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临床试验/NCT03534531
NCT03534531已完成不适用

Prospective Observational Trial of Intra-Articular Cervical Zygapophyseal Joint Corticosteroid Injections in Patients With Increased Peri-Zygapophyseal Joint MRI Short Tau Inversion Recovery Signal

Stanford University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Change in Numeric Pain Rating Scale

研究概览

简要总结

The purpose of this study is to determine if cortisone shots in the neck are helpful in patients with certain MRI findings. Additionally, the investigators hope to learn if cervical facet joint steroid injections are beneficial in the subset of patients with MRI findings consistent with facet joint synovitis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • at least 18 years old
  • Patient who will be getting a neck cortisone shot for pain that has been there for at least 4 weeks
  • A specific MRI finding (increased Short Tau Inversion Recovery signal) around 1 or more of the joints in the neck

排除标准

  • Those receiving disability, worker's compensation, or are involved in litigation related to their pain.
  • Those unable to read English and complete the assessment instruments.
  • Those unable to attend follow up appointments
  • The patient is incarcerated.
  • Grade 2 or greater spondylolisthesis at the involved or adjacent segments.
  • History of prior posterior cervical surgery. Anterior cervical surgery is not an exclusion criteria.
  • Progressive motor deficit, and/or clinical signs of myelopathy.
  • Prior neck cortisone shots within the past 6 months.
  • Possible pregnancy or other reason that precludes the use of fluoroscopy.
  • Allergy to contrast media or local anesthetics.
  • Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
  • Active infection or treatment of infection with antibiotics within the past 7 days.
  • Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
  • Addictive behavior, severe clinical depression, or psychotic features.

结局指标

主要结局

Change in Numeric Pain Rating Scale

时间窗: Baseline, 2-4 weeks, and 3 months

0 to 10 scale grading severity of pain

次要结局

  • Global Assessment of Change(2-4 weeks and 3 months)
  • Use of other treatments(Baseline, 2-4 weeks, and 3 months)
  • Neck Disability Index(Baseline, 2-4 weeks, and 3 months)
  • Work status(Baseline, 2-4 weeks, and 3 months)
  • Medication use(Baseline, 2-4 weeks, and 3 months)

研究者

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

Joshua Levin

Clinical Assistant Professor

Stanford University

研究点 (2)

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