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Clinical Trials/NCT03606707
NCT03606707UnknownEarly Phase 1

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

Assiut University2 sites in 1 country60 target enrollmentStarted: June 1, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Enrollment
60
Locations
2
Primary Endpoint
neck pain

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

corticosteroid

Experimental

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

Intervention: Steroids (Drug)

Outcomes

Primary Outcomes

neck pain

Time Frame: 3 months

Visual analog scale 0-10

Secondary Outcomes

  • sleep quality(3 months)
  • neck disability(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Manal Hassanien

principle investigaror

Assiut University

Study Sites (2)

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