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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the direction of tubing on cryotherapy machines affects patient satisfaction and pain levels. It seeks to determine whether patients prefer the tubing facing their head or feet during use. The trial seeks participants scheduled for specific knee surgeries who have access to a cryotherapy unit. This research could improve the overall experience and comfort for future patients using these devices. As an unphased trial, it offers participants the chance to contribute to enhancing patient comfort and satisfaction with cryotherapy treatments.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this tubing direction method is safe for patients?

Research has shown that cryotherapy machines, commonly used in medical treatments, are generally safe for patients. Studies have found no serious side effects in patients using these machines. For example, one study on cryotherapy for women with cervical issues reported no serious side effects within one to three months after treatment.

The current study examines patient preferences regarding the direction of the cryotherapy machine's tubing—whether it points towards the head or the feet. This study focuses more on comfort and satisfaction than safety. Importantly, no major safety concerns have been identified with this type of treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how the placement of cryotherapy machine tubing might affect patient comfort and preference. Unlike standard cryotherapy treatments that don't typically consider tubing direction, this study examines whether directing the tubing upwards towards the head or downwards towards the feet can enhance the patient experience. By focusing on the positioning of the equipment, this trial aims to improve the overall comfort and satisfaction for patients undergoing cryotherapy, potentially leading to better adherence and outcomes.

What evidence suggests that this tubing direction is effective for patient satisfaction and pain management?

Research has shown that cryotherapy can help reduce pain after surgery. For instance, patients who used cryotherapy reported feeling 1.6 points less pain on a scale from 0 to 10, just two days after their surgery. Another study found that cryotherapy also decreased blood loss in patients recovering from total knee replacement. Regarding comfort, up to 96% of patients had a positive experience with cryotherapy devices. This trial will compare two different tubing placements for cryotherapy machines: one with tubing directed downwards towards the feet and another with tubing directed upwards towards the head. These findings suggest that cryotherapy not only helps manage pain but also improves overall recovery after surgery. ^{1 6 7 8 9}

Who Is on the Research Team?

John Schlechter, DO

Principal Investigator

Children's Hospital of Orange County

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06772662

One Up, One Down: Analyzing Patient Preference on ... Patients will report their opinion and preference of tubing placement based on the group they are randomized to at the end of 7 days post-op.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10500624/

Cryotherapy following total knee replacement - PMC Pain was better by 1.6 points on a 0‐ to 10‐point scale with cryotherapy at 2 days after surgery. • People who had cryotherapy rated their pain as 3.2 points. • ...

3. arthroplasty.biomedcentral.com arthroplasty.biomedcentral.com/articles/10.1186/s42836-024-00287-7

Comparison of three cryotherapy techniques for early post ... This study aimed to evaluate and compare three cryotherapy techniques in terms of efficacy and patient satisfaction in patients undergoing total knee ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/os.14266

Cryotherapy for Rehabilitation After Total Knee Arthroplasty ... This study found that cryotherapy can significantly reduce blood loss in TKA patients, as evidenced by decreased hemoglobin decline and drainage ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10790989/

A randomised crossover trial of five cryocompression devices ... 87–96% reported a positive comfort rating for the Physiolab S1, VPulse, Cryo/Cuff and Gel Wrap, whereas 53% of participants reported a positive ...

6. withpower.com withpower.com/trial/cryotherapy-machine-tubing-placement-for-patient-preference-c5c20

Cryotherapy Machine Tubing Placement for Patient ... 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 ...

7. fda.gov fda.gov/about-fda/division-patient-centered-development/patient-preference-information-ppi-medical-device-decision-making

Patient Preference Information (PPI) in Medical Device ... Patient-preference information (PPI) captures the value patients place on features of medical devices. PPI includes different patient perspectives.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3261002/

Report on a cryotherapy service for women with cervical ... Complete data were available for 18 of 20 (90%) and 13 (72.2%) had no sign of CIN. No serious adverse events were reported 1 to 3 months after cryotherapy. All ...

9. researchgate.net researchgate.net/publication/279301759_Ensuring_proper_and_safe_use_of_the_cryotherapy_machine

Ensuring proper and safe use of the cryotherapy machine Cryotherapy machines, also known as cryosurgery machines, continue to be widely used for surgical procedures of the eye such as retinal ...