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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Back Strain
Neck Strain
Interventions Other: Heat
Other: Cold
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Heat Cold
Hide Arm/Group Description Application of Heat to site of muscle sprain. Application of cold to muscle sprain.
Period Title: Overall Study
Started 31 29
Completed 31 29
Not Completed 0 0
Arm/Group Title Heat Cold Total
Hide Arm/Group Description Application of Heat to site of muscle sprain. Application of cold to muscle sprain. Total of all reporting groups
Overall Number of Baseline Participants 31 29 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
<=18 years
0
   0.0%
0
   0.0%
 0.0
Between 18 and 65 years
31
 100.0%
29
 100.0%
 60.0
>=65 years
0
   0.0%
0
   0.0%
 0.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 31 participants 29 participants 60 participants
37.8  (14.7) 36.3  (11.2) 37.1  (13.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 29 participants 60 participants
Female
16
  51.6%
15
  51.7%
 31.0
Male
15
  48.4%
14
  48.3%
 29.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 31 participants 29 participants 60 participants
31 29 60
1.Primary Outcome
Title Pain Score After Treatment
Hide Description Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
this sample size gives 80% power to detect a size effect of one SD
Arm/Group Title Heat Pack Ice Pack
Hide Arm/Group Description:
Application of Heat to site of muscle sprain.
Application of cold to muscle sprain.
Overall Number of Participants Analyzed 31 29
Mean (95% Confidence Interval)
Unit of Measure: mm
66
(57 to 75)
64
(56 to 73)
2.Secondary Outcome
Title Request for Rescue Analgesia
Hide Description Number of participants requesting a rescue analgesic be given
Time Frame 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Heat Cold
Hide Arm/Group Description:
Application of heat to site of muscle sprain.
Application of cold to muscle sprain.
Overall Number of Participants Analyzed 31 29
Measure Type: Number
Unit of Measure: Participants
18 12
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Heat Cold
Hide Arm/Group Description Application of Heat to site of muscle sprain. Application of cold to muscle sprain.
All-Cause Mortality
Heat Cold
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Heat Cold
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/29 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Heat Cold
Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)   0/29 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Adam Singer
Organization: Stony Brook U
Phone: 631-444-7856
EMail: adam.singer@stonybrook.edu
Layout table for additonal information
Responsible Party: Adam Singer, Stony Brook University
ClinicalTrials.gov Identifier: NCT01535365    
Other Study ID Numbers: 20076955
First Submitted: November 5, 2010
First Posted: February 17, 2012
Results First Submitted: November 5, 2010
Results First Posted: February 17, 2012
Last Update Posted: February 17, 2012