Medical Policy



Subject: Cryoablation for Plantar Fasciitis and Plantar Fibroma
Document #: SURG.00100 Current Effective Date:    06/28/2017
Status: Reviewed Last Review Date:    05/04/2017

Description/Scope

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

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

Position Statement

Investigational and Not Medically Necessary:

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

Rationale

Plantar Fasciitis and Plantar Fibroma

There is currently a lack of data in the peer-reviewed literature in the form of controlled, double-blind, randomized controlled trials regarding the safety and efficacy of cryoablation for either plantar fasciitis or plantar fibroma.

Allen and colleagues (2007) tested the efficacy of cryosurgery on plantar fasciitis of the heel in a prospective, non-randomized study of 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 (VAS) administered preoperatively and up to 1 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<0.0001). 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.

Cavazos and colleagues (2009) investigated the short- and long-term efficacy of cryosurgery in a retrospective case series of individuals with recalcitrant heel pain. Subjects (137 feet) in the analysis included only individuals who had failed 6 months of conservative care prior to cryosurgery. Pain was measured using a Numeric Pain Scale (NPS, 0 to 10) at 3 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 3 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 subjects' 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. 

Costantino and colleagues (2014) evaluated the efficacy of combined cryoultrasound therapy on chronic plantar fasciitis with heel spurs resistant to pharmacological and instrumental therapies. A total of 84 individuals with painful symptoms for at least 6 months, intensity of pain higher than 5 on the VAS scale, and the presence of heel spurs were randomized into 2 groups: Group A (n=42) was treated with cryoultrasound therapy and Group B (n=42) with cryotherapy. Outcomes were measured before treatment and 3, 12, and 18 months after treatment; 4 participants were lost to follow-up (n=3, Group A; n=1, Group B). The primary outcome measure, the difference in pain intensity on the VAS scale between the 2 groups at 12 months after treatment, was 4.35 points in favor of Group A (95% confidence interval [CI], 3.75 to 4.95; p<0.001); however, both treatment groups showed improvement in pain perception and reported a statistically significant decrease in the VAS score. A limitation of this study is the evaluation of subjective pain alone without measurement of objective data (that is, use of imaging studies). In addition, a double-blind, randomized controlled trial comparing cryotherapy to placebo alone is necessary to determine the net health benefit of cryotherapy for the treatment of chronic plantar fasciitis without heel spurs.   

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.

Background/Overview

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. Most people who have plantar fasciitis recover with conservative treatments in just a few months with use of pain relievers (such as ibuprofen or naproxen to ease pain and inflammation), physical therapy (stretching and strengthening exercises), night splints, and over-the-counter orthotics (such as, heel cups, cushions, or custom-fitted arch supports).   

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 cryogenic 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, 2016). There are numerous 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. Devices with FDA clearance include, but are not limited to, the Cryo-PaC™ and CryoStar™ Systems (CryoMedical Instruments, Ltd., Mansfield, Nottinghamshire, England, UK) and the MyoScience Cryo-Touch and Cryo-Touch II devices (MyoScience, Inc., Redwood City, CA).

Potential Complications

There have been 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 nonsteroidal anti-inflammatory drugs (NSAIDs) or over-the-counter arch supports.

Definitions

Cryoablation: A minimally invasive procedure using 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 resulting 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.

Coding

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.

CPT  
28899 Unlisted procedure, foot or toes [when specified as cryoablation of plantar fasciitis or plantar fibroma]
64640 Destruction by neurolytic agent (eg, chemical, thermal, electrical or radiofrequency); other peripheral nerve or branch [when specified as cryosurgery]
   
ICD-10 Procedure  
  For the following codes, when specified as cryosurgery:
015G0ZZ Destruction of tibial nerve, open approach
015G3ZZ Destruction of tibial nerve, percutaneous approach
015G4ZZ Destruction of tibial nerve, percutaneous endoscopic approach
   
ICD-10 Diagnosis  
M72.2 Plantar fascial fibromatosis (plantar fasciitis)
   
References

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. Costantino C, Vulpiani MC, Romiti D, et al. Cryoultrasound therapy in the treatment of chronic plantar fasciitis with heel spurs. A randomized controlled clinical study. Eur J Phys Rehabil Med. 2014; 50(1):39-47.
  4. Lee TH, Wapner KL, Hecht PJ. Plantar fibromatosis. J Bone Joint Surg Am. 1993; 75(7):1080-1084.
  5. 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. Thomas JL, Christensen JC, Kravitz SR, et al. American College of Foot and Ankle Surgeons (ACFAS). The diagnosis and treatment of heel pain: a clinical practice guideline - revision 2010. J Foot Ankle Surg. 2010; 49:S1-S19.
  2. U.S. Food and Drug Administration (FDA). Center for Devices and Radiological Health. Cryogenic surgical device. April 1, 2016. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?FR=882.4250. Accessed on January 31, 2017.
  3. U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification Database. Product code GXH. Rockville, MD: FDA. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm. Accessed on January 31, 2017.
Websites for Additional Information
  1. American Academy of Orthopaedic Surgeons (AAOS). OrthoInfo. Plantar fasciitis and bone spurs. June 2010. Available at: http://orthoinfo.aaos.org/topic.cfm?topic=A00149. Accessed on January 31, 2017.
  2. American Podiatric Medical Association (APMA). Heel pain. Available at: http://www.apma.org/Learn/FootHealth.cfm?ItemNumber=985. Accessed on January 31, 2017.
Index

Cryogenic Neuroablation
Cryosurgery

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.

Document History

Status

Date

Action

Reviewed 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review. Updated Description, Rationale, Background/Overview, Definitions, References, Websites for Additional Information, and Index sections.
Reviewed 05/05/2016 MPTAC review. Updated Background, References, and Websites for Additional Information sections. Removed ICD-9 codes from Coding section.
Reviewed 05/07/2015 MPTAC review. Updated Rationale, Background, and References sections.
Reviewed 05/15/2014 MPTAC review. Minor format change to Position Statement. Updated Rationale, Definitions, References, Websites for Additional Information, and Index sections.
Reviewed 05/09/2013 MPTAC review. Updated Rationale, References, Websites for Additional Information, and Index.
Reviewed 05/10/2012 MPTAC review. Updated Background, References, and Websites for Additional Information.
Reviewed 05/19/2011 MPTAC review. Updated Background, Definitions, References, and Websites for Additional Information.
Reviewed 05/13/2010 MPTAC review. Updated Rationale and References.
Reviewed 05/21/2009 MPTAC review. Clarified Position Statement. Updated Rationale, Background, Definitions, and References.
Reviewed 05/15/2008 MPTAC review. Updated References.
  02/21/2008 The phrase "investigational/not medically necessary" was clarified to read "investigational and not medically necessary." This change was approved at the November 29, 2007 MPTAC meeting.
New 05/17/2007 MPTAC review. Initial document development.