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

Early Phase 1

• Conditions: Sleep Disturbance; Pain, Head
• Interventions: Drug: Steroids

• Registration Number: NCT03606707
• Lead Sponsor: Assiut University

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.

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.

Study Timeline

• Study Start: 2018-06-01
• Status Verified: 2018-07
• Study First Submitted: 2018-07-04
• Primary Completion: 2018-07-15
• Study First Submitted QC: 2018-07-23
• Last Update Submitted: 2018-07-23
• Study First Posted: 2018-07-31
• Last Update Posted: 2018-07-31
• Study Completion: 2018-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients with rheumatoid arthritis with MRI findings of atlantoaxial joint inflammation and failure of resolution after 2 weeks systemic steroid administration

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Exclusion Criteria

• Coagulopathy, allergy to contrast material, pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
corticosteroid	Steroids	steroid group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.

Primary Outcome Measures

Name	Time	Method
neck pain	3 months	Visual analog scale 0-10

Secondary Outcome Measures

Name	Time	Method
sleep quality	3 months	Pittsburgh sleep quality index
neck disability	3 months	Oswestry Neck Pain Questionnaire 0-50

Trial Locations

Locations (2)

Manal Hassanien; 🇪🇬 Assiut, Assuit, Egypt

Assiut governorate; 🇪🇬 Assiut, Egypt