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

Sleep Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03606707
• Other study ID #: Atlantoaxial injection in RA
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: Manal Hassanien, MD
• Phone: 01062679200
• Email: manal_hassanien[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 1, 2018
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Headache
• Neck Pain
• Pain, Head
• Parasomnias
• Sleep Disturbance
• Sleep Wake Disorders

Intervention

Drug:
• Steroids
intra-articular steroid injection for atlantoaxial joint

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut
Egypt	Manal Hassanien	Assiut	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neck pain	Visual analog scale 0-10	3 months
Secondary	neck disability	Oswestry Neck Pain Questionnaire 0-50	3 months
Secondary	sleep quality	Pittsburgh sleep quality index	3 months