the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03852355
• Other study ID #: IRB17300357
• Status: Completed
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: October 25, 2019

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 25, 2019
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Headache
• Rheumatoid Arthritis

Intervention

Drug:
• Radiofrequency
), received bilateral 3rd occipital nerve RF under fluoroscopic guidance. Levobupivacaine (0.3 mL; 0.75%) and triamcilonone (1 mg) were injected at each level
• Steroids
received systemic steroids oral prednisolone tablet, 10 mg/day

Locations

Country	Name	City	State
Egypt	Emad Zarief Kamel Said	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neck disability index score	maximum score = 50 worst paint , lowest score = no pain	6 months
Secondary	Severity of headache Visual analog scale	maximum scale= 100 worst paint , lowest scale = no pain	6 months