Medical Policy

This document addresses the use of cryoablation, also referred to as cryosurgery or cryogenic neuroablation, for the treatment of 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
• SURG.00088 Coblation^® Therapies for Musculoskeletal Conditions

Note: For a high-level overview of this document, please see “Summary for Members and Families” below. 

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.

This document describes clinical studies and expert recommendations and explains whether certain medical services are appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Cryoablation (also called cryosurgery or cryogenic neuroablation) is a type of surgical procedure that uses very cold temperatures to freeze and destroy nerve areas causing foot pain. It is sometimes used for plantar fasciitis (a common cause of heel or pain in the bottom of the foot) or plantar fibroma (a lump in the arch of the foot). The treatment involves inserting a long thin tool into the painful area of the foot through a small cut in the skin and freezing the nerves to stop pain signals. While some people have reported feeling better after this type of treatment, high quality studies have not proven that it improves health or works better than other treatments. Most people with these foot problems improve with simple care like stretching, shoe inserts, and pain relievers. Experts do not recommend using cryoablation for these foot conditions outside of a research study.

What the Studies Show

Cryoablation has been studied mostly in studies where people knew they were getting the treatment. This can make it hard to tell if the procedure really helped or if people improved for other reasons. One better-quality study compared cryoablation to surgery for plantar fasciitis. It found that people who had surgery felt better after 6 months than those who had cryoablation. However, after 1 year, the differences between groups were less noticeable. For plantar fibroma, there was only one study with just 4 people, which is not enough to tell if the treatment really worked or the results were due to chance. Better research is needed for that condition. No studies have yet compared cryoablation to non-surgical, simple treatments like physical therapy, splints, or medicines. Without those comparisons, we can’t know if cryoablation works better than doing nothing or using safer, easier care options.

Is this clinically appropriate?

This treatment is not appropriate because it has not been proven to improve health. Studies so far are small or low-quality. The one stronger study showed surgery worked better at first. More high-quality research is needed to know if freezing the nerves helps more than other treatments. Using tests or procedures that are not proven can lead to unnecessary care and worry.

(Return to Description/Scope)

Summary

The evidence base for cryoablation in treating plantar fasciitis and plantar fibroma consists primarily of observational studies with methodological limitations, alongside one randomized controlled trial that did not demonstrate that cryotherapy provides benefits comparable to surgical intervention. While multiple case series have reported improvements in pain scores following cryoablation for plantar fasciitis, these studies lack control groups and blinding, preventing definitive conclusions about treatment efficacy. The single randomized control trial available found that cryotherapy produced inferior functional outcomes compared to endoscopic plantar fascia release at six months, though differences resolved by one year. For plantar fibroma, the evidence is limited to a single small retrospective series. There are no randomized trials comparing cryoablation to sham treatment or standard conservative therapies such as medication, physical therapy, or splinting. These comparisons are essential for establishing true clinical benefit beyond placebo effects or natural disease progression.

Discussion

Plantar Fasciitis and Plantar Fibroma

One randomized controlled trial (RCT) compared cryotherapy to a different treatment for plantar fasciitis. In 2020, Catal and colleagues published findings of a single center RCT conducted in Turkey comparing cryotherapy and surgery (endoscopic plantar fascia release [EPFR]) in 48 individuals with plantar fasciitis resistant to 6 months of conservative treatment. The primary outcome was the American Orthopedic Foot and Ankle Society ankle/hindfoot scale (AOFAS-AHS) measurement. This has a potential range of 0-100 points, with a higher score indicating better outcomes. At baseline, mean scores were 51.0 in the EPFR group and 53.9 in the cryosurgery group (p=0.39). At 6 months, mean scores were significantly higher in the EPFR group than the cryosurgery group (82.4 vs. 71.7, p=0.007) and there was not a significant between-group difference at 1 year (p=0.11). No complications were reported in the EPFR group. This study did not clearly demonstrate a benefit from cryotherapy; RCTs are needed that compare cryotherapy with sham treatment or commonly used alternatives such as medication, physical therapy and/or splints.

A systematic review of RCTs on surgical interventions for plantar fasciopathy, which searched the literature through February, 2022, identified the Catal (2020) study (discussed above), but no additional RCTs on cryotherapy (MacRae, 2022).

