Vapocoolant Spray Application During Intraarticular Knee Injection: Myth or Reality? A Prospective Randomized Controlled Trial
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
- 2
- 主要终点
- pain during injection
研究概览
简要总结
The goal of this observational study is to learn about the effects of vapocoolant spray applied during intraarticular knee injections on pain and anxiety compared to injections without any agent application in patients with knee osteoarthritis.
The main questions it aims to answer are: • Contrary to popular belief, does coolant spray application really reduce pain? • Does it have an advantage over patients with placebo or no spray at all? After intraarticular knee hyaluronic acid application, patients will be asked to indicate injection-related pain and anxiety levels on a 100mm visual analog scale. Researchers will compare the patient groups who were applied coolant spray, placebo spray and injection without any spray.
详细描述
Patients who underwent intra-knee hyaluronic acid injection due to knee degenerative diseases (osteoarthritis), meniscus and cartilage problems between October 2022 and December 2022 will be prospectively included in the study. Demographic characteristics of the patients (age, gender, body mass index), degree of knee degeneration, and past surgical procedures will be recorded.
Before intra-articular injection can be given, one group will be sprayed with a vapocoolant, and one group will receive a placebo spray, while another group will receive no analgesic treatment while injection. Which patient will be evaluated in which group will be decided by randomization on the website www.random.org.
1 minute after the injection, the patients will be asked to indicate their pain level (1) and anxiety level (2) while inserting the needle on the 100mm Visual Analogue Scale (VAS). The same survey will be repeated after 10 minutes, and whether they are satisfied with the whole process will be measured with the same scale and the results will be recorded. The results will be compared between the groups, and the demographic characteristics of the patients, the level and types of disease, and the effects of vapocoolant spray application will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with osteoarthritis of the knee undergoing a normal HA injection scheduled between October 2022 and December 2022.
排除标准
- •Prior history of injection of the knee joint
- •Inability to understand the Visual Analog Scale,
- •History of cold intolerance
- •Use of pain medications or topical anesthetics within the previous 24 hours
- •Abnormal sensation or signs of infection over the injection site.
结局指标
主要结局
pain during injection
时间窗: 10 seconds
the level of pain felt when the needle is inserted
次要结局
- patient satisfaction level(10 minutes)
研究者
Cagdas PAMUK
Asisstant Professor
Istanbul Rumeli University