Vapocoolant Spray Application During Intraarticular Knee Injection

Not Applicable

Recruiting

• Conditions: Injection Fear; Osteo Arthritis Knee; Injection Site Discomfort
• Interventions: Other: Topical Cooling Spray; Other: Saline spray as Placebo

• Registration Number: NCT05581433
• Lead Sponsor: Istanbul Rumeli University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-14
• Last Update Submitted: 2022-10-19
• Study Start: 2022-10-20
• Primary Completion: 2022-10-20
• Last Update Posted: 2022-10-21
• Study Completion: 2023-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• The patients with osteoarthritis of the knee undergoing a normal HA injection scheduled between October 2022 and December 2022.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vapocoolan spray applied group before injection	Topical Cooling Spray	Vapocoolant spray will be applied to patients in this group before intra-articular knee injection.
placebospray applied group before injection	Saline spray as Placebo	Placebo spray will be applied to patients in this group before intra-articular knee injection.

Primary Outcome Measures

Name	Time	Method
pain during injection	10 seconds	the level of pain felt when the needle is inserted

Secondary Outcome Measures

Name	Time	Method
patient satisfaction level	10 minutes	patient satisfaction level due to the application

Trial Locations

Locations (1)

Private Silivri Anadolu Hospital; 🇹🇷 Istanbul, Silivri, Turkey