Injection FearNCT06651788
Does Ethyl Chloride Spray Work?
A study testing Ethyl Chloride and Cold Saline Spray in people with Injection Fear and Injection Pain Prevention, run by University of Chicago at 1 site in United States.
Trial summary
A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injection Fear, Injection Pain Prevention, Injection Complication
- What is being tested?
- Ethyl Chloride and Cold Saline Spray
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2025to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Receiving a corticosteroid injection in an upper or lower extremity (to include soft tissue and joint injections)
Who cannot join
- 17 years old and younger
- declines enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan Swindle, MD contact
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Jennifer M Wolf, MD, 773-834-3531, jmwolf@uchicagomedicine.org
Michael K Koch, Bachelor's, 7738340822, mkoch@bsd.uchicago.edu
About this study
Official title: Does "Freeze Spray" Work? Evaluating the Efficacy of Ethyl Chloride Usage Prior to Orthopaedic Injections
A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. While these injections have demonstrated effectiveness in alleviating symptoms, the discomfort associated with the procedure can be a source of anxiety and apprehension for patients. This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution.
Read the detailed description
A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. While these injections have demonstrated effectiveness in alleviating symptoms, the discomfort associated with the procedure can be a source of anxiety and apprehension for patients. This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution.
In response to this concern, orthopaedic providers have turned to freeze sprays (Ethyl chloride), which are topical anesthetics that rapidly cool the skin and underlying tissues. By numbing the injection site superficially, freeze sprays offer the potential to mitigate patient discomfort during corticosteroid injections, thus improving the overall patient experience and potentially enhancing treatment compliance.
However, despite the popularity of freeze spray usage in orthopaedics, many orthopaedic providers have concerns about its efficacy when it comes to providing pain relief. There still needs to be comprehensive scientific evidence evaluating its efficacy and safety. A previous study evaluated the efficacy of freeze spray in hand surgery in a randomized study of 150 subjects without standardized outcomes measures. These investigators showed no difference between those receiving freeze spray vs no spray in pain or anxiety; another study of vapocoolant spray in IV start sites in the emergency department similarly showed no difference in pain or anxiety. Based on the literature, there is no definitive standard of care to use freeze spray with injections and this is the gap in knowledge we wish to answer with a rigorous, placebo-controlled study. This study will differ from the previous similar study in that the investigators will recruit double the number of patients and use standardized commonly accepted questionnaires. The use of a questionnaire based on standardized metrics will provide a more comprehensive assessment of patient perceptions and satisfaction with the use of freeze spray. Through a rigorous research approach, the investigators aim to provide valuable insights into the impact of freeze spray on patient comfort, injection success rates, and any potential complications associated with its use.
This study will contribute to the ongoing efforts of hand surgeons to refine their techniques, minimize patient discomfort, and optimize the delivery of corticosteroid injections. Ultimately, the investigators' findings may have significant implications for the broader field of musculoskeletal medicine, offering evidence-based guidance to improve the patient experience and outcomes in orthopaedic surgery.
- Being tested
- Ethyl Chloride, Cold Saline Spray
- Keywords
- Injection, Freeze spray, corticosteroid injections, Ethyl chloride, Orthopeadics
- Medical subject headings
- Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ethyl ChlorideOther
Topical anesthetic that rapidly cools the skin and underlying tissues
Cold Saline SprayOther
placebo application of cold saline spray
| Study group | Role | What they receive |
|---|---|---|
| Freeze spray group | Experimental | Ethyl Chloride Usage Prior to Orthopaedic Injections Receives: Other: Ethyl Chloride |
| Placebo application of cold saline spray | Placebo comparator | Saline spray before injection Receives: Other: Cold Saline Spray |
| No spray prior to injection | No intervention | No intervention before injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores before injection
Using the visual analog pain scale (0 no pain - 10 worst possible pain) to ask patients their pain rating and if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure.
Measured: 10 minutes before subject receives injection
To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores after injeciton
Using the visual analog pain scale (0 no pain - 10 worst possible pain) to ask patients their pain rating and if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure.
Measured: 10 minutes after subject receives injection
To assess patient perception of freeze spray efficacy in decreasing anxiety regarding injections.
