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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Heat
• Intervention / Treatment: Device: thermacare heat wraps; Drug: Ibuprofen

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Nevada
    • Henderson, Nevada, United States, 89113
      • Future Sciecne Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: continuous low level heat; Drug: Ibuprofen; 1200 mg ibuprofen administered 400mg at 4 hour intervals; Other Names: 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 Names: continuous low level heat; Drug: Ibuprofen; 1200 mg ibuprofen administered 400mg at 4 hour intervals; Other Names: advil

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Future Sciene Technology
• Collaborators: Pfizer
• Investigators: Study Chair: Iman Khowailed, DSc, Touro University

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: A2014