Vapocoolant Spray Application During Intraarticular Knee Injection
Primary Purpose
Osteo Arthritis Knee, Injection Site Discomfort, Injection Fear
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Topical Cooling Spray
Saline spray as Placebo
Sponsored by
About this trial
This is an interventional health services research trial for Osteo Arthritis Knee
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.
Sites / Locations
- Private Silivri Anadolu HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
No Intervention
Arm Label
vapocoolan spray applied group before injection
placebospray applied group before injection
No administration group before injection
Arm Description
Vapocoolant spray will be applied to patients in this group before intra-articular knee injection.
Placebo spray will be applied to patients in this group before intra-articular knee injection.
In this group, no pain reliever application will be made before the application.
Outcomes
Primary Outcome Measures
pain during injection
the level of pain felt when the needle is inserted
Secondary Outcome Measures
patient satisfaction level
patient satisfaction level due to the application
Full Information
NCT ID
NCT05581433
First Posted
October 11, 2022
Last Updated
October 19, 2022
Sponsor
Istanbul Rumeli University
1. Study Identification
Unique Protocol Identification Number
NCT05581433
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Rumeli University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteo Arthritis Knee, Injection Site Discomfort, Injection Fear
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
vapocoolan spray applied group before injection
Arm Type
Active Comparator
Arm Description
Vapocoolant spray will be applied to patients in this group before intra-articular knee injection.
Arm Title
placebospray applied group before injection
Arm Type
Placebo Comparator
Arm Description
Placebo spray will be applied to patients in this group before intra-articular knee injection.
Arm Title
No administration group before injection
Arm Type
No Intervention
Arm Description
In this group, no pain reliever application will be made before the application.
Intervention Type
Other
Intervention Name(s)
Topical Cooling Spray
Intervention Description
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
Intervention Name(s)
Saline spray as Placebo
Intervention Description
Application of saline spray without cooling effect to the area to be injected for placebo purposes
Primary Outcome Measure Information:
Title
pain during injection
Description
the level of pain felt when the needle is inserted
Time Frame
10 seconds
Secondary Outcome Measure Information:
Title
patient satisfaction level
Description
patient satisfaction level due to the application
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Çağdaş Pamuk, MD
Phone
+905058133336
Email
cagdaspamuk@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Çağdaş Pamuk, MD
Organizational Affiliation
Istanbul Rumeli University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Silivri Anadolu Hospital
City
Istanbul
State/Province
Silivri
ZIP/Postal Code
34040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Halil Narlı, MD
Phone
05543749667
Email
halil.narli@anadoluhastaneleri.com
12. IPD Sharing Statement
Learn more about this trial
Vapocoolant Spray Application During Intraarticular Knee Injection
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