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

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ClinicalTrials.gov Identifier: NCT02327338
Recruitment Status : Completed
First Posted : December 30, 2014
Last Update Posted : August 1, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jerrold Petrofsky, Future Sciene Technology

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.


Condition or disease Intervention/treatment Phase
Heat Pain Device: thermacare heat wraps Drug: Ibuprofen Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Use of ThermaCare Heat Wraps and Ibuprofen as an Adjunct to Physical Therapy for Neck Pain
Study Start Date : November 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: continuous low level heat for neck
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
off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck
Other Name: continuous low level heat

Experimental: Ibuprofen and continuous low level heat
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
off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck
Other Name: continuous low level heat

Drug: Ibuprofen
1200 mg ibuprofen administered 400mg at 4 hour intervals
Other Name: advil

No Intervention: control
15 subjects with no heat or ibuprofen just physical therapy 2 times per week.
Sham Comparator: sham heat and sham ibuprofen
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
off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck
Other Name: continuous low level heat

Drug: Ibuprofen
1200 mg ibuprofen administered 400mg at 4 hour intervals
Other Name: advil




Primary Outcome Measures :
  1. analog visual pain scales [ Time Frame: up to 14 days ]
    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 :
  1. compliance for home exercise [ Time Frame: 10 days ]
    subjects will self assess their compliance for their assigned home exercise program each day of the 10 days they accomplished home exercise.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02327338


Locations
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United States, Nevada
Future Sciecne Technology
Henderson, Nevada, United States, 89113
Sponsors and Collaborators
Future Sciene Technology
Pfizer
Investigators
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Study Chair: Iman Khowailed, DSc Touro University

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Responsible Party: Jerrold Petrofsky, professor, Future Sciene Technology
ClinicalTrials.gov Identifier: NCT02327338     History of Changes
Other Study ID Numbers: A2014
First Posted: December 30, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Ibuprofen
Neck Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action