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NCT Number: NCT06651788

Does Ethyl Chloride Spray Work?

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years and older
  • Receiving a corticosteroid injection in an upper or lower extremity (to include soft tissue and joint injections) for the first time

Exclusion criteria

  • Patients with previous injection experiences

Treatment and study plan

Ethyl Chloride

Other

Topical anesthetic that rapidly cools the skin and underlying tissues

Cold Saline Spray

Other

placebo application of cold saline spray

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer M Wolf, MD, PhD

CONTACT

[email protected]

773-834-3531

Jordan Swindle, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

Does "Freeze Spray" Work? Evaluating the Efficacy of Ethyl Chloride Usage Prior to Orthopaedic Injections

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Oct 22, 2024
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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