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Completed

NCT Number: NCT05462483

Heat Application to Quadriceps Effect on Pain After 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.

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Key information

Conditions

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Idaho Clinic

Boise, Idaho, 83704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rice Sock and Instructions to heat the quadriceps.

Other

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.

Primary outcomes

  1. Change of Pain experienced at 2 and 6 week check-ins

    Time frame: Baseline, 2, and 6 week evaluations

    Measured via KOOS Jr survey

  2. Change of Pain experienced at 2 and 6 week check-ins

    Time frame: Baseline, 2, and 6 week evaluations

    Measured via VAS survey

  3. Change of Pain experienced at 2 and 6 week check-ins

    Time frame: Baseline, 2, and 6 week evaluations

    Measured via PROMIS survey

  4. Change in stiffness experienced at 2 and 6 week check-ins

    Time frame: Baseline, 2 and 6 week evaluations

    Measured via PROMIS survey

  5. Change in stiffness experienced at 2 and 6 week check-ins

    Time frame: Baseline, 2 and 6 week evaluations

    Measured via KOOS Jr survey

  6. Change in quality of life at 2 and 6 week check-ins

    Time frame: Baseline, 2 and 6 weeks

    Measured via PROMIS survey

  7. Change in Physical Health

    Time frame: Baseline, 2 and 6 weeks

    Measured via PROMIS survey

  8. Change in Mental Health

    Time frame: Baseline, 2 and 6 weeks

    Measured via PROMIS survey

  9. Change in knee function at 2 and 6 week check-ins

    Time frame: Baseline, 2 and 6 weeks

    Measured via Range of motion

  10. Change in knee function at 2 and 6 week check-ins

    Time frame: Baseline, 2 and 6 weeks

    Measured via PROMIS surveys

  11. Change in knee function at 2 and 6 week check-ins

    Time frame: Baseline, 2 and 6 weeks

    Measured via KOOS Jr

Secondary outcomes

  1. Opiate Refills

    Time frame: Up to 6 weeks post-operation

    Opiate usage/refills will be evaluated

  2. Change in Range of Motion at 2 and 6 week check-ins

    Time frame: Baseline, 2 and 6 week check-ins

    ROM will be evaluated

Sponsors and collaborators

Lead sponsor

The Idaho Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2022
Registry last updated
Sep 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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