A Phase 4 interventional study of thermacare heat wraps and Ibuprofen in Heat and Pain, sponsored by Future Sciene Technology. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-08-01.
Sponsored by Future Sciene Technology · Phase 4, Interventional, and Treatment
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.
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.
1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.
This study's enrollment of 90 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.
Browse Neck Pain studies →Future Sciene Technology is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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
15 subjects with no heat or ibuprofen just physical therapy 2 times per week.
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
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
1200 mg ibuprofen administered 400mg at 4 hour intervals
Also known as: advil
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.
Time frame: up to 14 days
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.
Time frame: 10 days
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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