Effect of Ear Acupuncture Using ASP needles in Improving Headache and Other Symptoms in comparison with Control Group ( no therapeutic intervention) in Migraine Patients.
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
Changing the person responsible for the scientific accountability of the trial
Correcting the job position and the person's latest degree responsible for the public accountability of the trial
Correcting the job position and latest degree of person responsible for updating information
Changing the person responsible for the scientific accountability of the trial Correcting the job position and the person's latest degree responsible for the public accountability of the trial Correcting the job position and latest degree of person responsible for updating information
empty
تغییر فرد مسوول پاسخگویی علمی مطالعه
تصحیح موقعیت شغلی و آخرین مدرک تحصیلی فرد مسوول پاسخگویی عمومی کارآزمایی
تصحیح موقعیت شغلی و آخرین مدرک تحصیلی فرد مسوول به روزرسانی اطلاعات
تغییر فرد مسوول پاسخگویی علمی مطالعه تصحیح موقعیت شغلی و آخرین مدرک تحصیلی فرد مسوول پاسخگویی عمومی کارآزمایی تصحیح موقعیت شغلی و آخرین مدرک تحصیلی فرد مسوول به روزرسانی اطلاعات
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mehran Rezvani
Full name of responsible person - Persian: مهران رضوانی
Street address - English: Hezar Jarib
Street address - Persian: هزار جریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3668 0048
Fax:
Email: Mehranerezvani@yahoo.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Sponsor Vice chancellor for research, Isfahan University of Medical Sciences
Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اصفهان
Full name of responsible person - English: Mehran Rezvani
Full name of responsible person - Persian: مهران رضوانی
Street address - English: Hezar Jarib
Street address - Persian: هزار جریب
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Country: Iran (Islamic Republic of)
Postal code: 8174673461
Phone: +98 31 3668 0048
Fax:
Email: Mehranerezvani@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Sponsor Vice chancellor for research, Isfahan University of Medical Sciences Name of organization / entity - Persian: معاونت پژوهشی دانشگاه علوم پزشکی اصفهان Full name of responsible person - English: Mehran Rezvani Full name of responsible person - Persian: مهران رضوانی Street address - English: Hezar Jarib Street address - Persian: هزار جریب City - English: Isfahan City - Persian: اصفهان Province: Isfehan Country: Iran (Islamic Republic of) Postal code: 8174673461 Phone: +98 31 3668 0048 Fax: Email: Mehranerezvani@yahoo.com Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Iman Raisi
Full name of responsible person - Persian: ایمان رئیسی
Position - English: Assistant Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ferdowsi St, Majmar Shomali Ave, Golzar Alley
Street address - Persian: خیابان فردوسی، خیابان مجمر شمالی، بن بست گلزار
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8143834483
Phone: +98 31 3223 9619
Mobile: +98 913 128 5696
Fax:
Email: imanr20@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Iman Raisi
Full name of responsible person - Persian: ایمان رئیسی
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ferdowsi St, Majmar Shomali Ave, Golzar Alley
Street address - Persian: خیابان فردوسی، خیابان مجمر شمالی، بن بست گلزار
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8143834483
Phone: +98 31 3223 9619
Mobile: +98 913 128 5696
Fax:
Email: imanr20@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Iman Raisi Full name of responsible person - Persian: ایمان رئیسی Position - English: Assistant ProfessorResident Position - Persian: دانشیاررزیدنت Latest degree: specialistmed_doctor Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ferdowsi St, Majmar Shomali Ave, Golzar Alley Street address - Persian: خیابان فردوسی، خیابان مجمر شمالی، بن بست گلزار City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8143834483 Phone: +98 31 3223 9619 Mobile: +98 913 128 5696 Fax: Email: imanr20@yahoo.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Iman Raisi
Full name of responsible person - Persian: ایمان رئیسی
Position - English: Assistant Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ferdowsi St, Majmar Shomali Ave, Golzar Alley
Street address - Persian: خیابان فردوسی، خیابان مجمر شمالی، بن بست گلزار
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8143834483
Phone: +98 31 3223 9619
Mobile: +98 913 128 5696
Fax:
