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Trial registered on ANZCTR


Registration number
ACTRN12616000750482
Ethics application status
Approved
Date submitted
5/03/2016
Date registered
7/06/2016
Date last updated
1/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy and safety of intra-articular steroid injection for inflamed atlantoaxial joint in patients with rheumatoid arthritis
Scientific title
In patients with rheumatoid arthritis and inflamed atlantoaxial joint, is intra-articular steroid injection,compared with systemic steroid administration effective and safe?
Secondary ID [1] 288693 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atlantoaxial joint arthritis in rheumatoid patients 297909 0
Condition category
Condition code
Inflammatory and Immune System 298075 298075 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(AS) group, received intra-articular steroid injection for atlantoaxial joint following failure of systemic steroids (prednisolone, oral tablet, 5 mg/3 times daily for 2 weeks) administration as part of the trial to resolve inflammation of the atlanto-axial joint assessed by MRI , (adherence to treatment is confirmed by empty drug packet return), in addition to intramuscular methotrexate 12.5 mg per week and hydroxychloroquine, oral tablet 200 mg, 2 tablets per day (regular treatment for patients with rheumatoid arthritis that continues for life).Injection technique: With the patient placed in the prone position and a pillow under the chest to allow for slight neck flexion, the C-arm is brought to the head of the table in an anteroposterior direction. The C-arm is rotated in a cephalad-caudad direction to better visualize the lateral atlantoaxial joint (AAJ). The needle insertion site is marked on the skin overlying the lateral third of the AAJ. The skin is prepped and draped in the usual sterile fashion, and a skin wheel is raised with 3 ml of lidocaine 1 % at the insertion site. Then, a 22 G 3 and 1/2 inches blunt needle is advanced towards the posterolateral aspect of the inferior margin of the inferior articular process of the atlas (C1). Then, a lateral view is obtained. The needle is withdrawn slightly, directed towards the posterolateral aspect of the (AAJ), and advanced for 2 millimetres. Usually a distinctive pop is felt signalling entering the joint cavity. After careful negative aspiration for blood or cerebrospinal fluid, 0.2 ml of omnipaque dye is injected to verify intra-articular placement of the tip of the needle under direct real-time fluoroscopy to check for inadvertent intra-arterial injection. Anteroposterior and lateral views are obtained to insure that the contrast agent remained confined to the joint cavity without escape to the surrounding structures and finally, 1.0 ml of a mixture of bupivacaine 0.5 % and 20 mg of triamcinolone is injected. The injection will be performed once (will not repeated) bilaterally ( both AAJ). The injection will be done by senior staff pain clinician.
Intervention code [1] 294119 0
Treatment: Drugs
Comparator / control treatment
(SS) group, following failure of systemic steroids (prednisolone, oral tablet, 5 mg/3 times daily for 2 weeks) as part of this trial to resolve inflammation of the atlanto-axial joint assessed by MRI, patients received systemic steroid with oral prednisolone, tablet, 5 mg, 2 tablet/8 h/ for 2 weeks tapered by 10 % reduction every 3 days as part of this trial, adherence to treatment is confirmed by empty drug packet return, in addition to intramuscular methotrexate 12.5 mg per week and hydroxychloroquine, oral tablet 200 mg, 2 tablets per day (regular treatment for patients with rheumatoid arthritis that continuess for life).
Control group
Active

Outcomes
Primary outcome [1] 297591 0
Resolution of MRI findings of inflammation of AAJ
Timepoint [1] 297591 0
after 3 month from the procedure
Primary outcome [2] 297592 0
Neck pain intensity assessed by VAS score reported by rheumatologist, on behalf of the participants.
Timepoint [2] 297592 0
every 2 weeks for 3 month following injection procedure.
Secondary outcome [1] 321521 0
Neck mobility assessed by rheumatologist using Oswestry cervical pain quetionnaire
Timepoint [1] 321521 0
every 2 weeks for 3 month following injection procedure.
Secondary outcome [2] 323425 0
Side effects of AAJ injection procedure e.g. intrathecal or epidural spread of injectate and nerve injury assessed by the injectionist (senior pain clinitian)using fluroscopy.
Timepoint [2] 323425 0
during injection and immediately following the injection

Eligibility
Key inclusion criteria
Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration
Minimum age
15 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Coagulopathy, allergy to contrast material, pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7640 0
Egypt
State/province [1] 7640 0
Assuit

Funding & Sponsors
Funding source category [1] 293051 0
Self funded/Unfunded
Name [1] 293051 0
Diab Fuad Hetta
Address [1] 293051 0
south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country [1] 293051 0
Egypt
Primary sponsor type
Individual
Name
Diab Fuad Hetta
Address
south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country
Egypt
Secondary sponsor category [1] 291830 0
None
Name [1] 291830 0
Address [1] 291830 0
Country [1] 291830 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294561 0
Ethical comittee of faculty of medicine,Assiut university
Ethics committee address [1] 294561 0
faculty of medicine, 1 university st., assuit university, assuit city,71111, egypt
Ethics committee country [1] 294561 0
Egypt
Date submitted for ethics approval [1] 294561 0
10/02/2016
Approval date [1] 294561 0
01/03/2016
Ethics approval number [1] 294561 0
ASSMED20161125

Summary
Brief summary
Rheumatoid arthritis is a chronic inflammatory disease involving multiple joints. The cervical spine is often affected, and cases involving atlantoaxial joint can lead to instability. Anterior atlantoaxial subluxation in RA patients can lead to posterior neck pain or occipital headache. intraarticular steroid injection of AAJ could stop the joint destruction
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64154 0
Dr Diab Fuad Hetta
Address 64154 0
south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 64154 0
Egypt
Phone 64154 0
+201091090009
Fax 64154 0
Email 64154 0
diabhetta25@gmail.com
Contact person for public queries
Name 64155 0
Dr Diab Fuad Hetta
Address 64155 0
south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 64155 0
Egypt
Phone 64155 0
+201091090009
Fax 64155 0
Email 64155 0
diabhetta25@gmail.com
Contact person for scientific queries
Name 64156 0
Dr Diab Fuad Hetta
Address 64156 0
south egypt cancer institute, 2 el methaque st., assuit university, assuit city, 71111, egypt
Country 64156 0
Egypt
Phone 64156 0
+201091090009
Fax 64156 0
Email 64156 0
diabhetta25@gmail.com

No information has been provided regarding IPD availability
Summary results
No Results