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IRCT20160621028567N2 IRCT 2021-03-10 Tarbiat Modares University Effect of Cervical Spine Manual Therapy on the Electrophysiological Findings in the Migraineur Subjects with Neck Pain The Effect of Upper Cervical Spine Manual Therapy on the Clinical and Physical Signs and Symptoms, Disability, and Electrophysiological Findings in the Migraineur Subjects with Neck Pain 2021-04-04 anticipated 50 Complete https://irct.ir/trial/52879 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Eligible individuals will be randomly assigned to groups 1 through 4 after the initial evaluation by a researcher who is not involved in the evaluations. In order to preserve allocation concealment, the subjects will be included in the study in 1:1 ratio by a random block of 2 using a sealed envelope, Blinding description: Assignments to study groups will be kept from the analyzer researcher, assessor researcher, and the participants. In order to blind the subjects, the sham intervention will be performed with the same force, palpation, and duration as the main intervention. Another independent researcher will perform statistical analysis and result interpretation. For obvious reasons, healthcare providers cannot be kept blinded. N/A Condition 1: Migraine. Condition 2: Neck Pain. Intervention 1: Intervention group: upper cervical spine manual therapy in 4 sessions. To perform manual therapy, the patient will be in a supine position and the physiotherapist will stand above the patient. The physiotherapist will then place his or her pointer finger on the articular processes t of the target segment (C1-C2). The other fingers of the physiotherapist will be spread over the patient's neck. The physiotherapist will then apply 5 times a 30-second nonthrust pressure to the C0 / C1 and C1 / C2 articular processes in a posterior-anterior displacement, lateral displacement, or rotation, in a direction that does not reproduce the headache symptoms. . Intervention 2: Intervention group: Sham upper cervical manual therapy in 4 sessions. The sham manual therapy will be performed as follows: the physiotherapist's hands will be in wide and non-specific contact with the person's neck, and the therapy will be a fake maneuver of pushing the vertebrae at a low speed and amplitude in a non-therapeutic direction. Intervention 3: Intervention group: without manual therapy interventions. Intervention 4: Intervention group: Migraine group without neck pain (without manual therapy intervention). Intervention 5: Control group: : Control group: healthy subjects of the same age (without migraine and neck pain). Yes - There is a plan to make this available What will be shared: a part of data When: 6 months after publications To whom: Researchers Conditions: for treatment and research goals Where to obtain: Farid Bahrpeyma How to obtain: Confirmation of advisor professors Comments:
public Farid Bahrpeyma
Jalal Ale Ahmad, Nasr
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3819 bahrpeyf@modares.ac.ir Tarbiat Modares University scientific Farid Bahrpeyma
Jalal Ale Ahmad, Nasr
Tehran Iran (Islamic Republic of) 1411713116 +98 21 8288 3819 bahrpeyf@modares.ac.ir Tarbiat Modares University Iran (Islamic Republic of) Migraine according to IHS criteria at least three days a month Neck pain (more than 30% NDI and at least one symptomatic segment according to PAIVMs in the upper cervical spine) with migraine Age between 18 and 50 years 18 years 50 years Both Other primary or secondary headaches Other neurological diseases Severe physical / psychiatric limitations Ear disorders Medication Overuse Headache Systemic diseases such as fibromyalgia or rheumatoid arthritis Vertebrobasilar insufficiency / atherosclerosis of cervical arteries Cervical spine instability and alar and transverse ligament defects Nerve blocks in the last 6 months Neck and shoulder physiotherapy treatments in the last 6 months Malignancies G43 G54.2 Migraine Cervical root disorders, not elsewhere classified Rehabilitation Placebo Other N/A N/A Intervention group: upper cervical spine manual therapy in 4 sessions. To perform manual therapy, the patient will be in a supine position and the physiotherapist will stand above the patient. The physiotherapist will then place his or her pointer finger on the articular processes t of the target segment (C1-C2). The other fingers of the physiotherapist will be spread over the patient's neck. The physiotherapist will then apply 5 times a 30-second nonthrust pressure to the C0 / C1 and C1 / C2 articular processes in a posterior-anterior displacement, lateral displacement, or rotation, in a direction that does not reproduce the headache symptoms. . Intervention group: Sham upper cervical manual therapy in 4 sessions. The sham manual therapy will be performed as follows: the physiotherapist's hands will be in wide and non-specific contact with the person's neck, and the therapy will be a fake maneuver of pushing the vertebrae at a low speed and amplitude in a non-therapeutic direction. Intervention group: without manual therapy interventions Intervention group: Migraine group without neck pain (without manual therapy intervention) Control group: : Control group: healthy subjects of the same age (without migraine and neck pain) Headache Intensity. Timepoint: At the beginning of the study, one month after end of interventions. Method of measurement: Designed form for recording the clinical characteristics of headache. Headache Frequency. Timepoint: At the beginning of the study, one month after end of interventions. Method of measurement: Designed form for recording the clinical characteristics of headache. Pain killer medications. Timepoint: At the beginning of the study, one month after end of interventions. Method of measurement: Designed form for recording the clinical characteristics of headache. Headache Duration. Timepoint: At the beginning of the study, one month after end of interventions. Method of measurement: Designed form for recording the clinical characteristics of headache. Wave I latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Brain Auditory Evoked Response. Wave II latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Brain Auditory Evoked Response. Wave III latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Brain Auditory Evoked Response. Wave IV latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Brain Auditory Evoked Response. Wave IV latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Brain Auditory Evoked Response. I-III interpeak latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Brain Auditory Evoked Response. III-IV interpeak latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Brain Auditory Evoked Response. I-IV interpeak latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Brain Auditory Evoked Response. R1 latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Blink Reflex. R2 latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Blink Reflex. R2 contralateral latency. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Blink Reflex. Cervical flexion range of motion. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: iPhone compass application. Cervical extension range of motion. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: iPhone compass application. Cervical right rotation range of motion. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: iPhone compass application. Cervical left rotation range of motion. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: iPhone compass application. Cervical right lateral flexion range of motion. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: iPhone compass application. Cervical left lateral flexion range of motion. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: iPhone compass application. Flexion-rotation test. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: iPhone compass application. Manual examination of upper cervical spine joints. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Manual. Visual examination of upper cervical subluxation. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Visual. Headache Impact Test score. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Persian HIT-6 questionnaire. Neck Disability Index Score. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Persian NDI questionnaire. Central Sensitivity Index score. Timepoint: At the beginning of the study, one month after the end of the study. Method of measurement: Persian CSI questionnaire. Tarbiat Modares University Approved 2020-11-09 Research Ethics Committee of Tarbiat Modares University Jalal AleAhmad Tehran Tehran Iran (Islamic Republic of)