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

NCT03852355 | Completed

• 1 other identifier: IRB17300357
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis; Headache

Outcome Measures

Primary Outcomes (1)

• neck disability index score

  maximum score = 50 worst paint , lowest score = no pain

  6 months

Secondary Outcomes (1)

• Severity of headache Visual analog scale

  6 months

Study Arms (2)

Radiofrequency

ACTIVE COMPARATOR

bilateral 3rd occipital nerve RF under fluoroscopic guidance

Drug: Radiofrequency

Systemic steroid

ACTIVE COMPARATOR

received systemic steroids oral prednisolone tablet, 10 mg/day.

Drug: Steroids

Interventions

Radiofrequency DRUG

), received bilateral 3rd occipital nerve RF under fluoroscopic guidance. Levobupivacaine (0.3 mL; 0.75%) and triamcilonone (1 mg) were injected at each level

Radiofrequency

Steroids DRUG

received systemic steroids oral prednisolone tablet, 10 mg/day

Systemic steroid

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients suffering from upper neck pain and/or headache due to bilateral 3rd occipital nerve involvement evidenced by magnetic resonance imaging (MRI).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Emad Zarief Kamel Said

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Headache

Interventions

Steroids

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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 Record Dates

• First Submitted: February 22, 2019
• First Posted: February 25, 2019
• Study Start: February 25, 2019
• Primary Completion: September 10, 2019
• Study Completion: October 25, 2019
• Last Updated: July 24, 2020

Record last verified: 2020-07

Locations

EG (1)