Ankylosing SpondylitisNCT04320459
Alexithymia in Ankylosing Spondylitis
An observational study of Ankylosing Spondylitis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The study included 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Bath Ankylosing Spondylitis Functional Index (BASFI)
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2016to 15 Aug 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study included 55 patients having AS for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects.
Who may be able to join
- Diagnosed as AS for at least 1 year according to the ASAS classification criteria
- over 18 years old
Who cannot join
- fibromyalgia
- age less than 18 years
- vision and hearing impairment
- neurological disease (Parkinson's disease, multiple sclerosis, cerebrovascular disease),
- history of a psychiatric disorder (schizophrenia, bipolar disorder)
- history of chronic condition (DM, thyroid disease) or malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Istanbul, 34732
About this study
The study included 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. Demographic data were recorded for 55 AS patients who were subsequently assessed using the BASMI (Bath Ankylosing Spondylitis Metrology Index) in terms of elasticity and spinal mobility as well as the BASFI (Bath Ankylosing Spondylitis Functional Index) to determine functional status, the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) to assess the disease activity and the ASQoL (Ankylosing Spondylitis Quality of Life Questionnaire) to evaluate quality of life. The Toronto Alexithymia Scale-20 (TAS-20) was used for assessment of alexithymia and Beck's Depression Inventory (BDI) for depression among patients.
Read the detailed description
The study included 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. Demographic data were recorded for 55 AS patients who were subsequently assessed using the BASMI (Bath Ankylosing Spondylitis Metrology Index) in terms of elasticity and spinal mobility as well as the BASFI (Bath Ankylosing Spondylitis Functional Index) to determine functional status, the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) to assess the disease activity and the ASQoL (Ankylosing Spondylitis Quality of Life Questionnaire) to evaluate quality of life. The Toronto Alexithymia Scale-20 (TAS-20) was used for assessment of alexithymia and Beck's Depression Inventory (BDI) for depression among patients.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Bath Ankylosing Spondylitis Metrology Index (BASMI), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL), Toronto Alexithymia Scale-20 (TAS-20)
- Keywords
- ankylosing spondylitis, alexithymia
- Medical subject headings
- Spondylitis, Ankylosing, Affective Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bath Ankylosing Spondylitis Metrology Index (BASMI)Diagnostic test
It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The total score of the 5 measurements was taken, the score range was 0-10, the low score meant that the spinal movement was better.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)Diagnostic test
It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.
Bath Ankylosing Spondylitis Functional Index (BASFI)Diagnostic test
It assess functional status. It was evaluated with a 10-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.
Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)Diagnostic test
It evaluates quality of life. Each statement on the ASQoL (18-item) is given a score of "1" or "0". A score of "1" is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL).
Toronto Alexithymia Scale-20 (TAS-20)Diagnostic test
It assess alexithymia. It is a 20 item questionnaire and each item is evaluated in a Likert type scale with five intervals (1= strongly disagree, 5=strongly agree). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
Beck's Depression Inventory (BDI)Diagnostic test
It assess depression status. It is a 21-question multiple-choice self-report inventory, each set is ranked in terms of severity and scored from 0 to 3 with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
| Study group | Role | What they receive |
|---|---|---|
| ankylosing spondylitis | 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic Receives: Diagnostic Test: Bath Ankylosing Spondylitis Metrology Index (BASMI); Diagnostic Test: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); Diagnostic Test: Bath Ankylosing Spondylitis Functional Index (BASFI); Diagnostic Test: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL); Diagnostic Test: Toronto Alexithymia Scale-20 (TAS-20); Diagnostic Test: Beck's Depression Inventory (BDI) | |
| healthy control | age and sex matched healthy controls Receives: Diagnostic Test: Bath Ankylosing Spondylitis Metrology Index (BASMI); Diagnostic Test: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI); Diagnostic Test: Bath Ankylosing Spondylitis Functional Index (BASFI); Diagnostic Test: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL); Diagnostic Test: Toronto Alexithymia Scale-20 (TAS-20); Diagnostic Test: Beck's Depression Inventory (BDI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alexithymia rate in AS patients and controls according to Toronto Alexithymia Scale-20
Measured: 7 months
Depression rate in AS patients and controls according to Beck Depression Inventory
Measured: 7 months
Relationship between alexithymia and depression and functional indexes (BASFI, BASMI, BASDAI, ASQoL)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Feb 2016
- Primary completion1 Aug 2016
- Study completion15 Aug 2016
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320459
- Sponsor's protocol ID
- MedeniyetRomato
- Status last verified
- Mar 2020
- First submitted
- 22 Mar 2020
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alexithymia in Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04320459
- Acronym / sponsor ID
- MedeniyetRomato
- Conditions
- Ankylosing Spondylitis
- Keywords
- ankylosing spondylitis, alexithymia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 15 Aug 2016 (actual)
- First posted
- 25 Mar 2020 (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.
