Cryotherapy Machine Tubing Placement for Patient Preference

Overseen By Kiran Athreya, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital of Orange County

Disqualifiers: No ACL or MPFL surgery, No cryotherapy access, Age outside 10-18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

100 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to better understand patient preference and their satisfaction rates with cryotherapy machines based on the direction of the tubing. This study will evaluate both satisfaction and pain of patients who use the cryotherapy machines in the two groups: tubing facing towards the head, and the other with tubing facing toward the feet.

Research Team

John Schlechter, DO

Principal Investigator

Children's Hospital of Orange County

Eligibility Criteria

This trial is for patients who are using cryotherapy machines. It's designed to understand if they prefer the tubing facing towards their head or feet, based on their satisfaction and pain levels.

Inclusion Criteria

I am scheduled for ACL or MPFL knee surgery.

Patients who have access to a cryotherapy unit at the time of surgery

Exclusion Criteria

I haven't had ACL or MPFL knee surgery.

Patients do not have access to a cryotherapy unit

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants use cryotherapy machines with tubing placed either upwards or downwards for 7 days

1 week

Daily use of cryotherapy machine

Follow-up

Participants are monitored for satisfaction and pain preference after treatment

1 week

Treatment Details

Interventions

• Tubing Direction

Trial Overview The study is testing patient preference for the direction of cryotherapy machine tubing—either towards the head or feet. Participants will be divided into two groups to compare satisfaction rates and pain experiences.

Participant Groups

Group I: Tubing Down Active Control 1 Intervention

Patients in this arm will have their cryotherapy machine tubing placed in the downwards position facing towards the feet.

Group II: Tubing up Active Control 1 Intervention

Patients in this arm will have their cryotherapy machine tubing placed in the upwards position facing towards the head.

Who Is Running the Clinical Trial?

Children's Hospital of Orange County

Lead Sponsor

Trials

38

Recruited

5,700+