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
About this trial
This is an interventional treatment trial for Pain
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
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
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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