Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
the freeze spray group (receiving freeze spray before the injection)
Primary Purpose
Treatment
Masking
Double (Participant, Care Provider)
Masking Description
The study will be double-blinded to minimize bias. After selection into either spray group the cans will be disguised only showing a number 1 or number 2. 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..

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Freeze spray group
Ethyl Chloride Usage Prior to Orthopaedic Injections
  • Other: Ethyl Chloride
    Topical anesthetic that rapidly cools the skin and underlying tissues
Placebo Comparator
Placebo application of cold saline spray
Saline spray before injection
  • Other: Cold Saline Spray
    placebo application of cold saline spray
No Intervention
No spray prior to injection
No intervention before injection

Recruiting Locations

University of Chicago
Chicago, Illinois 60637
Contact:
Jennifer M Wolf, MD
773-834-3531
jmwolf@uchicagomedicine.org

More Details

Status
Recruiting
Sponsor
University of Chicago

Study Contact

Jennifer M Wolf, MD, PhD
773-834-3531
jwolf@bsd.uchicago.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.