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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02327338
• Other study ID #: A2014
• Status: Completed
• Phase: Phase 4
• First received: December 11, 2014
• Last updated: July 28, 2017
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: July 2017
• Source: Future Sciene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heat
• Neck Pain
• Pain

Intervention

Device:
• thermacare heat wraps
off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck

Drug:
• Ibuprofen
1200 mg ibuprofen administered 400mg at 4 hour intervals

Locations

Country	Name	City	State
United States	Future Sciecne Technology	Henderson	Nevada

Sponsors (2)

Lead Sponsor	Collaborator
Future Sciene Technology	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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