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Completed

NCT Number: NCT02720315

Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries

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.

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Key information

Conditions

Pain Disease Attributes Emergencies Emergency Neurologic Manifestations Opiate Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Intensive cryotherapy

Procedure

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

Primary outcomes

  1. Change in pain level

    Time frame: 20 minutes

  2. Change in pain level

    Time frame: 60 minutes

Secondary outcomes

  1. Change in analgesic utilization

    Time frame: 24hr

    Measured by chart review to detail the type and quantity of analgesics utilized by the control and the intervention groups.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Mar 25, 2016
Registry last updated
Nov 6, 2019

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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