Allen and colleagues (2007) published data on 59 individuals (61 heels) who had failed conservative therapy and were considered surgical candidates. The primary outcome was pain using an 11-point visual analog scale (VAS) that was assessed preoperatively and up to 1 year of follow-up. The mean pain rating was 8.38 before cryosurgery (day 0) compared with a mean pain rating of 1.26 after a year, a statistically significant improvement after surgery (p<0.0001). This study lacked a control group with which to compare pain outcomes.

Cavazos and colleagues (2009) published findings of a retrospective case series in individuals with recalcitrant heel pain who had failed 6 months of conservative care. Pain was measured using a Numeric Pain Scale (NPS, 0 to 10) at 3 weeks and 24 months. A total of 106 individuals had successful pain relief and 31 individuals 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). Limitations of the analysis were the multiple etiologies of the individual’s heel pain and the variable treatment techniques of the clinicians performing the procedure.

One small retrospective, unblinded, uncontrolled series (Ahmed, 2018) evaluated cryoablation for symptomatic plantar fibromas. The study included 4 individuals with 5 plantar fibromas. Mean pain score (on a 10-point scale) was 5.8 at baseline and decreased to 0.4 after treatment. The study was limited by a small number of participants, lack of blinding and lack of a comparison group.

There continues to be insufficient scientific evidence published in peer-reviewed medical journals that permits reasonable conclusions concerning the effect of cryoablation on health outcomes. There is a lack of published studies comparing cryoablation to sham or alternative treatments for plantar fasciitis or plantar fibroma.

The plantar fascia is a ligament-like structure that covers the bottom of the foot, extending from the heel bone to the base of the toes, which 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 a common source of heel pain. The cause of this condition is not entirely clear, but it 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 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).

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 therapy, 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.

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 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 cryoprobe 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 cryogenic surgical device is defined by the U.S. Food and Drug Administration (FDA) under 21 CFR 882.4250 as a device used to destroy or produce lesions in tissue through the application of extreme cold. These devices are classified as Class II and cleared under a generic cryogenic surgical device classification, not for specific anatomical indications. Multiple systems hold 510(k) clearance under this classification, including historical devices such as Cryo-PaC™ (K050272) and CryoStar™ (CryoMedical Instruments Ltd., UK). The Cryo-Touch line, formerly by MyoScience Inc., is now marketed as iovera^TM  (Pacira BioSciences Inc., NJ) which received updated 510(k) clearances, including K243677 (December 26, 2024). No cryogenic device is FDA-cleared specifically for plantar fasciitis or plantar fibroma indications. All are cleared under the general category of cryogenic surgical devices.

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.

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.

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.

Peer Reviewed Publications:

1. Ahmed M, Weinstein JL, Hussain J, et al. Percutaneous ultrasound-guided cryoablation for symptomatic plantar fibromas. Cardiovasc Intervent Radiol. 2018; 41(2):298-304.
2. 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.
3. Çatal B, Bilge A, Ulusoy RG. Endoscopic plantar fascia release versus cryosurgery for the treatment of chronic plantar fasciitis: a prospective randomized study. J Am Podiatr Med Assoc. 2020; 110(5):Article_3.
4. Cavazos GJ, Khan KH, D'Antoni AV, et al. Cryosurgery for the treatment of heel pain. Foot Ankle Int. 2009; 30(6):500-505.
5. 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.
6. MacRae CS, Roche AJ, Sinnett TJ, et al. What is the evidence for efficacy, effectiveness and safety of surgical interventions for plantar fasciopathy? A systematic review. PLoS One. 2022; 17(5):e0268512.

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. September 25, 2025. Available at: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-882/subpart-E/section-882.4250. Accessed on October 4, 2025.

1. American Academy of Orthopaedic Surgeons (AAOS). Plantar fasciitis and bone spurs. Available at: https://orthoinfo.aaos.org/en/diseases--conditions/plantar-fasciitis-and-bone-spurs. Accessed on October 4, 2025.

Cryogenic Neuroablation
Cryosurgery
Ioveraº

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. 

Federal and State law, as well as contract language, including definitions and specific contract provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The member’s contract benefits in effect on the date that services are rendered must be used. Medical Policy, which addresses medical efficacy, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and we reserve the right to review and update Medical Policy periodically.

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