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

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Headache
• Intervention / Treatment: Drug: Radiofrequency; Drug: Steroids

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Emad Zarief Kamel Said

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiofrequency; bilateral 3rd occipital nerve RF under fluoroscopic guidance	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
Active Comparator: Systemic steroid; received systemic steroids oral prednisolone tablet, 10 mg/day.	Drug: Steroids; received systemic steroids oral prednisolone tablet, 10 mg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
neck disability index score	maximum score = 50 worst paint , lowest score = no pain	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of headache Visual analog scale	maximum scale= 100 worst paint , lowest scale = no pain	6 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Actual): September 10, 2019
• Study Completion (Actual): October 25, 2019

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 23, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Headache
• Other Study ID Numbers: IRB17300357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No