Ankylosing SpondylitisNCT05589922
The Relationship Between Abnormal Modified Schober Index and Demographic Characteristics and Clinical Variables
An observational study of Ankylosing Spondylitis, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
This study will aim to compare ankylosing spondylitis (AS) participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Oct 2022to 30 Jan 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Ankylosing Spondylitis
Who may be able to join
- Participants who meet the modified New York criteria for AS
- Participants over 18 years
Who cannot join
- Participants with other concomitant rheumatic diseases (such as fibromyalgia, rheumatoid arthritis, etc.),
- Participants with cognitive or psychiatric disorders,
- Participants with neuromuscular or orthopedic diseases
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University, Faculty of Health Science, Department of Physiotherapy and Rehabilitation
Hatay, Alahan, 31060
About this study
Official title: Determining the Relationship Between Abnormal Modified Schober Index and Demographic Characteristics and Clinical Variables in Patients With Ankylosing Spondylitis
This study will aim to compare ankylosing spondylitis (AS) participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur
Read the detailed description
Ankylosing spondylitis (AS), a common type of spondyloarthropathy, is a chronic inflammatory disease that affects spinal joints, and adjacent soft tissues such as sacroiliac joints, tendons, and entheses (1). Inflammation of the spinal structures and progressive changes in the surrounding tissue is largely responsible for decreased physical function and mobility in participants with AS (2).
It is unknown how these parameters of AS participants with AMSI (smaller than 5 cm) are affected compared to AS participants with normal modified Schober index (NMSI, bigger than 5 cm). In addition, it is unclear which demographic characteristics and variables predispose AMSI to occur.
This study will aim to compare AS participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Spinal mobility, Kinesiophobia, Balance
- Medical subject headings
- Spondylitis, Ankylosing, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with abnormal modified Schober index | This group will include the patients with Ankylosing Spondylitis who have modified Schober index smaller than 5 cm | |
| Patients with normal modified Schober index | This group will include the patients with Ankylosing Spondylitis who have modified Schober index bigger than 5 cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Schober Index
The measurement of the MSI starts with the subject in an upright posture. After being determined the posterior superior iliac spines, a horizontal line is drawn at the center of both posterior superior iliac spines. Ten cm above and five cm below the first line are marked. The distance between the top and bottom line is remeasured after the patient attempts to flex forward as far as possible while keeping the knees straight
Measured: at baseline
Bath AS Metrology Index (BASMI)
The BASMI is evulated quantify the mobility of the axial skeleton and includes assessments of lateral lumbar flexion, tragus-to-wall distance, lumbar flexion, intermalleolar distance, and cervical rotation. Each measure is assigned a score of 0 to 2 with the higher score indicating greater impairment in mobility
Measured: at baseline
Timed up and go test
It aims to assess mobility and balance. It measures the time in seconds for a subject to stand up from an armchair, walk 3 m, turn, walk back to the chair, and sit down
Measured: at baseline
tandem stance test
For the tandem stance test, patients stand holding onto a railing while placing one foot in front of the other. The researcher standing behind the patient starts timing when the patient's contact with the railing is released. It is recorded for 30 seconds or until participants contact external support or move out of tandem stance
Measured: At baseline
Falls Efficacy Scale-International
The FES-I consists of 16 questions questioning how confident patients are in performing activities without falling. According to the answers, each question is scored between 1 and 4 (1 = not at all concerned, 4 = very concerned), and a higher score is associated with a greater fear of falling
Measured: At baseline
Tampa Scale for Kinesiophobia
The TSK contains 17 questions which measures fear of movement and/or reinjury. The scale uses 4-point Likert scoring (1 = entirely disagree, 4 = entirely agree). A total score ranges from 11 to 44 points and a cut-off point was determined as ≥37 points indicate a high kinesiophobia level
Measured: At baseline
Secondary outcomes (5)
functional reach test
For the functional reach test, the patient is asked to stand erect with feet separated from each other in a comfortable position and reach the farthest distance without touching the wall or without taking a step. The difference in the distance between the starting point and the endpoint is recorded in cm.
Measured: At baseline
30-second chair sit-to-stand test
The proximal muscle strength and endurance of the lower extremities assessed by the 30-second chair sit-to-stand. The patients is seated in an armless chair with their back straight, arms crossed in front of the chest, and feet approximately a shoulder width apart and placed on the floor. Then patients are instructed to fully sit between each stand.
Measured: At baseline
single leg stance test
For the SLST is performed by standing on one leg (eyes open) barefoot for 20 seconds, the other knee flexed without touching the other leg, with arms are crossed. The test will be repeated thrice on each foot, and the average time will be used for analysis.
