Game Ready Cryotherapy with Compression for Postoperative Pain

Overseen By Matthew W Bradley, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Walter Reed National Military Medical Center

Disqualifiers: Concurrent injuries, others

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

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a new cryotherapy device aids recovery after joint surgeries, such as those on the knee, shoulder, or hip. Cryotherapy uses cold temperatures to reduce pain and swelling. The study will compare a new device that combines cold therapy with compression (Combined Cryotherapy with Compression) to standard ice packs. The goal is to determine if this new method speeds up recovery and reduces pain more effectively. Candidates may be suitable if scheduled for knee, shoulder, or hip arthroscopy and eligible for TRICARE health care. As an unphased trial, this study offers participants the opportunity to potentially experience faster recovery and reduced pain with an innovative treatment approach.

Do I need to stop my current medications for this trial?

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

What prior data suggests that these cryotherapy treatments are safe for postoperative pain management?

Research has shown that using Game Ready Cryotherapy with Compression is generally safe after surgery. Complications are extremely rare, occurring in only about 0.00225% of cases. Rare issues may include frostbite or ongoing pain, so individuals with certain risk factors should exercise caution.

The device cools and compresses the area, reducing pain and swelling more effectively than ice packs alone. Studies also indicate it can improve movement and lessen pain post-surgery. Overall, most people find the treatment manageable and experience positive results. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using Game Ready Cryotherapy with Compression for postoperative pain management because it combines cold therapy with compression, potentially enhancing recovery. This dual-action approach is unique compared to traditional cryotherapy, which typically involves just ice packs without compression. The compression component may improve blood flow and reduce swelling more effectively, leading to better pain management and faster healing. This innovative combination offers a promising alternative to conventional methods, providing hope for improved patient outcomes.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

Research has shown that using Game Ready cryotherapy with compression, which participants in this trial may receive, can be very helpful after surgery. Studies have found it reduces pain, swelling, and inflammation more effectively than regular ice packs. The added compression also improves joint movement and speeds up recovery. Some reports suggest that this treatment may reduce the need for pain medication. Overall, it offers a promising option for easing recovery after orthopedic surgery. ^{2 4 6 7 8}

Who Is on the Research Team?

Ashley B Bozzay, MD

Principal Investigator

Walter Reed National Military Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Eligible for DEERS (Defense Enrollment Eligibility Reporting System - A system that enables uniformed service members & family members to receive health care through TRICARE)

Fluent in speaking, reading, and understanding English

You are planning to have knee, shoulder, or hip arthroscopy.

Exclusion Criteria

Unable to understand and/or provide written informed consent

Presence of concurrent additional injuries (e.g., both a knee and hip injury). Participants can only have one injury

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cryotherapy with or without compression post-operatively to manage pain and reduce inflammation

2 weeks

Daily monitoring (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple intervals

24 months

Assessments at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Combined Cryotherapy with Compression
• Cryotherapy Alone

Trial Overview 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.

How Is the Trial Designed?

Group I: Game Ready Cryotherapy with Compression Group Experimental Treatment 1 Intervention

Post-operative treatment will involve using a Game Ready ® unit

Group II: Control Cryotherapy Group Active Control 1 Intervention

Post-operative treatment will involve using the standard of care cryotherapy (i.e., traditional ice packs without compression).

Combined Cryotherapy with Compression is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Cryotherapy for:

• Postoperative pain management
• Swelling reduction
• Rehabilitation after orthopaedic surgery

Approved in United States as Cryotherapy for:

• Postoperative pain management
• Swelling reduction
• Rehabilitation after orthopaedic surgery

Approved in Canada as Cryotherapy for:

• Postoperative pain management
• Swelling reduction
• Rehabilitation after orthopaedic surgery

Who Is Running the Clinical Trial?

Walter Reed National Military Medical Center

Lead Sponsor

Trials

149

Recruited

33,800+

Published Research Related to This Trial

The Game Ready© cryotherapy system significantly reduced postoperative pain at 24 and 48 hours after lumbar fusion surgery, leading to a 50% decrease in morphine consumption compared to the control group.

