Back to resultsthe Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis, Headache
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Radiofrequency
Steroids
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- patients suffering from upper neck pain and/or headache due to bilateral 3rd occipital nerve involvement evidenced by magnetic resonance imaging (MRI).
Exclusion Criteria:
- disc herniation with radicular pain,
- symptomatic spinal stenosis,
- surgical interventions of the cervical spine within the last 3 months,
- uncontrolled major depression or psychiatric disorders,
- heavy opioid usage
Sites / Locations
- Emad Zarief Kamel Said
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Radiofrequency
Systemic steroid
Arm Description
bilateral 3rd occipital nerve RF under fluoroscopic guidance
received systemic steroids oral prednisolone tablet, 10 mg/day.
Outcomes
Primary Outcome Measures
neck disability index score
maximum score = 50 worst paint , lowest score = no pain
Secondary Outcome Measures
Severity of headache Visual analog scale
maximum scale= 100 worst paint , lowest scale = no pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03852355
Brief Title
the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis
Official Title
the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
October 25, 2019 (Actual)
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
5. Study Description
Brief Summary
Rheumatoid arthritis is a common type of autoimmune arthritis that is characterized by inflammation of the synovial membranes. Even though any joint can be affected by the disease, cervical spine is often affected, and cervical pain is reported by 40-88% of RA patients, Cervical spine involvement is a feature of long-lasting disease, where atlantoaxial impaction with odontoid process vertical subluxation through the foramen magnum being one of the greatest and dangerous complications
Detailed Description
To our knowledge the effectiveness of 3rd occipital nerve blocks in managing chronic upper neck pain, headache in RA patients is not measured yet, so we aimed at assessing the the effectiveness of 3rd occipital nerve blocks in headache management in RA patients who used other medical agents and to compare the results with those of the patients who used only 3rd occipital nerve pulsed radiofrequancy on clinical and radiographic bases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
To our knowledge the effectiveness of 3rd occipital nerve blocks in managing chronic upper neck pain, headache in RA patients is not measured yet, so we aimed at assessing the the effectiveness of 3rd occipital nerve blocks in headache management in RA patients who used other medical agents and to compare the results with those of the patients who used only 3rd occipital nerve pulsed radiofrequancy on clinical and radiographic bases.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency
Arm Type
Active Comparator
Arm Description
bilateral 3rd occipital nerve RF under fluoroscopic guidance
Arm Title
Systemic steroid
Arm Type
Active Comparator
Arm Description
received systemic steroids oral prednisolone tablet, 10 mg/day.
Intervention Type
Drug
Intervention Name(s)
Radiofrequency
Intervention Description
), received bilateral 3rd occipital nerve RF under fluoroscopic guidance. Levobupivacaine (0.3 mL; 0.75%) and triamcilonone (1 mg) were injected at each level
Intervention Type
Drug
Intervention Name(s)
Steroids
Intervention Description
received systemic steroids oral prednisolone tablet, 10 mg/day
Primary Outcome Measure Information:
Title
neck disability index score
Description
maximum score = 50 worst paint , lowest score = no pain
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Severity of headache Visual analog scale
Description
maximum scale= 100 worst paint , lowest scale = no pain
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients suffering from upper neck pain and/or headache due to bilateral 3rd occipital nerve involvement evidenced by magnetic resonance imaging (MRI).
Exclusion Criteria:
disc herniation with radicular pain,
symptomatic spinal stenosis,
surgical interventions of the cervical spine within the last 3 months,
uncontrolled major depression or psychiatric disorders,
heavy opioid usage
Facility Information:
Facility Name
Emad Zarief Kamel Said
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis
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