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
The aim of this study is to evaluate the effect of upper cervical spine therapy on clinical and physical symptoms, disability and electrophysiological findings in people with migraine with neck pain.
Design
The subjects will be examined to diagnose migraines and upper cervical spine disorders. The subjects will be randomly divided into groups 1 to 4 (group 4 will include migraines without neck pain). Then electrophysiological assessments will be performed. At the end of the electrophysiological, physical, and disability assessments, individuals will be given a form to record headache-free days, headache days, headache intensity, and headache days and medications in the next month. Then people will be intervened in 4 sessions. After the end of the interventions, all evaluations will be done again so that the changes resulting from the interventions can be measured. The data from the evaluations will be compared in each group.
A group of people without migraine and neck pain will also be included in the study for electrophysiological comparison with people with migraine with neck pain.
Settings and conduct
Headache Clinic at Sina Hospital and Faculty of Medical Sciences, Tarbiat Modares University
Participants/Inclusion and exclusion criteria
Subjects with migraine in the age range of 18 to 50 years will be included in the study.
Intervention groups
Group 1: Manual therapy plus classical drug treatment
Group 2: ُSham manual therapy plus classical drug treatment
Group 3: Classic drug therapy group
Group 4: Migraine group without neck pain (without manual therapy intervention)
Group 5: Control group: healthy subjects of the same age (without migraine and 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
Public title
Effect of Cervical Spine Manual Therapy on the Electrophysiological Findings in the Migraineur Subjects with Neck Pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tarbiat Modares University
Street address
Jalal AleAhmad
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2020-11-09, 1399/08/19
Ethics committee reference number
IR.MODARES.REC.1399.120
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
2
Description of health condition studied
Neck Pain
ICD-10 code
G54.2
ICD-10 code description
Cervical root disorders, not elsewhere classified
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
Secondary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
5
Description
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
6
Description
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
7
Description
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
8
Description
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
9
Description
R1 latency
Timepoint
At the beginning of the study, one month after the end of the study
Method of measurement
Blink Reflex
10
Description
R2 latency
Timepoint
At the beginning of the study, one month after the end of the study
Method of measurement
Blink Reflex
11
Description
R2 contralateral latency
Timepoint
At the beginning of the study, one month after the end of the study
Method of measurement
Blink Reflex
12
Description
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
13
Description
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
14
Description
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
15
Description
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
16
Description
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
17
Description
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
18
Description
Flexion-rotation test
Timepoint
At the beginning of the study, one month after the end of the study
Method of measurement
iPhone compass application
19
Description
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
20
Description
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
21
Description
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
22
Description
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
23
Description
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
Intervention groups
1
Description
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. .
Category
Rehabilitation
2
Description
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.
Category
Placebo
3
Description
Intervention group: without manual therapy interventions
Category
Other
4
Description
Intervention group: Migraine group without neck pain (without manual therapy intervention)
Category
N/A
5
Description
Control group: : Control group: healthy subjects of the same age (without migraine and neck pain)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Mansoureh Togha
Street address
Emam Khomeyni Ave.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Taghi Ahmadi
Street address
Jalal AleAhmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2005
Email
mahmadi@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farid Bahrpeyma
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Ale Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3819
Email
bahrpeyf@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Farid Bahrpeyma
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Ale Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3819
Email
bahrpeyf@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mehdi Jafari
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Jalal Ale Ahmad, Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 3819
Fax
Email
m.jafarii@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
a part of data
When the data will become available and for how long
6 months after publications
To whom data/document is available
Researchers
Under which criteria data/document could be used
for treatment and research goals
From where data/document is obtainable
Farid Bahrpeyma
What processes are involved for a request to access data/document