Clinical trial NCT05581433: Vapocoolant Spray Application During Intraarticular Knee Injection
Official title: Vapocoolant Spray Application During Intraarticular Knee Injection: Myth or Reality? A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteo Arthritis Knee
Injection Site Discomfort
Injection Fear
Lead sponsor: Istanbul Rumeli University
Sponsor class: OTHER
First posted: 2022-10-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pain during injection
timeFrame: 10 seconds
Secondary outcomes:
measure: patient satisfaction level
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Private Silivri Anadolu Hospital
state: Silivri
Study officials:
affiliation: Istanbul Rumeli University
name: Çağdaş Pamuk, MD
role: PRINCIPAL_INVESTIGATOR
References: