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Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries

Primary Purpose

Pain, Opiate, Emergency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensive cryotherapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intensive cryotherapy

    Control

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Change in pain level
    Change in pain level

    Secondary Outcome Measures

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

    Full Information

    First Posted
    March 10, 2016
    Last Updated
    November 3, 2019
    Sponsor
    Stanford University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02720315
    Brief Title
    Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries
    Official Title
    Intensive Cryotherapy in the Emergency Department (ICED) Versus Conventional Treatment for Acute Musculoskeletal Injuries: The ICED Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    February 28, 2017 (Actual)
    Study Completion Date
    October 30, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Stanford University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Opiate, Emergency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intensive cryotherapy
    Arm Type
    Experimental
    Arm Description
    Application of ice in a plastic bag wrapped to the patient's site of pain, and kept in place for 20min.
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Existing pain control practice of physicians and nurses, which includes application of a chemical cold pack.
    Intervention Type
    Procedure
    Intervention Name(s)
    Intensive cryotherapy
    Intervention Description
    Application of ice inside a plastic bag wrapped to the patient's site of pain, and held in place for 20min.
    Primary Outcome Measure Information:
    Title
    Change in pain level
    Time Frame
    20 minutes
    Title
    Change in pain level
    Time Frame
    60 minutes
    Secondary Outcome Measure Information:
    Title
    Change in analgesic utilization
    Description
    Measured by chart review to detail the type and quantity of analgesics utilized by the control and the intervention groups.
    Time Frame
    24hr

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries

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