PainNCT02720315
Intensive Cryotherapy in the Emergency Department for Acute Musculoskeletal Injuries
A study testing Intensive cryotherapy in people with Pain and Opiate, run by Stanford University.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- Intensive cryotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2016to 30 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all people presenting to the ED with musculoskeletal injuries
Who cannot join
- 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
Show all 9Show fewer
- Prisoners
- Patients with known pregnancy
- Patient who are receiving investigational drug as part of another study
About this study
Official title: Intensive Cryotherapy in the Emergency Department (ICED) Versus Conventional Treatment for Acute Musculoskeletal Injuries: The ICED Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Intensive cryotherapy
- Medical subject headings
- Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive cryotherapyProcedure or surgery
Application of ice inside a plastic bag wrapped to the patient's site of pain, and held in place for 20min.
| Study group | Role | What they receive |
|---|---|---|
| Intensive cryotherapy | Experimental | Application of ice in a plastic bag wrapped to the patient's site of pain, and kept in place for 20min. Receives: Procedure: Intensive cryotherapy |
| Control | No intervention | Existing pain control practice of physicians and nurses, which includes application of a chemical cold pack. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain level
Measured: 20 minutes
Change in pain level
Measured: 60 minutes
Secondary outcomes (1)
Change in analgesic utilization
Measured by chart review to detail the type and quantity of analgesics utilized by the control and the intervention groups.
Measured: 24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start1 Feb 2016
- Primary completion28 Feb 2017
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Leroux, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720315
- Sponsor's protocol ID
- 34835
- Status last verified
- Nov 2019
- First submitted
- 10 Mar 2016
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Cryotherapy in the Emergency Department (ICED) Versus Conventional Treatment for Acute Musculoskeletal Injuries: The ICED Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02720315
- Acronym / sponsor ID
- 34835
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive cryotherapy | Experimental | Procedure: Intensive cryotherapyApplication of ice in a plastic bag wrapped to the patient's site of pain, and kept in place for 20min. |
| Control | No intervention | –Existing pain control practice of physicians and nurses, which includes application of a chemical cold pack. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all people presenting to the ED with musculoskeletal injuries
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive cryotherapyApplication of ice inside a plastic bag wrapped to the patient's site of pain, and held in place for 20min. | Procedure or surgery | Intensive cryotherapy |
Primary outcome
Change in pain level
Time frame: 20 minutes
Change in pain level
Time frame: 60 minutes
1 secondary outcome
Change in analgesic utilization
Time frame: 24hr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive cryotherapy in people with Pain and Opiate, run by Stanford University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain level (time frame: 20 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.