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Use of ThermaCare Heat Wraps and Ibuprofen as an Adjunct to Physical Therapy for Neck Pain

Primary Purpose

Heat, Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
thermacare heat wraps
Ibuprofen
Sponsored by
Future Sciene Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heat

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 18-80 years

Exclusion Criteria:

  • those with neck pain caused by fractures or spinal damage
  • those who have undergone neck surgery within the last year
  • those with radiculopathy or those with diagnosed diabetes were excluded from this study

Sites / Locations

  • Future Sciecne Technology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

No Intervention

Sham Comparator

Arm Label

continuous low level heat for neck

Ibuprofen and continuous low level heat

control

sham heat and sham ibuprofen

Arm Description

30 subjects to use ThermaCare heat wraps on their necks for 6 hours before home exercise programs each day for 10 days. Physical therapy 2 times per week will be used on days where heat wraps are not used.

30 subjects to use 1200 mg per day Ibuprofen dosed in 3 dosages 4 hours apart on the same days as heat wraps were to be used. ThermaCare heat wraps to be used on their necks for 6 hours before home exercise programs each day for 10 days. Physical therapy 2 times per week will be used on days where heat wraps and ibuprofen are not used.

15 subjects with no heat or ibuprofen just physical therapy 2 times per week.

30 subjects to use 1200 mg per day Ibuprofen sham dosed in 3 dosages 4 hours apart on the same days as sham heat wraps were to be used. ThermaCare heat sham wraps to be used on their necks for 6 hours before home exercise programs each day for 10 days. Physical therapy 2 times per week will be used on days where sham heat wraps andsham ibuprofen are not used.

Outcomes

Primary Outcome Measures

analog visual pain scales
subjects will be asked to place a mark on a 10cm line where one end shows no pain and the other represents extreme pain to assess their pain level.

Secondary Outcome Measures

compliance for home exercise
subjects will self assess their compliance for their assigned home exercise program each day of the 10 days they accomplished home exercise.

Full Information

First Posted
December 11, 2014
Last Updated
July 28, 2017
Sponsor
Future Sciene Technology
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02327338
Brief Title
Use of ThermaCare Heat Wraps and Ibuprofen as an Adjunct to Physical Therapy for Neck Pain
Official Title
Use of ThermaCare Heat Wraps and Ibuprofen as an Adjunct to Physical Therapy for Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Future Sciene Technology
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Objective- To see if the use of heat at home between physical therapy sessions results in better therapy outcomes in people with acute neck pain. Setting: Physical Therapy outpatient rehabilitation center Participants: 90 people with acute nonspecific neck pain broken into 4 groups. Intervention: All subjects will undergo 45 minutes of therapy 2 times per week for 2 weeks. All subjects will accomplish 1 hour of therapeutic exercise at home on days when there is no therapy. Thirty of the subjects will use ThermaCare neck wraps before home exercise, 30 used Ibuprofen plus ThermaCare neck wraps before home exercise, 15 will use a sham heat wrap and an Ibuprofen placebo each day (1200 mg / day) and the last 15 will be controls with conventional physical therapy.
Detailed Description
Neck pain patients admitted to an outpatient physical therapy program will be randomly assigned to either a control or 3 experimental groups. An initial evaluation and rehabilitation program will be established which includes a home exercise program. Therapy will be 2 days per week for 2 weeks. Thirty of the subjects will use ThermaCare continuous heat neck wraps applied for 6 hours before home exercise, 30 will use ibuprofen (1200 mg /day given in 3 dosages) plus ThermaCare neck wraps before home exercise, 15 will use a sham heat wrap and a Ibuprofen placebo each day and the last 15 will have conventional therapy. Intervention with heat or Ibuprofen will be used on days that they are not being treated in the clinic. All groups will be evaluated initially and after 2 weeks. They will be given home exercise and heat compliance logs and analog visual pain scales to be filled out each night before exercise and, if they used heat, before and after heat will be applied. The physical therapist will also be asked to evaluate their home compliance, pain and the benefit to them from the heat packs. Subjects will complete a neck disability questionnaire at the beginning and end of the study. At the end of the two weeks of treatment, a multivariate ANOVA will be performed to compare changes in home exercise compliance, functional level, pain level, range of motion, and strength. A statistical level of p≤.05 is considered predictive of a difference between groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
continuous low level heat for neck
Arm Type
Experimental
Arm Description
30 subjects to use ThermaCare heat wraps on their necks for 6 hours before home exercise programs each day for 10 days. Physical therapy 2 times per week will be used on days where heat wraps are not used.
Arm Title
Ibuprofen and continuous low level heat
Arm Type
Experimental
Arm Description
30 subjects to use 1200 mg per day Ibuprofen dosed in 3 dosages 4 hours apart on the same days as heat wraps were to be used. ThermaCare heat wraps to be used on their necks for 6 hours before home exercise programs each day for 10 days. Physical therapy 2 times per week will be used on days where heat wraps and ibuprofen are not used.
Arm Title
control
Arm Type
No Intervention
Arm Description
15 subjects with no heat or ibuprofen just physical therapy 2 times per week.
Arm Title
sham heat and sham ibuprofen
Arm Type
Sham Comparator
Arm Description
30 subjects to use 1200 mg per day Ibuprofen sham dosed in 3 dosages 4 hours apart on the same days as sham heat wraps were to be used. ThermaCare heat sham wraps to be used on their necks for 6 hours before home exercise programs each day for 10 days. Physical therapy 2 times per week will be used on days where sham heat wraps andsham ibuprofen are not used.
Intervention Type
Device
Intervention Name(s)
thermacare heat wraps
Other Intervention Name(s)
continuous low level heat
Intervention Description
off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
advil
Intervention Description
1200 mg ibuprofen administered 400mg at 4 hour intervals
Primary Outcome Measure Information:
Title
analog visual pain scales
Description
subjects will be asked to place a mark on a 10cm line where one end shows no pain and the other represents extreme pain to assess their pain level.
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
compliance for home exercise
Description
subjects will self assess their compliance for their assigned home exercise program each day of the 10 days they accomplished home exercise.
Time Frame
10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18-80 years Exclusion Criteria: those with neck pain caused by fractures or spinal damage those who have undergone neck surgery within the last year those with radiculopathy or those with diagnosed diabetes were excluded from this study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iman Khowailed, DSc
Organizational Affiliation
Touro University
Official's Role
Study Chair
Facility Information:
Facility Name
Future Sciecne Technology
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States

12. IPD Sharing Statement

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Use of ThermaCare Heat Wraps and Ibuprofen as an Adjunct to Physical Therapy for Neck Pain

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