Game Ready Cryotherapy with Compression Group for Pain, Postoperative

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Walter Reed National Military Medical Center, Bethesda, MD
Pain, Postoperative+3 More
Game Ready Cryotherapy with Compression Group - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This study is evaluating whether prolonged cooling can improve recovery after orthopaedic surgery.

See full description

Eligible Conditions

  • Pain, Postoperative
  • Post Operative Pain Management
  • Cryotherapy Effect
  • Compression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Game Ready Cryotherapy with Compression Group will improve 16 primary outcomes in patients with Pain, Postoperative. Measurement will happen over the course of Post-operative days 1-14.

Post-operative days 1-14
Change in the Defense and Veterans Pain Rating Scale (DVPRS) before and after each cryotherapy session
Cryotherapy Device Usage
Defense and Veterans Pain Rating Scale (DVPRS) at wake up
Defense and Veterans Pain Rating Scale (DVPRS) right before bed time
Medication Consumption
Pre-operation (baseline)
Demographics Survey
Month 24
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) from before surgery to after surgery
Change in the Hip Disability and Osteoarthritis Outcome Score (HOOS) from before surgery to after surgery
Change in the International Knee Documentation Committee (IKDC) from before surgery to after surgery
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety (ANX) from before surgery to after surgery
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Depression (DEP) from before surgery to after surgery
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference (PI) from before surgery to after surgery
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) from before surgery to after surgery
Change in the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Interference (SI) from before surgery to after surgery
Change in the Single Assessment Numeric Evaluation (SANE) from before surgery to after surgery

Trial Safety

Trial Design

2 Treatment Groups

Control Cryotherapy Group
1 of 2
Game Ready Cryotherapy with Compression Group
1 of 2
Active Control
Experimental Treatment

This trial requires 504 total participants across 2 different treatment groups

This trial involves 2 different treatments. Game Ready Cryotherapy With Compression Group is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Game Ready Cryotherapy with Compression Group
Device
Post-operative treatment will involve using a Game Ready ® unit
Control Cryotherapy Group
Other
Post-operative treatment will involve using the standard of care cryotherapy (i.e., traditional ice packs without compression).

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly pre-operation (baseline) and then post-operation at 2 weeks, 6 weeks, 6 months, 12 months, and 24 months for reporting.

Who is running the study

Principal Investigator
K. K.
Kelly Kilcoyne, MD
Walter Reed National Military Medical Center

Closest Location

Walter Reed National Military Medical Center - Bethesda, MD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Adult (18 years of age or older)
Eligible for DEERS (Defense Enrollment Eligibility Reporting System - A system that enables uniformed service members & family members to receive health care through TRICARE)
Scheduled to receive one of the following procedures: Knee arthroscopy, Shoulder arthroscopy, or Hip arthroscopy
Fluent in speaking, reading, and understanding English

Patient Q&A Section

What causes pain, postoperative?

"There may be environmental triggers causing postoperative pain. This could be used as a screening tool for patient education. It is important that patients are adequately counseled regarding the effects of postoperative pain on rehabilitation, mobilization, and work status." - Anonymous Online Contributor

Unverified Answer

What are common treatments for pain, postoperative?

"Common pain treatments in hospitals include opioids, nonselective sympathomimetics, antineoplastics, narcotic analgesics, nonsteroidal anti-inflammatory drugs, and paracetamol. Common pain treatments in communities include exercise/mobilization, medication, and talk therapy; a referral to a physician is also common. Some patients consider the use of complementary and alternative therapies for their pain." - Anonymous Online Contributor

Unverified Answer

What is pain, postoperative?

"Pain following surgery increases the risk of complications. Therefore, it is an effective care practice to identify pain early and monitor it effectively after surgery." - Anonymous Online Contributor

Unverified Answer

What are the signs of pain, postoperative?

"Symptoms of pain, especially sudden or unexplained, are frequent in hospitalized children. There are many possible reasons for these complaints, including postoperative pain and complications. An accurate pain history or observation of the child with postoperative pain can help the hospital clinician make an accurate diagnosis if needed, and help in designing a protocol for providing pain medication." - Anonymous Online Contributor

Unverified Answer

How many people get pain, postoperative a year in the United States?

"About 823,000 persons receive opioid analgesic medications post-operatively in the United States. Approximately 75% of all persons admitted for one of the most common surgical procedures undergo an operation requiring opioid analgesia after discharge. The cost of an opioid dose in the United States is US$3.17. However, there is a growing number of people who might benefit from long-acting opioid therapy." - Anonymous Online Contributor

Unverified Answer

Can pain, postoperative be cured?

"Postoperative pain is highly variable. It cannot be completely eliminated in most patients, although it can be effectively controlled in most others. However, patient preferences for methods of pain control are an important consideration when managing the condition." - Anonymous Online Contributor

Unverified Answer

Is game ready cryotherapy with compression group safe for people?

"Cryotherapy and compression group did not produce a larger proportion of people with a high post-treatment pain score than did the standard-care cryoprobe group. We conclude that cryotherapy and compression group with routine administration of NSAIDs and narcotic-free analgesics at pre-procedure is safe." - Anonymous Online Contributor

Unverified Answer

What is game ready cryotherapy with compression group?

"Game ready cryotherapy with compression is an easy technique to use that did not have a statistically significant difference in immediate pain scores compared to standard ice sheets and ice packs. It is inexpensive and avoids the inconvenience of needing to refill the freezer at home." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating pain, postoperative?

"The only area of research that showed any improvement was the use of NSAIDs in postoperative [pain management](https://www.withpower.com/clinical-trials/pain-management). There have been no new medicines found to be of value in treating postoperative pain. There is still the challenge of managing postoperative pain with multimodal pain treatment." - Anonymous Online Contributor

Unverified Answer

How does game ready cryotherapy with compression group work?

"Results from a recent paper demonstrates the efficacy, safety, tolerability, and satisfaction of the Game Ready Cryotherapy, and supports the use of cryotherapy as an adjunct to conventional adjuvant multimodality therapy for the treatment of early-stage breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the latest research for pain, postoperative?

"It is important to be aware of the latest research on analgesia in the postoperative period. It may be helpful to consider assessing and relieving pain with simple strategies." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of game ready cryotherapy with compression group?

"The most common side effects were mild-to-moderate pain and moderate-to-severe erythema or edema, which appeared on the skin within 1 week after the treatment. The pain and edema were relieved within 2-3 days after treatment, and there were no other side effects. We suggest that cryotherapy with compression for 5 minutes at 9 degrees C for 20 seconds can be safely administered with a low complication rate." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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