Trial Outcomes & Findings for Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries (NCT NCT01535365)
NCT ID: NCT01535365
Last Updated: 2012-02-17
Results Overview
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
30 minutes
Results posted on
2012-02-17
Participant Flow
Participant milestones
| Measure |
Heat
Application of Heat to site of muscle sprain.
|
Cold
Application of cold to muscle sprain.
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
29
|
|
Overall Study
COMPLETED
|
31
|
29
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Baseline characteristics by cohort
| Measure |
Heat
n=31 Participants
Application of Heat to site of muscle sprain.
|
Cold
n=29 Participants
Application of cold to muscle sprain.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0.0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
31 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
60.0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0.0 Participants
n=27 Participants
|
|
Age Continuous
|
37.8 years
STANDARD_DEVIATION 14.7 • n=93 Participants
|
36.3 years
STANDARD_DEVIATION 11.2 • n=4 Participants
|
37.1 years
STANDARD_DEVIATION 13.1 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
31.0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
29.0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=93 Participants
|
29 participants
n=4 Participants
|
60.0 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: this sample size gives 80% power to detect a size effect of one SD
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
Outcome measures
| Measure |
Heat Pack
n=31 Participants
Application of Heat to site of muscle sprain.
|
Ice Pack
n=29 Participants
Application of cold to muscle sprain.
|
|---|---|---|
|
Pain Score After Treatment
|
66 mm
95% Confidence Interval 16 • Interval 57.0 to 75.0
|
64 mm
95% Confidence Interval 10 • Interval 56.0 to 73.0
|
SECONDARY outcome
Timeframe: 30 minutesNumber of participants requesting a rescue analgesic be given
Outcome measures
| Measure |
Heat Pack
n=31 Participants
Application of Heat to site of muscle sprain.
|
Ice Pack
n=29 Participants
Application of cold to muscle sprain.
|
|---|---|---|
|
Request for Rescue Analgesia
|
18 Participants
|
12 Participants
|
Adverse Events
Heat
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cold
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place