Spondylitis, AnkylosingNCT01567878
Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
An observational study of Spondylitis, Ankylosing, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis. Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spondylitis, Ankylosing
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- May 2009to Dec 2014
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ankylosing spondylitis healthy subjects
Who may be able to join
- Ankylosing spondylitis by the Modified New York Criteria (1984)or ASAS classification (2009)
- Healthy people with no history of joint pain, inflammatory lumbar pain inflammatory disease,
- 18 - 65 years old
Who cannot join
- Fibromyalgia
- Corticosteroid injection in the last 3 months
- Previous surgery in joint or enthesis of study
- Peripheric neuropathy
- Diabetes mellitus
- Hypothyroidism
- Peripheric venous insufficiency (with edema or ocre dermatitis)
Trial locations and contacts
1 site in 1 country.
About this study
- Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis.
- Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables.
- Evaluate correlation between articular and enthesis ultrasound exam in this study.
- Compare patients and healthy individuals data, to calculate the ROC curve to estimate predictor value of disease.
- Conditions
- Spondylitis, Ankylosing
- Keywords
- ultrasound, MASEI index, clinical and ultrasound correlation, enthesis ultrasound, articular ultrasound, ankylosing spondylitis ultrasound, radiographic and ultrasound correlation
- Medical subject headings
- Spondylitis, Ankylosing
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 |
|---|---|---|
| ankylosing spondylitis | It will be held ultrasound exam in enthesis and joints in patients with ankylosing spondylitis and healthy subjects | |
| Healthy pelople | It will be held ultrasound exam in enthesis and joints of healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects
a comparative study of enthesis by ultrasound revealed statistical differences among patients with ankylosing spondylitis and healthy volunteers in analysis of calcaneal enthesis, plantar fascia and quadriceps.
Measured: december
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2012 (estimated)
- Study startMay 2009
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suellen Narimatsu, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01567878
- Sponsor's protocol ID
- 1649/09
- Status last verified
- Dec 2014
- First submitted
- 28 Mar 2012
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound of Enthesis in Patients With Ankylosing Spondylitis: a Comparative Study With Health Subjects
- ClinicalTrials.gov ID
- NCT01567878
- Acronym / sponsor ID
- 1649/09
- Conditions
- Spondylitis, Ankylosing
- Keywords
- ultrasound, MASEI index, clinical and ultrasound correlation, enthesis ultrasound, articular ultrasound, ankylosing spondylitis ultrasound, radiographic and ultrasound correlation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 30 Mar 2012 (estimated)
- 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.
- Evaluate the correlation of ultrasound MASEI index with clinical, functional, radiographic and laboratorial variables in patients with ankylosing spondylitis.
- Evaluate correlation between articular (shoulders, hips, knees and ankles) ultrasound (synovitis, erosions, power doppler) with same variables.
- Evaluate correlation between articular and enthesis ultrasound exam in this study.
- Compare patients and healthy individuals data, to calculate the ROC curve to estimate predictor value of disease.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ankylosing spondylitis | – | –It will be held ultrasound exam in enthesis and joints in patients with ankylosing spondylitis and healthy subjects |
| Healthy pelople | – | –It will be held ultrasound exam in enthesis and joints of healthy subjects |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ankylosing spondylitis healthy subjects
Key inclusion criteria (3 listed)
- Ankylosing spondylitis by the Modified New York Criteria (1984)or ASAS classification (2009)
- Healthy people with no history of joint pain, inflammatory lumbar pain inflammatory disease,
- 18 - 65 years old
Key exclusion criteria (7 listed)
- Fibromyalgia
- Corticosteroid injection in the last 3 months
- Previous surgery in joint or enthesis of study
- Peripheric neuropathy
- Diabetes mellitus
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
Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects
Time frame: december
a comparative study of enthesis by ultrasound revealed statistical differences among patients with ankylosing spondylitis and healthy volunteers in analysis of calcaneal enthesis, plantar fascia and quadriceps.
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 2 Dec 2014.
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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 Spondylitis, Ankylosing, run by University of Sao Paulo at 1 site in Brazil.
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 3 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 2 Dec 2014. 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 Brazil. 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?
Ultrasound of enthesis in patients with ankylosing spondylitis: a comparative study with healthy subjects (time frame: december). 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 2 Dec 2014.