Email: imanr20@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mehran Razavi
Full name of responsible person - Persian: مهران رضوی
Position - English: Associate professor
Position - Persian: استادیار
Latest degree: specialist
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian: فوق تخصص درد
Street address - English: Safe st, Al-Zahra Specialty Hospital, office of anesthesiology
Street address - Persian: خیابان صفه، بیمارستان تخصصی الزهرا، دفتر گروه بیهوشی
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8174675731
Phone: +98 31 3620 1992
Mobile: +98 913 310 4289
Fax:
Email: mehranerezvani@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Iman RaisiMehran Razavi Full name of responsible person - Persian: ایمان رئیسیمهران رضوی Position - English: Assistant ProfessorAssociate professor Position - Persian: دانشیاراستادیار Latest degree: specialist Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: فوق تخصص درد Street address - English: Ferdowsi StSafe st, Majmar Shomali AveAl-Zahra Specialty Hospital, Golzar Alleyoffice of anesthesiology Street address - Persian: خیابان فردوسیصفه، خیابان مجمر شمالیبیمارستان تخصصی الزهرا، بن بست گلزاردفتر گروه بیهوشی City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 81438344838174675731 Phone: +98 31 3223 96193620 1992 Mobile: +98 913 128 5696310 4289 Fax: Email: imanr20mehranerezvani@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Iman Raisi
Full name of responsible person - Persian: ایمان رئیسی
Position - English: Assistant Professor
Position - Persian: دانشیار
Latest degree: specialist
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ferdowsi St, Majmar Shomali Ave, Golzar Alley
Street address - Persian: خیابان فردوسی، خیابان مجمر شمالی، بن بست گلزار
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8143834483
Phone: +98 31 3223 9619
Mobile: +98 913 128 5696
Fax:
Email: imanr20@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Iman Raisi
Full name of responsible person - Persian: ایمان رئیسی
Position - English: Resident
Position - Persian: رزیدنت
Latest degree: med_doctor
Area of specialty/work: 24
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Ferdowsi St, Majmar Shomali Ave, Golzar Alley
Street address - Persian: خیابان فردوسی، خیابان مجمر شمالی، بن بست گلزار
City - English: Isfahan
City - Persian: اصفهان
Province: Isfehan
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 8143834483
Phone: +98 31 3223 9619
Mobile: +98 913 128 5696
Fax:
Email: imanr20@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Iman Raisi Full name of responsible person - Persian: ایمان رئیسی Position - English: Assistant ProfessorResident Position - Persian: دانشیاررزیدنت Latest degree: specialistmed_doctor Area of specialty/work: 24 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Ferdowsi St, Majmar Shomali Ave, Golzar Alley Street address - Persian: خیابان فردوسی، خیابان مجمر شمالی، بن بست گلزار City - English: Isfahan City - Persian: اصفهان Province: Isfehan Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 8143834483 Phone: +98 31 3223 9619 Mobile: +98 913 128 5696 Fax: Email: imanr20@yahoo.com Web page address:
Protocol summary
Study aim
The purpose of this study isto investigate the effect of auricular acupuncture with semi-permanent ASP needles on migraine patients.
Design
A single blind randomized clinical trial with control group
Settings and conduct
80 patients with migraine headache regardless of its type (aura or no aura) were referred to acupuncture clinic of Ayatollah Kashani hospital in Isfahan, Iran. Patients were blinded to the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with migraine between the ages of 18 and 65 years
Exclusion criteria: Pregnant women, patients with severe coagulation problems, patients with advanced malignancy or underlying disease, non-migraine headaches, history of drug use or medication abuse or alcohol dependence, history of neurological or psychiatric illness, history of asthma or respiratory problems , Analgesic for chronic pain more than three days a month, previous auricular acupuncture history, prophylactic migraine medication use within last 6 months, severe ear abnormalities, head or facial neuralgia, aura without headache, Migraine headache onset after age 50
Intervention groups
Intervention group treated with auricular acupuncture ear acupuncture using semi-permanent ASP needles on active points of the ears and then a label was placed on each needle.
