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临床试验/NCT05462483
NCT05462483已完成不适用

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

The Idaho Clinic2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
2
主要终点
Change in Physical Health

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Change in Physical Health

时间窗: Baseline, 2 and 6 weeks

Measured via PROMIS survey

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

时间窗: Baseline, 2 and 6 weeks

Measured via PROMIS survey

Change in Mental Health

时间窗: Baseline, 2 and 6 weeks

Measured via PROMIS survey

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

时间窗: Baseline, 2, and 6 week evaluations

Measured via KOOS Jr survey

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

时间窗: Baseline, 2 and 6 week evaluations

Measured via PROMIS survey

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

时间窗: Baseline, 2 and 6 weeks

Measured via Range of motion

次要结局

  • Change in Range of Motion at 2 and 6 week check-ins(Baseline, 2 and 6 week check-ins)
  • Opiate Refills(Up to 6 weeks post-operation)

研究者

发起方
The Idaho Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Cole Adams

Principal Investigator

The Idaho Clinic

研究点 (2)

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