Arthritis KneeNCT05462483
Heat Application to Quadriceps Effect on Pain After a Total Knee Arthroplasty
A study testing Rice Sock and Instructions to heat the quadriceps. in people with Arthritis Knee, run by The Idaho Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis Knee
- What is being tested?
- Rice Sock and Instructions to heat the quadriceps.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Anyone unable to give informed consent, pregnant individuals, children, or anyone whom the intervention may be harmful to.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heat Application to the Quadriceps Musculature and Its Effect on Pain Following a Total Knee Arthroplasty
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
- Being tested
- Rice Sock and Instructions to heat the quadriceps.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Rice sock and instructions to heat quadriceps | Experimental | Receives heating device and instructions to heat the quadriceps musculature. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Pain experienced at 2 and 6 week check-ins
Measured via KOOS Jr survey
Measured: Baseline, 2, and 6 week evaluations
Change of Pain experienced at 2 and 6 week check-ins
Measured via VAS survey
Measured: Baseline, 2, and 6 week evaluations
Change of Pain experienced at 2 and 6 week check-ins
Measured via PROMIS survey
Measured: Baseline, 2, and 6 week evaluations
Change in stiffness experienced at 2 and 6 week check-ins
Measured via PROMIS survey
Measured: Baseline, 2 and 6 week evaluations
Change in stiffness experienced at 2 and 6 week check-ins
Measured via KOOS Jr survey
Measured: Baseline, 2 and 6 week evaluations
Change in quality of life at 2 and 6 week check-ins
Measured via PROMIS survey
Measured: Baseline, 2 and 6 weeks
Change in Physical Health
Measured via PROMIS survey
Measured: Baseline, 2 and 6 weeks
Change in Mental Health
Measured via PROMIS survey
Measured: Baseline, 2 and 6 weeks
Change in knee function at 2 and 6 week check-ins
Measured via Range of motion
Measured: Baseline, 2 and 6 weeks
Change in knee function at 2 and 6 week check-ins
Measured via PROMIS surveys
Measured: Baseline, 2 and 6 weeks
Change in knee function at 2 and 6 week check-ins
Measured via KOOS Jr
Measured: Baseline, 2 and 6 weeks
Secondary outcomes (2)
Opiate Refills
Opiate usage/refills will be evaluated
Measured: Up to 6 weeks post-operation
Change in Range of Motion at 2 and 6 week check-ins
ROM will be evaluated
Measured: Baseline, 2 and 6 week check-ins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start1 Jun 2022
- Primary completion31 Jan 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Idaho Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cole Adams, The Idaho Clinic
- Investigators
- Cole Adams, Principal investigator, Idaho College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05462483
- Sponsor's protocol ID
- IdahoClinic
- Status last verified
- Sep 2023
- First submitted
- 27 May 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Application to the Quadriceps Musculature and Its Effect on Pain Following a Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05462483
- Acronym / sponsor ID
- IdahoClinic
- Conditions
- Arthritis Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- The Idaho ClinicUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rice sock and instructions to heat quadriceps | Experimental | Other: Rice Sock and Instructions to heat the quadriceps.Receives heating device and instructions to heat the quadriceps musculature. |
| No heating device or instructions to heat quadriceps | No intervention | –WIll not receive heating device or instructions to heat quadriceps musculature. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Anyone unable to give informed consent, pregnant individuals, children, or anyone whom the intervention may be harmful to.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Rice sock and instructions to heat quadriceps |
Primary outcome
Change of Pain experienced at 2 and 6 week check-ins
Time frame: Baseline, 2, and 6 week evaluations
Measured via KOOS Jr survey
Change of Pain experienced at 2 and 6 week check-ins
Time frame: Baseline, 2, and 6 week evaluations
Measured via VAS survey
Change of Pain experienced at 2 and 6 week check-ins
Time frame: Baseline, 2, and 6 week evaluations
Measured via PROMIS survey
Change in stiffness experienced at 2 and 6 week check-ins
Time frame: Baseline, 2 and 6 week evaluations
Measured via PROMIS survey
Change in stiffness experienced at 2 and 6 week check-ins
Time frame: Baseline, 2 and 6 week evaluations
Measured via KOOS Jr survey
Change in quality of life at 2 and 6 week check-ins
Time frame: Baseline, 2 and 6 weeks
Measured via PROMIS survey
Change in Physical Health
Time frame: Baseline, 2 and 6 weeks
Measured via PROMIS survey
Change in Mental Health
Time frame: Baseline, 2 and 6 weeks
Measured via PROMIS survey
Change in knee function at 2 and 6 week check-ins
Time frame: Baseline, 2 and 6 weeks
Measured via Range of motion
Change in knee function at 2 and 6 week check-ins
Time frame: Baseline, 2 and 6 weeks
Measured via PROMIS surveys
Change in knee function at 2 and 6 week check-ins
Time frame: Baseline, 2 and 6 weeks
Measured via KOOS Jr
2 secondary outcomes
Opiate Refills
Time frame: Up to 6 weeks post-operation
Change in Range of Motion at 2 and 6 week check-ins
Time frame: Baseline, 2 and 6 week check-ins
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cole Adams principal investigator
Idaho College of Osteopathic Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rice Sock and Instructions to heat the quadriceps. in people with Arthritis Knee, run by The Idaho Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Pain experienced at 2 and 6 week check-ins (time frame: Baseline, 2, and 6 week evaluations). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.