Using the treatment satisfaction questionnaire for medication-II to ask patients their anxiety and if freeze spray usage before corticosteroid injections significantly reduces patient anxiety during the procedure.
Measured: 10 minutes after subject receives injection
To assess their current overall status compared to their pre-injection baseline
Using the single assessment numeric evaluation (0% furthest from normal and 100% normal) to ask patients their current status
Measured: 10 minutes after subject receives injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start1 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Injection FearStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- the freeze spray group (receiving freeze spray before the injection)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651788
- Sponsor's protocol ID
- IRB23-2039
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2024
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Randall DJ, Zhang Y, Li H, Hubbard JC, Kazmers NH. Establishing the Minimal Clinically Important Difference and Substantial Clinical Benefit for the Pain Visual Analog Scale in a Postoperative Hand Surgery Population. J Hand Surg Am. 2022 Jul;47(7):645-653. doi: 10.1016/j.jhsa.2022.03.009. Epub 2022 May 27.
PubMed 35644742Edwards C, Noah C. A Randomized, Double-Blind Trial to Determine if Vapocoolant in the Adult Population Improves Patient Perception of Pain With Peripheral Intravascular Access. Adv Emerg Nurs J. 2017 Oct/Dec;39(4):288-294. doi: 10.1097/TME.0000000000000165.
PubMed 29095180Franko OI, Stern PJ. Use and Effectiveness of Ethyl Chloride for Hand Injections. J Hand Surg Am. 2017 Mar;42(3):175-181.e1. doi: 10.1016/j.jhsa.2016.12.013.
PubMed 28259274Morote Robles J, Lorente JA, Reig C, Lopez Pacios MA, de Torres JA, Soler Rosello A. [The clinical and prognostic value of inversion of the PSA/PAP ratio in prostatic cancer]. Actas Urol Esp. 1994 May;18(5):559-61. Spanish.
PubMed 7521563
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does "Freeze Spray" Work? Evaluating the Efficacy of Ethyl Chloride Usage Prior to Orthopaedic Injections
- ClinicalTrials.gov ID
- NCT06651788
- Acronym / sponsor ID
- IRB23-2039
- Keywords
- Injection, Freeze spray, corticosteroid injections, Ethyl chloride, Orthopeadics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 22 Oct 2024 (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.
A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. While these injections have demonstrated effectiveness in alleviating symptoms, the discomfort associated with the procedure can be a source of anxiety and apprehension for patients. This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution.
Detailed description
A procedure frequently performed by orthopaedic providers is the administration of corticosteroid injections for the management of various soft tissues and joint-related conditions, such as osteoarthritis, tendinitis, carpal tunnel syndrome, trigger finger, and de Quervain's tenosynovitis. While these injections have demonstrated effectiveness in alleviating symptoms, the discomfort associated with the procedure can be a source of anxiety and apprehension for patients. This discomfort arises from the sensation of the needle entering the affected area and the burning sensation induced by the corticosteroid solution.
In response to this concern, orthopaedic providers have turned to freeze sprays (Ethyl chloride), which are topical anesthetics that rapidly cool the skin and underlying tissues. By numbing the injection site superficially, freeze sprays offer the potential to mitigate patient discomfort during corticosteroid injections, thus improving the overall patient experience and potentially enhancing treatment compliance.
However, despite the popularity of freeze spray usage in orthopaedics, many orthopaedic providers have concerns about its efficacy when it comes to providing pain relief. There still needs to be comprehensive scientific evidence evaluating its efficacy and safety. A previous study evaluated the efficacy of freeze spray in hand surgery in a randomized study of 150 subjects without standardized outcomes measures. These investigators showed no difference between those receiving freeze spray vs no spray in pain or anxiety; another study of vapocoolant spray in IV start sites in the emergency department similarly showed no difference in pain or anxiety. Based on the literature, there is no definitive standard of care to use freeze spray with injections and this is the gap in knowledge we wish to answer with a rigorous, placebo-controlled study. This study will differ from the previous similar study in that the investigators will recruit double the number of patients and use standardized commonly accepted questionnaires. The use of a questionnaire based on standardized metrics will provide a more comprehensive assessment of patient perceptions and satisfaction with the use of freeze spray. Through a rigorous research approach, the investigators aim to provide valuable insights into the impact of freeze spray on patient comfort, injection success rates, and any potential complications associated with its use.
