Cryoanalgesia and Therapeutic Cold

Number: 0297

Policy

1. Aetna considers the use of cryoanalgesia medically necessary for the temporary relief of pain due to chronic refractory trigeminal neuralgia (see Appendix for selection criteria).

2. Aetna considers intra-operative and post-operative cryoanalgesia of the intercostal nerves experimental and investigational for the management of post-thoracotomy pain and other types of chronic pain.  

3. Aetna considers passive cold compression therapy units (e.g., Aircast Cryo/Cuff products, the Polar Care Cub, and Polar Care Packs) medically necessary DME to control swelling, edema, hematoma, hemarthrosis and pain.  Aetna considers the passive cold compression therapy units experimental and investigational for all other indications because their effectiveness for indications other than the ones listed above has not been established.

4. Aetna considers active cold units with mechanical pumps and portable refrigerators with or without compression therapy (e.g., AutoChill, BioCryo Cold Compression System, Breg Polar Care Cube, Game Ready control units with attached cooling systems, Donjoy IceMan products, Ossur Cold Rush Cold Therapy System, Hilotherm devices, and VPULSE) experimental and investigational because they have not been proven to offer clinically significant benefits over passive cold compression therapy units. Note: Aetna considers active cold units with compression therapy are considered experimental and investigational, even if they are only prescribed for the compression component of the device. 

5. Aetna considers the use of devices that deliver both hot and cold therapy (e.g., Aqua Relief System, Waegener cTreatment, NanoTherm therapy system, ProThermo PT-9 therapy system, Thermacure Contrast Compression Therapy, Kinex ThermoComp device, VascuTherm 4, VascuTherm 5, Recovery+ Thermal Compression System, Thermo Plus-System) experimental and investigational for reducing pain and swelling after surgery or injury, or for other indications.  Studies in the published literature have been poorly designed and have failed to show that these devices offer any benefit over standard cryotherapy with ice bags/packs; and there are no studies evaluating their use as a heat source.

Note: Aetna considers passive hot and cold therapy medically necessary.  Mechanical circulating units with pumps have not been proven to be more effective than passive hot and cold therapy.

Background

Cryoanalgesia for Trigeminal Neuralgia:

Trigeminal neuralgia (TN), also known as tic douloureux, is a disorder characterized by excruciating episodic pain in the areas innervated by one or more divisions (usually the mandibular and maxillary, rarely the ophthalmic divisions) of the trigeminal nerve.  The anti-epileptic drug carbamazepine (Tegretol) is the drug most frequently used for the management of TN.  For patients who can not tolerate carbamazepine because of its adverse side effects (poor liver function, confusion, ataxia, drowsiness, and allergic responses), the literature indicates baclofen and other anticonvulsant drugs such as clonazepam (Klonopin) may be useful.

Cryoanalgesia, cryotherapy, or cryoneurotomy has also been used in the treatment of TN.  It entails the use of high pressure (approximately 600 pounds per square inch) gas (nitrous oxide or carbon dioxide) administered by a 12- to 14-G needle-shaped cryoprobe.  Studies have shown that cryoanalgesia provides temporary pain relief or cure with minimal morbidity (e.g., no permanent sensory loss) in patients with refractory TN.

Intra-Operative and Post-Operative Cryoanalgesia for the Management of Post-Thoracotomy Pain:

Thoracotomy, the establishment of an opening into the chest cavity for the management of various cardiopulmonary disorders/diseases, is one of the most painful surgical incisions.  Post-thoracotomy pain impairs patients' ability to breathe deeply and cough frequently to prevent atelectasis.  Pain relief medication may decrease the coughing reflex as well as depress respiratory functions when the dosage is high enough to achieve analgesia.  On the other hand, if the dosage of analgesics is too low to relieve pain, it may render patients with shallow breathing and inadequate coughing reflex.  Epidural anesthesia or analgesia may produce some pain relief, but the side effects of severe hypotension, nausea, and urinary retention, as well as the variability of effect limit the usefulness of this approach.  Intercostal or paravertebral nerve blocks by means of local anesthetics and severing of the intercostal nerves have also been used to reduce incisional pain following thoracotomy.  However, the duration of relief for neural blockade is only a few hours and the procedure is painful, while severing of the intercostal nerves during thoracotomy may result in neuromas, which cause late post-operative pain.

