Back Strain, Neck Strain
Conditions
Keywords
muscular sprain, acute back pain, acute neck pain, heat treatment, cold treatment
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
Interventions
OTHERHeat
Application of heat pack to the back or neck sprain.
OTHERCold
Application of ice pack to the back or neck sprain.
Sponsors
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score After Treatment | 30 minutes | Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Request for Rescue Analgesia | 30 minutes | Number of participants requesting a rescue analgesic be given |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Heat Application of Heat to site of muscle sprain. | 31 |
| Cold Application of cold to muscle sprain. | 29 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Heat | Cold |
|---|---|---|---|
| Age, Categorical <=18 years | 0.0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0.0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60.0 Participants | 31 Participants | 29 Participants |
| Age Continuous | 37.1 years STANDARD_DEVIATION 13.1 | 37.8 years STANDARD_DEVIATION 14.7 | 36.3 years STANDARD_DEVIATION 11.2 |
| Region of Enrollment United States | 60.0 participants | 31 participants | 29 participants |
| Sex: Female, Male Female | 31.0 Participants | 16 Participants | 15 Participants |
| Sex: Female, Male Male | 29.0 Participants | 15 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 29 |
| serious Total, serious adverse events | 0 / 31 | 0 / 29 |
Outcome results
Primary
Pain Score After Treatment
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
Time frame: 30 minutes
Population: this sample size gives 80% power to detect a size effect of one SD
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Heat Pack | Pain Score After Treatment | 66 mm | 95% Confidence Interval 16 |
| Ice Pack | Pain Score After Treatment | 64 mm | 95% Confidence Interval 10 |
Secondary
Request for Rescue Analgesia
Number of participants requesting a rescue analgesic be given
Time frame: 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Heat Pack | Request for Rescue Analgesia | 18 Participants |
| Ice Pack | Request for Rescue Analgesia | 12 Participants |