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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

Tracking Information
First Submitted Date  ICMJE February 22, 2019
First Posted Date  ICMJE February 25, 2019
Last Update Posted Date March 22, 2019
Actual Study Start Date  ICMJE February 25, 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
neck disability index score [ Time Frame: 6 months ]
maximum score = 50 worst paint , lowest score = no pain
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
neck disability index [ Time Frame: 6 months ]
maximum score = 50 worst paint , lowest score = no pain
Change History Complete list of historical versions of study NCT03852355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
Severity of headache Visual analog scale [ Time Frame: 6 months ]
maximum scale= 100 worst paint , lowest scale = no pain
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2019)
Severity of headache Visual analog scale [ Time Frame: 6 months ]
maximum score = 100 worst paint , lowest score = no pain
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis
Official Title  ICMJE the Effectiveness of 3rd Occipital Radiofrequency Versus Systemic Steroid in Headache Management in Rheumatoid Arthritis; a Randomized Controlled Trial
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
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Rheumatoid Arthritis
  • Headache
Intervention  ICMJE
  • 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
  • Drug: Steroids
    received systemic steroids oral prednisolone tablet, 10 mg/day
Study Arms  ICMJE
  • Active Comparator: Radiofrequency
    bilateral 3rd occipital nerve RF under fluoroscopic guidance
    Intervention: Drug: Radiofrequency
  • Active Comparator: Systemic steroid
    received systemic steroids oral prednisolone tablet, 10 mg/day.
    Intervention: Drug: Steroids
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 22, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03852355
Other Study ID Numbers  ICMJE IRB00009925
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Emad Zarief , MD, Assiut University
Study Sponsor  ICMJE Assiut University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Assiut University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP