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Investigation of the Effect of upper cervical Mobilization on Migraine headaches by functional Magnetic Resonance Imaging (fMRI) findings with Trigeminal nerve stimulation

Protocol summary

Study aim
The effect of upper cervical mobilization in migraine patients on brain fMRI findings and intensity, frequency and duration of headache attacks before and after treatment.
Design
Sham controlled clinical trial with a parallel group design of 30 patients, Concealed, randomized, blinded, follows for 12 weeks.
Settings and conduct
Interventions are done by the researcher at Doran Hospital in Shiraz, Radiology Technician and analyzer , assessor and the statistics group are unaware of how they are puts in the groups
Participants/Inclusion and exclusion criteria
Inclusion criteria : 20 to 55 years; Diagnosis of Episodic Migraine without aura by a neurologist; attacks at least 2-5 per month; At least one year ; No change in medication in the last three months Exclusion criteria: Malignancy; Diabetes; Rheumatism; Peripheral neuropathy, Fibromyalgia, Osteoporosis, Surgical history, Radiculopathy, Cervical spine disorders in simple graphic image and its soft tissue components (disc or soft tissue elements); Nerve block or non-drug treatments in the last 6 months; Severe physical / psychiatric / internal limitations (blood pressure, heart disease) / eye and ear diseases, normal or surgical menopause, pregnancy, lactation; Headache due to drug overdose, other primary or secondary headaches; Positive response to Tectorial membrane, Alar and Transverse ligaments tests; Cases of not entering the MRI scanner.
Intervention groups
intervention group Mobilization of the upper cervical spine (grade 3 Maitland) in the form of extension, lateral flexion and rotation glides In supine position control group Sham treatment ( very gentle massage at neck)
Main outcome variables
Findings of fMRI images Average severity, duration and frequency of headaches Questionnaires scores (HIT-6), (MIDAS), (VAS)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170524034119N3
Registration date: 2022-07-03, 1401/04/12
Registration timing: registered_while_recruiting

Last update: 2022-07-03, 1401/04/12
Update count: 0
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Jaleh Farahmand Farzaneh
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8052
Email address
jalehfarahmand4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-04, 1401/01/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Effect of upper cervical Mobilization on Migraine headaches by functional Magnetic Resonance Imaging (fMRI) findings with Trigeminal nerve stimulation
Public title
"Investigation of the Effect of cervical Mobilization on Migraine by functional Magnetic Resonance Imaging (fMRI) findings"
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
In this study: Patients, Radiologist and Researcher analyzing the fMRI data will be blind to group assignments.
Placebo
Used
Assignment
Parallel
Other design features
The effect of cervical spines mobilization on fMRI findings

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Tarbiat Modares University
Street address
NO.46, Afifabad Ave.,Ghasrdasht
City
Shiraz
Province
Fars
Postal code
7183793353
Approval date
2022-03-08, 1400/12/17
Ethics committee reference number
IR.MODARES.REC.1400.349

Health conditions studied

1

Description of health condition studied
Migraine
ICD-10 code
G43.0
ICD-10 code description
Migraine without aura

Primary outcomes

1

Description
"Brain fMRI findings"
Timepoint
before the intervention, 5 weeks after the start of the intervention (after the intervention)
Method of measurement
fMRI image analysis

2

Description
"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"

3

Description
"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)

4

Description
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

Secondary outcomes

1

Description
Active cervical flexion movement
Timepoint
Before the intervention and after the last intervention session
Method of measurement
iPhone inclinometer app

2

Description
Active cervical extension movement
Timepoint
Before the intervention and after the last intervention session
Method of measurement
iPhone inclinometer app

3

Description
Active cervical lateral flexion movement
Timepoint
Before the intervention and after the last intervention session
Method of measurement
iPhone inclinometer app

4

Description
Active cervical rotation movement
Timepoint
Before the intervention and after the last intervention session
Method of measurement
iPhone inclinometer app

5

Description
Flexion-rotation test (FRT)
Timepoint
Before the intervention and after the last intervention session
Method of measurement
iPhone compass app

6

Description
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.

Intervention groups

1

Description
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).
Category
Rehabilitation

2

Description
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.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Doran Hospital
Full name of responsible person
Morteza Ghanbari
Street address
Physiotherapy department, Doran Hospital, Modares Blvd,
City
Shiraz
Province
Fars
Postal code
7158793117
Phone
+98 71 3723 9972
Fax
+98 71 3722 1979
Email
doranhospital1396@gmail.com
Web page address
https://www.drsaina.com/hospital/2321/%D8%A8%DB%8C%D9%85%D8%A7%D8%B1%D8%B3%D8%AA%D8%A7%D9%86-%D8%B4%D9%87%DB%8C%D8%AF-%D8%AF%D9%88%D8%B1%D8%A7%D9%86-%D8%B4%DB%8C%D8%B1%D8%A7%D8%B2

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdullah Zadeh
Street address
No. 7, Jalal Al Ahmad Street, Tehran
City
Tehran
Province
Tehran
Postal code
111-- 14115
Phone
+98 21 8288 2009
Fax
+98 21 8800 6544
Email
pres@modares.ac.ir
Web page address
https://www.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
NO.7, Jalal Al Ahmad street, Tarbiat Modares University, Faculty of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14115-331
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
NO.7, Jalal Al Ahmad street, Tarbiat Modares University, Faculty of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14115-331
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
Jaleh Farahmand Farzaneh
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
NO.46,Vally 3, Affif Abad Street
City
Shiraz
Province
Fars
Postal code
7183793353
Phone
+98 71 3626 7440
Email
jalehfarahmand4@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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