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临床试验/NCT04959721
NCT04959721Unknown不适用

The Effectiveness of Intra-articular Corticosteroid Injection in Patients With Whiplash-related Neck Pain

Min Cheol Chang2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
32
试验地点
2
主要终点
Pain after intervention to be assessed with Numeric Rating Scale

研究概览

简要总结

Objective: Cervical facet joint (CFJ) pain is commonly seen after whiplash injuries, and is frequently refractory to physical therapy and oral medication. The investigators will evaluate the effectiveness of intra-articular corticosteroid injection for managing whiplash-related CFJ pain.

Methods: The investigators will recruit 32 patients with chronic and persistent CFJ pain (≥ 3 on the Numeric Rating Scale [NRS]) despite physical therapy and oral medication. Under fluoroscopy guidance, The investigators will inject 10 mg (0.25 mL) of triamcinolone acetonide, mixed with 0.25 mL of 0.125% bupivacaine and 0.5 mL of normal saline. At 1 and 2 months after the injection, pain intensity will be reassessed using the NRS.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • history of a traffic accident
  • ≥ 3-month history of axial cervical pain after the accident without radicular symptoms
  • whiplash-associated disorder (WAD) severity of Grade II (neck complaint, decreased range of motion of neck, and point tenderness) at first hospital visit
  • failure to respond to physical therapy and oral medication (axial cervical pain of ≥ 3 on the numeric rating scale (NRS 0-10; 0, no pain; 10, worst pain imaginable)
  • ≥ 80% temporary pain relief following a diagnostic block with an intra-articular (IA) injection of 0.3 mL of 2% lidocaine

排除标准

  • presence of cervical spine fracture, coagulopathy, iodinated contrast allergy, rheumatic disorders, and any uncontrolled medical or psychiatric condition

结局指标

主要结局

Pain after intervention to be assessed with Numeric Rating Scale

时间窗: The NRS score will be assessed 2 month after the intervention

The investigators will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).

Pain before intervention to be assessed with Numeric Rating Scale

时间窗: The NRS score will be assessed the day before starting the intervention (pre-treatment).

The investigators will be assessed pain intensity using the NRS score as the primary outcome. Average pain intensity during the 24 hours before NRS assessment will be investigated. The Numeric Rating Scale (NRS) is the simplest and most commonly used numeric scale in which people rate the pain from 0 (no pain) to 10 (worst pain).

次要结局

未报告次要终点

研究者

发起方
Min Cheol Chang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Min Cheol Chang

Associate Professor

Yeungnam University College of Medicine

研究点 (2)

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