Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000516482
Ethics application status
Approved
Date submitted
12/09/2007
Date registered
9/10/2007
Date last updated
13/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
CORRELATION BETWEEN THE LUMBAR LORDOSIS ANGLE AND THE DEGREE OF GYNOID LYPODYSTROPHY (CELLULITE) IN ASYMPTOMATIC WOMEN.
Scientific title
Correlation between the degree of cellulite and lumbar lordosis measured by Cobb’s method in 50 asymptomatic women
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cellulite 2363 0
Lumbar lordosis 2364 0
Condition category
Condition code
Skin 2470 2470 0 0
Dermatological conditions
Skin 2519 2519 0 0
Dermatological conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The volunteers were evaluated by using photograph, palpation and thermograph Therefore the cellulite grading was classified in 1,2,3 and 4. ). The volunteers performed the x-ray in lateral view and the angle of lumbar lordosis was measured by using Cobb’s method (inferior endplate of T12 and superior endplate of S1). All the procedures were done at the same day. It takes one year to finish the 50 voluntaries.
Intervention code [1] 2083 0
Diagnosis / Prognosis
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3366 0
lumbar lordosis and correlation with cellullite
Timepoint [1] 3366 0
at 1 year when all volunteers have undergone the procedures
Secondary outcome [1] 5719 0
no
Timepoint [1] 5719 0
none

Eligibility
Key inclusion criteria
Sex (women), age (20 to 35 years) and that with no exclusion criteria
Minimum age
20 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
neurological, respiratory, circulatory or rheumatic disease, sedentary, women with current or previous pregnancy, obesity or with index of corporal mass (IMC) bigger or equal the 24,9 kg/m2, description of previous surgeries of the vertebral column, lumbar back pain or other disease of lumbar region.

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 602 0
Brazil
State/province [1] 602 0
Sao Paulo

Funding & Sponsors
Funding source category [1] 2616 0
University
Name [1] 2616 0
University of Sao Paulo
Country [1] 2616 0
Brazil
Funding source category [2] 2665 0
University
Name [2] 2665 0
Universidade de Sao Paulo
Country [2] 2665 0
Brazil
Primary sponsor type
Individual
Name
Giovana Milani
Address
Rua Cipotanea, 51
CEP: 05360-160 São Paulo, SP
Country
Brazil
Secondary sponsor category [1] 2366 0
University
Name [1] 2366 0
University of Sao paulo
Address [1] 2366 0
Rua Cipotanea, 51
CEP: 05360-160 Sao Paulo, SP
Country [1] 2366 0
Brazil
Secondary sponsor category [2] 2393 0
Individual
Name [2] 2393 0
Silvia Maria Amado Joao
Address [2] 2393 0
Rua Cipotanea, 51
CEP: 05360-160 Sao Paulo, SP
Country [2] 2393 0
Brazil
Other collaborator category [1] 37 0
Hospital
Name [1] 37 0
Hospital Universitario da Universidade de Sao Paulo (USP)
Address [1] 37 0
Av. Prof Lineu Prestes, 2565
Country [1] 37 0
Brazil
Other collaborator category [2] 51 0
Hospital
Name [2] 51 0
AlDayr Natal Filho
Address [2] 51 0
Av. Prof Lineu Prestes, 2565
Country [2] 51 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4536 0
Comissao de Ensino e Pesquisa do Hospital Universitario da Universidade de Sao Paulo
Ethics committee address [1] 4536 0
Av. Prof Lineu Prestes, 2565
Ethics committee country [1] 4536 0
Brazil
Date submitted for ethics approval [1] 4536 0
01/12/2004
Approval date [1] 4536 0
17/03/2006
Ethics approval number [1] 4536 0
521/04
Ethics committee name [2] 4563 0
Comissao de Ensino e Pesquisa do Hospital Universitario da Universidade de Sao Paulo
Ethics committee address [2] 4563 0
Av. Prof Lineu Prestes, 2565
Ethics committee country [2] 4563 0
Brazil
Date submitted for ethics approval [2] 4563 0
01/12/2004
Approval date [2] 4563 0
17/03/2006
Ethics approval number [2] 4563 0
521/04
Ethics committee name [3] 4585 0
Comissao de Ensino e Pesquisa do Hospital Universitario da Universidade de Sao Paulo
Ethics committee address [3] 4585 0
Av. Prof Lineu Prestes, 2565
Ethics committee country [3] 4585 0
Date submitted for ethics approval [3] 4585 0
Approval date [3] 4585 0
17/03/2006
Ethics approval number [3] 4585 0

Summary
Brief summary
Gynoid Lypodystrophy (cellulite) is a common dermatological alteration. Its presence and severity have been related to many factors as biotype, age, sex, circulatory alteration and some authors have suggested also a relation with some mechanical alterations like the hyperlordosis. The objective of this study was to correlate the cellulite grading with the angle of lumbar lordosis in asymptomatic women.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28049 0
Address 28049 0
Country 28049 0
Phone 28049 0
Fax 28049 0
Email 28049 0
Contact person for public queries
Name 11206 0
Giovana Milani
Address 11206 0
Rua: Cipotânea, 51
CEP: 05360-160 São Paulo, SP
Country 11206 0
Brazil
Phone 11206 0
55-11-30918424
Fax 11206 0
55 11 3091-7462
Email 11206 0
[email protected]
Contact person for scientific queries
Name 2134 0
Giovana Milani
Address 2134 0
Rua Cipotanea, 51
CEP: 05360-160 São Paulo, SP
Country 2134 0
Brazil
Phone 2134 0
55-11-30918424
Fax 2134 0
55 11 3091-7462
Email 2134 0
[email protected]

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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Documents added automatically
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