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临床试验/NCT06651788
NCT06651788招募中不适用

Does "Freeze Spray" Work? Evaluating the Efficacy of Ethyl Chloride Usage Prior to Orthopaedic Injections

University of Chicago2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores before injection

研究概览

简要总结

A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. While these injections have demonstrated effectiveness in alleviating symptoms, the discomfort associated with the procedure can be a source of anxiety and apprehension for patients. This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution.

详细描述

A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. While these injections have demonstrated effectiveness in alleviating symptoms, the discomfort associated with the procedure can be a source of anxiety and apprehension for patients. This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution.

In response to this concern, orthopaedic providers have turned to freeze sprays (Ethyl chloride), which are topical anesthetics that rapidly cool the skin and underlying tissues. By numbing the injection site superficially, freeze sprays offer the potential to mitigate patient discomfort during corticosteroid injections, thus improving the overall patient experience and potentially enhancing treatment compliance.

However, despite the popularity of freeze spray usage in orthopaedics, many orthopaedic providers have concerns about its efficacy when it comes to providing pain relief. There still needs to be comprehensive scientific evidence evaluating its efficacy and safety. A previous study evaluated the efficacy of freeze spray in hand surgery in a randomized study of 150 subjects without standardized outcomes measures. These investigators showed no difference between those receiving freeze spray vs no spray in pain or anxiety; another study of vapocoolant spray in IV start sites in the emergency department similarly showed no difference in pain or anxiety. Based on the literature, there is no definitive standard of care to use freeze spray with injections and this is the gap in knowledge we wish to answer with a rigorous, placebo-controlled study. This study will differ from the previous similar study in that the investigators will recruit double the number of patients and use standardized commonly accepted questionnaires. The use of a questionnaire based on standardized metrics will provide a more comprehensive assessment of patient perceptions and satisfaction with the use of freeze spray. Through a rigorous research approach, the investigators aim to provide valuable insights into the impact of freeze spray on patient comfort, injection success rates, and any potential complications associated with its use.

This study will contribute to the ongoing efforts of hand surgeons to refine their techniques, minimize patient discomfort, and optimize the delivery of corticosteroid injections. Ultimately, the investigators' findings may have significant implications for the broader field of musculoskeletal medicine, offering evidence-based guidance to improve the patient experience and outcomes in orthopaedic surgery.

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
Double (Participant, Care Provider)

盲法说明

The study will be double-blinded to minimize bias. After selection into either spray group the cans will be disguised only showing a number 1 or number 2.

Given that the freeze spray is a skin refrigerant, the saline placebo will be refrigerated to mimic the temperature on the skin. The freeze spray is odorless, as is saline, so should not pose a different in smell experience. Neither the participants or physicians will be unblinded at any point; the unblinded investigator will be the only person with access to unblinded data..

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

  • 18 years and older
  • Receiving a corticosteroid injection in an upper or lower extremity (to include soft tissue and joint injections) for the first time

排除标准

  • Patients with previous injection experiences

研究组 & 干预措施

Placebo application of cold saline spray

Placebo Comparator

Saline spray before injection

干预措施: Cold Saline Spray (Other)

No spray prior to injection

No Intervention

No intervention before injection

Freeze spray group

Experimental

Ethyl Chloride Usage Prior to Orthopaedic Injections

干预措施: Ethyl Chloride (Other)

结局指标

主要结局

To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores before injection

时间窗: 10 minutes before subject receives injection

Using the visual analog pain scale (0 no pain - 10 worst possible pain) to ask patients their pain rating and if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure.

To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores after injeciton

时间窗: 10 minutes after subject receives injection

Using the visual analog pain scale (0 no pain - 10 worst possible pain) to ask patients their pain rating and if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure.

To assess patient perception of freeze spray efficacy in decreasing anxiety regarding injections.

时间窗: 10 minutes after subject receives injection

Using the treatment satisfaction questionnaire for medication-II to ask patients their anxiety and if freeze spray usage before corticosteroid injections significantly reduces patient anxiety during the procedure.

To assess their current overall status compared to their pre-injection baseline

时间窗: 10 minutes after subject receives injection

Using the single assessment numeric evaluation (0% furthest from normal and 100% normal) to ask patients their current status

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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