Heat Application to Quadriceps Effect on Pain After a Total Knee Arthroplasty

Study Overview
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Brief Summary
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The goal of this study is to explore an under-researched aspect of recovery. Typically, post-operative care after a knee arthroplasty consists of compression (stockings), medications, rest, ice, elevation, physical therapy, and wound care. All of these treatments perform their role well, however, medications such opiates run the risk of addiction. An additional method of pain management such as heat application to the surrounding musculature warrants exploration. The goal of this study is to reduce the amount of pain, and improve the quality of life in post-operative patients. Pain, stiffness, symptoms, quality of life and function of the knee will be evaluated utilizing patient-reported measures and range of motion. Patients will be assessed using the Knee Injury and Osteoarthritis Outcome survey (KOOS Jr), Visual Analogue Scale (VAS) and PROMIS. Patients will be given these surveys during their two and six week check-in with the surgeon. In addition to these patient-reported measures, the investigators will also be tracking range of motion (ROM) and opioid usage. The data will then be collected via the patient's electronic health record, or by the researcher directly. The treatment group will be given a written order to apply heat to the quadriceps at least three times per day for 10-15 minutes each. This can be done in four hour increments or when patients symptoms begin to worsen. The patient will receive a rice sock for heat application. The control group will not be withheld from heat application, but will not be instructed to do so. The control group will instead follow the current standard of care as advised by the physician.

Official Title
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Heat Application to the Quadriceps Musculature and Its Effect on Pain Following a Total Knee Arthroplasty

Conditions
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Arthritis Knee

Intervention / Treatment
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* Other: Rice Sock and Instructions to heat the quadriceps.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a total knee arthroplasty ages 18 and older at Saint Alphonsus Hospital and at The Idaho Clinic between the months of June-February, or until the estimated sample size (150) is reached. Must be able to withstand heat to thigh. Must consent to research. Exclusion Criteria: Anyone unable to give informed consent, pregnant individuals, children, or anyone whom the intervention may be harmful to.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rice sock and instructions to heat quadriceps<br>Receives heating device and instructions to heat the quadriceps musculature. | Other: Rice Sock and Instructions to heat the quadriceps.<br>* A rice sock will be provided to the experimental group to heat the quadriceps 3x per day for six weeks. The participants will be encouraged to heat before and after rehabilitation exercises as well.<br>|
| No Intervention: No heating device or instructions to heat quadriceps<br>WIll not receive heating device or instructions to heat quadriceps musculature. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Pain experienced at 2 and 6 week check-ins | Measured via KOOS Jr survey | Baseline, 2, and 6 week evaluations | 
| Change of Pain experienced at 2 and 6 week check-ins | Measured via VAS survey | Baseline, 2, and 6 week evaluations | 
| Change of Pain experienced at 2 and 6 week check-ins | Measured via PROMIS survey | Baseline, 2, and 6 week evaluations | 
| Change in stiffness experienced at 2 and 6 week check-ins | Measured via PROMIS survey | Baseline, 2 and 6 week evaluations | 
| Change in stiffness experienced at 2 and 6 week check-ins | Measured via KOOS Jr survey | Baseline, 2 and 6 week evaluations | 
| Change in quality of life at 2 and 6 week check-ins | Measured via PROMIS survey | Baseline, 2 and 6 weeks | 
| Change in Physical Health | Measured via PROMIS survey | Baseline, 2 and 6 weeks | 
| Change in Mental Health | Measured via PROMIS survey | Baseline, 2 and 6 weeks | 
| Change in knee function at 2 and 6 week check-ins | Measured via Range of motion | Baseline, 2 and 6 weeks | 
| Change in knee function at 2 and 6 week check-ins | Measured via PROMIS surveys | Baseline, 2 and 6 weeks | 
| Change in knee function at 2 and 6 week check-ins | Measured via KOOS Jr | Baseline, 2 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiate Refills | Opiate usage/refills will be evaluated | Up to 6 weeks post-operation | 
| Change in Range of Motion at 2 and 6 week check-ins | ROM will be evaluated | Baseline, 2 and 6 week check-ins |