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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00832910
Other study ID # FDAAA
Secondary ID
Status Completed
Phase N/A
First received January 29, 2009
Last updated January 29, 2009
Start date June 2007
Est. completion date December 2008

Study information

Verified date January 2009
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

Investigate body image of patients with rheumatoid arthritis, correlating with self-esteem, function and quality of life.


Description:

Methods: Forty-three RA patients and thirty-nine control patients between 18 and 70 years were evaluated. The RA group was made up of individuals with a diagnosis of RA and the control group was made up of individuals from the community, paired for gender, age and body mass index. The patients were assessed with regard to body image (Body dysmorphic disorder examination (BDDE)), self-esteem (Rosenberg self-esteem scale), function (Health assessment questionnaire (HAQ)) and quality of life (Short form-36 (SF-36)).


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date December 2008
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- The RA group included patients between 18 and 70 years of age, of either gender, with an established diagnosis of RA based ACR criteria and belonging to functional classes I, II and III. The control group was made up of individuals from the community paired for gender, age and body mass index with RA group.

Exclusion Criteria:

- Individuals with fibromyalgia, neurological disease, psychiatric disorders or other severe co-morbidity were excluded from the study.

Study Design

Observational Model: Case Control


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Outcome

Type Measure Description Time frame Safety issue
Primary Body Dysmorphic Disorder Examination baseline Yes
Secondary Short Form - 36 baseline Yes
Secondary Health assessment questionnaire baseline Yes
Secondary Rosenberg self-esteem scale baseline Yes
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