Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients

NCT03606707 — Early Phase 1, Unknown, 60 participants, Assiut University

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Registry	NCT03606707
Status	Unknown
Phase	Early Phase 1
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	60 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Pain, Head, Sleep Disturbance
Interventions	Steroids (Drug)
Dates	start 2018-06-01, primary completion 2018-07-15, completion 2018-08-01 (estimated), first posted 2018-07-31, last updated 2018-07-31
Locations	2 sites in Egypt

-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.

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+Detailed description

Efficacy of intra-articular steroid injection for inflamed atlantoaxial joint on sleep quality and head and neck pain 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 Interventional group (AS) group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

+Arms and interventions

Arm	Type	Interventions	Description
corticosteroid	Experimental	Drug: Steroids	steroid group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.
oral steroid	No intervention		systemic group, received systemic steroid 20 mg/d , in addition to methotrexate and chloroquine 400 mg per day.

Steroids (Drug), also known as cortecosteroid: intra-articular steroid injection for atlantoaxial joint

+Outcome measures

Primary outcomes

neck pain [3 months]: Visual analog scale 0-10

Secondary outcomes

neck disability [3 months]: Oswestry Neck Pain Questionnaire 0-50
sleep quality [3 months]: Pittsburgh sleep quality index

+Eligibility

Sex: All, ages: 20 Years to 80 Years

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

+Locations (2)

Facility	City	Country	Status
Manal Hassanien	Asyut, Assuit	Egypt	Recruiting
Assiut governorate	Asyut	Egypt	Recruiting

+Investigators

Manal Hassanien, MD, Principal investigator, Assiut University

My Notes

Public

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