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Completed

NCT Number: NCT04810715

Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Ankylosing Spondilitis

Exclusion criteria

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

Treatment and study plan

Patients with Ankylosing Spondylitis

Other

Observational study, not applicable

Primary outcomes

  1. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Time frame: Will be done only once on the first day after inclusion

    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.

  2. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Time frame: Will be done only once on the first day after inclusion

    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.

  3. Ankylosing Spondylitis Quality of Life Scale (ASQOL)

    Time frame: Will be done only once on the first day after inclusion

    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.

Secondary outcomes

  1. Functional reach test

    Time frame: Will be done only once on the first day after inclusion

    Functional reach test: It is the maximum distance that the participants can reach forward in the horizontal plane while maintaining her/his stability on the support surface in the standing position.

  2. Timed up and go test (TUG)

    Time frame: Will be done only once on the first day after inclusion

    The TUG test is a simple evaluative test used to measure functional mobility. It uses the time that participants take to rise from a chair, walk three meters, turn around 180 degrees, walk back to the chair, and sit down while turning 180 degrees. During the test, the participant is expected to wear their regular footwear and use any mobility aids that they would normally require.11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the worse scores.

  3. Berg Balance Scale

    Time frame: Will be done only once on the first day after inclusion

    The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. The total score is 56. A score of < 45 indicates participants may be at greater risk of falling.

  4. Foot and Ankle Outcome Score (FAOS)

    Time frame: Will be done only once on the first day after inclusion

    The FAOS is a 42-item questionnaire assessing patient-relevant outcomes in five separate subscales (Pain, other Symptoms, Activities of daily living, Sport and recreation function, foot and ankle-related Quality of life). Scores range from 0 to 100 with a score of 0 indicating the worst possible foot/ankle symptoms and 100 indicating no foot/ankle symptoms. Lower scores mean the worse scores.

  5. Ultrasonographic evaluation of the posterior tibial tendon

    Time frame: Will be done only once on the first day after inclusion

    Posterior tibial tendon evaluation will be evaluated in 2 different locations in the retromalleolar area.Tendon diameter, continuity and fluid presence will be evaluated ultrasonographically. Power Doppler signal levels will be graded on a 4-point semi-quantitative scale (none-grade 0 / minor-grade 1 / middle-grade 2 / severe-grade 3).

  6. Static and Dynamic Balance measurment with SportKAT Device.

    Time frame: Will be done only once on the first day after inclusion

    The SportKAT device used for determining postural oscillation consists of a balance platform and sensors that detect oscillations.There is a screen in front of the participant standing on the platform to provide feedback. During the static balance test, it is asked to keep the 'X' mark seen on the screen constant in the center. During the dynamic balance test, it is asked to to follow the moving cursor. The score range varies between 0 and 6000. The lower the score, the better the balance.

Sponsors and collaborators

Lead sponsor

Afyonkarahisar Health Sciences University

Other

Registry information

Official study title

Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis Ultrasonographic Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 23, 2021
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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