Medical Policy

Policy Num:      01.001.026
Policy Name:    Cooling & Heating Devices Used in the Outpatient Setting
Policy ID:          [01.001.026] [Ac / L / M- / P-] [1.01.26]

Last Review:      October 24, 2024
Next Review:      October 20, 2025
 

Related Policies:

01.001.010 - Continuous Passive Motion in the Home Setting

Cooling & Heating Devices Used in the Outpatient Setting

summary

Description

Cooling devices use chilled water to decrease the local temperature of tissue. There are a variety of cooling devices available, ranging from gravity-fed devices that manually fill with iced water, to motorized units that both cool and circulate chilled water. These devices are typically used when ice packs would normally be applied (eg, after orthopedic surgical procedures).

Summary of Evidence

For individuals who have pain and/or swelling after knee surgery who receive a cooling device, the evidence includes several randomized controlled trials (RCTs) and a case-control study. Relevant outcomes are symptoms, functional outcomes, medication use, and resource utilization. Evidence on manually operated passive noncirculating cooling devices is limited by the control condition used in the trials. Studies on manually operated passive noncirculating cooling devices were limited by the control condition used in the trials. Studies that used either a no-icing control or infrequent ice applications did not provide sufficient evidence of comparative efficacy. Other studies provided no information on the frequency of ice changes, limiting interpretation of the results. Several randomized trials have compared active circulating cooling devices with standard intermittent icing or cold packs, and 2 of the larger trials found no significant benefit of the continuous cooling devices. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have pain and/or swelling after shoulder surgery who receive a cooling device, the evidence includes 2 RCTs. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. Evidence found that use of compressive cryotherapy produced no significant reduction in pain or medication use compared with the standard ice wrap. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have pain and/or swelling after facial surgery who receive a cooling device, the evidence includes several small RCTs and a pilot study. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. There have been mixed results regarding the intervention’s efficacy in reducing neurologic problems as well as improving eye motility, diplopia, mandible functioning, and mouth opening compared with conventional cooling regimens. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For Individual with Chronic pain management, Arthritis, Muscle spasm relief, Post-surgical pain, Sprains and strains, Back pain Triple S considers mechanical heated water-circulating pads and pumps investigational because they have not been proven to produce outcomes superior to standard electric heating pad.

Additional Information

Not applicable.

OBJECTIVE

The objective of this evidence review is to determine whether the use of cooling and heating devices improves the net health outcome in postsurgical patients compared with standard icing regimens.

POLICY

Circulating and noncirculating cooling devices are considered investigational.

Combination circulating cooling and compression (cryopneumatic) devices are considered investigational.

Triple S considers mechanical heated water-circulating pads and pumps investigational because they have not been proven to produce outcomes superior to standard electric heating pad.

POLICY GUIDELINES

Coding

See the Codes table for details.

BENEFIT APPLICATION

BlueCard/National Account Issues

State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.

Plans may want to consider whether passive cooling devices would be considered durable medical equipment according to their contract or benefit language.

Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered.  Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.

BACKGROUND

Cold and Compression Therapy

Use of ice packs and various bandages and wraps following surgery or musculoskeletal and soft tissue injury is common. A variety of manually operated and mechanical continuous cooling devices are commercially available.

The standard postoperative treatment for musculoskeletal surgeries consists of cryotherapy (cold therapy) and various types of compressive wraps. Both ice packs (with or without additives to maintain temperature) and cooling devices can provide cryotherapy. Circulating cooling devices are designed to provide a constant low temperature, which might provide additional benefit compared with the more variable temperature achieved with the intermittent replacement of ice packs. Noncirculating cooling devices might also allow less variable cooling due to the larger volume of ice stored in the insulated tank and the use of circulated ice water.

Noncirculating Cooling Devices

The CryoCuff® and Polar Care Cub devices are examples of passive, noncirculating cooling devices. The CryoCuff device consists of an insulated container filled with iced water that is attached to a compressive cuff. When the CryoCuff 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 water drained. The cooler is then raised above the affected limb, and cold water refills the compressive cuff. The Polar Care 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 that circulates the water through the pads at the same time as increasing the compression around the joint.

Circulating Cooling Devices

In active, circulating cooling devices, a motorized pump circulates chilled water and may also provide pneumatic compression. For example, the AutoChill® device, which may be used 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 circulating cooling device. It consists of 2 rubber pads connected by a rubber hose to the main cooling unit. Fluid is 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 a circulating cooling device combined with a pneumatic component. The system consists of various soft wraps and a computer-control unit to circulate the water through the wraps and to provide intermittent pneumatic compression. The Hilotherm® Clinic circulates cooled water through preshaped thermoplastic polyurethane facial masks for use after different types of facial surgery. ThermaZone® provides thermal therapy with pads specific to various joints as well as different areas of the head (front, sides, back, eyes). CTM™ 5000 and cTreatment are computer-controlled devices that provide cooling at a specific (11°C) and continuous temperature.

