Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients
1 other identifier
interventional
60
1 country
2
Brief Summary
Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint in patients with rheumatoid arthritis Inclusion criteria Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration Exclusion criteria Coagulopathy, allergy to contrast material, pregnancy Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jun 2018
Shorter than P25 for early_phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJuly 31, 2018
July 1, 2018
1 month
July 4, 2018
July 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
neck pain
Visual analog scale 0-10
3 months
Secondary Outcomes (2)
neck disability
3 months
sleep quality
3 months
Study Arms (2)
corticosteroid
EXPERIMENTALsteroid group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.
oral steroid
NO INTERVENTIONsystemic group, received systemic steroid 20 mg/d , in addition to methotrexate and chloroquine 400 mg per day.
Interventions
intra-articular steroid injection for atlantoaxial joint
Eligibility Criteria
You may qualify if:
- Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration
You may not qualify if:
- Coagulopathy, allergy to contrast material, pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Manal Hassanien
Asyut, Assuit, 71111, Egypt
Assiut governorate
Asyut, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manal Hassanien, MD
Assiut University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigaror
Study Record Dates
First Submitted
July 4, 2018
First Posted
July 31, 2018
Study Start
June 1, 2018
Primary Completion
July 15, 2018
Study Completion
August 1, 2018
Last Updated
July 31, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 3 months
Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint in patients with rheumatoid arthritis Inclusion criteria Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration Exclusion criteria Coagulopathy, allergy to contrast material, pregnancy Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.