Study Results
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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RECRUITING
NA
300 participants
INTERVENTIONAL
2025-04-01
2028-12-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Given that the freeze spray is a skin refrigerant, the saline placebo will be refrigerated to mimic the temperature on the skin. The freeze spray is odorless, as is saline, so should not pose a different in smell experience. Neither the participants or physicians will be unblinded at any point; the unblinded investigator will be the only person with access to unblinded data..
Study Groups
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Freeze spray group
Ethyl Chloride Usage Prior to Orthopaedic Injections
Ethyl Chloride
Topical anesthetic that rapidly cools the skin and underlying tissues
Placebo application of cold saline spray
Saline spray before injection
Cold Saline Spray
placebo application of cold saline spray
No spray prior to injection
No intervention before injection
No interventions assigned to this group
Interventions
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Ethyl Chloride
Topical anesthetic that rapidly cools the skin and underlying tissues
Cold Saline Spray
placebo application of cold saline spray
Eligibility Criteria
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Inclusion Criteria
* Receiving a corticosteroid injection in an upper or lower extremity (to include soft tissue and joint injections) for the first time
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Edwards 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.
Franko 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.
Morote 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.
Other Identifiers
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IRB23-2039
Identifier Type: -
Identifier Source: org_study_id
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