Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries

NCT ID: NCT02720315

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2019-10-30

Brief 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.

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.

Conditions

Pain; Opiate; Emergency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive cryotherapy

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

Group Type: EXPERIMENTAL

Intensive cryotherapy

Intervention Type: PROCEDURE

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

Control

Existing pain control practice of physicians and nurses, which includes application of a chemical cold pack.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Intensive cryotherapy

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Eric Leroux

Chief Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

34835

Identifier Type: -

Identifier Source: org_study_id