this study is randomized controlled clinical trial triple blind .The purpose of this study is Evaluation of the impact of traditional medicine product in the treatment of low back pain in pregnancy This clinical trial will be performed at Tehran University of Medical Sciences, in 2014.80 pregnant women with non-specific chronic low back pain will be selected through simple non-probability sampling .The patients were randomly divided into two groups of 40 subjects. One group received the traditional medicine product and the other group received the placebo . The outcome were assessed with Roland-Mores disability questionnaire and visual analogue scale (VAS)at before, 1 week and 2 week after interventions . Primary outcome of this study is improvement in back pain during pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014091419150N1
Registration date:2015-01-01, 1393/10/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-01, 1393/10/11
Registrant information
Name
ُSafieh Mohebitabar
Name of organization / entity
Tehran University of Medical Sciences(TUMS)
Country
Iran (Islamic Republic of)
Phone
+98 21 5563 9723
Email address
s-mohebitabar@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tehran University of Medical Sciences(TUMS)
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-12-22, 1393/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing traditional medicine product with placebo on low back and posterior pelvic pain in pregnant women : Randomized Clinical Trial Study
Public title
Evaluation the effect of traditional medicine product on low back and posterior pelvic pain in pregnant women
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18- 35 y; gestational age 12 - 32week; having pain score≥2 (by visual analog scale(VAS)
Exclusion criteria: patient’s dissatisfaction; taking any analgesics; history of spinal surgery, spine and pelvic trauma; pregnancy urges
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences(TUMS)
Street address
Tehran University of Medical Sciences ,Ghods st ,tehran
City
Tehran
Postal code
1417614411
Approval date
2014-11-23, 1393/09/02
Ethics committee reference number
8821309005-128051
Health conditions studied
1
Description of health condition studied
low back pain in pergnancy
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Reduce low back pain
Timepoint
1 week after intervention
Method of measurement
VAS
Secondary outcomes
1
Description
Quality of life
Timepoint
1 and2 weeks after interventions
Method of measurement
Roland-Mores disability questionnaire
Intervention groups
1
Description
intervention group : 7 drops of topical traditional medicine product oil for 10 cm2 on skin of painful part two times daily for 14 days
Category
Treatment - Drugs
2
Description
control group: 7 drops of topical placebo oil for 10 cm2 on skin of painful part two times daily for 14 days
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Maternal, Fetal, and Neonatal Research Center, Tehran University of Medical Sciences(TUMS)
Full name of responsible person
Safieh Mohebitabar
Street address
Moheb e yas hospital, North Ostad Nejatollahi, Karimkhan st
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Tehran University of Medical Sciences(TUMS)
Full name of responsible person
Mahdi Jahromi
Street address
Traditional Medicine and Pharmacy Research Center, Jamali Str, Vafamanesh Str, Tehran
City
Tehran
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 of Tehran University of Medical Sciences(TUMS)
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
Tehran University of Medical Sciences(TUMS)
Full name of responsible person
Safieh Mohebitabar
Position
Traditional MedicinePhd candidate
Other areas of specialty/work
Street address
Traditional Medicine and Pharmacy Research Center, Jamali Str, Vafamanesh Str, Tehran