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

Future Sciene Technology

Status and phase: Completed; Phase 4

Conditions: Heat; Pain

Treatments: Device: thermacare heat wraps; Drug: Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT02327338

A2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 4 patient groups

continuous low level heat for neck

Experimental group

Description:

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.

Treatment:

Device: thermacare heat wraps

Ibuprofen and continuous low level heat

Experimental group

Description:

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.

Treatment:

Drug: Ibuprofen

Device: thermacare heat wraps

control

No Intervention group

Description:

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

sham heat and sham ibuprofen

Sham Comparator group

Description:

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.

Treatment:

Drug: Ibuprofen

Device: thermacare heat wraps