The aim of this study is Comparison of the effect of acupuncture on pain relife in patients with dysmenorrhea. Study design: After explaining the purpose of the study and obtaining the informed consent, patients will be allocated into A and B groups. The study is single-center, phase 3 trial. Inclusion criteria: Patients with dysmenorrhea. Exclusion criteria: Opium addiction; history of chronic disease. Sample size:40 patients are participated in the study with 20 patients in each group.
Study groups: Intervention group: 5-7 sterile acupuncture needle (needle gauge 13-15 or 25) for 5 effective sessions using true acupuncture needle.
Control group: Treated ineffectively, as similar to usual acupuncture method for 5 sessions but by fake needles.
Primary outcome: Rate of pain
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050833870N1
Registration date:2017-06-11, 1396/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-11, 1396/03/21
Registrant information
Name
Marjan Pazireh
Name of organization / entity
Islamic Azad University of Shahrood
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 4530
Email address
asal.pazireh@iau-shahrood.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and technology, Islamic Azad University of Shahrood
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of acupuncture on pain relief in patients with dysmenorrhea: A clinical trial
Public title
The effect of acupuncture on pain relife in dysmenorrhea
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients with dysmenorrhea
Exclusion criteria: Opium addiction; history of chronic disease
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University of Shahrood
Street address
Islamic Azad University of Shahrood, Tehran Blvd, Shahrood
City
Shahroud
Postal code
Approval date
2017-03-09, 1395/12/19
Ethics committee reference number
IR.IAU.SHAHROOD.REC.1395.31
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Pain intensity
Timepoint
Menstrual initiation and 1,2,3 hours after that
Method of measurement
Numerical pain scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 5-7 sterile acupuncture needle (needle gauge 13-15 or 25) for 5 effective sessions using true acupuncture needle.
Category
Treatment - Drugs
2
Description
Control group: Treated ineffectively, as similar to usual acupuncture method for 5 sessions but by fake needles
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Alanbia Hospital of Shahrood
Full name of responsible person
Yousef Kolukhi
Street address
Khatam Alanbia Hospital, Tehran Blvd, Shahrood
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Full name of responsible person
Sahebali Manafi
Street address
Islamic Azad University of Shahroud, Tehran Blvd
City
Shahroud
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research and Technology, Islamic Azad University of Shahrood
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Marjan Pazireh
Position
Medical Student
Other areas of specialty/work
Street address
Islamic Azad University of Shahroud, Tehran Blvd, Shahrood
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
asal.pazireh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Shahrood
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University, Shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
amir.h.sayadi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Shahroud
Full name of responsible person
Yousef Kolukhi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Tehran Blvd, Shahrood Islamic Azad University, Shahroud
City
Shahroud
Postal code
3613773955
Phone
+98 23 3239 1796
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)