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

Arthritis Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05462483
• Other study ID #: IdahoClinic
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: July 1, 2023

Study information

• Verified date: September 2023
• Source: The Idaho Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: July 1, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis Knee

Intervention

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.

Locations

Country	Name	City	State
United States	The Idaho Clinic	Boise	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
The Idaho Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Pain experienced at 2 and 6 week check-ins	Measured via KOOS Jr survey	Baseline, 2, and 6 week evaluations
Primary	Change of Pain experienced at 2 and 6 week check-ins	Measured via VAS survey	Baseline, 2, and 6 week evaluations
Primary	Change of Pain experienced at 2 and 6 week check-ins	Measured via PROMIS survey	Baseline, 2, and 6 week evaluations
Primary	Change in stiffness experienced at 2 and 6 week check-ins	Measured via PROMIS survey	Baseline, 2 and 6 week evaluations
Primary	Change in stiffness experienced at 2 and 6 week check-ins	Measured via KOOS Jr survey	Baseline, 2 and 6 week evaluations
Primary	Change in quality of life at 2 and 6 week check-ins	Measured via PROMIS survey	Baseline, 2 and 6 weeks
Primary	Change in Physical Health	Measured via PROMIS survey	Baseline, 2 and 6 weeks
Primary	Change in Mental Health	Measured via PROMIS survey	Baseline, 2 and 6 weeks
Primary	Change in knee function at 2 and 6 week check-ins	Measured via Range of motion	Baseline, 2 and 6 weeks
Primary	Change in knee function at 2 and 6 week check-ins	Measured via PROMIS surveys	Baseline, 2 and 6 weeks
Primary	Change in knee function at 2 and 6 week check-ins	Measured via KOOS Jr	Baseline, 2 and 6 weeks
Secondary	Opiate Refills	Opiate usage/refills will be evaluated	Up to 6 weeks post-operation
Secondary	Change in Range of Motion at 2 and 6 week check-ins	ROM will be evaluated	Baseline, 2 and 6 week check-ins