Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02720315
• Other study ID #: 34835
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: October 30, 2019

Study information

• Verified date: November 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 30, 2019
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Emergency
• Opiate
• Pain

Intervention

Procedure:
• Intensive cryotherapy
Application of ice inside a plastic bag wrapped to the patient's site of pain, and held in place for 20min.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in pain level		20 minutes
Primary	Change in pain level		60 minutes
Secondary	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