The study included 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. Demographic data were recorded for 55 AS patients who were subsequently assessed using the BASMI (Bath Ankylosing Spondylitis Metrology Index) in terms of elasticity and spinal mobility as well as the BASFI (Bath Ankylosing Spondylitis Functional Index) to determine functional status, the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) to assess the disease activity and the ASQoL (Ankylosing Spondylitis Quality of Life Questionnaire) to evaluate quality of life. The Toronto Alexithymia Scale-20 (TAS-20) was used for assessment of alexithymia and Beck's Depression Inventory (BDI) for depression among patients.
Detailed description
The study included 55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects. Demographic data were recorded for 55 AS patients who were subsequently assessed using the BASMI (Bath Ankylosing Spondylitis Metrology Index) in terms of elasticity and spinal mobility as well as the BASFI (Bath Ankylosing Spondylitis Functional Index) to determine functional status, the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) to assess the disease activity and the ASQoL (Ankylosing Spondylitis Quality of Life Questionnaire) to evaluate quality of life. The Toronto Alexithymia Scale-20 (TAS-20) was used for assessment of alexithymia and Beck's Depression Inventory (BDI) for depression among patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ankylosing spondylitis | – | Diagnostic Test: Bath Ankylosing Spondylitis Metrology Index (BASMI), Diagnostic Test: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Diagnostic Test: Bath Ankylosing Spondylitis Functional Index (BASFI), Diagnostic Test: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL), Diagnostic Test: Toronto Alexithymia Scale-20 (TAS-20), Diagnostic Test: Beck's Depression Inventory (BDI)55 patients having Ankylosing Spondylitis (AS) for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic |
| healthy control | – | Diagnostic Test: Bath Ankylosing Spondylitis Metrology Index (BASMI), Diagnostic Test: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Diagnostic Test: Bath Ankylosing Spondylitis Functional Index (BASFI), Diagnostic Test: Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL), Diagnostic Test: Toronto Alexithymia Scale-20 (TAS-20), Diagnostic Test: Beck's Depression Inventory (BDI)age and sex matched healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study included 55 patients having AS for at least 1 year diagnosed according to the ASAS classification criteria who presented to our hospital's outpatient clinic and 55 healthy subjects.
Key inclusion criteria (2 listed)
- Diagnosed as AS for at least 1 year according to the ASAS classification criteria
- over 18 years old
Key exclusion criteria (6 listed)
- fibromyalgia
- age less than 18 years
- vision and hearing impairment
- neurological disease (Parkinson's disease, multiple sclerosis, cerebrovascular disease),
- history of a psychiatric disorder (schizophrenia, bipolar disorder)
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 |
|---|---|---|
| Bath Ankylosing Spondylitis Metrology Index (BASMI)It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The total score of the 5 measurements was taken, the score range was 0-10, the low score meant that the spinal movement was better. | Diagnostic test | ankylosing spondylitis, healthy control |
| Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions. | Diagnostic test | ankylosing spondylitis, healthy control |
| Bath Ankylosing Spondylitis Functional Index (BASFI)It assess functional status. It was evaluated with a 10-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions. | Diagnostic test | ankylosing spondylitis, healthy control |
| Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)It evaluates quality of life. Each statement on the ASQoL (18-item) is given a score of "1" or "0". A score of "1" is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL). | Diagnostic test | ankylosing spondylitis, healthy control |
| Toronto Alexithymia Scale-20 (TAS-20)It assess alexithymia. It is a 20 item questionnaire and each item is evaluated in a Likert type scale with five intervals (1= strongly disagree, 5=strongly agree). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia. | Diagnostic test | ankylosing spondylitis, healthy control |
| Beck's Depression Inventory (BDI)It assess depression status. It is a 21-question multiple-choice self-report inventory, each set is ranked in terms of severity and scored from 0 to 3 with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression. | Diagnostic test | ankylosing spondylitis, healthy control |
Primary outcome
Alexithymia rate in AS patients and controls according to Toronto Alexithymia Scale-20
Time frame: 7 months
Depression rate in AS patients and controls according to Beck Depression Inventory
Time frame: 7 months
Relationship between alexithymia and depression and functional indexes (BASFI, BASMI, BASDAI, ASQoL)
Time frame: 7 months
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 25 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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 Istanbul Medeniyet 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 6 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 25 Mar 2020. 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?
Alexithymia rate in AS patients and controls according to Toronto Alexithymia Scale-20 (time frame: 7 months). 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?
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 25 Mar 2020.