Back StrainNCT01535365
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
A study testing Heat and Cold in people with Back Strain and Neck Strain, run by Stony Brook University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Back Strain, Neck Strain
- What is being tested?
- Heat and Cold
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients with acute neck or back pain who are able to consent and are in pain on arrival to Emergency Department.
Who cannot join
- Those unable or unwilling to consent, those with suspected fractures or neurologic deficits.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Medical Center
Stony Brook, New York, 11794
About this study
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.
Read the detailed description
as above
- Conditions
- Back Strain, Neck Strain
- Being tested
- Heat, Cold
- Keywords
- muscular sprain, acute back pain, acute neck pain, heat treatment, cold treatment
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeatOther
Also called warm pack
Application of heat pack to the back or neck sprain.
ColdOther
Application of ice pack to the back or neck sprain.
| Study group | Role | What they receive |
|---|---|---|
| Heat | Active comparator | Application of Heat pad to site of muscle sprain. Receives: Other: Heat |
| Cold | Active comparator | Application of ice pack to muscle sprain. Receives: Other: Cold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score After Treatment
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
Measured: 30 minutes
Secondary outcomes (1)
Request for Rescue Analgesia
Number of participants requesting a rescue analgesic be given
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2012 (estimated)
- Study startMar 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Back StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Singer, Stony Brook University
- Investigators
- ADAM SINGER, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535365
- Sponsor's protocol ID
- 20076955
- Status last verified
- Feb 2012
- First submitted
- 5 Nov 2010
- Last updated
- 17 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
- ClinicalTrials.gov ID
- NCT01535365
- Acronym / sponsor ID
- 20076955
- Conditions
- Back Strain, Neck Strain
- Keywords
- muscular sprain, acute back pain, acute neck pain, heat treatment, cold treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Feb 2012 (estimated)
- Results
- Posted 17 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat | Active comparator | Other: HeatApplication of Heat pad to site of muscle sprain. |
| Cold | Active comparator | Other: ColdApplication of ice pack to muscle sprain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients with acute neck or back pain who are able to consent and are in pain on arrival to Emergency Department.
Key exclusion criteria (1 listed)
- Those unable or unwilling to consent, those with suspected fractures or neurologic deficits.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeatAlso: warm packApplication of heat pack to the back or neck sprain. | Other | Heat |
| ColdApplication of ice pack to the back or neck sprain. | Other | Cold |
Primary outcome
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
1 secondary outcome
Request for Rescue Analgesia
Time frame: 30 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ADAM SINGER, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat and Cold in people with Back Strain and Neck Strain, run by Stony Brook University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score After Treatment (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.