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临床试验/NCT05438277
NCT05438277已完成4 期

Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)

Campbell Clinic1 个研究点 分布在 1 个国家目标入组 421 人开始时间: 2020年1月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
421
试验地点
1
主要终点
Incidence of a Flare Reaction

研究概览

简要总结

Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.

详细描述

Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space.

Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.

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
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subacromial or glenohumeral shoulder pain to be treated with steroid injection
  • Fluent in written and oral English
  • Willing and able to provide written consent
  • Willing to complete follow up pain scores (visual analog score)

排除标准

  • Unable to provide written consent
  • Chronic pain syndrome
  • Unwilling to complete follow up pain scores (visual analog score)

研究组 & 干预措施

methylprednisolone acetate (MPA)

Experimental

subacromial or glenohumeral shoulder injection

干预措施: Methylprednisolone (MPA) (Drug)

triamcinolone acetonide (TA)

Active Comparator

subacromial or glenohumeral shoulder injection

干预措施: Triamcinolone Acetonide (TA) (Drug)

结局指标

主要结局

Incidence of a Flare Reaction

时间窗: Post-injection day 1 through 7

A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain.

次要结局

未报告次要终点

研究者

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

Tyler J. Brolin

Principal Investigator

Campbell Clinic

研究点 (1)

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