Neck PainMRINCT02774070
Characteristics of Rheumatoid Arthritis Patients With Atlantoaxial Synovitis Detected by Plain X-ray and MRI
A study testing Plain X-ray and Magnetic resonance imaging in people with Neck Pain, run by Assiut University.
Trial summary
This study detects the presence of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients revealed by plain X-ray and magnetic resonance imaging of the cervical spine Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Plain X-ray and Magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Feb 2017
- Phase
- Interventional
- 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
Who may be able to join
- Rheumatoid arthritis patients complaining or not complaining of atlantoaxial affection symptomatology
Who cannot join
- Pregnant females
- Patients with pacemakers or metallic bony plates.
- Patients that have claustrophobia
About this study
Official title: Characteristics of Rheumatoid Arthritis Patients With Asymptomatic Versus Symptomatic Atlantoaxial Joint Affection Detected by Plain X-ray and Magnetic Resonance Imaging
This study detects the presence of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients revealed by plain X-ray and magnetic resonance imaging of the cervical spine
Read the detailed description
Atlantoaxial joint affection in rheumatoid arthritis patients may have life-threatening complications if not detected early. It may not be detected unless it becomes symptomatic. However, asymptomatic atlantoaxial joint affection is not uncommon. Investigators will try to detect atlantoaxial joint affection at an early stage and its relation to symptomatology and other disease criteria. So investigators will use conventional plain X-ray examination combined with magnetic resonance imaging of the cervical spine to detect soft tissue as well as bony changes of this condition.
- Conditions
- Neck Pain
- Being tested
- Plain X-ray, Magnetic resonance imaging
- Keywords
- AAJ RA MRI synovitis
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plain X-rayRadiation
antero-posterior, lateral neutral, flexion, extension and open-mouth views
Magnetic resonance imagingRadiation
Magnetic resonance imaging sagittal T1W,T2W and STIR, axial T1W and coronal T2W and post contrast sagittal and axial sequences
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic atlantoaxial joint affection | Other | Undergo plain X-ray and magnetic resonance imaging Receives: Radiation: Plain X-ray; Radiation: Magnetic resonance imaging |
| Asymptomatic atlantoaxial joint aff. | Other | Undergo plain X-ray and magnetic resonance imaging Receives: Radiation: Plain X-ray; Radiation: Magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevelance of atlantoaxial joint affection in clinically and laboratory proven rheumatoid arthritis patients
Prevelance of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017 (estimated)
- Study completionFeb 2017 (estimated)
Why it stopped: No financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nisreen Adel Abbas, Assiut University
- Investigators
- Nisreen A Abbas, Doctor, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774070
- Sponsor's protocol ID
- Rheumatoid AAJ
- Acronym
- MRI
- Status last verified
- Jan 2020
- First submitted
- 11 May 2016
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Yurube T, Sumi M, Nishida K, Miyamoto H, Kohyama K, Matsubara T, Miura Y, Hirata H, Sugiyama D, Doita M. Accelerated development of cervical spine instabilities in rheumatoid arthritis: a prospective minimum 5-year cohort study. PLoS One. 2014 Feb 18;9(2):e88970. doi: 10.1371/journal.pone.0088970. eCollection 2014.
PubMed 24558457Nazarinia M, Jalli R, Kamali Sarvestani E, Farahangiz S, Ataollahi M. Asymptomatic atlantoaxial subluxation in rheumatoid arthritis. Acta Med Iran. 2014;52(6):462-6.
PubMed 25130155
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Rheumatoid Arthritis Patients With Asymptomatic Versus Symptomatic Atlantoaxial Joint Affection Detected by Plain X-ray and Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT02774070
- Acronym / sponsor ID
- MRI / Rheumatoid AAJ
- Conditions
- Neck Pain
- Keywords
- AAJ RA MRI synovitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No financial support
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 17 May 2016 (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.
This study detects the presence of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients revealed by plain X-ray and magnetic resonance imaging of the cervical spine
Detailed description
Atlantoaxial joint affection in rheumatoid arthritis patients may have life-threatening complications if not detected early. It may not be detected unless it becomes symptomatic. However, asymptomatic atlantoaxial joint affection is not uncommon. Investigators will try to detect atlantoaxial joint affection at an early stage and its relation to symptomatology and other disease criteria. So investigators will use conventional plain X-ray examination combined with magnetic resonance imaging of the cervical spine to detect soft tissue as well as bony changes of this condition.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic atlantoaxial joint affection | Other | Radiation: Plain X-ray, Radiation: Magnetic resonance imagingUndergo plain X-ray and magnetic resonance imaging |
| Asymptomatic atlantoaxial joint aff. | Other | Radiation: Plain X-ray, Radiation: Magnetic resonance imagingUndergo plain X-ray and magnetic resonance imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Rheumatoid arthritis patients complaining or not complaining of atlantoaxial affection symptomatology
Key exclusion criteria (3 listed)
- Pregnant females
- Patients with pacemakers or metallic bony plates.
- Patients that have claustrophobia
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 |
|---|---|---|
| Plain X-rayantero-posterior, lateral neutral, flexion, extension and open-mouth views | Radiation | Asymptomatic atlantoaxial joint aff., Symptomatic atlantoaxial joint affection |
| Magnetic resonance imagingMagnetic resonance imaging sagittal T1W,T2W and STIR, axial T1W and coronal T2W and post contrast sagittal and axial sequences | Radiation | Asymptomatic atlantoaxial joint aff., Symptomatic atlantoaxial joint affection |
Primary outcome
Prevelance of atlantoaxial joint affection in clinically and laboratory proven rheumatoid arthritis patients
Time frame: 3 months
Prevelance of atlantoaxial joint affection in symptomatic versus asymptomatic rheumatoid arthritis patients
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Background: PubMed 24558457Yurube T, Sumi M, Nishida K, Miyamoto H, Kohyama K, Matsubara T, Miura Y, Hirata H, Sugiyama D, Doita M. Accelerated development of cervical spine instabilities in rheumatoid arthritis: a prospective minimum 5-year cohort study. PLoS One. 2014 Feb 18;9(2):e88970. doi: 10.1371/journal.pone.0088970. eCollection 2014.
- Background: PubMed 25130155Nazarinia M, Jalli R, Kamali Sarvestani E, Farahangiz S, Ataollahi M. Asymptomatic atlantoaxial subluxation in rheumatoid arthritis. Acta Med Iran. 2014;52(6):462-6.
- 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.
Nisreen A Abbas, Doctor principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Plain X-ray and Magnetic resonance imaging in people with Neck Pain, run by Assiut University.
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 1 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: withdrawn, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Prevelance of atlantoaxial joint affection in clinically and laboratory proven rheumatoid arthritis patients (time frame: 3 months). 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 NCT02774070, which also lists 2 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 14 Jan 2020.