Water circulating heat pad with pump

A water circulating heat pad with pump (E0217) is a flexible pad containing a series of channels through which water is circulated by means of an electrical pumping mechanism. The water is heated in an external reservoir. The pump, pad, and all accessories needed for the pad to be functional are included in the code. The device must be certified by an Occupational Safety and Health Administration (OSHA) Nationally Recognized Testing Laboratory 

Regulatory Status

A large number of circulating and noncirculating cooling devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process since 1976.

FDA product code: ILO.

Table 1. Cooling Devices Cleared by the U.S. Food and Drug Administration

RATIONALE

This evidence review was created in November 2004 with searches of the PubMed database. The most recent literature update was performed through January 15, 2024.

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Population Reference No. 1

Cooling Device After Knee Surgery

Clinical Context and Therapy Purpose

The purpose of a cooling device is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as a standard icing regimen, in patients with pain and/or swelling after knee surgery.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with pain and/or swelling after knee surgery.

Interventions

The therapy being considered is a cooling device.

Comparators

Comparators of interest include a standard icing regimen. Treatments include postoperative exercises, nonsteroidal anti-inflammatory drugs (NSAIDs), and opioids.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, medication use, and resource utilization.

The existing literature evaluating a cooling device as a treatment for pain and/or swelling after knee surgery has varying lengths of follow-up, ranging from 1 to 6 weeks. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 1 to 6 weeks of follow-up is considered necessary to demonstrate efficacy.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

4. Studies with duplicative or overlapping populations were excluded.

Because studies that include the preferred comparator (standard icing regimen) are available, studies that use other comparators, such as no icing therapy or room temperature devices, were not evaluated in this evidence review.

Review of Evidence

Noncirculating Cooling Devices

Randomized Controlled Trials

Schroder and Passler (1994) compared the CryoCuff device with ice therapy in 44 patients who had undergone repair of the anterior cruciate ligament.^1,(Table 2.) Those receiving ice therapy administered an ice bag 3 times a day postoperatively. While those randomized to the CryoCuff group reported significant decreases in pain, swelling, and analgesic use, it is not clear whether icing 3 times a day is a typical icing regimen. (Table 3.)

Whitelaw et al (1995) reported on results of a trial that randomized 102 patients undergoing knee arthroscopy in the outpatient setting to a CryoCuff device or traditional ice therapy (Table 2).^2, Those in the CryoCuff group reported decreased pain medication compared with the control group but there was no significant difference in average pain assessment (Table 3). Interpretation of these results is limited because the number of exchanges of ice packs and water recirculation was not reported. In 1994, Healy et al reported that the CryoCuff device provided no benefit to pain control or swelling compared with ice packs in a randomized trial of 76 patients (105 knees) undergoing total knee arthroplasty.^3, No data were provided on the number of ice pack exchanges, although the water was recirculated in the CryoCuff device every 1 to 4 hours.

Table 2. Summary of Key RCT Characteristics

 CC: CryoCuff; EU: European Union; ICE: standard ice packs; NR: not reported; RCT: randomized controlled trial.

Table 3. Summary of Key RCT Results

 CC: CryoCuff; ICE: standard ice packs; RCT: randomized controlled trial.

Tables 4 and 5 summarize notable limitations identified in each study.

Table 4. Study Relevance Limitations

 The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 5. Study Design and Conduct Limitations

 The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias. b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication. d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials). e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference. f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Circulating Cooling Devices

Randomized Controlled Trials

In the largest study to date, Thienpont (2014) evaluated 116 patients who had undergone total knee arthroplasty who were assigned in a quasi-randomized order to 8 hours of daily advanced cryotherapy at a fixed temperature or to the application of cold packs for 15 minutes after each of 2 physical therapy sessions (Table 6).^4, Both groups could apply cryotherapy during the evening and night whenever they wanted for comfort and pain control. Thirty percent of patients in the advanced cryotherapy group did not use the device at night due to excessive noise. Primary outcomes were visual analog scale pain scores at rest and during deep active knee flexion, walking without aid, and analgesic use. Secondary outcomes were knee range of motion, active straight-leg raising, walking without aid, swelling, visual hematoma, and length of stay. There were no significant differences between groups in visual analog scores, need for analgesics, or any of the secondary outcomes. There was a significant decrease in flexion at 6 weeks in the advanced cryotherapy group (114° vs. 120°; Table 7).

Woolf et al (2008), in a RCT of 60 patients, compared a temperature-controlled cryotherapy device with a standard icing regimen following outpatient knee arthroscopy (Table 6).^5, Both groups were instructed to apply the treatment for 20 minutes every 2 hours during waking hours for the first 4 days after surgery. All night, the cooling device group was instructed to use the device throughout the first 4 nights, whereas the control group was advised to use ice packs as needed. No differences in daytime pain were observed between groups. There was a tendency for more patients in the cryotherapy group to report that they did not awaken from pain during the night; this difference was significant only for postoperative day 2 (36% vs. 6%; p=.04; Table 7). Additional study with a larger number of patients is needed to determine whether the use of continuous cooling at night improves health outcomes.

More recently, a RCT of 47 participants by Rufilli et al (2015) compared 2 homogenous groups of patients with anterior cruciate ligament reconstruction to evaluate the efficacy of a continuous cold flow device (10° to 30°C) relative to conventional crushed ice bags (intervention group n=23; control group n=24; Table 6).^6, All patients were discharged the day after surgery. Primary endpoints included: knee pain (using the numeric rating scale that ranged from 0 [no pain] to 10 [worst pain]); blood loss; measures of knee swelling at 3 sites (patellar apex, 10 cm proximal to the superior patellar pole, 15 cm distal to the superior patellar pole); knee range of motion; and the use of pain medicine. Relative to the control, the intervention group had a significant reduction in numeric rating scale pain scores (p<.001) and a significant decrease in blood loss (p<.001). Knee volume was also significantly lower in the intervention group at the patellar apex (p=.013) and 10 cm proximal to the superior patellar pole (p=.001). Although there was a significant increase in mean flexion (p<.001) for the intervention group relative to the control, there was no difference between groups in the use of pain medication (Table 7). No adverse events were reported in either group postoperatively or related to the use of the cooling device or the ice bags. Researchers noted several limitations to the trial, including small sample size, lack of blinding, and lack of evaluation of longer-term efficacy after hospital discharge.

Rufilli et al (2017) investigated the use of the continuous-flow cold device in a RCT of 50 patients with end-stage knee osteoarthritis after primary total knee arthroplasty who had the same rehabilitation program and pain-relieving strategy.^7, The intervention group (n=24) received the continuous-flow cold device (10° and 30°C) and the control group (n=26) received crushed ice bags postoperatively (Table 6). There were no statistically significant differences between groups in terms of subjective pain scores (using a numeric rating scale), medication use, or knee circumference. In addition, there were no statistically significant differences in blood loss, need for transfusion, or range of motion. However, there was a nonsignificant trend at day 7 toward a lesser increase in knee circumference in the intervention group (Table 7). Reported limitations included small sample size, lack of blinding, lack of evaluation of longer-term efficacy after hospital discharge, and no skin temperature evaluation. Compared with a traditional icing regimen, the use of a continuous-flow cold device was no better than traditional icing in patients with total knee arthroplasty.

Coviello et al (2022) investigated the use of continuous cold flow device therapy on pain reduction, opioid consumption, recovery time, perioperative bleeding, and patient satisfaction in patients undergoing a total knee arthroplasty (Table 6).^8, Patients (N=100) were randomized into 2 groups receiving either postoperative continuous cold flow therapy (5°) or standard ice pack therapy. There were no differences in preoperative visual analog scale pain scores between gropus. Reduction of pain per visual analog scale scores was lower in the continuous cold flow therapy group only at day 1 postoperatively (p=.01) (Table 7). There was an increase in passive range of movement post-surgery in both groups, and a larger difference in the continuous cold flow group at days 1 (111.57° ± 7.04 vs 105.49° ± 11.24; p=.01) and 3 (110.94° ± 7.52 vs 107.39° ± 7.89; p=.01). There was no difference in blood loss between groups. Limitations include small sample size, no mention of blinding, short follow-up time, and measurement of opioids defined as tramadol capsules, which differs from practice in the United States.

Table 6. Summary of Key RCT Characteristics

 EU: European Union; ICE: standard ice packs; NR: not reported; RCT: randomized controlled trial.

 Table 7. Summary of Key RCT Results

 ICE: standard ice packs; RCT: randomized controlled trial; ROM: range of motion. 1Mild defined as “did not awaken” due to pain. 2Pain evaluated using a numeric rating scale ranging from 0, no pain, to 10, worst pain imaginable.

Tables 8 and 9 summarize notable limitations identified in each study.

Table 8. Study Relevance Limitations

 FDA: US Food and Drug Administration. The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 9. Study Design and Conduct Limitations

 The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias. b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication. d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials). e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference. f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Combination Circulating Cooling and Compression (Cryopneumatic) Devices

Randomized Controlled Trials

In a multicenter RCT, Su et al (2012) compared 280 total knee arthroplasty patients treated with the Game Ready cryopneumatic device or with ice packs plus static compression.^8,(Tables 10 and 11). On hospital discharge, the treatments were given at the same application cycle of 1 hour on and 30 minutes off. Compliance rates were similar for the 2 groups. Blinded evaluation of 187 patients (67% of patients had complete evaluations) found no significant difference between the groups in visual analog score for pain, range of motion, 6-minute walk test, Timed Up & Go test, or knee girth under this more typical icing regimen. Narcotic consumption decreased from 680 to 509 mg morphine equivalents over the first 2 weeks (14 mg less per day), and patient satisfaction increased with the cryopneumatic device.

