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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.
as above
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heat | Active Comparator | Application of Heat pad to site of muscle sprain. |
|
| Cold | Active Comparator | Application of ice pack to muscle sprain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heat | Other | Application of heat pack to the back or neck sprain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Score After Treatment | Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Request for Rescue Analgesia | Number of participants requesting a rescue analgesic be given | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ADAM SINGER, MD | Stony Brook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Heat | Application of Heat to site of muscle sprain. |
| FG001 | Cold | Application of cold to muscle sprain. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Heat | Application of Heat to site of muscle sprain. |
| BG001 | Cold | Application of cold to muscle sprain. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Score After Treatment | Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable | this sample size gives 80% power to detect a size effect of one SD | Posted | Mean | 95% Confidence Interval | mm | 30 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Heat | Application of Heat to site of muscle sprain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam Singer | Stony Brook U | 631-444-7856 | adam.singer@stonybrook.edu |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006358 | Hot Temperature |
| D003080 | Cold Temperature |
| ID | Term |
|---|---|
| D013696 | Temperature |
| D013816 | Thermodynamics |
| D055585 | Physical Phenomena |
| D014887 | Weather |
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| Cold | Other | Application of ice pack to the back or neck sprain. |
|
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Request for Rescue Analgesia | Number of participants requesting a rescue analgesic be given | Posted | May 2009 | Number | Participants | 30 minutes |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Cold | Application of cold to muscle sprain. | 0 | 29 | 0 | 29 |
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| D001272 |
| Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D008685 | Meteorological Concepts |
| D004778 | Environment and Public Health |