Posterior Tibial Tendon DysfunctionNCT04810715
Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis
An observational study of Posterior Tibial Tendon Dysfunction and Pes Planus, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This investigation aims to investigate the frequency of pes planus and posterior tibial tendon dysfunction in patients with ankylosing spondylitis. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Posterior Tibial Tendon Dysfunction, Pes Planus, Spondylitis, Ankylosing
- What is being tested?
- Patients with Ankylosing Spondylitis
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinic patients
Who may be able to join
- 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
Who cannot join
- Malignity
- Previous ankle surgery history
- Muscle disease
- Neuropsychiatric illnesses
- İmbalance
- Visual problems
- Deafness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis Ultrasonographic Study
This investigation aims to investigate the frequency of pes planus and posterior tibial tendon dysfunction in patients with ankylosing spondylitis.
Read the 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.
- Being tested
- Patients with Ankylosing Spondylitis
- Keywords
- Posterior Tibial Tendon Dysfunction, Ultrasonographic Evaluation, Pes Planus
- Medical subject headings
- Posterior Tibial Tendon Dysfunction, Flatfoot, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with Ankylosing SpondylitisOther
Observational study, not applicable
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Anklyosing Spondilitis Receives: Other: Patients with Ankylosing Spondylitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Will be done only once on the first day after inclusion
Secondary outcomes (6)
Functional reach test
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.
Measured: Will be done only once on the first day after inclusion
Timed up and go test (TUG)
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.
Measured: Will be done only once on the first day after inclusion
Berg Balance Scale
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.
Measured: Will be done only once on the first day after inclusion
Foot and Ankle Outcome Score (FAOS)
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.
Measured: Will be done only once on the first day after inclusion
Ultrasonographic evaluation of the posterior tibial tendon
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).
Measured: Will be done only once on the first day after inclusion
Static and Dynamic Balance measurment with SportKAT Device.
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.
Measured: Will be done only once on the first day after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Mar 2021
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Posterior Tibial Tendon DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afyonkarahisar Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuran Eyvaz, Afyonkarahisar Health Sciences University
- Investigators
- Nuran EYVAZ, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810715
- Sponsor's protocol ID
- NEAS2021
- Status last verified
- Sep 2022
- First submitted
- 19 Mar 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26037267Guelfi 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.
PubMed 28121362Hasler 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.
PubMed 12120910
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Pes Planus and Posterior Tibial Tendon Dysfunction in Patients With Ankylosing Spondylitis Ultrasonographic Study
- ClinicalTrials.gov ID
- NCT04810715
- Acronym / sponsor ID
- NEAS2021
- Keywords
- Posterior Tibial Tendon Dysfunction, Ultrasonographic Evaluation, Pes Planus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Afyonkarahisar Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 23 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | Other: Patients with Ankylosing SpondylitisAnklyosing Spondilitis |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- Malignity
- Previous ankle surgery history
- Muscle disease
- Neuropsychiatric illnesses
- İmbalance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with Ankylosing SpondylitisObservational study, not applicable | Other | Patient Group |
Primary outcome
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.
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.
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.
6 secondary outcomes
Functional reach test
Time frame: Will be done only once on the first day after inclusion
Timed up and go test (TUG)
Time frame: Will be done only once on the first day after inclusion
Berg Balance Scale
Time frame: Will be done only once on the first day after inclusion
Foot and Ankle Outcome Score (FAOS)
Time frame: Will be done only once on the first day after inclusion
Ultrasonographic evaluation of the posterior tibial tendon
Time frame: Will be done only once on the first day after inclusion
Static and Dynamic Balance measurment with SportKAT Device.
Time frame: Will be done only once on the first day after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Background: PubMed 26037267Arnoldner 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.
- Background: PubMed 28121362Guelfi 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.
- Background: PubMed 12120910Hasler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nuran EYVAZ, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Posterior Tibial Tendon Dysfunction and Pes Planus, run by Afyonkarahisar Health Sciences University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (time frame: Will be done only once on the first day after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810715, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.