Durable Medical Equipment Section - Cooling Devices Used in the Home Setting

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

Description

Cold and/or compression therapy following surgery or musculoskeletal and soft tissue injury has long been accepted in the medical field as an effective tool for reducing inflammation, pain, and swelling. Ice packs and various bandages and wraps are commonly used. In addition, a variety of continuous cooling devices are commercially available and can be broadly subdivided into those providing passive cold therapy, and those providing active cold therapy using a mechanical device.

Passive Cold Therapy

The CryoCuff® device and the Polar Care Cub devices are examples of passive cooling devices. The CryoCuff® device consists of an insulated container filled with cold water that is attached to a compressive cuff. When the container is raised, the water fills and pressurizes the cuff. The amount of pressure is proportional to the height of the container. When body heat warms the water, the cooler is lowered and the water drains out. The cooler is then raised above the affected limb and cold water refills the compressive cuff. The PolarCare Cub unit consists of pads held in place with elastic straps, which may also provide compression. The pads are attached to a built-in hand pump which circulates the water through the pads at the same time as increasing the compression around the joint.

Active Cold Therapy

In active devices, a motorized pump both circulates cold water and may also provide pneumatic Compression.  For example, the AutoChill® device, which may be used in conjunction with a CryoCuff®, consists of a pump that automatically exchanges water from the cuff to the cooler, eliminating the need for manual water recycling.  The Hot/Ice Thermal Blanket is another example of an active cooling device, which consists of two rubber pads connected by a rubber hose to the main cooling unit.  Fluid is then circulated via the hose through the thermal blankets.  The temperature of the fluid is controlled by the main unit and can be either hot or cold.  The Game Ready™ Accelerated Recovery System is an example of an active cooling device combined with a pneumatic compression component.  The system consists of various soft wraps and a computer-controlled control unit to circulate the water through the wraps.

Policy/Criteria

Active and passive cooling devices used in the home setting are considered not medically necessary.

Scientific Background

The standard postoperative treatment of musculoskeletal surgeries consists of ice packs and various types of compressive wraps. Both ice packs and the passive cooling devices are essentially designed to provide cold therapy, with the primary difference being that water recirculation is more convenient with passive cooling devices. Therefore, to document a benefit beyond convenience, the trial design must control the number of exchanges of ice bags and episodes of water recirculation. In contrast, active cooling devices are designed to provide a steady low temperature, which might provide a unique benefit compared to the more variable temperature achieved with ice packs or passive cooling devices. Benefit is typically focused on pain control and swelling.

The use of constant controlled cold therapy using units with pumps or portable refrigerators has not been shown to offer any clinically significant benefit over passive methods of delivering cold therapy. An updated search of the MEDLINE database through September 11, 2008 for clinical studies that compared controlled cold therapy with passive cold therapy failed to return any new studies since the last policy update.

The discussion below focuses only on randomized studies.

Passive Cooling Devices

Schroder compared the CryoCuff® device to traditional ice therapy in 44 patients who had undergone repair of the anterior cruciate ligament (ACL). (2) Those receiving ice therapy received an ice bag three times per day postoperatively. While those randomized to the CryoCuff® group reported significant decreases in pain, swelling and analgesic use, it was not reported how frequently the cold water was recirculated in the device. Additionally, the patients in this study were hospitalized for 14 days, thus the setting is not relevant to this policy. Whitelaw and colleagues reported on the results of a trial that randomized 102 patients undergoing knee arthroscopy in the outpatient setting to receive either the CryoCuff® device or traditional ice therapy. (3) The number of exchanges of ice packs and water recirculation was not reported. There was no significant difference in average pain assessment, although those in the CryoCuff® group reported decreased pain medication use compared to the control group. Edwards and colleagues studied the outcomes of 71 patients undergoing ACL reconstruction who were randomized to receive either CryoCuff® therapy with ice water, CryoCuff® therapy with room temperature water, or no cold therapy. (4) Therefore, this trial did not include the relevant control group of patients treated with conventional ice packs. Nevertheless, there were no significant differences in analgesic use or pain assessment among the three groups, including the group that received no cold therapy. Another randomized trial by Brandsson suffers from the same limitation. (5) In this study of 50 patients undergoing ACL repair, there was no group who received standard therapy with ice packs. Healy and colleagues reported that the CryoCuff® device provided no benefit for pain control or swelling compared to ice packs in a randomized trial of 76 patients (105 knees) undergoing total knee arthroplasty. (6) No data was provided on the number of ice pack exchanges, although the water was recirculated in the CryoCuff® device every one to four hours. The duration of therapy, and whether or not it was applied in the inpatient or outpatient setting is not clear from the published article. Levy and colleagues also compared the outcomes in a trial randomizing 80 patients (100 knees) undergoing total knee arthroplasty to receive either passive cold therapy with a CryoCuff® device or no cold therapy. (7) The CryoCuff® group reported a significant decrease in blood loss and mild decrease in analgesic requirements. Similar to the Edwards trial, this trial did not include the relevant control group (patients treated with ice packs).

