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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01833468
Other study ID # Foot-SpA
Secondary ID
Status Completed
Phase N/A
First received April 8, 2013
Last updated April 16, 2013
Start date February 2013
Est. completion date April 2013

Study information

Verified date April 2013
Source Vakif Gureba Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Observational

Clinical Trial Summary

Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of the SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The functional status of the SpA patients are usually evaluated globally.The aim of this study is to assess specifically the foot -related functional limitations of the SpA patients.


Description:

SpA patients who had foot pain at least for 4 weeks and those having bilateral anteroposterior and lateral feet x-rays will be included into the study. Foot x-rays will be evaluated by a radiologist by using the spondyloarthropathy tarsal radiographic index (SpA-TRI). The foot related functional status of the patients will be determined by the Turkish version of the Foot and Ankle Outcome Score (FAOS).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- SpA patients who had foot pain at least for 4 weeks

- Those having bilateral anteroposterior and lateral feet x-rays will be included into the study

Exclusion Criteria:

- Patients who had flatfoot

- Previous foot surgery

- Any other disorder unrelated to the SpA will be excluded

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Vakif Gureba Training and Research Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary The foot-related functional status of SpA patients The foot related functional status of the subjects will be measured with Foot Ankle Outcome Score (FAOS) 1 month No
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