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Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries

Primary Purpose

Back Strain, Neck Strain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heat
Cold
Sponsored by
Stony Brook University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Strain focused on measuring muscular sprain, acute back pain, acute neck pain, heat treatment, cold treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stony Brook University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Heat

Cold

Arm Description

Application of Heat pad to site of muscle sprain.

Application of ice pack to muscle sprain.

Outcomes

Primary Outcome Measures

Pain Score After Treatment
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable

Secondary Outcome Measures

Request for Rescue Analgesia
Number of participants requesting a rescue analgesic be given

Full Information

First Posted
November 5, 2010
Last Updated
February 16, 2012
Sponsor
Stony Brook University
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1. Study Identification

Unique Protocol Identification Number
NCT01535365
Brief Title
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Official Title
Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stony Brook University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Strain, Neck Strain
Keywords
muscular sprain, acute back pain, acute neck pain, heat treatment, cold treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Heat
Arm Type
Active Comparator
Arm Description
Application of Heat pad to site of muscle sprain.
Arm Title
Cold
Arm Type
Active Comparator
Arm Description
Application of ice pack to muscle sprain.
Intervention Type
Other
Intervention Name(s)
Heat
Other Intervention Name(s)
warm pack
Intervention Description
Application of heat pack to the back or neck sprain.
Intervention Type
Other
Intervention Name(s)
Cold
Intervention Description
Application of ice pack to the back or neck sprain.
Primary Outcome Measure Information:
Title
Pain Score After Treatment
Description
Pain measured with validated 100 mm VAS with 0 representing no pain and 100 representing most severe pain imaginable
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Request for Rescue Analgesia
Description
Number of participants requesting a rescue analgesic be given
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ADAM SINGER, MD
Organizational Affiliation
Stony Brook University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States

12. IPD Sharing Statement

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Heat Versus Ice in the Acute Management of Neck and Back Strain Injuries

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