Waterman et al (2012) reported on a RCT of the Game Ready device in 36 patients who had anterior cruciate ligament reconstruction.^9, Patients were instructed to use ice or the cryopneumatic device for 30 minutes at least 3 times a day and return to the clinic at 1, 2, and 6 weeks postoperatively. Compliance during the first 2 weeks did not differ significantly between groups (100% for Game Ready vs. 83% for icing). The primary outcome measure (visual analog pain score) differed at baseline, limiting interpretation of the results. There were no significant differences between the groups for knee circumference, the Lysholm Knee Score, 36-Item Short-Form Health Survey, or Single Assessment Numerical Evaluation scores. A greater percentage of patients treated with the Game Ready device discontinued narcotic use by 6 weeks (83% vs. 28%).

Table 10. Summary of Key RCT Characteristics

 ICE: standard ice packs; NR: not reported; RCT: Randomized controlled trials.

Table 11. Summary of Key RCT Results

 ICE: standard ice packs; RCT: randomized controlled trial  1 Decrease from preoperative values.

Tables 12 and 13 summarize notable limitations identified in each study.

Table 12. Study Relevance Limitations

 The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use. b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest. c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively. d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported. e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 13. Study Design and Conduct Limitations

 The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias. b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician. c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication. d Follow-Up key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials). e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference. f Statistical key: 1. Intervention is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Intervention is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Nonrandomized Studies

Murgier et al (2017) conducted a prospective case-control study of the Game Ready device, comparing 43 individuals (27 men, 16 women) recovering from revision total knee arthroplasty; the control group (n=19) was treated with a cold pack applied intermittently (4 hours daily), while the Game Ready group was treated with 2, 8-hour cycles in 30-minute off-on increments.^10, While the main outcome was the reduction of total blood loss, a secondary outcome was postoperative pain, as measured by visual analog score 3 days postsurgery. Patients using the Game Ready device showed decreased blood loss compared with the control group (260 mL vs. 465 mL; p<.05), as well as an improvement in postoperative pain (visual analog score, 1 vs. 3; p<.05). Limitations included the possibility of a type II error due to the specialized surgical unit where the study was performed; additional limitations (eg, variability of results, concerns about patients’ comorbidities) affected the study’s secondary outcomes. The authors concluded that, overall, the cryopneumatic device aided patients’ recovery from revision total knee arthroplasty but additional prospective randomized trials would be needed to confirm results.

Section Summary: Post–Knee Surgery

For individuals who have pain and/or swelling after knee surgery, the evidence includes several RCTs and a case-control study. Studies on manually operated passive noncirculating cooling devices were limited by the control condition used in the trials. Studies that used either a no-icing control or infrequent ice applications did not provide sufficient evidence of comparative efficacy. Other studies provided no information on the frequency of ice changes, limiting interpretation of the results. Randomized trials comparing active circulating cooling devices with standard intermittent icing or cold packs have had mixed results, with several studies reporting a significant reduction in medication use or other outcomes (eg, pain, blood loss, swelling, range of motion) and others finding no significant improvements in outcomes. The results also differ across patient populations. A case-control study of the Game Ready device, which provides cooling and compression, found that the device decreased postoperative blood loss and reduced postoperative pain, compared with intermittent application of a cold pack. However, it is unclear whether constant cooling provides greater pain relief than standard icing or intermittent use of the device.

Population Reference No. 2 

Cooling Device Post–Shoulder Surgery

Clinical Context and Therapy Purpose

The purpose of a cooling device is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as a standard icing regimen, in patients with pain and/or swelling after shoulder surgery.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with pain and/or swelling after shoulder surgery.

Interventions

The therapy being considered is a cooling device.

Comparators

Comparators of interest include a standard icing regimen. Treatments include postoperative exercises, NSAIDs, and opioids.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, medication use, and resource utilization.

The existing literature evaluating a cooling device as a treatment for pain and/or swelling after shoulder surgery has varying lengths of follow-up, ranging from 7 to 10 days. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 7 to 10 days of follow-up is considered necessary to demonstrate efficacy.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

4. Studies with duplicative or overlapping populations were excluded.

Because studies that include the preferred comparator (standard icing regimen) are available, studies that use other comparators, such as no icing therapy or room temperature devices, were not evaluated in this evidence review.