Measured: At baseline
finger-to-floor distance measure
For finger-to-floor distance (FFD), the subject is asked to perform maximal lumbar flexion while keeping the knees extend. After which, the distance between the right middle finger and the floor is measured using a tape measure
Measured: At baseline
Visual Analogue Scale
Pain scores of the patients at night, at rest, and during activity are measured using visual analogue scale (VAS). (0-10 mm; 0 indicates no pain and 10 indicates severe pain)
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start24 Oct 2022
- Primary completion18 Nov 2022
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Kus, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589922
- Sponsor's protocol ID
- MustafaKU07
- Status last verified
- Jun 2023
- First submitted
- 18 Oct 2022
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Relationship Between Abnormal Modified Schober Index and Demographic Characteristics and Clinical Variables in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT05589922
- Acronym / sponsor ID
- MustafaKU07
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, Spinal mobility, Kinesiophobia, Balance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 24 Oct 2022 (actual)
- Primary completion
- 18 Nov 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 21 Oct 2022 (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 study will aim to compare ankylosing spondylitis (AS) participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur
Detailed description
Ankylosing spondylitis (AS), a common type of spondyloarthropathy, is a chronic inflammatory disease that affects spinal joints, and adjacent soft tissues such as sacroiliac joints, tendons, and entheses (1). Inflammation of the spinal structures and progressive changes in the surrounding tissue is largely responsible for decreased physical function and mobility in participants with AS (2).
It is unknown how these parameters of AS participants with AMSI (smaller than 5 cm) are affected compared to AS participants with normal modified Schober index (NMSI, bigger than 5 cm). In addition, it is unclear which demographic characteristics and variables predispose AMSI to occur.
This study will aim to compare AS participants with abnormal modified Schober index (AMSI) versus AS participants with normal modified Schober index (NMSI) in pain, morning stiffness, balance, kinesiophobia and the fear of falling. In addition, the investigators will aim to determine which demographic characteristics and variables predispose AMSI to occur
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with abnormal modified Schober index | – | –This group will include the patients with Ankylosing Spondylitis who have modified Schober index smaller than 5 cm |
| Patients with normal modified Schober index | – | –This group will include the patients with Ankylosing Spondylitis who have modified Schober index bigger than 5 cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ankylosing Spondylitis
Key inclusion criteria (2 listed)
- Participants who meet the modified New York criteria for AS
- Participants over 18 years
Key exclusion criteria (3 listed)
- Participants with other concomitant rheumatic diseases (such as fibromyalgia, rheumatoid arthritis, etc.),
- Participants with cognitive or psychiatric disorders,
- Participants with neuromuscular or orthopedic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Schober Index
Time frame: at baseline
The measurement of the MSI starts with the subject in an upright posture. After being determined the posterior superior iliac spines, a horizontal line is drawn at the center of both posterior superior iliac spines. Ten cm above and five cm below the first line are marked. The distance between the top and bottom line is remeasured after the patient attempts to flex forward as far as possible while keeping the knees straight
Bath AS Metrology Index (BASMI)
Time frame: at baseline
The BASMI is evulated quantify the mobility of the axial skeleton and includes assessments of lateral lumbar flexion, tragus-to-wall distance, lumbar flexion, intermalleolar distance, and cervical rotation. Each measure is assigned a score of 0 to 2 with the higher score indicating greater impairment in mobility
Timed up and go test
Time frame: at baseline
It aims to assess mobility and balance. It measures the time in seconds for a subject to stand up from an armchair, walk 3 m, turn, walk back to the chair, and sit down
tandem stance test
Time frame: At baseline
For the tandem stance test, patients stand holding onto a railing while placing one foot in front of the other. The researcher standing behind the patient starts timing when the patient's contact with the railing is released. It is recorded for 30 seconds or until participants contact external support or move out of tandem stance
Falls Efficacy Scale-International
Time frame: At baseline
The FES-I consists of 16 questions questioning how confident patients are in performing activities without falling. According to the answers, each question is scored between 1 and 4 (1 = not at all concerned, 4 = very concerned), and a higher score is associated with a greater fear of falling
Tampa Scale for Kinesiophobia
Time frame: At baseline
The TSK contains 17 questions which measures fear of movement and/or reinjury. The scale uses 4-point Likert scoring (1 = entirely disagree, 4 = entirely agree). A total score ranges from 11 to 44 points and a cut-off point was determined as ≥37 points indicate a high kinesiophobia level
5 secondary outcomes
functional reach test
Time frame: At baseline
30-second chair sit-to-stand test
Time frame: At baseline
single leg stance test
Time frame: At baseline
finger-to-floor distance measure
Time frame: At baseline
Visual Analogue Scale
Time frame: At baseline
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 12 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ankylosing Spondylitis, run by Mustafa Kemal 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 3 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 12 Jun 2023. 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?
Modified Schober Index (time frame: at baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2023.