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

Primary Purpose

Arthritis Knee

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rice Sock and Instructions to heat the quadriceps.
Sponsored by
The Idaho Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthritis Knee

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Idaho Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Rice sock and instructions to heat quadriceps

No heating device or instructions to heat quadriceps

Arm Description

Receives heating device and instructions to heat the quadriceps musculature.

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

Outcomes

Primary Outcome Measures

Change of Pain experienced at 2 and 6 week check-ins
Measured via KOOS Jr survey
Change of Pain experienced at 2 and 6 week check-ins
Measured via VAS survey
Change of Pain experienced at 2 and 6 week check-ins
Measured via PROMIS survey
Change in stiffness experienced at 2 and 6 week check-ins
Measured via PROMIS survey
Change in stiffness experienced at 2 and 6 week check-ins
Measured via KOOS Jr survey
Change in quality of life at 2 and 6 week check-ins
Measured via PROMIS survey
Change in Physical Health
Measured via PROMIS survey
Change in Mental Health
Measured via PROMIS survey
Change in knee function at 2 and 6 week check-ins
Measured via Range of motion
Change in knee function at 2 and 6 week check-ins
Measured via PROMIS surveys
Change in knee function at 2 and 6 week check-ins
Measured via KOOS Jr

Secondary Outcome Measures

Opiate Refills
Opiate usage/refills will be evaluated
Change in Range of Motion at 2 and 6 week check-ins
ROM will be evaluated

Full Information

First Posted
May 27, 2022
Last Updated
September 26, 2023
Sponsor
The Idaho Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05462483
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
January 31, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Idaho Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis Knee

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rice sock and instructions to heat quadriceps
Arm Type
Experimental
Arm Description
Receives heating device and instructions to heat the quadriceps musculature.
Arm Title
No heating device or instructions to heat quadriceps
Arm Type
No Intervention
Arm Description
WIll not receive heating device or instructions to heat quadriceps musculature.
Intervention Type
Other
Intervention Name(s)
Rice Sock and Instructions to heat the quadriceps.
Intervention Description
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 Outcome Measure Information:
Title
Change of Pain experienced at 2 and 6 week check-ins
Description
Measured via KOOS Jr survey
Time Frame
Baseline, 2, and 6 week evaluations
Title
Change of Pain experienced at 2 and 6 week check-ins
Description
Measured via VAS survey
Time Frame
Baseline, 2, and 6 week evaluations
Title
Change of Pain experienced at 2 and 6 week check-ins
Description
Measured via PROMIS survey
Time Frame
Baseline, 2, and 6 week evaluations
Title
Change in stiffness experienced at 2 and 6 week check-ins
Description
Measured via PROMIS survey
Time Frame
Baseline, 2 and 6 week evaluations
Title
Change in stiffness experienced at 2 and 6 week check-ins
Description
Measured via KOOS Jr survey
Time Frame
Baseline, 2 and 6 week evaluations
Title
Change in quality of life at 2 and 6 week check-ins
Description
Measured via PROMIS survey
Time Frame
Baseline, 2 and 6 weeks
Title
Change in Physical Health
Description
Measured via PROMIS survey
Time Frame
Baseline, 2 and 6 weeks
Title
Change in Mental Health
Description
Measured via PROMIS survey
Time Frame
Baseline, 2 and 6 weeks
Title
Change in knee function at 2 and 6 week check-ins
Description
Measured via Range of motion
Time Frame
Baseline, 2 and 6 weeks
Title
Change in knee function at 2 and 6 week check-ins
Description
Measured via PROMIS surveys
Time Frame
Baseline, 2 and 6 weeks
Title
Change in knee function at 2 and 6 week check-ins
Description
Measured via KOOS Jr
Time Frame
Baseline, 2 and 6 weeks
Secondary Outcome Measure Information:
Title
Opiate Refills
Description
Opiate usage/refills will be evaluated
Time Frame
Up to 6 weeks post-operation
Title
Change in Range of Motion at 2 and 6 week check-ins
Description
ROM will be evaluated
Time Frame
Baseline, 2 and 6 week check-ins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cole Adams
Organizational Affiliation
Idaho College of Osteopathic Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Idaho Clinic
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States

12. IPD Sharing Statement

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

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