In the control group only a label was placed on the inactive points of the ears.
Main outcome variables
Severity of headache, headache frequency, dose of Novafen, severity of nausea, vomiting frequency
General information
Reason for update
Changing the person responsible for the scientific accountability of the trial
Correcting the job position and the person's latest degree responsible for the public accountability of the trial
Correcting the job position and latest degree of person responsible for updating information
Acronym
IRCT registration information
IRCT registration number:IRCT20200213046477N1
Registration date:2020-03-18, 1398/12/28
Registration timing:retrospective
Last update:2020-03-30, 1399/01/11
Update count:1
Registration date
2020-03-18, 1398/12/28
Registrant information
Name
iman reisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3223 9619
Email address
imanr20@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
2018-12-08, 1397/09/17
Actual recruitment end date
2019-09-23, 1398/07/01
Trial completion date
2019-10-23, 1398/08/01
Scientific title
Effect of Ear Acupuncture Using ASP needles in Improving Headache and Other Symptoms in comparison with Control Group ( no therapeutic intervention) in Migraine Patients.
Public title
Effects of Ear Acupuncture Using ASP Needles in Control of Migraine Symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with migraine who need treatment
The ages of 18 to 65
Consent to participate in the study
Exclusion criteria:
Pregnant women
Patients with severe coagulation problems receiving anti-coagulant medications in which acupuncture may cause bleeding
Patients with advanced malignancies or underlying diseases
Patients with non-migraine headaches
Patients with a history of drug or alcohol abuse or alcohol dependence
A history of neurological or psychiatric illnesses
Patients with asthma or respiratory problems
Analgesic use for chronic pain more than three days a month
Prior auricular acupuncture history
Use of prophylactic migraine medication within the past six months
Severe ear abnormalities
Head or facial neuralgia
Other neurological diseases
Aura without headache
Migraine headache incidence after age 50
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
84
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization using the toss method
Blinding (investigator's opinion)
Single blinded
Blinding description
In the control or sham group, In areas where the point-finding device detected to be inactive, a needle-free patch was inserted.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2018-12-08, 1397/09/17
Ethics committee reference number
Ir.mui.med.rec.1397.153
Health conditions studied
1
Description of health condition studied
Migraine
ICD-10 code
G43
ICD-10 code description
Migraine
Primary outcomes
1
Description
Headache
Timepoint
weekly for a month
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Nausea
Timepoint
Weekly for a month
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group:In this group, Treatment wwas done using auricular acupuncture with semi-permanent ASP needles in the active ear pionts. After examining 15 migraine-affected acupuncture points by the Pointoselect pointers in each ear, active points were found and a maximum of 4 ASP needles were implanted in the most active points in each ear and then labled. The technique was repeated for patients after two weeks and patients were visited weekly for up to one month.
Category
Treatment - Devices
2
Description
Control group: In the control or sham group, a piece of needle-free adhesive was inserted at points identified by the Pointoselect pointers as inactive. The technique was repeated for patients after two weeks and patients were visited weekly for up to one month.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
َAyatollah Kashani Hospital
Full name of responsible person
Mehran Rezvani
Street address
Ayatollah Kashani
City
Isfahan
Province
Isfehan
Postal code
8183983434
Phone
+98 31 3233 0091
Email
Mehranerezvani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sponsor Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mehran Rezvani
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Mehranerezvani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sponsor Vice chancellor for research, Isfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Iman Raisi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ferdowsi St, Majmar Shomali Ave, Golzar Alley
City
Isfahan
Province
Isfehan
Postal code
8143834483
Phone
+98 31 3223 9619
Email
imanr20@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mehran Razavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Safe st, Al-Zahra Specialty Hospital, office of anesthesiology
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 1992
Email
mehranerezvani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Iman Raisi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Ferdowsi St, Majmar Shomali Ave, Golzar Alley
City
Isfahan
Province
Isfehan
Postal code
8143834483
Phone
+98 31 3223 9619
Email
imanr20@yahoo.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