Cryoanalgesia has been used on the intercostal nerves to reduce post-thoracotomy pain.  Although the procedure is generally performed prior to closure of the chest at the completion of thoracotomy and may add 10 to 15 mins to the total operating time, it can also be carried out percutaneously in a clinical setting.  Cryoanalgesia of the intercostal nerves circumvents the need for repetitive injections of nerve blocks and avoids the toxicity of long acting agents, which may lead to chemically induced intercostal neuritis. 

Khanbhai et al (2014) examined if cryoanalgesia improves post-thoracotomy pain and recovery.  A total of 12 articles were identified that provided the best evidence to answer the question.  The authors, date, journal, study type, population, main outcome measures and results were tabulated.  Reported measures were pain scores, additional opiate requirements, incidence of hypoesthesia and change in lung function.  Half of the articles reviewed failed to demonstrate superiority of cryoanalgesia over other pain relief methods; however, additional opiate requirements were reduced in patients receiving cryoanalgesia.  Change in lung function post-operatively was equivocal.  Cryoanalgesia potentiated the incidence of post-operative neuropathic pain.  Further analysis of the source of cryoanalgesia, duration, temperature obtained and extent of blockade revealed numerous discrepancies; 3 studies utilized CO2 as the source of cryoanalgesia, and 4 used nitrous oxide but at differing temperatures and duration; 5 studies did not reveal the source of cryoanalgesia.  The number of intercostal nerves anesthetized in each study varied; 7 articles anesthetized 3 intercostal nerves, 3 articles used 5 intercostal nerves, 1 article used 4 intercostal nerves and 1 used 1 intercostal nerve at the thoracotomy site.  Thoracotomy closure and site of area of chest drain insertion may have a role in post-operative pain; but only 1 article explained method of closure, and 2 articles mentioned placement of chest drain through blocked dermatomes.  No causal inferences can be made by the above results as they are not directly comparable due to confounding variables between studies.  The authors concluded that currently, the evidence does not support the use of cryoanalgesia alone as an effective method for relieving post-thoracotomy pain.

1. appropriate dose regimes of gabapentinoids, anti-depressants, local anesthetics and regional anesthesia may potentially reduce the severity of both acute and chronic pain for patients;
2. ketamine was not effective at reducing chronic pain;
3. intercostal cryoanalgesia was not effective and has the potential to increase the risk of chronic pain; and
4. TIVA may be beneficial but the effects of opioids are unclear.

Cold Therapy Units and Hot/Ice Machine: 

Cold therapy devices combine cold temperatures and compression to decrease discomfort and swelling following injury or surgery to an extremity. The theory behind cold therapy is that by decreasing the temperature of the tissue, which produces vasoconstriction, pain is lessened, muscle spasm is decreased and inflammation is reduced.

Active cold therapy devices and combined heat and cold therapy devices utilize pneumatic or mechanical pumps that may be battery or electrically operated. The intended function of the pump is to provide cyclical compression and cooling or heating to the affected area. The devices generally consist of two basic parts: a wrap or wrap system and a control unit or pump, which is filled with ice and/or water. The control unit or pump circulates the cooled or heated water through the wrap system to the affected area.

Active cooling or heating devices

Examples of active cooling or heating devices include, but may not be limited to:

• Auto Chill Device –

  Cold therapy device in which a pump is used in conjunction with the Cryo/Cuff System. The pump automatically exchanges water from the pump to the cooler and eliminates the need for manual water recycling.

• cTreatment -

  Computer controlled heat and cold.

• Hilotherm -

  Heat and cold water pump with pads.

• Game Ready Accelerated Recovery System -

  System that combines cold and intermittent pneumatic compression therapies. It includes a computer that controls treatment time, level of compression and temperature. The unit continuously cycles liquid through circumferential wraps for consistent, long lasting cold treatment, even over large surface areas.

• Hot/Ice Thermal Blanket –

  Provides heat/cold therapy by the application of rubber pads (blankets) that are connected by a hose to a main cooling unit. The pads receive fluid that has circulated from the main unit and can be either hot or cold.

• IceMan Cryotherapy Unit –

  Utilizes a semi-closed loop system with a mechanical pump that allows warm water to circulate, at a constant flow rate, with cooler water providing consistent cold distribution throughout the pad.

• Kinex ThermoComp Device –

  Another example of a device that combines cold therapy with intermittent pneumatic compression.

• NanoTherm –

  System that combines cold or heat with intermittent pneumatic compression therapies. 

• Ossur Cold Rush Cold Therapy System –

   Combines cold pump with compression. 

• Thermocure Contrast Compression Therapy –

   Combines heat or cold pump with compression. 

• VitalWrap System –

  Consists of three components: a control unit, a tubing set and a thermal fabric wrap. The control unit, which includes a fluid reservoir, manages the temperature of water used by the system to supply heat or cold to the fabric wrap attached to the body. Compression is delivered through the wrap itself. 

• VPULSE -

  Intermittent pneumatic compression with cold water pump.

Passive cold therapy devices operate by gravity or a hand pump without the use of a battery or electricity. Generally, they consist of a cuff or wrap and a cooler. Ice water is placed in the reservoir or cooler. The cooler is placed above the affected body area or joint and then utilizes gravity to fill the cuff and compress the joint. 

Passive Cold Therapy Devices

Examples of passive cold therapy devices include, but may not be limited to:

• AirCast Cryo/Cuff System–

  Therapy system consisting of a cuff, a cooler and a hose. The hose exchanges cooled ice water between the cooler and the cuff which covers the injured area. Elevating the cooler fills and pressurizes the cuff. Compression is controlled by gravity and is proportional to the elevation of the cooler.

• Polar Care (PC) Cub Unit–

  Cold therapy system which includes a PC Cub cooler, manual pump and wrap on pads. The pads are held in place with elastic straps or an ace wrap. The built-in hand pump circulates the cold water through the polar pad, while at the same time increases the compression around the joint.

Cold therapy units are devices in which fluid flows through a blanket or cuff, providing immediate cooling to an affected area.  The AirCast Cryo/Cuff uses a insulated jug filled with cold water attached to a cuff.  Elevating the jug fills and pressurizes the cuff.  Compression is controlled by gravity, and is proportional to the elevation of the cooler.  When body heat warms the water, it is re-chilled simply by lowering the cooler.  Another passive cold compression therapy unit is the Polar Care Cub unit.

More complicated cold therapy units may employ mechanical pumps and refrigerators that are powered by battery or electricity (e.g., IceMan).  The Game Ready system is an example of an active cooling device that combines cold and intermittent pneumatic compression therapies.  The system consists of a wrap, a connector hose, and a control unit.  The wrap contains two internal chambers, one for air and the other for cooling water.  The microprocessor control unit features various adjustable compression cycles and temperature controls.  However, there is no evidence that these more complicated cold therapy units provide any additional benefit over the CryoCuff or conventional ice bags or packs.  Aetna's current policy on mechanical cold therapy pumps is consistent with Medicare DME MAC policy.

Leutz and Harris (1995) described a retrospective study that assessed 52 consecutive patients who underwent total knee arthroplasty (TKA).  A total of 33 patients underwent TKA and received cold therapy pads placed over a thin dressing in the operating room; 19 patients underwent TKA using an identical operative and post-operative procedure, but did not receive continuous cold therapy.  Continuous cold therapy consisted of 2 sterile plastic pads connnected by rubber hoses containing cool water from an electric main unit that maintained a constant temperature of 42 degrees F for the immediate post-operative period.  Cold therapy pads were used an average of 3 days and removed with the first dressing change.  Patients who had continuous cold therapy averaged a 200 ml decrease in post-operative blood loss.  There was no significant difference in the amount of narcotic use, transfusion requirements, or hospital stay between the two groups.  Post-operative swelling and range of motion were not consistently recorded.  Twenty-eight other variables were also examined, but no significant differences were found between groups.  Based on these results, the authors stated that they can not recommend continuous cold therapy or justify the extra expense for all patients who undergo TKA.

A Hot/Ice Machine consists of 2 rubber pads connected by a rubber hose to a unit that circulates hot or cold fluid through the pads.  Studies in the published literature have been poorly designed and have failed to show that the Hot/Ice Machine offers any benefit over standard cryotherapy with ice packs, and there are no studies evaluating the use of this device as a heat source.

The VitalWrap (VitalWear Inc. South San Francisco, CA) is an active heating/cooling device that allows the user to circulate either hot or cold fluid through the system.  The VitalWrap system consists of a bladder filled body wrap/pad, tubing, and a reservoir/pump device.  Cooled or heated water may be added to the pump reservoir and then circulated through the tubing to the body wrap/pad and then back to the reservoir.  The benefits of this type of device above other cooling or heating methods have not been established at this time.

Vascutherm (ThermoTek, Carrollton, TX) is an active cold compression therapy unit with a pneumatic pump.  It provides heating, cooling and compression therapies.  The device also includes a deep vein thrombosis (DVT) mode -- this is a compression (or air) only mode, that is intended to prevent DVT.  However, it provides no additional clinical utility or impact on health outcomes than the use of ice or compression wraps.

The TEC Thermoelectric Cooling System (Maldonado Medical, Phoenix, AZ) is marketed to reduce post-operative pain and edema.  It is an iceless cold therapy compression/DVT prophylaxis machine that can also provide heat.  It is limited to a cold temperature of 49 degrees F to minimize the potential for frostbite.  However, it provides no additional clinical utility or impact on health outcomes than the use of ice or compression wraps.

1. cold-compression,
2. contrast-compression, and
3. intermittent pneumatic compression for DVT prophylaxis.

Continuous cold is delivered by a solid-state system without ice.  Cold temperature is microprocessor-controlled within 1^° making this one of the safest devices for unsupervised use in a patient's home.  Contrast therapy cycles every 30 mins with cold at 49° for 20 mins followed by heat at 105^° for 10 mins.  Intermittent compression is delivered distal-to-proximal through a segmented pad.  Deep vein thrombosis prophylaxis is delivered from a rapid inflation pump at 50 mm Hg through a calf pad or 100 mm Hg through a foot pad.  All 3 therapies are delivered separately, however cold-compression and DVT compression can run at the same time with the device cycling DVT compression separate from limb compression.  The Kinex ThermoComp^™ Device is intended to treat post-operative injuries in the home, to reduce edema and pain, to improve blood flow to the surgical site, and to provide DVT prophylaxis therapy for high-risk patients. However, there is a lack of evidence regarding the safety and effectiveness of this device.

According to the manufacturer, the VascuTherm2 solid state device provides heat, cold (without ice), compression, and/or DVT prophylaxis therapy.  The system is pre-programmed per written physician's instructions for fully automatic, safe, trouble-free use in the patient's home.  It is indicated for pain, edema, and DVT prophylaxis for the post-operative orthopedic patient.  The precisely controlled temperature range of 43 degrees F to 105 degrees F insures against frost-bite or burns.  Therapy times are also pre-programmed to insure maximum patient compliance.  It is extremely easy for patients to set up and use. However, there is a lack of evidence regarding the safety and effectiveness of this device.

Appendix

Selection Criteria of Cryoanalgesia for Trigeminal Neuralgia:

1. Members have experienced pain for at least 6 months, and 

2. Members have tried and failed pharmacotherapies (e.g., baclofen, carbamazepine, phenytoin), or are unable to tolerate the side effects of the medication. 

Repeat cryoanalgesia may be medically necessary every 6 months.

The above policy is based on the following references: