Vapocoolant Spray Application During Intraarticular Knee Injection

NCT05581433 | Unknown DMC

• 1 other identifier: E-10840098-772.02-762
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee; Injection Site Discomfort; Injection Fear

Outcome Measures

Primary Outcomes (1)

• pain during injection

  the level of pain felt when the needle is inserted

  10 seconds

Secondary Outcomes (1)

• patient satisfaction level

  10 minutes

Study Arms (3)

vapocoolan spray applied group before injection

ACTIVE COMPARATOR

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

Other: Topical Cooling Spray

placebospray applied group before injection

PLACEBO COMPARATOR

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

Other: Saline spray as Placebo

No administration group before injection

NO INTERVENTION

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

Interventions

Topical Cooling Spray OTHER

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

vapocoolan spray applied group before injection

Saline spray as Placebo OTHER

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

placebospray applied group before injection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients with osteoarthritis of the knee undergoing a normal HA injection scheduled between October 2022 and December 2022.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul Rumeli University: lead

Study Sites (1)

Private Silivri Anadolu Hospital

Istanbul, Silivri, 34040, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Iatrophobia

Study Officials

• Çağdaş Pamuk, MD

  Istanbul Rumeli University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Çağdaş Pamuk, MD

CONTACT

+905058133336; cagdaspamuk@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asisstant Professor

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: October 20, 2022
• Primary Completion: October 20, 2022
• Study Completion: January 30, 2023
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

TU (1)