Review of Evidence

Combination Circulating Cooling and Compression (Cryopneumatic) Devices

Randomized Controlled Trials

Kraeutler et al (2015) compared the Game Ready shoulder wrap with standard icing in a RCT of 46 patients who had undergone rotator cuff repair or subacromial decompression.^11, The average age at the time of surgery was 55.4 years in the compressive cryotherapy intervention group (n=25) and 55.8 years in the control group (n=21; p=0.91). Patients were instructed to apply the cryotherapy every other hour for the first 3 days and 2 to 3 times a day until the follow-up visit at 7 to 10 days. In the immediate postoperative week (days 0-7), participants used diaries to document pain level using a visual analog score (no pain to extreme pain) twice per day. They also reported use of pain medication (converted to morphine equivalent dosage). Analysis of patient diaries showed no significant differences in average pain, worst pain, and morphine equivalent dosage between the 2 groups on any day during the week after surgery. Post hoc power analysis showed that 13 patients per group would provide sufficient power to detect a 25 mm (out of 100 mm) difference in visual analog scores between the 2 groups. Trial limitations included a small sample size (noting that 11 [19%] enrolled patients were excluded due to noncompliance), lack of blinding, potential recall bias due to the use of patient-reported diaries, and uncertainty whether the correct usage of cryotherapy was followed.

Noyes et al (2018) published a RCT comparing continuous cryotherapy (CC) (Polar Care) and standard ice packs (plain ice, ICE) as a means of improving postoperative pain control for patients undergoing a primary or revision shoulder arthroplasty procedure.^12, Forty patients (20 in each group), between 30 to 90 years of age, were randomly assigned to the 2 treatments. Visual analog pain scores were similar for both the CC and ICE groups preoperatively (5.9 vs. 6.8; p=.121) and postoperatively at 24 hours (4.2 vs. 4.3; p=.989), 3 days (4.8 vs. 4.7; p=.944), 7 days (2.9 vs. 3.3; p=.593), and 14 days (2.5 vs. 2.7; p=.742). Continuous cryotherapy and ICE did not differ significantly in the number of morphine equivalents of pain medication postoperatively at 24 hours (43 vs. 38 mg; p=.579), 3 days (149 vs. 116 mg; p=.201), 7 days (308 vs. 228 mg; p=.181), or 14 days (431 vs. 348 mg; p=.213). The visual analog score for quality of sleep was not different between CC and ICE postoperatively at 24 hours (5.1 vs. 4.3; p=.382), 3 days (5.1 vs. 5.3; p=.601), 7 days (6.0 vs. 6.7; p=.319), or 14 days (6.5 vs. 7.2; p=.348). The study was limited by patient compliance not being measured objectively, all patients receiving a single-shot interscalene block, and final outcomes not being evaluated.

Section Summary: Post-Shoulder Surgery

Two RCTs found that, for patients undergoing shoulder arthroscopy for rotator cuff repair or subacromial decompression, the use of compressive cryotherapy produced no significant reductions in pain or medication use compared with the standard ice wrap.

For individuals who have pain and/or swelling after shoulder surgery who receive a cooling device, the evidence includes 2 RCTs. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. Evidence found that use of compressive cryotherapy produced no significant reduction in pain or medication use compared with the standard ice wrap. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 3

Cooling Devices Post–Facial Surgery

Clinical Context and Therapy Purpose

The purpose of a cooling device is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as a standard icing regimen, in patients with pain and/or swelling after facial surgery.

The following PICO was used to select literature to inform this review.

Populations

The relevant population of interest is individuals with pain and/or swelling after facial surgery.

Interventions

The therapy being considered is a cooling device.

Comparators

Comparators of interest include a standard icing regimen. Treatments include postoperative exercises, NSAIDs, and opioids.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, medication use, and resource utilization.

The existing literature evaluating a cooling device as a treatment for pain and/or swelling after facial surgery has varying lengths of follow-up, ranging from 1 to 6 weeks. While studies described below all reported at least 1 outcome of interest, longer follow-up was necessary to fully observe outcomes. Therefore, 1 to 6 weeks of follow-up is considered necessary to demonstrate efficacy.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;

2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

4. Studies with duplicative or overlapping populations were excluded.

Because studies that include the preferred comparator (standard icing regimen) are available, studies that use other comparators, such as no icing therapy or room temperature devices, were not evaluated in this evidence review.