This study will contribute to the ongoing efforts of hand surgeons to refine their techniques, minimize patient discomfort, and optimize the delivery of corticosteroid injections. Ultimately, the investigators' findings may have significant implications for the broader field of musculoskeletal medicine, offering evidence-based guidance to improve the patient experience and outcomes in orthopaedic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- the freeze spray group (receiving freeze spray before the injection)
| Arm | Type | Receives |
|---|---|---|
| Freeze spray group | Experimental | Other: Ethyl ChlorideEthyl Chloride Usage Prior to Orthopaedic Injections |
| Placebo application of cold saline spray | Placebo comparator | Other: Cold Saline SpraySaline spray before injection |
| No spray prior to injection | No intervention | –No intervention before injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years and older
- Receiving a corticosteroid injection in an upper or lower extremity (to include soft tissue and joint injections)
Key exclusion criteria (2 listed)
- 17 years old and younger
- declines enrollment
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 |
|---|---|---|
| Ethyl ChlorideTopical anesthetic that rapidly cools the skin and underlying tissues | Other | Freeze spray group |
| Cold Saline Sprayplacebo application of cold saline spray | Other | Placebo application of cold saline spray |
Primary outcome
To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores before injection
Time frame: 10 minutes before subject receives injection
Using the visual analog pain scale (0 no pain - 10 worst possible pain) to ask patients their pain rating and if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure.
To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores after injeciton
Time frame: 10 minutes after subject receives injection
Using the visual analog pain scale (0 no pain - 10 worst possible pain) to ask patients their pain rating and if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure.
To assess patient perception of freeze spray efficacy in decreasing anxiety regarding injections.
Time frame: 10 minutes after subject receives injection
Using the treatment satisfaction questionnaire for medication-II to ask patients their anxiety and if freeze spray usage before corticosteroid injections significantly reduces patient anxiety during the procedure.
To assess their current overall status compared to their pre-injection baseline
Time frame: 10 minutes after subject receives injection
Using the single assessment numeric evaluation (0% furthest from normal and 100% normal) to ask patients their current status
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 35644742Randall DJ, Zhang Y, Li H, Hubbard JC, Kazmers NH. Establishing the Minimal Clinically Important Difference and Substantial Clinical Benefit for the Pain Visual Analog Scale in a Postoperative Hand Surgery Population. J Hand Surg Am. 2022 Jul;47(7):645-653. doi: 10.1016/j.jhsa.2022.03.009. Epub 2022 May 27.
- Background: PubMed 29095180Edwards C, Noah C. A Randomized, Double-Blind Trial to Determine if Vapocoolant in the Adult Population Improves Patient Perception of Pain With Peripheral Intravascular Access. Adv Emerg Nurs J. 2017 Oct/Dec;39(4):288-294. doi: 10.1097/TME.0000000000000165.
- Background: PubMed 28259274Franko OI, Stern PJ. Use and Effectiveness of Ethyl Chloride for Hand Injections. J Hand Surg Am. 2017 Mar;42(3):175-181.e1. doi: 10.1016/j.jhsa.2016.12.013.
- Background: PubMed 7521563Morote Robles J, Lorente JA, Reig C, Lopez Pacios MA, de Torres JA, Soler Rosello A. [The clinical and prognostic value of inversion of the PSA/PAP ratio in prostatic cancer]. Actas Urol Esp. 1994 May;18(5):559-61. Spanish.
- Individual participant dataSharing planned: No
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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.
Jordan Swindle, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ethyl Chloride and Cold Saline Spray in people with Injection Fear and Injection Pain Prevention, run by University of Chicago at 1 site in United States.
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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer M Wolf, MD, PhD (773-834-3531, jwolf@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if freeze spray usage before corticosteroid injections significantly reduces patient discomfort during the procedure as measured by pain scores before injection (time frame: 10 minutes before subject receives injection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06651788, which also lists 4 linked publications.
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 8 Oct 2026.