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

NCT ID: NCT03852355

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-25

Study Completion Date

2019-10-25

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Radiofrequency

bilateral 3rd occipital nerve RF under fluoroscopic guidance

Group Type ACTIVE_COMPARATOR

Radiofrequency

Intervention Type 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

Systemic steroid

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

Group Type ACTIVE_COMPARATOR

Steroids

Intervention Type DRUG

received systemic steroids oral prednisolone tablet, 10 mg/day

Interventions

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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

Intervention Type DRUG

Steroids

received systemic steroids oral prednisolone tablet, 10 mg/day

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Emad Zarief , MD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emad Zarief Kamel Said

Asyut, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IRB17300357

Identifier Type: -

Identifier Source: org_study_id

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