massage every few minutes). Twice a week, a total of 10 sessions (5 weeks) will be done. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Counseling is needed
public Farid Bahrpeyma
NO.7, Jalal Al Ahmad street, Tarbiat Modares University, Faculty of Medical Sciences
Tehran Iran (Islamic Republic of) 14115-331 +98 21 8288 3819 bahrpeyf@modares.ac.ir Tarbiat Modares University scientific Farid Bahrpeyma
NO.7, Jalal Al Ahmad street, Tarbiat Modares University, Faculty of Medical Sciences
Tehran Iran (Islamic Republic of) 14115-331 +98 21 8288 3819 bahrpeyf@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Diagnosis of episodic migraine without aura by a neurologist The minimum duration of the disease is one year Number of attacks at least 2-5 attacks per month No change in medications in the last three months 20 years 55 years Both Positive response to VBI tests of Alar ligament, Transverse ligament, Tectorial membrane Any abnormal signs in the structural condition of the cervical spines in X-Ray findings Symptoms of Vertebrobasilar Insufficiency (VBI) Malignancy, Diabetes, Rheumatoid disease, peripheral neuropathy, Fibromyalgia, Osteoporosis, history of surgery, radiculopathy, disc dysfunction or soft tissue elements in the neck Performing Nerve Block or non-drug treatment (Physiotherapy, Manual therapy, Acupuncture, etc.) in the last 6 months G43.0 Migraine without aura Rehabilitation Placebo Intervention group: Mobilization of the first and second and third cervical spine in the form of extension, rotation and lateral flexion glides to both sides, which is done by the radial side of the index finger. A total of 15 movements. Each movement is repeated 30 times with a frequency of 1 to 2 Hz. The duration of each treatment session is approximately 20 to 30 minutes, which will be done twice a week, a total of 10 sessions (5 weeks). Control group: The intervention is sham (the therapist holds the patient's head in his hands for 30 minutes and applies a very gentle massage every few minutes). Twice a week, a total of 10 sessions (5 weeks) will be done. "Brain fMRI findings". Timepoint: before the intervention, 5 weeks after the start of the intervention (after the intervention). Method of measurement: fMRI image analysis. "Midas Disability Questionnaire Score (MIDAS)". Timepoint: Before the intervention and 12 weeks after the last intervention session. Method of measurement: "The MIDAS (Migraine Disability Assessment) questionnaire". "Mean severity of attacks in people with migraine (VAS)". Timepoint: Before the intervention, after ten session intervention and 12 weeks after the last intervention session. Method of measurement: The visual analog scale (VAS). Questionnaire score of the impact of headache on the life of people with migraine (HIT-6). Timepoint: Before the intervention, after ten session intervention and 12 weeks after the last intervention session. Method of measurement: Headache Impact Test-6 (HIT-6) for Migraine Patients questionnaire. Active cervical flexion movement. Timepoint: Before the intervention and after the last intervention session. Method of measurement: iPhone inclinometer app. Active cervical extension movement. Timepoint: Before the intervention and after the last intervention session. Method of measurement: iPhone inclinometer app. Active cervical lateral flexion movement. Timepoint: Before the intervention and after the last intervention session. Method of measurement: iPhone inclinometer app. Active cervical rotation movement. Timepoint: Before the intervention and after the last intervention session. Method of measurement: iPhone inclinometer app. Flexion-rotation test (FRT). Timepoint: Before the intervention and after the last intervention session. Method of measurement: iPhone compass app. Head postural assessment (FHP). Timepoint: Before the intervention and after the last intervention session. Method of measurement: Photographic images by Canon IXY 12 digital camera from lateral and sagittal plane in standing position with measurement of craniovertebral angle (CVA) showing the position of the head in relation to the C7 vertebra. Tarbiat Modares University Approved 2022-03-08 Ethics committee Tarbiat Modares University NO.46, Afifabad Ave.,Ghasrdasht Shiraz Fars Iran (Islamic Republic of)