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Vapocoolant Spray Application During Intraarticular Knee Injection

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05581433
Enrollment
150
Registered
2022-10-14
Start date
2022-10-20
Completion date
2023-01-30
Last updated
2022-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injection Fear, Injection Site Discomfort, Osteo Arthritis Knee

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.

Interventions

OTHERTopical Cooling Spray

The process of cooling the area to be injected with a cooling spray before the application in order to reduce the pain.

OTHERSaline spray as Placebo

Application of saline spray without cooling effect to the area to be injected for placebo purposes

Sponsors

Istanbul Rumeli University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
pain during injection10 secondsthe level of pain felt when the needle is inserted

Secondary

MeasureTime frameDescription
patient satisfaction level10 minutespatient satisfaction level due to the application

Countries

Turkey (Türkiye)

Contacts

Primary ContactÇağdaş Pamuk, MD
cagdaspamuk@hotmail.com+905058133336

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026