Patients using the cryotherapy system experienced less blood loss and were discharged earlier (3.9 days) than those who did not use it (5.1 days), indicating enhanced recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced recovery after lumbar fusion surgery: Benefits of using Game Ready©. De Bie, A., Siboni, R., Smati, MF., et al.[2022]

Cryotherapy, including methods like bagged ice and continuous cryotherapy devices, has been shown to reduce pain and analgesic consumption in about half of the studies reviewed, particularly after orthopedic surgeries, but its effectiveness in improving range of motion and reducing swelling is less clear.

Continuous cryotherapy devices appear to provide better outcomes in terms of pain reduction and recovery after knee arthroscopy compared to traditional ice methods, but more high-quality studies are needed to establish their superiority and safety as a standard treatment in orthopedic care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orthopaedic Application of Cryotherapy: A Comprehensive Review of the History, Basic Science, Methods, and Clinical Effectiveness. Kunkle, BF., Kothandaraman, V., Goodloe, JB., et al.[2023]

Dynamic intermittent compression cryotherapy combined with an intravenous nefopam-based pain management protocol significantly reduced postoperative pain after ACL reconstruction compared to static compression cryotherapy, with patients in the DCIVNPP group achieving acceptable pain levels sooner (Day 3) than those in the control group.

While both groups experienced similar side effects, the DCIVNPP group reported more dizziness and malaise, suggesting that the method of nefopam administration may influence side effect profiles, but overall, significant side effects diminished after Day 3.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic intermittent compression cryotherapy with intravenous nefopam results in faster pain recovery than static compression cryotherapy with oral nefopam: post-anterior cruciate ligament reconstruction. Moussa, MK., Lefevre, N., Valentin, E., et al.[2023]

The Cryo/Cuff system, which combines cold therapy and hydrostatic pressure, was tested on 25 participants undergoing bilateral foot surgery and showed promising results in reducing postoperative pain and swelling.

Eighty percent of participants reported a decrease in pain and edema during follow-up visits, indicating that the Cryo/Cuff system is an effective tool for enhancing recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Cryo/Cuff for the control of postoperative pain and edema. Scheffler, NM., Sheitel, PL., Lipton, MN.[2009]

In a study of 39 patients who underwent ACL reconstruction, dynamic intermittent compression combined with cryotherapy significantly reduced the need for analgesic drugs compared to static compression, with a notable decrease in tramadol and morphine usage.

Patients receiving dynamic compression also achieved better knee flexion at discharge, with an average of 90.5° compared to 84.5° for those with static compression, indicating improved postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryotherapy with dynamic intermittent compression for analgesia after anterior cruciate ligament reconstruction. Preliminary study. Murgier, J., Cassard, X.[2022]

In a study of 30 patients undergoing total hip arthroplasty, the use of the Game Ready System, which combines cyclic compression and cryotherapy, significantly reduced postoperative blood loss compared to a control group using only a compression bandage.

Patients receiving cryocompression showed trends towards lower morphine usage, shorter hospital stays, and less wound discharge, suggesting potential benefits in pain management and recovery, although no significant differences in pain scores were observed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryocompression therapy after elective arthroplasty of the hip. Leegwater, NC., Willems, JH., Brohet, R., et al.[2017]

Cryotherapy, particularly using continuous cold flow devices, is associated with better postoperative outcomes in patients undergoing knee surgeries, as evidenced by 5 out of 8 studies favoring its use over no cryotherapy.

Using cryotherapy may help reduce the need for pain medications like opioids, which can have serious side effects and risks of dependence, highlighting its potential as a safer pain management option after knee surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryotherapy Treatment After Unicompartmental and Total Knee Arthroplasty: A Review. Chughtai, M., Sodhi, N., Jawad, M., et al.[2018]

Continuous-flow cryotherapy units effectively reduce pain, inflammation, swelling, blood loss, and the need for narcotics after surgery, making them a beneficial postoperative treatment option.

