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

NCT02327338 | Completed Phase 4

• 1 other identifier: A2014
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Heat; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• compliance for home exercise

  10 days

Study Arms (4)

continuous low level heat for neck

EXPERIMENTAL

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

Ibuprofen and continuous low level heat

EXPERIMENTAL

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; Drug: Ibuprofen

control

NO INTERVENTION

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

sham heat and sham ibuprofen

SHAM COMPARATOR

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; Drug: Ibuprofen

Interventions

thermacare heat wraps DEVICE

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

Also known as: continuous low level heat

Ibuprofen and continuous low level heat; continuous low level heat for neck; sham heat and sham ibuprofen

Ibuprofen DRUG

1200 mg ibuprofen administered 400mg at 4 hour intervals

Also known as: advil

Ibuprofen and continuous low level heat; sham heat and sham ibuprofen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-80 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Future Sciene Technology: lead
• Pfizer: collaborator

Study Sites (1)

Future Sciecne Technology

Henderson, Nevada, 89113, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Iman Khowailed, DSc

  Touro University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 30, 2014
• Study Start: November 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

US (1)