Determining the effect of tying the belly band on the severity of back pain and the disability caused by it
Design
Clinical trial with a control group, with randomized parallel groups, on 90 patients. For randomization, the rand function of Excel software was used.
Settings and conduct
Pregnant women in the third trimester of pregnancy referred to Shahid Mostafa Khomeini Prenatal Clinic in Tehran, were enrolled in the study in case of satisfaction and low back pain and after giving corset and supportive training in two stages, before and after intervention in terms of severity of low back pain and disability during pregnancy.
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of lumbar disc herniation/ No history of trauma/ No previous surgery in lumbar vertebrae/ No lumbar tumors
Exclusion criteria: Failure to complete the questionnaire, Patient Request
Intervention groups
Carrying out supportive measures (massage, heating) and closing the belly band for 2 weeks and during daily activities
Main outcome variables
Severity of Back Pain؛Disability؛Mother's Age؛Gestational Age؛Number of Pregnancy Times؛Number Births؛ Job؛Body Mass Index؛The weight of Previous hildren
General information
Reason for update
Acronym
LBP
IRCT registration information
IRCT registration number:IRCT20240215061015N1
Registration date:2024-03-14, 1402/12/24
Registration timing:retrospective
Last update:2024-03-14, 1402/12/24
Update count:0
Registration date
2024-03-14, 1402/12/24
Registrant information
Name
Fatemeh Sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3369 6803
Email address
fatemehsadeghi2418@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-22, 1401/06/31
Expected recruitment end date
2023-12-20, 1402/09/29
Actual recruitment start date
2022-10-22, 1401/07/30
Actual recruitment end date
2023-12-20, 1402/09/29
Trial completion date
2023-12-20, 1402/09/29
Scientific title
The Effect of Girdle on The Severity of Low Back Pain and It’s Subsequent Disability During Pregnancy
Public title
The effect of girdle on the severity of low back pain and it’s subsequent disability during pregnancy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having back pain
No history of lumbar disc herniation
No history of trauma
No previous surgery in lumbar vertebrae
Exclusion criteria:
Failure to complete the questionnaire
Patient Request
Age
From 21 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
Randomized
Randomization description
First of all, the national ID of all the visitors was registered. Then, using random table numbers, 90 numbers from 1 to 90 were constructed. Odd numbers were selected as the control group and even numbers as the intervention group. Since we had two intervention groups, 30 first paired numbers were in intervention group 1 and the second 30 were in the intervention group.
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
Shahed University
Street address
Shahed University, opposite Holy Shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2022-07-04, 1401/04/13
Ethics committee reference number
IR.SHAHED.REC.1401.046
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
The severity of low back pain and it’s subsequent disability during pregnancy
Timepoint
2 Weeks after the intervention.
Method of measurement
Oswestry Disability Questionare and Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
In the "first intervention group:" in addition to carrying out support measures that include massage and heating, the abdominal strap was used for two weeks and during daily activities.
Category
Rehabilitation
2
Description
In the "second intervention group:" in addition to performing supportive measures that include massage and heating, a belly band without a band was used for two weeks and during daily activities.
Category
Rehabilitation
3
Description
In the control group: only supportive measures including warm-up and massage were recommended and no intervention was performed.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Mostafa Khomeini Prenatal Clinic
Full name of responsible person
Maryam Rabiei
Street address
Italy Street
City
Tehran
Province
Tehran
Postal code
141664643491
Phone
+98 21 8896 6130
Email
Info@mkht.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Shahriar Bijani
Street address
Shahed University, opposite Holy shrine of Imam Khomeini, Khalij Fars Expressway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 0021
Email
Info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
Proportion provided by this source
1
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
Shahed University
Full name of responsible person
Maryam Rabiei
Position
PhD. in Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Italy Street
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 6130
Email
fatemehsadeghi2418@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Rabiei
Position
Gynecologist Infertility
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
italy Street
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
+98 21 8896 6130
Email
fatemehsadeghi2418@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Maryam Rabiei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Italy Street
City
Tehran
Province
Tehran
Postal code
1416643491
Phone
01288966130
Email
fatemehsadeghi2418@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
The whole data is potentially shareable after making people unidentifiable.
When the data will become available and for how long
Starting access period 8 months after the results are published
To whom data/document is available
Data will only be available to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Data will only be available to researchers working in academic and scientific institutions.
From where data/document is obtainable
Fatemeh Sadeghi.fatemehsadeghi2418@gmail.com
What processes are involved for a request to access data/document