Evaluating the effect of the Valsalva maneuver as a non-pharmacological method on reducing and control of migraine headaches.
Design
The double-blind randomized clinical trial, 62 patients in the intervention group and 62 patients in the control group, diagnoses migraine based on the ICHD3 criterion, randomized using Sealdenvelop.com.
Settings and conduct
The patients use the device in the acute phase of headache at home. Patients and researchers collecting the information and the person analyzing the data are unaware of classifying. The blinding is done for all of them.
Participants/Inclusion and exclusion criteria
The inclusion criterion is migraine headache and the exclusion criteria are contraindications of Valsalva maneuvers such as some heart, brain and eye diseases.
Intervention groups
To create the Valsalva maneuver, we have designed a device that is similar to the Valsalva maneuver. People exhale in this device, against a pressure of 40 mm Hg for 15 seconds and then normal breathing, experience all four phases of the Valsalva maneuver. The control group are given an inefficient device.
Main outcome variables
Migraine headaches, analgesic medicine consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210525051405N1
Registration date:2021-09-15, 1400/06/24
Registration timing:retrospective
Last update:2021-09-15, 1400/06/24
Update count:0
Registration date
2021-09-15, 1400/06/24
Registrant information
Name
Kamran Shirbache
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3786 8449
Email address
k-shirbache@alumnus.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2021-03-18, 1399/12/28
Actual recruitment start date
2020-09-22, 1399/07/01
Actual recruitment end date
2021-03-18, 1399/12/28
Trial completion date
2021-06-20, 1400/03/30
Scientific title
The effect of Valsalva maneuver on migraine
Public title
The effect of Valsalva maneuver on migraine
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Migraine patients who have been diagnosed with migraine for more than one year
Patients less than 50 years old.
Exclusion criteria:
history of cerebrovascular aneurysm, history of recent brain surgery (less than 6 months), history of hemorrhagic stroke
history of recent myocardial infarction (less than 6 months), history of heart failure and coronary artery disease
history of syncope
Uncontrolled hypertension, Systolic blood pressure less than 90 mm Hg and above 140 mm Hg
retinopathy, Recent history of retinal surgery (less than 6 months), Intraocular lens implantation,
history of cough induced headache
Uncontrolled diabetes
Aortic valve stenosis, Carotid artery stenosis
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
124
Actual sample size reached:
124
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, among the patients referred to the neurology clinic, migraine patients entered the intervention or control group based on random blocked method. The website named “Sealdenvelop.com” is used for this purpose. This site randomly divides the patients into groups of 4. The intervention group is given code A and the control group is given code B, and the groups are formed like ABBA, ABAB, BABA, etc. The examiner puts the patients in the order of enrollment in groups of four, and accordingly, each person is randomly given the code of the intervention group (A) or the code of the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients in the study, are unaware of the classifying of the intervention or control group, and in explaining the use of the Valsalva maneuver simulator (true or false), they have been told that it might be effective on their headache. Therefore, they use it according to the instructions and mention its effect in the questionnaire.
The Investigators who are in touch with the patients, track the use of devices, and gather information are unaware of the intervention and control group division; that is to say, they do not know coding A and B.
The person who extracts the information and conducts the statistical analysis is unaware of the intervention and control group division and the meaning of coding.
Placebo
Used
Assignment
Parallel
Other design features
A false Valsalva maneuver simulator is given to the control group to remove the Placebo effect without putting pressure on the individual.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Neuroscience Institute
Street address
Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2020-11-21, 1399/09/01
Ethics committee reference number
IR.TUMS.NI.REC.1399.043
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
score of headache in the questionnaire
Timepoint
before and after Valsalva maneuver
Method of measurement
Questionnaire and individual statement
Secondary outcomes
1
Description
Taking medicine
Timepoint
In acute and chronic phases of headache
Method of measurement
questionnaire and individual statement
2
Description
quality of life
Timepoint
Before and during the trial
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: To create the Valsalva maneuver, we have designed a device that is similar to the Valsalva maneuver. People exhale in this device, against a pressure of 40 mm Hg for 15 seconds and then normal breathing, experience all four phases of the Valsalva maneuver. They are asked to do this action in the acute phase headache for three times with five minutes intervals. They are also allowed to repeat this maneuver later in the chronic phase headache and register the data.
Category
Treatment - Devices
2
Description
Control group: To counteract the placebo effect, people in this group are given a device similar to the intervention group, but in this device there is no pressure on the exhalation of people and they only do normal exhalation in this device, they do not experience any of the steps of Valsalva maneuver. . They are asked to perform this operation three times in the acute phase of the headache, five minutes apart. They are also allowed to repeat the maneuver later in the chronic phase of the headache and record the data.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Mansoureh Togha
Street address
Sina hospital, hassan abad square, Emam Khomeini street, Tehran
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 4561 7676
Fax
+98 21 6634 8553
Email
hosp_sina@sina.tums.ac.ir
Web page address
http://sinahospital.tums.ac.ir/
2
Recruitment center
Name of recruitment center
Doctor Mansoureh Togh's neurology clinic
Full name of responsible person
Mansoureh Togha
Street address
Unit 20, Floor 5, Iranian Doctors Building, Street No. 24, First Ghaem magham street, seventh of Tir square, Tehran
City
Tehran
Province
Tehran
Postal code
1586984447
Phone
+98 21 8832 8351
Email
Toghae@sina.tums.ac.ir
Web page address
3
Recruitment center
Name of recruitment center
Doctor Vahid Shaygan nejad's neurology clinic
Full name of responsible person
Vahid Shaygan Nejad
Street address
Unit 25, Third Floor, Hakim building, Ferdowsi St, Palestine Crossroads, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8143995155
Phone
+98 31 3224 0626
Email
v.shaygannejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Iranian Center of Neurological Research
Full name of responsible person
Payam Sarraf
Street address
Fourth Floor, Iranian Center of Neurological Research Building, Imam Khomeini Hospital, Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2398
Fax
+98 21 6658 1558
Email
icnr@tums.ac.ir
Web page address
http://ni.tums.ac.ir/nd/en/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Kamran Shirbache
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
plate 3, alley 70, Bagh Daryache street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
817674461
Phone
+98 31 3786 8449
Fax
+98 21 6642 0556
Email
k-shirbache@alumnus.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mansoureh Togha
Position
Professor of Neurology
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Unit 20, Floor 5, Iranian Doctors Building, Street No. 24, First Ghaem magham street, seventh of Tir square, Tehran
City
Tehran
Province
Tehran
Postal code
1586984447
Phone
+98 21 6694 0036
Fax
+98 21 6642 0556
Email
Toghae@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Shirbache
Position
General practitioner
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
plate 3, alley 70, Bagh Daryache street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
817674461
Phone
+98 31 3786 8449
Email
k-shirbache@alumnus.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To protect patients' personal information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Only information on reducing the severity of headaches and taking painkillers will be provided. Excel file of patients' information extracted from questionnaires will be provided.
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
It is only available for people working in academic institutions.
Under which criteria data/document could be used
Request information will be available for further studies or meta-analysis.
From where data/document is obtainable
Through correspondence with the scientific supervisor of the project, Dr. Togha, or the project manager, Dr. Kamran Shirbacheh
(toghae@sina.tums.ac.ir, k-shirbache@alumnus.tums.ac.ir)
What processes are involved for a request to access data/document
After correspondence and persuasion of the project owners, information will be sent to the applicant at the earliest opportunity.