Clinical trial NCT05462483: Heat Application to Quadriceps Effect on Pain After a Total Knee Arthroplasty
Official title: Heat Application to the Quadriceps Musculature and Its Effect on Pain Following a Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis Knee
Lead sponsor: The Idaho Clinic
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of Pain experienced at 2 and 6 week check-ins
timeFrame: Baseline, 2, and 6 week evaluations
measure: Change of Pain experienced at 2 and 6 week check-ins
timeFrame: Baseline, 2, and 6 week evaluations
measure: Change of Pain experienced at 2 and 6 week check-ins
timeFrame: Baseline, 2, and 6 week evaluations
measure: Change in stiffness experienced at 2 and 6 week check-ins
timeFrame: Baseline, 2 and 6 week evaluations
measure: Change in stiffness experienced at 2 and 6 week check-ins
timeFrame: Baseline, 2 and 6 week evaluations
measure: Change in quality of life at 2 and 6 week check-ins
timeFrame: Baseline, 2 and 6 weeks
measure: Change in Physical Health
timeFrame: Baseline, 2 and 6 weeks
measure: Change in Mental Health
timeFrame: Baseline, 2 and 6 weeks
measure: Change in knee function at 2 and 6 week check-ins
timeFrame: Baseline, 2 and 6 weeks
measure: Change in knee function at 2 and 6 week check-ins
timeFrame: Baseline, 2 and 6 weeks
measure: Change in knee function at 2 and 6 week check-ins
timeFrame: Baseline, 2 and 6 weeks
Secondary outcomes:
measure: Opiate Refills
timeFrame: Up to 6 weeks post-operation
measure: Change in Range of Motion at 2 and 6 week check-ins
timeFrame: Baseline, 2 and 6 week check-ins
Other outcomes:
Locations:
city: Boise
country: United States
facility: The Idaho Clinic
state: Idaho
Study officials:
affiliation: Idaho College of Osteopathic Medicine
name: Cole Adams
role: PRINCIPAL_INVESTIGATOR
References: