Vapocoolant Spray Application During Intraarticular Knee Injection

NCT ID: NCT05581433

Last Updated: 2022-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-20

Study Completion Date

2023-01-30

Brief Summary

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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

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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.

Conditions

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Osteo Arthritis Knee Injection Site Discomfort Injection Fear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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vapocoolan spray applied group before injection

Vapocoolant spray will be applied to patients in this group before intra-articular knee injection.

Group Type ACTIVE_COMPARATOR

Topical Cooling Spray

Intervention Type OTHER

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

placebospray applied group before injection

Placebo spray will be applied to patients in this group before intra-articular knee injection.

Group Type PLACEBO_COMPARATOR

Saline spray as Placebo

Intervention Type OTHER

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

No administration group before injection

In this group, no pain reliever application will be made before the application.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Saline spray as Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Rumeli University

OTHER

Sponsor Role lead

Responsible Party

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Cagdas PAMUK

Asisstant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Çağdaş Pamuk, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Rumeli University

Locations

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Private Silivri Anadolu Hospital

Istanbul, Silivri, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Çağdaş Pamuk, MD

Role: CONTACT

+905058133336

Facility Contacts

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Halil Narlı, MD

Role: primary

05543749667

Other Identifiers

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E-10840098-772.02-762

Identifier Type: -

Identifier Source: org_study_id

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