Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04810715
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Nuran Eyvaz, Afyonkarahisar Health Sciences University

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

Condition or disease Intervention/treatment
Posterior Tibial Tendon Dysfunction Pes Planus Spondylitis, Ankylosing Other: 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis Ultrasonographic Study
Actual Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patient Group
Anklyosing Spondilitis
Other: Patients with Ankylosing Spondylitis
Observational study, not applicable




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatient clinic patients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04810715


Contacts
Layout table for location contacts
Contact: Nuran EYVAZ, MD 5334262442 n_eyvaz@hotmail.com

Locations
Layout table for location information
Turkey
Afyonkarahisar Recruiting
Afyonkarahisar, Turkey, 0300
Contact: Nuran EYVAZ, MD    05334262442    n_eyvaz@hotmail.com   
Sponsors and Collaborators
Afyonkarahisar Health Sciences University
Investigators
Layout table for investigator information
Principal Investigator: Nuran EYVAZ, MD Afyonkarahisar Health Sciences University
Publications:
Layout table for additonal information
Responsible Party: Nuran Eyvaz, Assistant Professor, Afyonkarahisar Health Sciences University
ClinicalTrials.gov Identifier: NCT04810715    
Other Study ID Numbers: NEAS2021
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuran Eyvaz, Afyonkarahisar Health Sciences University:
Posterior Tibial Tendon Dysfunction
Ultrasonographic Evaluation
Pes Planus
Additional relevant MeSH terms:
Layout table for MeSH terms
Spondylitis
Spondylitis, Ankylosing
Flatfoot
Posterior Tibial Tendon Dysfunction
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Talipes
Foot Deformities, Acquired
Foot Deformities
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Foot Diseases