Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000503022
Ethics application status
Approved
Date submitted
16/06/2010
Date registered
18/06/2010
Date last updated
18/06/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analysis of postural changes in pregnant women in the three pregnancy trimesters through computerized biophotogrammetry and its correlation with low back pain.
Scientific title
Analysis of postural changes in pregnant women and its correlation with low back pain measured by computerized biophotogrammetry
Secondary ID [1] 251960 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postural Evaluation in pregnancy 257534 0
Low back pain 257577 0
Condition category
Condition code
Reproductive Health and Childbirth 257755 257755 0 0
Normal pregnancy
Musculoskeletal 257756 257756 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cross-sectional study with a sample of convenience of 30 participants. Single session with 2 hours assessment will be performed. Photogrammetry method will be used to evaluate the posture of the volunteers. Pictures will be taken on the same session in the sagittal and frontal plane. A few anatomical points will be marked out, including the occipital protuberance, C4, C7, T7, T12, L3 and L5 spinous processes, greater trochanter, anterosuperior iliac spine (ASIS), posteroinferior iliac spine (PIIS), tibial tuberosity (TT), head of the fibula, lateral malleolus, and head of the 5th toe. These markings will be made with red 0.9mm-diameter PIMACO labels and green-colored styrofoam balls will be fixed in place with double-sided tape. The images will be analyzed with the application SAPO (Postural Evaluation Software) version through measures of the angles formed by lines drawn between the previously marked anatomical points. This analysis identifies and quantifies possible asymmetries and vertebral curvature angles. The volunteers will be divided in three groups with 10 participants:
1- First Trimester
2- Second Trimester
3- Third Trimester
Intervention code [1] 256672 0
Not applicable
Comparator / control treatment
N/A - There is not control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258629 0
Postural alterations measured by Postural Evaluation Software (SAPO)
Timepoint [1] 258629 0
For each participant, the measurements for posture will be collected in one single day and analysed immediately at the end of the 2 hour assessment session.
Secondary outcome [1] 264585 0
Analysed the correlation of the posture in pregnancy with the presence of low back pain through the Patrick's Faber test, Posterior pelvic pain provocation, Compression and Separation of the sacroiliac joint, Active straight leg raise (ASLR).
Timepoint [1] 264585 0
For each participant, the measurements for posture will be collected in one single day and analysed immediately at the end of the 2 hour assessment session

Eligibility
Key inclusion criteria
low-risk pregnancy; over 15 years old, literate, speak and understand the Portuguese language, which are oriented as to time and place, having absence of genitourinary pathology.
Minimum age
15 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Subjects will be excluded if they show signs or symptoms of any of the following: musculoskeletal pathological conditions; or previous surgery of the trunk or lower limbs.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 2687 0
Brazil
State/province [1] 2687 0
Petrolina/Pernambuco

Funding & Sponsors
Funding source category [1] 257140 0
University
Name [1] 257140 0
University of Pernambuco
Country [1] 257140 0
Brazil
Primary sponsor type
University
Name
University of Pernambuco
Address
BR 203 Km 2 s/n Vila Eduardo, Campus Universitario, zip code: 56300-000, Petrolina, Pernambuco.
Country
Brazil
Secondary sponsor category [1] 256400 0
None
Name [1] 256400 0
Address [1] 256400 0
Country [1] 256400 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259177 0
Research Ethics Committee of the University of Pernambuco
Ethics committee address [1] 259177 0
Av. Agamenon Magalhaes s/n Santo Amaro, zipe code: 50100-010, Recife, Pernambuco.
Ethics committee country [1] 259177 0
Brazil
Date submitted for ethics approval [1] 259177 0
Approval date [1] 259177 0
04/12/2009
Ethics approval number [1] 259177 0
1/09/0251

Summary
Brief summary
This is a cross-sectional study with a sample of convenience of 30 participants. The volunteers will be divided in three groups: First Trimester, Second Trimester and Third Trimester. The aim of this study will be analysis the postural changes in pregnant women and its correlation with low back pain measured by computerized biophotogrammetry. The images will be analyzed with the application SAPO (Postural Evaluation Software).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31267 0
Address 31267 0
Country 31267 0
Phone 31267 0
Fax 31267 0
Email 31267 0
Contact person for public queries
Name 14514 0
Ana Carolina Rodarti Pitangui
Address 14514 0
Jose Francisco de Almeida, Street, no 216 ap 202, Caminho do Sol, zipe code: 56330-545
Country 14514 0
Brazil
Phone 14514 0
+55 87 38666496
Fax 14514 0
Email 14514 0
carolpitangui@hotmail.com
Contact person for scientific queries
Name 5442 0
Ana Carolina Rodarti Pitangui
Address 5442 0
Jose Francisco de Almeida, Street, no 216 ap 202, Caminho do Sol, zipe code: 56330-545
Country 5442 0
Brazil
Phone 5442 0
+55 87 38666496
Fax 5442 0
Email 5442 0
carolpitangui@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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