Vapocoolant Spray Application During Intraarticular Knee Injection

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteo Arthritis Knee; Injection Site Discomfort; Injection Fear
• Intervention / Treatment: Other: Topical Cooling Spray; Other: Saline spray as Placebo

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 Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Çağdaş Pamuk, MD; Phone Number: +905058133336; Email: cagdaspamuk@hotmail.com

Study Locations

• Turkey
  • Silivri
    • Istanbul, Silivri, Turkey, 34040
      • Recruiting
      • Private Silivri Anadolu Hospital
      • Contact: Halil Narlı, MD; Phone Number: 05543749667; Email: halil.narli@anadoluhastaneleri.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: vapocoolan spray applied group before injection; Vapocoolant spray will be applied to patients in this group before intra-articular knee injection.	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.
Placebo Comparator: placebospray applied group before injection; Placebo spray will be applied to patients in this group before intra-articular knee injection.	Other: Saline spray as Placebo; Application of saline spray without cooling effect to the area to be injected for placebo purposes
No Intervention: No administration group before injection; In this group, no pain reliever application will be made before the application.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain during injection	the level of pain felt when the needle is inserted	10 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient satisfaction level	patient satisfaction level due to the application	10 minutes

Collaborators and Investigators

• Sponsor: Istanbul Rumeli University
• Investigators: Principal Investigator: Çağdaş Pamuk, MD, Istanbul Rumeli University

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2022
• Primary Completion (Actual): October 20, 2022
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 12, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 21, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: E-10840098-772.02-762

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No