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Combined Cryotherapy With Compression Versus Cryotherapy Alone After Orthopaedic Surgery

Walter Reed National Military Medical Center logo

Walter Reed National Military Medical Center

Status

Enrolling

Conditions

Postoperative Pain Management
Cryotherapy Effect
Compression

Treatments

Other: Control Cryotherapy Group
Device: Game Ready Cryotherapy with Compression Group

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT05011084
WRNMMC-2020-0310

Details and patient eligibility

About

Cryotherapy has been used to enhance recovery after orthopaedic surgery. Many devices are available but few can guarantee a temperature regulation during a prolonged time and therefore have been criticized. The arrival of new advanced cryotherapy devices made it possible to test the effect of prolonged cooling on rehabilitation after arthroscopic orthopaedic procedures.

Full description

Opioids are most commonly administered for the treatment of pain and are among the most prescribed drugs in the United States (US). Between 2003 and 2011, opioid prescriptions increased from 149 million to 238 million [3,5,7,11]. In 2004, while constituting only 4.5% of the world's population, the US consumed 99% of the global supply of hydrocodone [3,11]. These trends resulted in the Centers for Disease Control and Prevention recognizing opioid abuse as an epidemic [2,11].

Pain management after orthopaedic arthroscopic procedures is mandatory regardless of the surgical technique. Cold therapy (cryotherapy) has been widely used for many years in the treatment of postoperative pain management in orthopaedic surgery and most studies have reported better pain scores and reduced drug consumptions [1,6,8]. Cryotherapy involves applying a cold device to the skin surrounding the injured soft tissues to reduce the intraarticular temperature. It reduces local blood flow by vasoconstriction, which in turn also reduces local inflammatory reaction, swelling, and heat experience. It also decreases the conduction of nerve signals potentially reducing pain transmission [14,15]. Several cryotherapy options are available: first generation cold therapy like crushed ice in a plastic bag, cold or gel packs; second-generation cold therapy with circulating ice water with or without compression; and third-generation advanced computer-assisted devices with continuous controlled cold therapy.

Cryotherapy is the standard of care in some countries and rarely is used in others [17]. Conflicting evidence regarding the value of this treatment from randomized trials may contribute to that practice disparity [16]. Raynor et al [8] showed that cryotherapy has a statistically significant benefit in postoperative pain control, while no improvement in postoperative range of motion or drainage was found. Cryotherapy with compression units are inexpensive, easy to use, have a high level of patient satisfaction, and are rarely associated with adverse events. Raynor et al [8] concluded cryotherapy may be justified in the postoperative management of knee surgery.

Postoperative cryotherapy with compression was proposed as a method of reducing pain and the inflammatory response in the early postoperative period after orthopaedic arthroscopic procedures. Previous study results are equivocal. Kraeutler et al [12] reported that there does not appear to be a significant benefit to use of cold compression over standard ice wraps in patients undergoing shoulder arthroscopy for rotator cuff repair or subacromial decompression. While Alfuth et al [13] concluded no recommendations can be made regarding the question whether cold compression therapy or cold therapy should be preferred immediately after arthroscopic surgery of the shoulder. Our goal is to analyze the analgesic efficacy of cryotherapy after shoulder, knee, and hip arthroscopic procedures using the Game Ready © which is a second generation cryotherapy with compression system. The investigators hypothesize this may decrease postoperative opioid usage as well as be more cost effective when compared to first generation cryotherapy (ice packs without compression) for medical healthcare systems.

Enrollment

504 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)
  • Fluent in speaking, reading, and understanding English
  • Scheduled to receive one of the following procedures: Knee arthroscopy, Shoulder arthroscopy, 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

504 participants in 2 patient groups

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

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Matthew W Bradley, MPH; Ashley B Anderson, MD

Data sourced from clinicaltrials.gov

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