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Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries

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ClinicalTrials.gov Identifier: NCT01535365
Recruitment Status : Completed
First Posted : February 17, 2012
Results First Posted : February 17, 2012
Last Update Posted : February 17, 2012
Sponsor:
Information provided by (Responsible Party):
Adam Singer, Stony Brook University

Tracking Information
First Submitted Date  ICMJE November 5, 2010
First Posted Date  ICMJE February 17, 2012
Results First Submitted Date  ICMJE November 5, 2010
Results First Posted Date  ICMJE February 17, 2012
Last Update Posted Date February 17, 2012
Study Start Date  ICMJE March 2008
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2012)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2012)		 Request for Rescue Analgesia [ Time Frame: 30 minutes ]
Number of participants requesting a rescue analgesic be given
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Official Title  ICMJE Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Back Strain
  • Neck Strain
Intervention  ICMJE
  • Other: Heat
    Application of heat pack to the back or neck sprain.
    Other Name: warm pack
  • Other: Cold
    Application of ice pack to the back or neck sprain.
Study Arms  ICMJE
  • Active Comparator: Heat
    Application of Heat pad to site of muscle sprain.
    Intervention: Other: Heat
  • Active Comparator: Cold
    Application of ice pack to muscle sprain.
    Intervention: Other: Cold
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 16, 2012)		 60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01535365
Other Study ID Numbers  ICMJE 20076955
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Adam Singer, Stony Brook University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Stony Brook University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: ADAM SINGER, MD Stony Brook University
PRS Account Stony Brook University
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP