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临床试验/NCT05862454
NCT05862454招募中不适用

Magnesium Injection Ensures Analgesia and Steroid Avoidance During Vaccination, Viremia or Immunocompromise

Salem Anaesthesia Pain Clinic1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年7月2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
招募中
发起方
入组人数
150
试验地点
1
主要终点
Pain score, objective measurement using the validated Numeric Pain Rating scale

研究概览

简要总结

Steroid injections are used for interventional pain management. However, their side-effect of immunosuppression may increase the risk of infections. Magnesium is an alternative anti-nociceptive injection that may be used instead of steroids.

Prospective observational study of patients who received magnesium injection for interventional pain therapy, instead of steroid injection. Post-injection data collection includes numerical rating pain score, and sleep quality score. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant.

详细描述

Corticosteroid injections are used for interventional pain management. The immunosuppression effect of steroid injection may increase the risk of infections. Magnesium is an alternative anti-nociceptive agent that may be used for interventional pain injection therapy, instead of steroids.

Prospective observational clinical study of pain clinic patients who received magnesium injection for interventional pain therapy, instead of steroid injection. Post-injection data collection includes numerical rating pain score, and sleep quality score. Pain is measured using the numeric pain rating scale. Sleep score is measured using the Likert sleep scale. A change in the pain or sleep scores by 2-points is considered significant. Data analyzed with IBM® SPSS® Statistics 25 (IBM Corp, Armonk, NY); 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
  • previous interventional injection therapy
  • consent for interventional injection therapy
  • good treatment compliance
  • regular sleep diary
  • regular pain diary
  • informed consent for diary review
  • consent for clinical record quality assurance review

排除标准

  • organ insufficiency
  • cognitive disorder
  • inability to provide consent
  • major neuropsychiatric disorder
  • unreliable diary
  • poor treatment compliance
  • previous adverse/allergic reactions to magnesium

研究组 & 干预措施

Adult chronic pain patients

Cohort of adult chronic pain patients, undergoing interventional injection therapy for pain management at a Canadian pain clinic

干预措施: Magnesium (Drug)

结局指标

主要结局

Pain score, objective measurement using the 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 the 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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