- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01535365
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
February 16, 2012 updated by: Adam Singer, Stony Brook University
Muscle sprains of the back and neck are very common.
In addition to pain and antiinflammatory medications the use of either cold or hot packs has been recommended.
In the current study we will compare ice packs and heat packs to see which is more effective at relieving pain from back and neck sprains while in the Emergency Department.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
as above
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Stony Brook, New York, United States, 11794
- Stony Brook University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult Patients with acute neck or back pain who are able to consent and are in pain on arrival to Emergency Department.
Exclusion Criteria:
- Those unable or unwilling to consent, those with suspected fractures or neurologic deficits.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Heat
Application of Heat pad to site of muscle sprain.
|
Application of heat pack to the back or neck sprain.
Other Names:
|
Active Comparator: Cold
Application of ice pack to muscle sprain.
|
Application of ice pack to the back or neck sprain.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Score After Treatment
Time Frame: 30 minutes
|
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Request for Rescue Analgesia
Time Frame: 30 minutes
|
Number of participants requesting a rescue analgesic be given
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
November 5, 2010
First Submitted That Met QC Criteria
February 16, 2012
First Posted (Estimate)
February 17, 2012
Study Record Updates
Last Update Posted (Estimate)
February 17, 2012
Last Update Submitted That Met QC Criteria
February 16, 2012
Last Verified
February 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20076955
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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