Vapocoolant Spray Application During Intraarticular Knee Injection

Osteo Arthritis Knee Clinical Trial

Official title:

Vapocoolant Spray Application During Intraarticular Knee Injection: Myth or Reality? A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05581433
• Other study ID #: E-10840098-772.02-762
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: October 2022
• Source: Istanbul Rumeli University
• Contact: Çagdas Pamuk, MD
• Phone: +905058133336
• Email: cagdaspamuk[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 30, 2023
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Injection Site Discomfort
• Osteo Arthritis Knee
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Topical Cooling Spray
The process of cooling the area to be injected with a cooling spray before the application in order to reduce the pain.
• Saline spray as Placebo
Application of saline spray without cooling effect to the area to be injected for placebo purposes

Locations

Country	Name	City	State
Turkey	Private Silivri Anadolu Hospital	Istanbul	Silivri

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Rumeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain during injection	the level of pain felt when the needle is inserted	10 seconds
Secondary	patient satisfaction level	patient satisfaction level due to the application	10 minutes