Clinical trial NCT04810715: Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis
Official title: Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis Ultrasonographic Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Posterior Tibial Tendon Dysfunction
Pes Planus
Spondylitis, Ankylosing
Keywords: Posterior Tibial Tendon Dysfunction
Ultrasonographic Evaluation
Pes Planus
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-03-23
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatient clinic patients

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

Detailed description: Posterior tibial tendon dysfunction is the most common cause of acquired pes planus deformity in healthy adults. The posterior tibial tendon stabilizes the hindfoot against valgus and eversion forces and acts as a support along the medial longitudinal arch. If the posterior tibial tendon loses its functionality, the other ligaments of the foot and the joint capsule gradually weaken as the height of the medial longitudinal arch decreases or disappears, and it develops with pes planus. The presence of pes planus and spondyloarthropathy are also risk factors for the development of posterior tibial tendon dysfunction.

100 participants aged between 20-70 years with ankylosing spondylitis were planned to be included in this investigation. Posterior tibial tendon dysfunction frequency of patients with ankylosing spondylitis will be evaluated by both clinical examination and musculoskeletal ultrasonography device. The posterior tibial tendon will be evaluated by ultrasonography in terms of tendon diameter and fluid presence in 2 different locations in the retromalleolar area.

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life (ASQoL) Scale, Functional reach test, Timed up and go test, Berg Balance Scale, Dynamic and static balance with the Sportkat device will be used as evaluation parameters. It was planned that the evaluations were made once.

Eligibility criteria: Inclusion Criteria:

* 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.

  1. Ankylosing Spondilitis

Exclusion Criteria:

1. Malignity
2. Previous ankle surgery history
3. Muscle disease
4. Neuropsychiatric illnesses
5. İmbalance
6. Visual problems
7. Deafness

Primary outcomes:
measure: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: Will be done only once on the first day after inclusion
measure: Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: Will be done only once on the first day after inclusion
measure: Ankylosing Spondylitis Quality of Life Scale (ASQOL)
timeFrame: Will be done only once on the first day after inclusion
Secondary outcomes:
measure: Functional reach test
timeFrame: Will be done only once on the first day after inclusion
measure: Timed up and go test (TUG)
timeFrame: Will be done only once on the first day after inclusion
measure: Berg Balance Scale
timeFrame: Will be done only once on the first day after inclusion
measure: Foot and Ankle Outcome Score (FAOS)
timeFrame: Will be done only once on the first day after inclusion
measure: Ultrasonographic evaluation of the posterior tibial tendon
timeFrame: Will be done only once on the first day after inclusion
measure: Static and Dynamic Balance measurment with SportKAT Device.
timeFrame: Will be done only once on the first day after inclusion
Other outcomes:
Locations:
city: Afyonkarahisar
country: Turkey
facility: Afyonkarahisar
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Nuran EYVAZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.