Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries

Intensive Cryotherapy in the Emergency Department (ICED) Versus Conventional Treatment for Acute Musculoskeletal Injuries: The ICED Randomized Controlled Trial

Acute musculoskeletal (MSK) injuries, including strains, sprains or contusions, are a common reason patients seek emergency care. Pain control is an essential component of treatment. Within the orthopedic literature, there is robust body of research supporting the use of cryotherapy for post-operative patients and injured athletes. However, within the emergency department (ED), studies have been focused on pharmacologic analgesia. The absence of evidence on optimal method or impact of ice therapy for acute MSK injuries contributes to inconsistent practice patterns that may impede symptom control or increase narcotic usage.

The specific aim of the ICED investigation is to evaluate the effectiveness of intensive cryotherapy for the treatment of pain due to acute MSK injuries treated in the ED. Secondary outcomes include length-of-stay (LOS), patient satisfaction, and narcotic usage.

Study Overview

• Status: Completed
• Conditions: Pain; Emergency; Opiate
• Intervention / Treatment: Procedure: Intensive cryotherapy

Detailed Description

Background Acute musculoskeletal (MSK) injuries, including strains, sprains or contusions, are a common reason patients seek emergency care. Pain control is an essential component of treatment. Within the orthopedic literature, there is robust body of research supporting the use of cryotherapy for post-operative patients and injured athletes. However, within the emergency department (ED), studies have been focused on pharmacologic analgesia. The absence of evidence on optimal method or impact of ice therapy for acute MSK injuries contributes to inconsistent practice patterns that may impede symptom control or increase narcotic usage.

Objectives The specific aim of the ICED investigation is to evaluate the effectiveness of intensive cryotherapy for the treatment of pain due to acute MSK injuries treated in the ED. Secondary outcomes include length-of-stay (LOS), and narcotic usage.

Methods Adults younger than sixty-six years-old presenting to the ED with acute MSK pain are enrolled through a process of informed consent, unless one or more of the exclusion criteria are met. Crushed ice is double-bagged and applied at the site of injury, where it is wrapped in place for twenty minutes. Pain scores are measured using a visual analog scale (VAS) when the ice is applied, at 20 minutes and at 60 minutes. Treating physicians do not alter their management. Data on LOS and use of pharmacologic analgesics are obtained through chart review.

Results Change in VAS will be analyzed with regression analysis and analysis of variance. Patients are grouped into categories of pharmacologic analgesic usage. Patient satisfaction scores and narcotic usage will be analyzed using a Chi Square test, while LOS data compared with an unpaired two-tailed t-test.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all people presenting to the ED with musculoskeletal injuries

Exclusion Criteria:

• Patients with hip fractures
• Patients with open fractures
• Patients with altered mental status who are unable to consent to participate in the study
• Patients activated as a trauma
• Patients with fractures or dislocations requiring closed reduction in the emergency department
• Minors
• Prisoners
• Patients with known pregnancy
• Patient who are receiving investigational drug as part of another study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intensive cryotherapy; Application of ice in a plastic bag wrapped to the patient's site of pain, and kept in place for 20min.	Procedure: Intensive cryotherapy; Application of ice inside a plastic bag wrapped to the patient's site of pain, and held in place for 20min.
No Intervention: Control; Existing pain control practice of physicians and nurses, which includes application of a chemical cold pack.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in pain level	20 minutes
Change in pain level	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in analgesic utilization	Measured by chart review to detail the type and quantity of analgesics utilized by the control and the intervention groups.	24hr

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 28, 2017
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: March 10, 2016
• First Submitted That Met QC Criteria: March 21, 2016
• First Posted (Estimate): March 25, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2019
• Last Update Submitted That Met QC Criteria: November 3, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 34835

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No