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临床试验/NCT05983055
NCT05983055已完成不适用

Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy

Salem Anaesthesia Pain Clinic1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年1月30日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Numeric pain score, objective measurement using validated Numeric Pain Rating scale

研究概览

简要总结

Sickle cell disease (SCD) is associated with arthropathy. Arthropathy may require periarticular corticosteroid injection therapy. This observational study examines efficacy, and safety of steroid injections in SCD patients. Data collection includes patient's gender, age, race, smoking history, alcohol intake, analgesic use, pain score, sleep quality, limb joint injections, post-injection analgesia, and post-injection complication. Pain is measured using numeric pain scale. Sleep quality is measured using Likert scale.

详细描述

Sickle cell disease (SCD) is associated with arthropathy. Arthropathy causes pain which may require periarticular corticosteroid injection therapy. There is inadequate data about the suitability of steroid therapy in SCD patients. This prospective observational study examines the efficacy, and safety of periarticular steroid injections in SCD patients.

This is a cohort study of adult patients undergoing pain management at a pain clinic in Canada. Data collection includes patient's gender, age, race, smoking history, alcohol intake, analgesic usage, numeric pain score, sleep quality score, limb joint injections, post-injection analgesia, and post-injection complication. Pain is measured using numeric pain rating scale. Sleep quality is measured using the Likert Sleep scale. A change in the pain or sleep scores by 2-points is considered significant. Data are analyzed with IBM® SPSS® Statistics 25; using Student's t-test, ANOVA, Pearson Chi-square test, and regression analysis. P-value <0.05 is considered significant.

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
20 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult chronic pain patients
  • sickle cell disease arthropathy
  • periarticular steroid injection therapy
  • regular sleep diary
  • regular pain diary
  • informed consent for therapy and diary review

排除标准

  • pediatric patients
  • patient without sickle cell disease arthropathy
  • patient without periarticular steroid injection
  • irregular sleep diary
  • irregular pain diary

结局指标

主要结局

Numeric pain score, objective measurement using validated Numeric Pain Rating scale

时间窗: 12 weeks

Pain score, using the Numeric Pain Rating scale of 0 to 10, low scores indicate less pain, high scores indicate worse pain

次要结局

  • Sleep quality score, objective measurement using validated Likert sleep scale(12 weeks)

研究者

发起方
Salem Anaesthesia Pain Clinic
申办方类型
Other
责任方
Sponsor

研究点 (1)

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