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

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis Knee
• Intervention / Treatment: Other: Rice Sock and Instructions to heat the quadriceps.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Idaho
    • Boise, Idaho, United States, 83704
      • The Idaho Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rice sock and instructions to heat quadriceps; Receives heating device and instructions to heat the quadriceps musculature.	Other: Rice Sock and Instructions to heat the quadriceps.; 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.
No Intervention: No heating device or instructions to heat quadriceps; WIll not receive heating device or instructions to heat quadriceps musculature.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Idaho Clinic
• Investigators: Principal Investigator: Cole Adams, Idaho College of Osteopathic Medicine

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): January 31, 2023
• Study Completion (Actual): July 1, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Arthritis
• Other Study ID Numbers: IdahoClinic

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No