Back to resultsHeat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Primary Purpose
Back Strain, Neck Strain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heat
Cold
Sponsored by
About this trial
This is an interventional treatment trial for Back Strain focused on measuring muscular sprain, acute back pain, acute neck pain, heat treatment, cold treatment
Eligibility Criteria
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.
Sites / Locations
- Stony Brook University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Heat
Cold
Arm Description
Application of Heat pad to site of muscle sprain.
Application of ice pack to muscle sprain.
Outcomes
Primary Outcome Measures
Pain Score After Treatment
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
Secondary Outcome Measures
Request for Rescue Analgesia
Number of participants requesting a rescue analgesic be given
Full Information
NCT ID
NCT01535365
First Posted
November 5, 2010
Last Updated
February 16, 2012
Sponsor
Stony Brook University
1. Study Identification
Unique Protocol Identification Number
NCT01535365
Brief Title
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Official Title
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
as above
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Strain, Neck Strain
Keywords
muscular sprain, acute back pain, acute neck pain, heat treatment, cold treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Heat
Arm Type
Active Comparator
Arm Description
Application of Heat pad to site of muscle sprain.
Arm Title
Cold
Arm Type
Active Comparator
Arm Description
Application of ice pack to muscle sprain.
Intervention Type
Other
Intervention Name(s)
Heat
Other Intervention Name(s)
warm pack
Intervention Description
Application of heat pack to the back or neck sprain.
Intervention Type
Other
Intervention Name(s)
Cold
Intervention Description
Application of ice pack to the back or neck sprain.
Primary Outcome Measure Information:
Title
Pain Score After Treatment
Description
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Request for Rescue Analgesia
Description
Number of participants requesting a rescue analgesic be given
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADAM SINGER, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
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