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

Primary Purpose

Pain, Head, Sleep Disturbance

Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Steroids
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Head

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manal HassanienRecruiting
  • Assiut governorateRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

corticosteroid

oral steroid

Arm Description

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

systemic group, received systemic steroid 20 mg/d , in addition to methotrexate and chloroquine 400 mg per day.

Outcomes

Primary Outcome Measures

neck pain
Visual analog scale 0-10

Secondary Outcome Measures

neck disability
Oswestry Neck Pain Questionnaire 0-50
sleep quality
Pittsburgh sleep quality index

Full Information

First Posted
July 4, 2018
Last Updated
July 23, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03606707
Brief Title
Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients
Official Title
Efficacy of Fluoroscopic Guided Atlantoaxial Joint Injection on Head and Neck Pain and Sleep Quality in RA Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
August 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Head, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
corticosteroid
Arm Type
Experimental
Arm Description
steroid group, received intra-articular steroid injection for atlantoaxial joint. , in addition to methotrexate and chloroquine 400 mg per day.
Arm Title
oral steroid
Arm Type
No Intervention
Arm Description
systemic group, received systemic steroid 20 mg/d , in addition to methotrexate and chloroquine 400 mg per day.
Intervention Type
Drug
Intervention Name(s)
Steroids
Other Intervention Name(s)
cortecosteroid
Intervention Description
intra-articular steroid injection for atlantoaxial joint
Primary Outcome Measure Information:
Title
neck pain
Description
Visual analog scale 0-10
Time Frame
3 months
Secondary Outcome Measure Information:
Title
neck disability
Description
Oswestry Neck Pain Questionnaire 0-50
Time Frame
3 months
Title
sleep quality
Description
Pittsburgh sleep quality index
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manal Hassanien, MD
Phone
01062679200
Email
manal_hassanien@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Abdelraheem Elawamy, MD
Phone
01000032655
Email
arawamyyy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Hassanien, MD
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manal Hassanien
City
Assiut
State/Province
Assuit
ZIP/Postal Code
71111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal Hassanien, MD
Phone
01062679200
Email
manal_hassanien@yahoo.com
First Name & Middle Initial & Last Name & Degree
Abdelraheem Elawamy, MD
Phone
01000032655
Email
arawamyyy@yahoo.com
Facility Name
Assiut governorate
City
Assiut
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
manal hassanien, MD
Phone
01062679200
Email
<manal_hassanien@yahoo.com>
First Name & Middle Initial & Last Name & Degree
MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
3 months

Learn more about this trial

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

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