Osteo Arthritis KneeNCT05581433
Vapocoolant Spray Application During Intraarticular Knee Injection
A study testing Topical Cooling Spray in people with Osteo Arthritis Knee and Injection Site Discomfort, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Osteo Arthritis Knee, Injection Site Discomfort, Injection Fear
- What is being tested?
- Topical Cooling Spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2022to 30 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients with osteoarthritis of the knee undergoing a normal HA injection scheduled between October 2022 and December 2022.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Private Silivri Anadolu Hospital
Istanbul, Silivri, 34040
Halil Narlı, MD, 05543749667, halil.narli@anadoluhastaneleri.com
About this study
Official title: Vapocoolant Spray Application During Intraarticular Knee Injection: Myth or Reality? A Prospective Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Topical Cooling Spray, Saline spray as Placebo
- Medical subject headings
- Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Cooling SprayOther
The process of cooling the area to be injected with a cooling spray before the application in order to reduce the pain.
Saline spray as PlaceboOther
Application of saline spray without cooling effect to the area to be injected for placebo purposes
| Study group | Role | What they receive |
|---|---|---|
| vapocoolan spray applied group before injection | Active comparator | Vapocoolant spray will be applied to patients in this group before intra-articular knee injection. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain during injection
the level of pain felt when the needle is inserted
Measured: 10 seconds
Secondary outcomes (1)
patient satisfaction level
patient satisfaction level due to the application
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start20 Oct 2022
- Primary completion20 Oct 2022
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Rumeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas PAMUK, Istanbul Rumeli University
- Investigators
- Çağdaş Pamuk, MD, Principal investigator, Istanbul Rumeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581433
- Sponsor's protocol ID
- E-10840098-772.02-762
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2022
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vapocoolant Spray Application During Intraarticular Knee Injection: Myth or Reality? A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05581433
- Acronym / sponsor ID
- E-10840098-772.02-762
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istanbul Rumeli UniversityUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 20 Oct 2022 (actual)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 14 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vapocoolan spray applied group before injection | Active comparator | Other: Topical Cooling SprayVapocoolant spray will be applied to patients in this group before intra-articular knee injection. |
| placebospray applied group before injection | Placebo comparator | Other: Saline spray as PlaceboPlacebo spray will be applied to patients in this group before intra-articular knee injection. |
| No administration group before injection | No intervention | –In this group, no pain reliever application will be made before the application. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The patients with osteoarthritis of the knee undergoing a normal HA injection scheduled between October 2022 and December 2022.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Cooling SprayThe process of cooling the area to be injected with a cooling spray before the application in order to reduce the pain. | Other | vapocoolan spray applied group before injection |
| Saline spray as PlaceboApplication of saline spray without cooling effect to the area to be injected for placebo purposes | Other | placebospray applied group before injection |
Primary outcome
pain during injection
Time frame: 10 seconds
the level of pain felt when the needle is inserted
1 secondary outcome
patient satisfaction level
Time frame: 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
Related trials for Osteo Arthritis Knee
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
Not yet recruiting
The PERK Study: Predicting and Evaluating Response to Knee RFA Using fNIRS
Osteo Arthritis of the Knee, Pain
Recruiting
Comparison of Distal IPACK and Popliteal Plexus Block Combined With Femoral Triangle Block After Total Knee Arthroplasty
Osteo Arthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Çağdaş Pamuk, MD principal investigator
Istanbul Rumeli University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Cooling Spray in people with Osteo Arthritis Knee and Injection Site Discomfort, run by Istanbul Rumeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Çağdaş Pamuk, MD (+905058133336, cagdaspamuk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain during injection (time frame: 10 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2022.