Comparison of the Effect of Dry Cupping at Acupuncture Point (BL23) on the Women with Postpartum Low Back Pain According to VAS & Short Form McGill Pain Questionnaires in 2012.
1) Objectives: This randomized clinical trial study has been carried on 100 primiparous women with postpartum low back pain who referred to selected medical-educational centers (of Hafez & Shooshtari Hospitals) of Shiraz University of Medical Sciences, comprising the effect of cupping therapy at BL 23 Point According to VAS & Short Form McGill Pain Questionnaires. 2) Design: After informed consent, eligible patients were randomly assigned in to two groups: Cupping therapy and control. As control group performance has not been observed by the researcher, she is allowed to use Acetaminophen.) 3) Setting and conduct: In the interventional group, cupping therapy was done in at least 4 to 8 hours after childbirth in their postpartum part for every other day and four times a week (15-20 minutes per time). 4)Participants) Inclusion criteria: 1) 18 - 40 years old; 2) Graduate School at least; 3) Lacking any of overt & Serious psycho-somatic diseases during the study such as: vertebral fractures, herniated disk, acute inflammation, deep vein thrombosis; 4) Residents of shiraz; 5) Willingness to participate in research and complete consent form; 6) Low back pain only results from lordosis of pregnancy and childbirth deteriorating by fetous weight and position or labour in some mothers. Exclusion criteria: 1) Medical and obstetric complications in the postpartum during the study; 2) Not lookup for following at certain appointments; 3) Asking for exclusion; 4) Using of drugs for pain relief. 5) Intervention: Cupping therapy 6) Main outcome measures variables): Patients filled out the VAS & Short Form McGill Pain Questionnaires as self-reports, in phases of once before, once immediately after, once 24 hours after and once 2 weeks after treatments.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013072611944N3
Registration date:2013-08-25, 1392/06/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-25, 1392/06/03
Registrant information
Name
Mehrnoush Ghaemmaghami
Name of organization / entity
Faculty of Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
mehrnoushghmghm68@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-01-09, 1391/10/20
Expected recruitment end date
2013-02-08, 1391/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Dry Cupping at Acupuncture Point (BL23) on the Women with Postpartum Low Back Pain According to VAS & Short Form McGill Pain Questionnaires in 2012.
Public title
The Effect of Cupping Therapy on Postpartum Low Back Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion criteria to study: 1) 18 - 40 years old; 2) Graduate School at least; 3) Lacking any of overt & Serious psycho-somatic diseases during the study such as: vertebral fractures, herniated disk, acute inflammation, deep vein thrombosis; 4) Residents of Shiraz; 5) Willingness to participate in research and complete consent form; 6) Low back pain only results from lordosis of pregnancy and childbirth deteriorating by fetous weight and position or labour in some mothers. Main exclusion criteria from study: 1) Medical and obstetric complications in the postpartum during the study; 2) Not lookup for following at certain appointments; 3) Asking for exclusion; 4) Using of drugs for pain relief.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
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
Shiraz University of Medical Sciences Ethics Committee
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province, Iran, 1978 -71345
City
Shiraz
Postal code
1978 -71345
Approval date
2012-11-26, 1391/09/06
Ethics committee reference number
CT-91-6341
Health conditions studied
1
Description of health condition studied
Low Back Pain
ICD-10 code
M54.5
ICD-10 code description
Low Back Pain
Primary outcomes
1
Description
low back pain
Timepoint
4-8 hours at least after childbirth
Method of measurement
VAS & Short Form McGill Pain Questionnaires
Secondary outcomes
empty
Intervention groups
1
Description
In the interventional group, cupping therapy is done in at least 4 to 8 hours of childbirth in their postpartum part for every other day and four times a week (15-20 minutes per time); 2 times of interventions were done inpatient and the last outpatient. In this study cupping is done in the mode of dry and hot blazing cotton dipped in alcohol inside the cup and warming it and right after, laying it on the surface of the patient's body. It is possible to apply cupping on BL23 for low back pain.
Category
Treatment - Other
2
Description
As control group performance has not been observed by the researcher, she is not allowed to use Acetaminophen. Finally the both types of treatments are presented to the patients through instructional classes or pamphlets.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hospital
Full name of responsible person
Mohammadali Tadayon
Street address
Martyr Chamran Blvd, Shiraz, Fars
City
Shiraz
2
Recruitment center
Name of recruitment center
Shooshtari Hospital
Full name of responsible person
Andisheh Jorkesh
Street address
Bascule Nader, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
7th floor, Central Building of Shiraz University of Medical Sciences, Zand Street, Shiraz, Fars Province, Iran
City
Shiraz
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, Shiraz University of Medical Sciences
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
Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoush ghaemmaghami
Position
Master of Midwifery
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
________
Phone
+98 71 1647 4254
Fax
Email
AKBARZADEHMARZIEH@YAHOO.COM
Web page address
www.sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoush ghaemmaghami
Position
Master of Midwifery
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
71345- 1978
Phone
+98 71 1647 4254
Fax
Email
AKBARZADEHMARZIEH@YAHOO.COM
Web page address
www.sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mehrnoush Ghaemmaghami
Position
Master of Midwifery
Other areas of specialty/work
Street address
Hazrat-e-Fatemeh nursing and midwifery college, Namazi Hospital, Namazi Square, Shiraz.
City
Shiraz
Postal code
Phone
00
Fax
Email
ghaem_m@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)