In summary, the available scientific literature is insufficient to document that the use of passive cooling systems is associated with a benefit beyond convenience, thus these devices are considered not medically necessary. Many of the published randomized studies failed to include the relevant control group of standard ice packs. Studies that did include a control group of standard ice packs reported inconsistent results, and some studies reported no significant benefit of passive cooling devices compared to no cold therapy.

Manually Operated Passive Cooling Devices

Konrath and colleagues reported on the results of a trial that randomized 103 patients undergoing ACL reconstruction to one of four different postoperative cold therapy strategies (8):

1. Active cooling with a Polar Care pad set at a temperature of 40 to 50 degrees centigrade
2. Active cooling with a Polar Care pad set at a temperature of 70 to 80 degrees centigrade
3. Ice packs
4. No cold therapy

Both the water in the Polar Care pad and the ice packs were changed every 4 hours.  The length of hospital stay, range of motion at discharge, use of oral and intramuscular pain medicine and drain output were not significantly different between groups.  These results suggest that the Polar Care device is similar to ice packs, but there is inadequate evidence to demonstrate that compared to ice packs, there is benefit beyond convenience.

Active Cooling Devices

Several randomized studies compared active cooling devices to no cold therapy; however, these studies do not address whether or not there is benefit from active cooling devices compared to standard therapy with ice packs. (9-11)  Saito and colleagues reported on the results of a trial that randomized patients who had undergone a hip arthroplasty to a group receiving a computer-controlled cooling device or a control group that did not receive cryotherapy. (12) This study focused on the immediate postoperative period in the inpatient setting and thus is not relevant to this policy.

Other Devices and Indications

A literature search did not identify any published articles focusing on the use of an active cooling device equipped with pneumatic compression. Similarly, there were no published articles focusing on the role of cooling devices in nonsurgical settings or for nonsurgical indications, e.g., treatment of sprains or strains, or chiropractic treatments.

References

1. BlueCross BlueShield Association Medical Policy Reference Manual, Policy No. 1.01.26
2. Schroder D, Passler HH. Combination of cold and compression after knee surgery. A prospective randomized trial. Knee Surg Sports Traumatol Arthrosc 1994;2:158-65
3. Whitelaw GP, DeMuth KA, Demos HA et al. The use of the CryoCuff versus ice and elastic wrap in the postoperative care of knee arthroscopy patients. Am J Knee Surg 1995;8:28-31
4. Healy WL, Seidman J, Pfeifer BA, Brown DG. Cold compressive dressing after total knee arthroplasty. Clin Orthop 1994;299:143-49
5. Brandsson S, Rydgren B, Hedner T et al. Postoperative analgesic effects of an external cooling system and intra-articular bupivacaine/morphine after arthroscopic cruciate ligament surgery. Knee Surg Sports Traumatol Arthroscopy 1996;4:200-205
6. Edwards DJ, RImmer M, Keene GCR. The use of cold therapy in the postoperative management of patients undergoing arthroscopic anterior cruciate ligament reconstruction. Am J Sports Med 1996;24:193-95
7. Levy AS, Marmar E. The role of cold compression dressings in the postoperative treatment of total knee arthroplasty. Clin Orthop Rel Res 1993;297:174-78
8. Konrath GA, Lock T, Goitz HT, Scheidler J. The use of cold therapy after anterior cruciate ligament reconstruction. Am J Sports Med 1996;24:629-33
9. Cohn BT, Draeger RI, Jackson DW. The effects of cold therapy in the postoperative management of pain in patients undergoing anterior cruciate ligament reconstruction. Am J Sports Med 1989;17:344-49
10. Barber FA, McGuire DA, Click S. Continuous-flow cold therapy for outpatient anterior cruciate ligament reconstruction. J Arthroscopy Rel Surg 1998;14:130-35
11. DervinGF, Taylor DE, Keene GCR. Effects of cold and compression dressings on early postoperative outcomes for the arthroscopic anterior cruciate ligament reconstruction patient. J Orthop Sports Phys Ther 1998;27:403-6
12. Saito N, Horiuchi H, Kobayashi S et al. Continuous local cooling for pain relief following total hip arthroplasty. J Arthroplasty 2004;19(3):334-7

Cross References

None

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