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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Heat, Pain

Intervention / Treatment
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* Device: thermacare heat wraps
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continuous low level heat for neck<br>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. | Device: thermacare heat wraps<br>* off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck<br>* Other names: continuous low level heat;|
| Experimental: Ibuprofen and continuous low level heat<br>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. | Device: thermacare heat wraps<br>* off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck<br>* Other names: continuous low level heat;Drug: Ibuprofen<br>* 1200 mg ibuprofen administered 400mg at 4 hour intervals<br>* Other names: advil;|
| No Intervention: control<br>15 subjects with no heat or ibuprofen just physical therapy 2 times per week. | |
| Sham Comparator: sham heat and sham ibuprofen<br>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. | Device: thermacare heat wraps<br>* off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck<br>* Other names: continuous low level heat;Drug: Ibuprofen<br>* 1200 mg ibuprofen administered 400mg at 4 hour intervals<br>* Other names: advil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 days |