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Procedure

Game Ready Cryotherapy with Compression for Postoperative Pain

N/A
Recruiting
Led By Jonathan F Dickens, MD
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a special cold and pressure device to help patients who have had shoulder, knee, or hip surgery. The device aims to reduce pain and swelling, potentially lowering the need for pain medications. Cryotherapy has been used for years to decrease swelling and pain after trauma or surgery, and it is gaining wider acceptance in sports medicine for acute and postoperative care.

Who is the study for?
This trial is for adults over 18 who are scheduled for knee, shoulder, or hip arthroscopy and can understand English. They must be eligible for military health care benefits (DEERS). It's not open to those with multiple injuries or who can't consent.
What is being tested?
The study compares two post-surgery recovery methods: one group receives advanced cryotherapy with compression (Game Ready), while the control group gets standard cryotherapy without compression after orthopaedic surgery.
What are the potential side effects?
Potential side effects may include skin irritation from cold temperatures, discomfort from the compression device, and possible numbness or tingling in the treated area due to prolonged cooling.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the American Shoulder and Elbow Surgeons Standardized Shoulder Form (ASES) from before surgery to after surgery
Change in the Defense and Veterans Pain Rating Scale (DVPRS) before and after each cryotherapy session
Change in the Defense and Veterans Pain Rating Scale (DVPRS) from before surgery to after surgery
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Game Ready Cryotherapy with Compression GroupExperimental Treatment1 Intervention
Post-operative treatment will involve using a Game Ready ® unit
Group II: Control Cryotherapy GroupActive Control1 Intervention
Post-operative treatment will involve using the standard of care cryotherapy (i.e., traditional ice packs without compression).

Find a Location

Who is running the clinical trial?

Walter Reed National Military Medical CenterLead Sponsor
140 Previous Clinical Trials
32,669 Total Patients Enrolled
Jonathan F Dickens, MDPrincipal InvestigatorWalter Reed National Military Medical Center
Ashley B Anderson, MDPrincipal InvestigatorWalter Reed National Military Medical Center

Media Library

Combined Cryotherapy with Compression (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT05011084 — N/A
Post Operative Pain Management Research Study Groups: Game Ready Cryotherapy with Compression Group, Control Cryotherapy Group
Post Operative Pain Management Clinical Trial 2023: Combined Cryotherapy with Compression Highlights & Side Effects. Trial Name: NCT05011084 — N/A
Combined Cryotherapy with Compression (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05011084 — N/A
~39 spots leftby Mar 2025
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