NCT01535365

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2010

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
Same day until next milestone

Results Posted

Study results publicly available

February 17, 2012

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

1 year

First QC Date

November 5, 2010

Results QC Date

November 5, 2010

Last Update Submit

February 16, 2012

Conditions

Keywords

muscular sprainacute back painacute neck painheat treatmentcold treatment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Request for Rescue Analgesia

    30 minutes

Study Arms (2)

Heat

ACTIVE COMPARATOR

Application of Heat pad to site of muscle sprain.

Other: Heat

Cold

ACTIVE COMPARATOR

Application of ice pack to muscle sprain.

Other: Cold

Interventions

HeatOTHER

Application of heat pack to the back or neck sprain.

Also known as: warm pack
Heat
ColdOTHER

Application of ice pack to the back or neck sprain.

Cold

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult Patients with acute neck or back pain who are able to consent and are in pain on arrival to Emergency Department.

You may not qualify if:

  • Those unable or unwilling to consent, those with suspected fractures or neurologic deficits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook University Medical Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Fever

Interventions

Hot TemperatureCold Temperature

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TemperatureThermodynamicsPhysical PhenomenaWeatherAtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Results Point of Contact

Title
Adam Singer
Organization
Stony Brook U

Study Officials

  • ADAM SINGER, MD

    Stony Brook University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
md

Study Record Dates

First Submitted

November 5, 2010

First Posted

February 17, 2012

Study Start

March 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 17, 2012

Results First Posted

February 17, 2012

Record last verified: 2012-02

Locations