While complications from cryotherapy are very rare (about 0.00225%), they can be serious, so it's important to monitor patients closely for signs of cold injury, especially those with known risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative cryotherapy: risks versus benefits of continuous-flow cryotherapy units. Wilke, B., Weiner, RD.[2005]

In a study involving 46 patients who underwent shoulder arthroscopy, there was no significant difference in postoperative pain levels or pain medication usage between those using compressive cryotherapy (CC) and those using a standard ice wrap (IW).

The results suggest that compressive cryotherapy may not provide additional benefits over standard ice treatment for managing pain after rotator cuff repair or subacromial decompression, indicating a need for further research on the cost-effectiveness of CC devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. Kraeutler, MJ., Reynolds, KA., Long, C., et al.[2016]

Dynamic cryo-compression (DC) therapy significantly reduced pain levels in patients after lumbar spinal surgery, with lower visual analogue scale (VAS) scores compared to a control group, indicating its efficacy in postoperative pain management.

Patients receiving DC therapy required less analgesic medication overall, suggesting that DC not only alleviates pain but may also decrease the need for additional painkillers during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cryo-Compression Therapy After Elective Spinal Surgery for Pain Management: A Cross-Sectional Study With Historical Control. Nabıyev, VN., Ayhan, S., Adhıkarı, P., et al.[2020]

In a study of 102 patients undergoing total knee arthroplasty, computer-assisted cryotherapy significantly reduced postoperative pain and opioid consumption during the first week compared to a control group.

While cryotherapy improved pain management, there were no significant differences in knee function or swelling between the two groups, indicating that while it helps with pain, it may not impact overall recovery metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of computer-assisted cryotherapy in the postoperative treatment after total knee arthroplasty: positive effects on pain and opioid consumption. Brouwers, HFG., de Vries, AJ., van Zuilen, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10900683/

Randomized controlled trial of compressive cryotherapy ... Both cryotherapy methods improved joint ROM, trophic changes, pain and function. Adding dynamic compression to a cryotherapy protocol provided further benefits.

2. withpower.com withpower.com/trial/phase-pain-postoperative-10-2020-7552d

Game Ready Cryotherapy with Compression for ... Continuous-flow cryotherapy units have been shown to decrease pain, inflammation, swelling, blood loss, and narcotic usage postoperatively. Complications are ...

3. lni.wa.gov lni.wa.gov/patient-care/_docs/TechAsssesGameReadyupdate2020.pdf

Game Ready® Injury Treatment System The efficacy of Game Ready® for treating post-surgery injuries to reduce pain and swelling has been examined in seven studies as referred to by the manufacturer ...

4. gameready.com gameready.com/wp-content/uploads/2019/10/Effects_of_Intermittent_Cryo-Compression_in_Primary_Total_Knee_Arthroplasty.pdf

Effects of Intermittent Cryo-Compression Therapy in ... The results of this preliminary report indicate a positive correlation between the use of the. Game Ready Injury Treatment System and accelerated improvement in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S187705682100178X

Enhanced recovery after lumbar fusion surgery: Benefits of ... The primary aim of this study was to evaluate how the Game Ready© cryotherapy system impacts postoperative analgesia following lumbar fusion.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10471706/

The role of a cryocompression device following total knee ... The study sought to investigate the effectiveness of a cryocompression Game Ready™ (GR) versus usual care protocol (UC) on early ...

7. gameready.com gameready.com/clinical-evidence/

cold and hot contrast therapy device information Integrates cold and compression therapies to help reduce pain and edema – outperforming conventional rest, ice, compression, and elevation (RICE) methods.

8. drrossradic.com.au drrossradic.com.au/wp-content/uploads/Study-Protocol-TKA.pdf

Post-operative use of Game Ready cryocompression ... Previous orthopaedic research on the use of cryotherapy has shown positive outcomes in decreasing pain, inflammation, blood loss and improving range of movement ...