Protocol summary
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Study aim
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The purpose of this study isto investigate the effect of auricular acupuncture with semi-permanent ASP needles on migraine patients.
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Design
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A single blind randomized clinical trial with control group
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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Severity of headache, headache frequency, dose of Novafen, severity of nausea, vomiting frequency
General information
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Reason for update
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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
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Acronym
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IRCT registration information
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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
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Registration date
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2020-03-18, 1398/12/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-11-22, 1397/09/01
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Expected recruitment end date
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2019-09-23, 1398/07/01
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Actual recruitment start date
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2018-12-08, 1397/09/17
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Actual recruitment end date
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2019-09-23, 1398/07/01
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Trial completion date
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2019-10-23, 1398/08/01
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Scientific title
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Effect of Ear Acupuncture Using ASP needles in Improving Headache and Other Symptoms in comparison with Control Group ( no therapeutic intervention) in Migraine Patients.
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Public title
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Effects of Ear Acupuncture Using ASP Needles in Control of Migraine Symptoms
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
84
Actual sample size reached:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization using the toss method
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In the control or sham group, In areas where the point-finding device detected to be inactive, a needle-free patch was inserted.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-08, 1397/09/17
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Ethics committee reference number
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Ir.mui.med.rec.1397.153
Health conditions studied
1
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Description of health condition studied
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Migraine
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ICD-10 code
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G43
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ICD-10 code description
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Migraine
Primary outcomes
1
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Description
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Headache
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Timepoint
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weekly for a month
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Method of measurement
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Visual Analogue Scale
Secondary outcomes
1
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Description
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Nausea
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Timepoint
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Weekly for a month
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Method of measurement
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Visual Analogue Scale
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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.
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Category
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Placebo
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Sponsor Vice chancellor for research, Isfahan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available