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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606707
Recruitment Status : Unknown
Verified July 2018 by Manal Hassanien, Assiut University.
Recruitment status was:  Recruiting
First Posted : July 31, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Manal Hassanien, 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.

Condition or disease Intervention/treatment Phase
Pain, Head Sleep Disturbance Drug: Steroids Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : July 15, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: corticosteroid
steroid group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.
Drug: Steroids
intra-articular steroid injection for atlantoaxial joint
Other Name: cortecosteroid

No Intervention: oral steroid
systemic group, received systemic steroid 20 mg/d , in addition to methotrexate and chloroquine 400 mg per day.



Primary Outcome Measures :
  1. neck pain [ Time Frame: 3 months ]
    Visual analog scale 0-10


Secondary Outcome Measures :
  1. neck disability [ Time Frame: 3 months ]
    Oswestry Neck Pain Questionnaire 0-50

  2. sleep quality [ Time Frame: 3 months ]
    Pittsburgh sleep quality index



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606707


Contacts
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Contact: Manal Hassanien, MD 01062679200 manal_hassanien@yahoo.com
Contact: Abdelraheem Elawamy, MD 01000032655 arawamyyy@yahoo.com

Locations
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Egypt
Manal Hassanien Recruiting
Assiut, Assuit, Egypt, 71111
Contact: Manal Hassanien, MD    01062679200    manal_hassanien@yahoo.com   
Contact: Abdelraheem Elawamy, MD    01000032655    arawamyyy@yahoo.com   
Assiut governorate Recruiting
Assiut, Egypt
Contact: manal hassanien, MD    01062679200    <manal_hassanien@yahoo.com>   
Contact: MD         
Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Manal Hassanien, MD Assiut University
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Responsible Party: Manal Hassanien, principle investigaror, Assiut University
ClinicalTrials.gov Identifier: NCT03606707    
Other Study ID Numbers: Atlantoaxial injection in RA
First Posted: July 31, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Time Frame: 3 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Neck Pain
Headache
Pain
Neurologic Manifestations
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders