Medical policy: Ablation of Peripheral Nerves to Treat Pain

Número de política: MP 2.376

Fecha de entrada en vigor: 3/1/2026

Política

Radiofrequency ablation of peripheral nerves to treat pain associated with knee osteoarthritis or plantar fasciitis is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cryoneurolysis of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Radiofrequency ablation or cryoneurolysis of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache is considered investigational. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Ablation of peripheral nerves to treat pain is considered investigational in all other conditions, with the exception of facet joint pain (see MP 5.049). There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-references:

• MP 2.084 Minimally invasive ablation procedures for Morton and other peripheral neuromas
• MP 5.048 Diagnosis and treatment of sacroiliac joint pain
• MP 5.049 Facet joint denervation

Variaciones del producto

Esta política solo se aplica a ciertos programas y productos administrados por Capital Blue Cross y está sujeta a variaciones en los beneficios. Consulte la información adicional a continuación.

FEP PPO - Consulte el Manual de Políticas Médicas de FEP.

Descripción/Antecedentes

Nerve radiofrequency ablation

Nerve RFA is a minimally invasive method that involves the use of heat and coagulation necrosis to destroy tissue. A needle electrode is inserted through the skin and into the tissue to be ablated. A high-frequency electrical current is applied to the target tissue and a small sphere of tissue is coagulated around the needle by the heat generated. It is theorized that the thermal lesioning of the nerve destroys peripheral sensory nerve endings, resulting in the alleviation of pain. Cooled RFA is a variation of nerve RFA using a water-cooled probe that applies more energy at the desired location without excessive heat diffusing beyond the area, causing less tissue damage away from the nerve (see Table 1). The goal of ablating the nerve is the same.

RFA is also distinguished from pulsed RF treatment, which has been investigated for different types of pain. The mechanism of action of pulsed RF treatment is uncertain but it is thought not to destroy the nerve. It does produce some degree of nerve destruction but it is thought to cause less damage than standard RFA. Some studies refer to pulsed RF treatment as ablation.

For the indications assessed in this evidence review, nerve RFA should be distinguished from RF energy applied to areas other than the nerve to cause tissue damage. Some individuals have been treated for plantar fasciitis with a fasciotomy procedure using an RF device. This procedure does not ablate a specific nerve.

Table 1. Types of radiofrequency ablation

RF: radiofrequency; RFA: radiofrequency ablation

Adapted from Oladeji et al (2019)

Cryoneurolysis

Cryoneurolysis is being investigated to alleviate pain. Temperatures of -20° to -100°C applied to a nerve cause Wallerian (anterograde axonal) degeneration, with disruption of nerve structure and conduction but maintenance of the perineural and epineural elements of the nerve bundle. Wallerian degeneration allows complete regeneration and recovery of nerve function in about 3 to 5 months. The iovera^® cryoablation system is a portable handheld device that applies percutaneous and targeted delivery of cold to superficial peripheral nerves.

Regulatory status

A number of RF generators and probes for the peripheral nervous system have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. Some examples are listed in Table 2.

In 2017, the COOLIEF Cooled Radiofrequency Probe (Avanos, previously known as Halyard Health) was cleared for marketing by the FDA through the 510(k) process to be used in conjunction with a radiofrequency generator to create lesions in nervous tissue (K163461). One of the indications is specifically for "creating radiofrequency lesions of the genicular nerves for the management of moderate to severe knee pain of more than 6 months with conservative therapy, including medication, in patients with radiologically confirmed osteoarthritis (grade 2-4) and a positive response (> 50% reduction in pain) to a diagnostic genicular nerve block."

Table 2. Radiofrequency and cryoneurolysis devices

Fundamento

For individuals who have knee osteoarthritis (OA) who receive radiofrequency ablation (RFA) of peripheral nerves, the evidence includes systematic reviews of randomized controlled trials (RCTs), RCTs with 24 to 200 individuals, and non-randomized comparative studies with up to 12 months of follow-up. Relevant outcomes include symptoms, functional outcomes, and quality of life (QOL). Knee OA is a common disorder in older adults. RFA of the genicular nerves has the potential to alleviate pain and improve function in this population and might also delay or eliminate the need for total knee arthroplasty (TKA). At this time, there is high heterogeneity in methods and comparators. The systematic reviews generally found that RFA had a benefit on pain, function, and composite scores compared to the control treatments at 3 and 6-month follow-up; however, most estimates were determined to have moderate to high heterogeneity. The network meta-analysis compared multiple RFA modalities and found that cooled RFA had significantly improved efficacy for pain and function through 6 months follow-up compared with traditional or pulsed RFA. A small, double-blind RCT of bipolar RFA with genicular nerve block compared to pulsed RFA. A small, double-blind RCT of bipolar RFA with genicular nerve block compared to genicular nerve block and sham RFA found no differences between groups for visual analog score (VAS) pain or the Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores through 12 months follow-up. Given that OA of the knee is a common condition; adequately powered studies, preferably blinded with active and sham controls and follow-up of at least 12 months, is needed to determine the benefits and potential harms of this treatment. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have knee OA or TKA who receive cryoneurolysis of peripheral nerves, the evidence includes 2 RCTs with a total of 304 participants, a comparative, retrospective cohort study of 57 participants, and a registry study of 140 individuals. Relevant outcomes include symptoms, functional outcomes, and QOL. In one RCT, cryoneurolysis in individuals with knee OA resulted in a greater decrease in WOMAC pain score, WOMAC total score, and VAS score at 30 days compared with sham-treated controls. However, subsequent measurements showed no significant benefit of cryoneurolysis on WOMAC score at 60 days or VAS scores at 60 or 90 days. Another RCT investigated cryoneurolysis compared to standard of care for patients with knee OA who were planning to undergo TKA. Cryoneurolysis resulted in a lower rate of opioid consumption, a reduction in numeric rating scale (NRS) pain scores, and Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) functional performance at 12 weeks post discharge. The retrospective cohort study reported superiority of cryoneurolysis on the KOOS JR and Short Form-12 item (SF-12) mental score at 1 year follow-up; no significant differences were observed on the SF-12 physical score at 1 year follow-up or for any outcome at earlier 3-month assessment. A registry study found improved pain and lowered opioid use with cryoneurolysis prior to TKA; however, functional outcomes through 6 months were similar. Several technical issues including the optimal number of applications for each nerve, the duration of treatment, and the duration of thawing before moving the cannula have not been resolved. The most effective method for determining probe insertion location (e.g., ultrasound-guided or based on anatomic landmarks) also needs to be established. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have plantar fasciitis who receive RFA of peripheral nerves, the evidence includes 2 RCTs and a meta-analysis. Relevant outcomes include symptoms, functional outcomes, and QOL. The meta-analysis pooled evidence from 2 RCTs and did not demonstrate a significant improvement in pain outcomes compared to the control group. The analysis revealed significant heterogeneity, and the overall quality of evidence was graded as low. One of the randomized trials only evaluated 17 individuals, and assessment of randomized outcomes was limited to 4 weeks post-treatment. A second RCT evaluated 36 individuals out to 12 weeks. Both trials found RFA associated with pain reduction, but to be more confident in the efficacy of this treatment, controlled trials with larger samples and longer follow-up would be necessary. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

For individuals who have occipital neuralgia or cervicogenic headache who receive RFA or cryoneurolysis of peripheral nerves, the evidence includes RCTs and systematic reviews of RCTs. Relevant outcomes are symptoms, functional outcomes, and QOL. No RCTs of RFA for chronic occipital neuralgia have been identified. Three RCTs of RFA for a cervicogenic headache have been published, none of which were high quality. Pain is a subjective, patient-reported measure that is particularly susceptible to placebo effect. Randomized trials with sham or active controls are needed to evaluate the efficacy of this treatment. One controlled trial found a temporary benefit of cryoneurolysis for cervicogenic headache, but the effect was not significantly better than injection of corticosteroid and local anesthetic. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

N/D

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen asesoramiento médico y están sujetas a cambios según lo exija la ley o las pruebas clínicas aplicables de las directrices de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas pólizas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. La identificación de un código en esta sección no denota cobertura, ya que la cobertura está determinada por los términos de la información de beneficios del miembro. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Investigational; therefore, not covered:

Referencias

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