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

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ClinicalTrials.gov Identifier: NCT03852355
Recruitment Status : Recruiting
First Posted : February 25, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
Emad Zarief , MD, Assiut University

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Headache Drug: Radiofrequency Drug: Steroids Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. neck disability index score [ Time Frame: 6 months ]
    maximum score = 50 worst paint , lowest score = no pain


Secondary Outcome Measures :
  1. Severity of headache Visual analog scale [ Time Frame: 6 months ]
    maximum scale= 100 worst paint , lowest scale = no pain



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852355


Locations
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Egypt
Emad Zarief Kamel Said Recruiting
Assiut, Egypt, 71111
Contact: Emad Kamel, M.D.    +201007046058    emadzarief@gmail.com   
Sponsors and Collaborators
Assiut University

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Responsible Party: Emad Zarief , MD, Associate professor, Assiut University
ClinicalTrials.gov Identifier: NCT03852355     History of Changes
Other Study ID Numbers: IRB00009925
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Headache
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms