This document addresses the use of cryoablation, also referred to as cryosurgery or neuroablation, for the treatment of both plantar fasciitis and plantar fibroma.

Note:  Please see the following related documents for additional information:

• CG-SURG-25 Injection Treatment for Morton's Neuroma
• SURG.00045 Extracorporeal Shock Wave Therapy for Orthopedic Conditions
• SURG.00088 Coblation^® Therapies for Musculoskeletal Conditions

Investigational and Not Medically Necessary:

Use of cryoablation (e.g. cryosurgery, neuroablation) for the treatment of either plantar fasciitis or plantar fibroma is considered investigational and not medically necessary.

Plantar Fasciitis and Plantar Fibroma

There is currently a lack of data in the peer-reviewed literature in the form of placebo-controlled, double-blinded randomized controlled trials regarding the safety and efficacy of cryoablation for either plantar fasciitis or plantar fibroma. There have been multiple investigations to identify epidemiologic factors associated with these conditions and their recurrence, and to determine which method of treatment most successfully eliminated recurrence, but none of these studies evaluated the use of cryoablation or cryosurgery procedures (Lee, 1993).

A prospective, non-randomized study  by Allen and colleagues (2007) tested the efficacy of cryosurgery on plantar fasciitis of the heel in 59 consecutive subjects (61 heels) who had failed prior conservative therapy and were considered surgical candidates. Subjects were evaluated on an 11-point visual analog scale administered preoperatively and up to one year of follow-up. The mean pain rating (8.38) before cryosurgery (day 0) was reported as statistically significant to the mean pain rating (1.26) at day 365 postoperatively. Pain decreased significantly after the procedure (p<.0001). The authors suggested that cryosurgery is an effective treatment modality after failed conservative treatment for individuals with recalcitrant plantar fasciitis without resorting to open invasive outpatient surgery.

Stuber and Kristmanson (2006) performed a narrative literature review of randomized controlled trials to ascertain which conservative treatments provide the best results for plantar fasciitis. Stretching, prefabricated and custom-made orthotics and night splints were all scrutinized in numerous studies with mixed results. Chiropractic manipulative therapy was examined in one study with "favorable results." Therapeutic ultrasound and low intensity laser therapy was examined in one study with "unsatisfactory results." Based on the trials reviewed, the authors reported a trial of therapy beginning with treatments targeted for the individual is recommended, particularly stretching, over-the-counter orthotics, and education. Several of the reviewed articles indicated that custom-made orthotics were more beneficial for plantar fasciitis than over-the-counter orthotics. In the event that these treatments do not provide satisfactory results, the studies suggested that the use of night splints should be considered. There were no studies evaluated on the use of cryosurgery for plantar fasciitis. The authors found that most of the studies reviewed had at least one methodological flaw, including inadequate sample sizes, high drop-out rates, and comparison of multiple interventions to each other, making it difficult to determine the treatment effect of each intervention (Stuber and Kristmanson, 2006).

In a retrospective case series of 137 feet, Cavazos and colleagues (2009) investigated the short- and long-term efficacy of cryosurgery in relieving recalcitrant heel pain. Subjects in the analysis included only individuals who had failed six months of conservative care prior to cryosurgery. Pain was measured using a Numeric Pain Scale (NPS, zero to 10) at three weeks and 24 months. A total of 106 subjects had successful pain relief and 31 subjects failed to gain relief; the success and failure rates were 77.4% and 22.6%, respectively. Mean pain before cryosurgery was 7.6, after cryosurgery at three weeks was 1.6 (p<0.0005), and after cryosurgery at 24 months was 1.1 (p<0.0005). The authors suggested that cryosurgery was successful in resolving both short- and long-term heel pain; however, limitations of the analysis were the multiple etiologies of the subject's heel pain and the variable treatment techniques of the clinicians performing the procedure. Further investigation is needed as to the potential cause-and-effect relationship that may exist between cryosurgery and heel pain relief. 

There continues to be a lack of prospective clinical trials evaluating the use of cryoablation for the treatment of plantar fibroma published in the peer-reviewed medical literature which does not allow for adequate evaluation of its use in the clinical setting. Studies and materials are available on the safety and effectiveness of cryoablation procedures for plantar fasciitis and plantar fibroma in the form of unpublished manufacturer-funded reports that have not been subjected to the peer review process. In the absence of strong peer-reviewed data, the use of cryoablation cannot be recommended for either indication.

Description of Plantar Fasciitis

The plantar fascia is a wide ligament-like structure that covers the bottom of the foot, extending from the heel bone to the base of the toes. This band of thick tissue protects the bottom of the heel bone and acts like a shock absorber for the bottom of the foot.

In many individuals, the plantar fascia may become irritated, causing a condition called plantar fasciitis. This is the most common cause of heel pain. The cause of this condition is not entirely clear, but is associated with or due to repetitive trauma. It is common in several sub-groups of people, including runners and other athletes, people who have jobs that require a fair amount of walking or standing (especially if it is done on a hard surface), and in some cases it is seen in people who have put on weight, including through pregnancy. One disturbing fact about plantar fasciitis is that it sometimes takes many months to resolve. Seventy-five percent of all individuals may not recover until approximately six months and then only 98% may recover by 12 months. In a 2004 report, data from the National Ambulatory Medical Care Survey (NAMCS) and the National Hospital Ambulatory Medical Care Survey (NHAMCS) described the number of outpatient visits for plantar fasciitis and the care given during those visits to office-based physicians and visits to nonfederal, short-stay, and general hospitals to consult doctors of medicine and doctors of osteopathy. Data was combined for a six year period to increase the reliability of the estimates. Overall, the research suggested that plantar fasciitis was a relatively common disorder seen by several physician specialties. The report stated the disorder was not managed in a consistent way, rather, "there appears to be a large amount of variation in the way these patients are managed." The researchers suggested these findings support the argument that additional research is needed to identify effective interventions for plantar fasciitis and to determine if physician specialty influences treatment outcome (Riddle, 2004).

Description of Plantar Fibroma

Plantar fibromas are relatively uncommon, benign but locally invasive lesions that are characterized by fibrous proliferation arising from the plantar fascia. On clinical examination, fibrous nodules in the plantar arch with frequent bilateral involvement characterize plantar fibroma. Typically, these nodules are painless or cause only vague or perhaps moderate pain. Fascial scarring and contracture may be seen late in the disease course. Radiographic findings are usually normal. Diagnosis is made with palpation of plantar nodules. Treatment is initially conservative, but surgery may be indicated in individuals with painful or deep infiltrating lesions. The high incidence of recurrence after surgical excision and the potential for problematic wound healing and scarring presents a significant challenge in the management of this condition.

Description of Cryoablation

Cryoablation, also referred to as cryosurgery or neuroablation, has been proposed as an alternative treatment for individuals who have failed prior attempts of conservative therapies for plantar fasciitis and plantar fibroma. Cryoablation is described as a minimally invasive outpatient procedure typically performed on the proximal plantar area of the foot. After administration of a local anesthetic, a small incision is made adjacent to the area of primary discomfort. A specialized probe is inserted into the area of "trigger point" type pain and the area is then treated with a series of cooling then thawing cold applications. The resultant 6- to 8-mm "ice ball" formed at the cyroprobe tip will destroy nerve tissue by causing extensive vascular damage to the endoneural capillaries or blood vessels supplying the nerves. Freezing the particular areas of pain caused by plantar fasciitis creates a block that stops the conduction of pain. No sutures are necessary and a small dressing is applied to the surgical area. There is minimal need for post-operative pain medication and most individuals promptly resume normal activities.

A cryosurgery device is described in the U.S. Food and Drug Administration (FDA) database as a "device used to destroy nervous tissue or produce lesions in nervous tissue by the application of extreme cold to the selected site" (FDA, 2006). There are five cryosurgery devices with 510(k) clearance, although none of these Class II devices is approved specifically for the indications of plantar fasciitis or plantar fibroma. The two devices with FDA approval documents include the Cryo-PaC™ and CryoStar™ Systems (CryoMedical Instruments, Ltd., Mansfield, Nottinghamshire, England, UK).

Potential Complications and Proposed Benefits

There have been very few complications reported with cryoablation procedures for plantar fasciitis and plantar fibroma. Infection has rarely been reported; the most common post-procedure symptom described is the development of pain in another location of the heel or arch. This pain usually responds to the use of non-steroidal anti-inflammatory drugs (NSAIDs) or over-the-counter arch supports. Although the unpublished cryosurgery literature suggests that there is almost no recurrence of pain associated with plantar fasciitis after this procedure, the long-term analgesic relief has not been reported due to the lack of double-blinded, randomized controlled trials measuring long-term outcomes of the procedure.

Calcaneus: The heel bone of the foot.

Cryoablation: A minimally invasive procedure using the Joule-Thompson effect within a closed-probe, gas-based system. This procedure uses extremely cold temperatures to selectively destroy nerve endings to create a block that stops the conduction of pain. 

Plantar fasciitis: Inflammation of thick tissue on the bottom of the foot caused by chronic irritation that results in pain while standing, walking, and running.

Plantar fibroma: A single mass or clusters of fibrous, nodular lesions that form within a ligament in the arch of the foot.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Allen BH, Fallat LM, Schwartz SM. Cryosurgery: an innovative technique for the treatment of plantar fasciitis. J Foot Ankle Surg. 2007; 46(2):75-79.
2. Cavazos GJ, Khan KH, D'Antoni AV, et al. Cryosurgery for the treatment of heel pain. Foot Ankle Int. 2009; 30(6):500-505.
3. Lee TH, Wapner KL, Hecht PJ. Plantar fibromatosis. J Bone Joint Surg Am. 1993; 75(7):1080-1084.
4. Riddle DL, Schappert SM. Volume of ambulatory visits and patterns of care for patients diagnosed with plantar fasciitis: a national study of medical doctors. Foot Ankle Int. 2004; 25(5):303-310.
5. Stuber K, Kristmanson K. Conservative therapy for plantar fasciitis: a narrative review of randomized controlled trials. J Can Chiropr Associa. 2005; 50(2):118-133.
6. Tisdel CL, Donley BG, Sferra JJ. Diagnosing and treating plantar fasciitis: a conservative approach to plantar heel pain. Cleve Clin J Med. 1999; 66(4):231-235.

Government Agency, Medical Society, and Other Authoritative Publications:

1. American College of Foot and Ankle Surgeons™ (ACFAS). The diagnosis and treatment of heel pain: a clinical practice guideline - revision 2010. The Journal of Foot & Ankle Surgery. 2010; 49:S1-S19. Available at: http://www.acfas.org/uploadedFiles/Healthcare_Community/Education_and_Publications/Clinical_Practice_Guidelines/HeelPainCPG.pdf. Accessed on February 7, 2011.
2. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Cryogenic surgical device. April 1, 2010. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.4250. Accessed on February 7, 2011.
3. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. Medical devices. CryoStar™ System. No. K031482. Rockville, MD: FDA. July 10, 2003. Available at: http://www.fda.gov/cdrh. Accessed on February 7, 2011.

1. American Academy of Orthopaedic Surgeons (AAOS). Plantar fasciitis and bone spurs. June 2010. Available at: http://orthoinfo.aaos.org/fact/thr_report.cfm?Thread_ID=144&topcategory=Foot . Accessed on February 7, 2011.
2. American Podiatric Medical Association (APMA). Heel pain has many causes. Available at: http://www.apma.org/MainMenu/Foot-Health/Foot-Health-Brochures-category/Learn-About-Your-Feet/Heel-Pain.aspx.  Accessed on February 7, 2011.

Cryoablation
Cryosurgery
Neuroablation
Plantar Fasciitis
Plantar Fibroma

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.