Review of Evidence

Circulating Cooling Devices

Randomized Controlled Trials

Several studies have been reported by a research group that compared the Hilotherm cooling mask device with cooling compresses. In a 2013 randomized trial, Rana et al assessed 32 patients with postoperative swelling of bilateral mandibular fractures using a cooling mask around the head and jaw.^13, Swelling was reduced for the cooling mask group on day 1, 2, and 3 after surgery. Visual analog scores for pain were also reduced for the cooling mask group, compared with day 1 (3.87 vs. 5.53) and day 2 (3.63 vs. 6.31). There were no significant differences between groups for a postoperative neurologic score, trismus, or mandibular dysfunction. Earlier research by Rana et al (2011) randomized 30 patients scheduled for third molar surgery to a water circulating cooling face mask (Hilotherm; n=15) or cool compresses (control, n=15).^14, The intervention group had significantly less facial swelling (72.2 mL) relative to the control group (96.6 mL) on postoperative day 2 (p=.005). This trend was maintained at day 10 (intervention, 23.3 mL; control, 46.7 mL, p<.001). There was also a significantly lower pain score in the intervention group relative to the control group on both postoperative days 2 (intervention, 3.4; control, 4.8; p<.05) and 3 (intervention, 2.9; control, 3.7; p<.05). Both the intervention and the control groups had a significant decrease in the neurologic score on day 10 compared with day 2, but there were no significant differences between groups in the neurologic score. Compared with immediately after surgery, both groups had a significant increase in mouth opening on postoperative day 2. At postoperative day 28, there were no differences between the groups with regard to facial swelling, pain score, or neurologic score. The authors did not report study limitations. However, it should be noted the study had a small sample size and used observer-blinding only. In a 2011 pilot study, Rana et al found that the use of the cooling device in patients scheduled for treatment of bilateral mandibular fractures also reduced postoperative swelling and pain relative to the traditional cooling regimen.^15, But there were no significant benefits with regard to mandible functioning, mouth opening, or neurologic scores.

A similar study design was reported by Modabber et al (2013), who treated 42 patients for unilateral zygomatic fractures.^16, Patients were randomized to a water circulating continuous cooling face mask, the Hilotherm device, (n=21), or conventional cooling (n=21) postoperatively. Three-dimensional optical scans were recorded postoperatively. On postoperative days 1, 2, and 3, respectively, there were significant decreases in swelling with the intervention relative to control (intervention, 9.45 mL; control, 20.69 mL; p<.001; intervention, 13.20 mL; control, 22.97 mL; p<.001; intervention, 14.44 mL; control, 23.52 mL; p=.002). This trend was maintained on day 7 (p=.019). After 28 days, there were no significant differences between groups. Pain analysis conducted using a visual analog score, ranging from 0 (no pain) to 10 (maximum pain), was reported before surgery and postoperatively. There were significant increases in pain in the control group relative to the intervention during postoperative day 1 (intervention, 2.38; control, 4.10; p=.001) and day 2 (intervention, 2.34; control, 4.38; p<.001). However, there were no significant differences in pain between groups by day 7. Nerve dysfunction, reported on a 9-point scale (9 being the worst) and assessed pre- and postoperatively, showed a significant reduction in the neurologic score in the intervention group (2.57) relative to the control (3.90) at day 1 (p=.008), with no significant differences between the groups at days 7, 28, and 90 postoperatively. On postoperative day 1, there was a significant (p=.050) reduction in eye motility limitation in the intervention group (n=17 with no limitation; n=4 with limitation) relative to the control (n=11 with no limitation; n=10 with limitation). There were also significantly fewer patients in the intervention group with diplopia (n=18 without diplopia, n=3 with diplopia) compared with the control group (n=11 without diplopia, n=10 with diplopia; p=.019). There were no statistically significant differences in eye motility limitation or diplopia between the groups on days 7 and 28. Overall patient satisfaction was significantly higher in the intervention group (1.43) relative to the control (2.29; p<.001). In addition to the small sample size, trial limitations included observer-only blinding and 3-dimensional optical scans that only measured localized facial swelling.

Section Summary: Post-Facial Surgery

Several small RCTs and a pilot study of patients receiving cooling therapy found significant decreases in facial swelling and pain. However, there were mixed results in terms of the intervention’s efficacy in reducing neurologic problems as well as improving eye motility, diplopia, mandible functioning, and mouth opening compared with conventional cooling regimens. Several of the trials had observer-only blinding.

For individuals who have pain and/or swelling after facial surgery who receive a cooling device, the evidence includes several small RCTs and a pilot study. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. There have been mixed results regarding the intervention’s efficacy in reducing neurologic problems as well as improving eye motility, diplopia, mandible functioning, and mouth opening compared with conventional cooling regimens. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Population Reference No. 4

Clinical Context and Therapy Purpose

Heating devices (fomentation devices) are used for a variety of indications including joint pain and muscle spasms. Application of heat results in the production of hyperemia, induction of reflex vasodilation, and acceleration of metabolic processes. The application of heat may ease pain by dilating the blood vessels and decreasing painful stiffness of soft tissues surrounding the injured area. General indications for therapeutic heat include pain, muscle spasm, contracture, tension myalgia, hematoma resolution, bursitis, tenosynovitis, fibrositis, fibromyalgia, superficial thrombophlebitis, and collagen vascular diseases.  General contraindications and precautions for therapeutic heat include acute inflammation, trauma, or hemorrhage; bleeding disorders; temperature insensitivity; inability to communicate or respond to pain; poor thermal regulation (e.g., from neuroleptics); malignancy; edema; ischemia; atrophic skin; and scar tissue.

Water Circulating Heating Pad with Pump

A water circulating heat pad with pump is a flexible pad containing a series of channels through which water is circulated by means of an electrical pumping mechanism. The water is heated in an external reservoir. The pump, pad, and all accessories needed for the pad to be functional are included in the code. The device must be certified by Underwriters Laboratory.

A pad for water circulating heat unit, for replacement only is a durable replacement pad used with a water circulating heat pump system. It is made of rubber, heavy plastic, or durable fabric. It can be cleaned and is designed for long term use.

According to Medicare DME MAC policy, it has not been established that a water circulating heat pad with pump is reasonable and necessary compared to a standard electric heating pad.  The policy states that, because a water-circulating heating pad system is not medically necessary, a replacement pump or pad is not reasonable and necessary.

A water circulating heat pad with pump (E0217) is a flexible pad containing a series of channels through which water is circulated by means of an electrical pumping mechanism. The water is heated in an external reservoir. The pump, pad, and all accessories needed for the pad to be functional are included in the code. The device must be certified by an Occupational Safety and Health Administration (OSHA) Nationally Recognized Testing Laboratory .

Section Summary:

Triple S considers mechanical heated water-circulating pads and pumps experimental and investigational because they have not been proven to produce outcomes superior to standard electric heating pads.

Summary of Evidence

For individuals who have pain and/or swelling after knee surgery who receive a cooling device, the evidence includes several RCTs and a case-control study. Relevant outcomes are symptoms, functional outcomes, medication use, and resource utilization. Evidence on manually operated passive noncirculating cooling devices is limited by the control condition used in the trials. Studies on manually operated passive noncirculating cooling devices were limited by the control condition used in the trials. Studies that used either a no-icing control or infrequent ice applications did not provide sufficient evidence of comparative efficacy. Other studies provided no information on the frequency of ice changes, limiting interpretation of the results. Several randomized trials have compared active circulating cooling devices with standard intermittent icing or cold packs, and 2 of the larger trials found no significant benefit of the continuous cooling devices. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have pain and/or swelling after shoulder surgery who receive a cooling device, the evidence includes 2 RCTs. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. Evidence found that use of compressive cryotherapy produced no significant reduction in pain or medication use compared with the standard ice wrap. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have pain and/or swelling after facial surgery who receive a cooling device, the evidence includes several small RCTs and a pilot study. Relevant outcomes include symptoms, functional outcomes, medication use, and resource utilization. There have been mixed results regarding the intervention’s efficacy in reducing neurologic problems as well as improving eye motility, diplopia, mandible functioning, and mouth opening compared with conventional cooling regimens. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Supplemental Information

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Clinical Input From Physician Specialty Societies and Academic Medical Centers

While the various physician specialty societies and academic medical centers may collaborate with and make recommendations during this process, through the provision of appropriate reviewers, input received does not represent an endorsement or position statement by the physician specialty societies or academic medical centers, unless otherwise noted.

2008 Input

In response to requests, input was received from 3 specialty societies and 3 academic medical centers while the policy was under review in 2008. Input was mixed regarding the medical necessity of continuous cooling devices.

Practice Guidelines and Position Statements

Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Orthopaedic Surgeons

In 2022 , the American Academy of Orthopaedic Surgeons updatedthe 2016 guidelines on the surgical management of osteoarthritis of the knee after knee arthroplasty.^18, The 2016 guideline statement , “Moderate evidence supports that the use of cryotherapy devices after knee arthroscopy do not improve outcomes" was not modified in the 2022 update. did not revisit several prior recommendations including cryotherapy devices.^18,19,

U.S. Preventive Services Task Force Recommendations

Not applicable.

MEDICARE NATIONAL COVERAGE

Medicare National Coverage

There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.

Ongoing and Unpublished Clinical Trials

Some currently ongoing and unpublished trials that might influence this review are listed in Table 14.

Table 14. Summary of Key Trials

 NCT: national clinical trial. a Denotes industry-sponsored or cosponsored trial. 

References

1. Schröder D, Pässler HH. Combination of cold and compression after knee surgery. A prospective randomized study. Knee Surg Sports Traumatol Arthrosc. 1994; 2(3): 158-65. PMID 7584198
2. Whitelaw GP, DeMuth KA, Demos HA, et al. The use of the Cryo/Cuff versus ice and elastic wrap in the postoperative care of knee arthroscopy patients. Am J Knee Surg. 1995; 8(1): 28-30; discussion 30-1. PMID 7866800
3. Healy WL, Seidman J, Pfeifer BA, et al. Cold compressive dressing after total knee arthroplasty. Clin Orthop Relat Res. Feb 1994; (299): 143-6. PMID 7907012
4. Thienpont E. Does advanced cryotherapy reduce pain and narcotic consumption after knee arthroplasty?. Clin Orthop Relat Res. Nov 2014; 472(11): 3417-23. PMID 25059851
5. Woolf SK, Barfield WR, Merrill KD, et al. Comparison of a continuous temperature-controlled cryotherapy device to a simple icing regimen following outpatient knee arthroscopy. J Knee Surg. Jan 2008; 21(1): 15-9. PMID 18300666
6. Ruffilli A, Buda R, Castagnini F, et al. Temperature-controlled continuous cold flow device versus traditional icing regimen following anterior cruciate ligament reconstruction: a prospective randomized comparative trial. Arch Orthop Trauma Surg. Oct 2015; 135(10): 1405-10. PMID 26141535
7. Ruffilli A, Castagnini F, Traina F, et al. Temperature-Controlled Continuous Cold Flow Device after Total Knee Arthroplasty: A Randomized Controlled Trial Study. J Knee Surg. Sep 2017; 30(7): 675-681. PMID 27903009
8. Coviello M, Abate A, Ippolito F, et al. Continuous Cold Flow Device Following Total Knee Arthroplasty: Myths and Reality. Medicina (Kaunas). Oct 27 2022; 58(11). PMID 36363493
9. Su EP, Perna M, Boettner F, et al. A prospective, multi-center, randomised trial to evaluate the efficacy of a cryopneumatic device on total knee arthroplasty recovery. J Bone Joint Surg Br. Nov 2012; 94(11 Suppl A): 153-6. PMID 23118406
10. Waterman B, Walker JJ, Swaims C, et al. The efficacy of combined cryotherapy and compression compared with cryotherapy alone following anterior cruciate ligament reconstruction. J Knee Surg. May 2012; 25(2): 155-60. PMID 22928433
11. Murgier J, Cailliez J, Wargny M, et al. Cryotherapy With Dynamic Intermittent Compression Improves Recovery From Revision Total Knee Arthroplasty. J Arthroplasty. Sep 2017; 32(9): 2788-2791. PMID 28465126
12. Kraeutler MJ, Reynolds KA, Long C, et al. Compressive cryotherapy versus ice-a prospective, randomized study on postoperative pain in patients undergoing arthroscopic rotator cuff repair or subacromial decompression. J Shoulder Elbow Surg. Jun 2015; 24(6): 854-9. PMID 25825138
13. Noyes MP, Denard PJ. Continuous Cryotherapy vs Ice Following Total Shoulder Arthroplasty: A Randomized Control Trial. Am J Orthop (Belle Mead NJ). Jun 2018; 47(6). PMID 29979799
14. Rana M, Gellrich NC, von See C, et al. 3D evaluation of postoperative swelling in treatment of bilateral mandibular fractures using 2 different cooling therapy methods: a randomized observer blind prospective study. J Craniomaxillofac Surg. Jan 2013; 41(1): e17-23. PMID 22626630
15. Rana M, Gellrich NC, Ghassemi A, et al. Three-dimensional evaluation of postoperative swelling after third molar surgery using 2 different cooling therapy methods: a randomized observer-blind prospective study. J Oral Maxillofac Surg. Aug 2011; 69(8): 2092-8. PMID 21496998
16. Rana M, Gellrich NC, Joos U, et al. 3D evaluation of postoperative swelling using two different cooling methods following orthognathic surgery: a randomised observer blind prospective pilot study. Int J Oral Maxillofac Surg. Jul 2011; 40(7): 690-6. PMID 21411291
17. Modabber A, Rana M, Ghassemi A, et al. Three-dimensional evaluation of postoperative swelling in treatment of zygomatic bone fractures using two different cooling therapy methods: a randomized, observer-blind, prospective study. Trials. Jul 29 2013; 14: 238. PMID 23895539
18. Srivastava AK, Godin J, Srivastava A, et al. American Academy of Orthopaedic Surgeons Clinical Practice Guideline Summary of Surgical Management of Osteoarthritis of the Knee. J Am Acad Orthop Surg. Dec 15 2023; 31(24): 1211-1220. PMID 37883429
19. McGrory BJ, Weber KL, Jevsevar DS, et al. Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline. J Am Acad Orthop Surg. Aug 2016; 24(8): e87-93. PMID 27355286

Codes

Applicable Modifiers

N/A

Policy History