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

NCT05462483 | Completed

• 1 other identifier: IdahoClinic
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthritis Knee

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (2)

• Opiate Refills

  Up to 6 weeks post-operation

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

  Baseline, 2 and 6 week check-ins

Study Arms (2)

Rice sock and instructions to heat quadriceps

EXPERIMENTAL

Receives heating device and instructions to heat the quadriceps musculature.

Other: Rice Sock and Instructions to heat the quadriceps.

No heating device or instructions to heat quadriceps

NO INTERVENTION

WIll not receive heating device or instructions to heat quadriceps musculature.

Interventions

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.

Rice sock and instructions to heat quadriceps

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Anyone unable to give informed consent, pregnant individuals, children, or anyone whom the intervention may be harmful to.

Sponsors & Collaborators

• The Idaho Clinic: lead

Study Sites (1)

The Idaho Clinic

Boise, Idaho, 83704, United States

Location

Study Officials

• Cole Adams

  Idaho College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: July 18, 2022
• Study Start: June 1, 2022
• Primary Completion: January 31, 2023
• Study Completion: July 1, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

US (1)