Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects

Spondylitis, Ankylosing Clinical Trial

Official title:

Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01567878
• Other study ID #: 1649/09
• Status: Completed
• Phase: N/A
• First received: March 28, 2012
• Last updated: December 1, 2014
• Start date: May 2009
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial Summary

• Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis.

• Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables.

• Evaluate correlation between articular and enthesis ultrasound exam in this study.

• Compare patients and healthy individuals data, to calculate the ROC curve to estimate predictor value of disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Ankylosing spondylitis by the Modified New York Criteria (1984)or ASAS classification (2009)

• Healthy people with no history of joint pain, inflammatory lumbar pain inflammatory disease,

• 18 - 65 years old

Exclusion Criteria:

• Fibromyalgia

• Corticosteroid injection in the last 3 months

• Previous surgery in joint or enthesis of study

• Peripheric neuropathy

• Diabetes mellitus

• Hypothyroidism

• Peripheric venous insufficiency (with edema or ocre dermatitis)

Study Design

N/A

Related Conditions & MeSH terms

• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Brazil	Suellen Narimatsu	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects	a comparative study of enthesis by ultrasound revealed statistical differences among patients with ankylosing spondylitis and healthy volunteers in analysis of calcaneal enthesis, plantar fascia and quadriceps.	december	Yes