NCT04810715

Brief Summary

This investigation aims to investigate the frequency of pes planus and posterior tibial tendon dysfunction in patients with ankylosing spondylitis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

1.5 years

First QC Date

March 19, 2021

Last Update Submit

September 27, 2022

Conditions

Keywords

Posterior Tibial Tendon DysfunctionUltrasonographic EvaluationPes Planus

Outcome Measures

Primary Outcomes (3)

  • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    BASDAI includes six questions evaluating five important findings of the disease (Fatigue, hip and spine pain, swelling and pain in peripheral joints, enthesitis, duration and severity of morning stiffness). The pain levels of the patients will be evaluated with a Visual Analog scale (0: I have no pain, 10: I have very severe pain). Higher scores mean active disease.

    Will be done only once on the first day after inclusion

  • Bath Ankylosing Spondylitis Functional Index (BASFI)

    BASFI; consists of eight questions that evaluate the function of patients with AS and two questions that evaluate their daily life. Higher scores indicate greater limitations.

    Will be done only once on the first day after inclusion

  • Ankylosing Spondylitis Quality of Life Scale (ASQOL)

    Ankylosing Spondylitis Quality of Life (ASQoL) scale is a disease-specific assessment parameter designed to measure health-related quality of life. It includes yes or no questions with a total score ranging from 0 to 18. The lower scores represent better quality of life.

    Will be done only once on the first day after inclusion

Secondary Outcomes (6)

  • Functional reach test

    Will be done only once on the first day after inclusion

  • Timed up and go test (TUG)

    Will be done only once on the first day after inclusion

  • Berg Balance Scale

    Will be done only once on the first day after inclusion

  • Foot and Ankle Outcome Score (FAOS)

    Will be done only once on the first day after inclusion

  • Ultrasonographic evaluation of the posterior tibial tendon

    Will be done only once on the first day after inclusion

  • +1 more secondary outcomes

Study Arms (1)

Patient Group

Anklyosing Spondilitis

Other: Patients with Ankylosing Spondylitis

Interventions

Observational study, not applicable

Patient Group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Outpatient clinic patients

You may qualify if:

  • Participitans who apply to the rheumatology outpatient clinic between the ages of 20-70 and who have been diagnosed with ankylosing spondylitis according to the Modified Newyork criteria will be included in this study.
  • Ankylosing Spondilitis

You may not qualify if:

  • Malignity
  • Previous ankle surgery history
  • Muscle disease
  • Neuropsychiatric illnesses
  • İmbalance
  • Visual problems
  • Deafness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar

Afyonkarahisar, 0300, Turkey (Türkiye)

Location

Related Publications (3)

  • Arnoldner MA, Gruber M, Syre S, Kristen KH, Trnka HJ, Kainberger F, Bodner G. Imaging of posterior tibial tendon dysfunction--Comparison of high-resolution ultrasound and 3T MRI. Eur J Radiol. 2015 Sep;84(9):1777-81. doi: 10.1016/j.ejrad.2015.05.021. Epub 2015 May 21.

    PMID: 26037267BACKGROUND
  • Guelfi M, Pantalone A, Mirapeix RM, Vanni D, Usuelli FG, Guelfi M, Salini V. Anatomy, pathophysiology and classification of posterior tibial tendon dysfunction. Eur Rev Med Pharmacol Sci. 2017 Jan;21(1):13-19.

    PMID: 28121362BACKGROUND
  • Hasler P, Hintermann B, Meier M. Posterior tibial tendon dysfunction and MR imaging in rheumatoid arthritis. Rheumatol Int. 2002 May;22(1):38-40. doi: 10.1007/s00296-002-0183-1.

    PMID: 12120910BACKGROUND

MeSH Terms

Conditions

Posterior Tibial Tendon DysfunctionFlatfootSpondylitis, Ankylosing

Interventions

HLA-B Antigens

Condition Hierarchy (Ancestors)

Foot DiseasesMusculoskeletal DiseasesTalipesFoot Deformities, AcquiredFoot DeformitiesFoot Deformities, CongenitalLower Extremity Deformities, CongenitalLimb Deformities, CongenitalMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Histocompatibility Antigens Class IMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and ProteinsMembrane ProteinsHistocompatibility AntigensAntigens, SurfaceAntigensBiological FactorsHLA AntigensIsoantigens

Study Officials

  • Nuran EYVAZ, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 23, 2021

Study Start

March 1, 2021

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

September 28, 2022

Record last verified: 2022-09

Locations