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临床试验/NCT03852355
NCT03852355已完成不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年2月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
neck disability index score

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Radiofrequency

Active Comparator

bilateral 3rd occipital nerve RF under fluoroscopic guidance

干预措施: Radiofrequency (Drug)

Systemic steroid

Active Comparator

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

干预措施: Steroids (Drug)

结局指标

主要结局

neck disability index score

时间窗: 6 months

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

次要结局

  • Severity of headache Visual analog scale(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emad Zarief , MD

Associate professor

Assiut University

研究点 (1)

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