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| Thermal Ablation of Peripheral Nerves and Genicular Artery Embolization to Treat Pain (e.g., Plantar Fasciitis, Knee Pain, Sacroiliac Pain, and Other Conditions) | |
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| Description: |
The policy applies to the following service/procedure: Thermal Ablation of Peripheral Nerves and Genicular Artery Embolization to Treat Pain (e.g., Plantar Fasciitis, Knee Pain, Sacroiliac Pain, and Other Conditions).
Radiofrequency ablation (RFA) and cryoneurolysis of nerves have been proposed as treatments for several different types of pain. RFA has been used to treat a number of clinical pain syndromes such as trigeminal neuralgia as well as cervical and lumbar pain. Genicular artery embolization has been proposed as a treatment of symptomatic knee osteoarthritis refractory to conservative management.
Plantar Fasciitis
Plantar fasciitis is a common cause of foot pain in adults, characterized by deep pain in the plantar aspect of the heel, particularly on arising from bed. While the pain may subside with activity, in some patients the pain may persist, impairing activities of daily living. On physical examination, firm pressure will elicit a tender spot over the medial tubercle of the calcaneus. The exact etiology of plantar fasciitis is unclear, although repetitive injury is suspected. Heel spurs are a common associated finding, although it has never been proven that heel spurs cause the pain. Asymptomatic heel spurs can be found in up to 10% of the population. Most cases of plantar fasciitis are treated with conservative therapy, including rest or minimization of running and jumping, heel cups, and nonsteroidal anti-inflammatory drugs. Local steroid injection may also be used. Improvement may take up to 1 year in some cases.
Knee Osteoarthritis
Knee osteoarthritis (OA) is common, costly, and cause of substantial disability. Among U.S. Adults, the most common causes of disability are arthritis and rheumatic disorders. Treatment for OA of the knee aims to alleviate pain and improve function. However, most treatments do not modify the natural history or progression of OA and are not considered curative. Nonsurgical modalities used include exercise; weight loss; various supportive devices; acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen; nutritional supplements (glucosamine, chondroitin); and intra-articular viscosupplements. Corticosteroid injection may be considered when relief from NSAIDs is insufficient, or the patient is at risk from gastrointestinal adverse effects. If symptom relief is inadequate with conservative measures, invasive treatments may be considered. Operative treatments for symptomatic OA of the knee include arthroscopic lavage and cartilage debridement, osteotomy, and, ultimately, total joint arthroplasty. Surgical procedures intended to repair or restore articular cartilage in the knee (e.g., abrasion arthroplasty, microfracture techniques, autologous chondrocyte implantation) are appropriate only for younger patients with focal cartilage defects secondary to injury and are not addressed in this policy.
Occipital Neuralgia
Occipital neuralgia is a specific type of headache that is located on one side of the upper neck, back of the head, and behind the ears, and sometimes extending to the scalp, forehead, and behind the eyes. The pain, which may be piercing, throbbing, or electric-shock-like, follows the course of the greater and lesser occipital nerves. Occipital neuralgia is believed to occur due to pressure or irritation to the occipital nerves, which may result from injury, entrapment by tight muscles, or inflammation. Treatment may include massage and rest, muscle relaxants, nerve blocks, and injection of steroids directly into the affected area.
Cervicogenic Headache
Cervicogenic headache is a headache that is secondary to a disorder of the cervical spine. The pain may be referred from facet joints, intervertebral discs, or soft tissue. The pain is constant rather than throbbing and may be aggravated by movements of the neck or pressure to certain areas on the neck. The first 3 cervical spinal nerves can refer pain to the head. The C1 suboccipital nerve innervates the atlanto-occipital joint; the C2 spinal nerve and the C3 dorsal ramus have close proximity to and innervate the C2-C3 facet joint. The C2-3 facet joint is the most frequent source of a cervicogenic headache. A diagnosis of a cervicogenic headache may be confirmed by an anesthetic block of the lateral atlanto-axial joint, the C2-3 facet joint, or the C3-4 facet joint. Treatment may include nerve blocks, physical therapy, and exercise.
Nerve Radiofrequency Ablation
Nerve radiofrequency ablation (RFA) is a minimally invasive method that involves use of heat and coagulation necrosis to destroy tissue. A needle electrode is inserted through the skin and then into the tissue to be ablated. A high-frequency electrical current is applied to the target tissue. 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 radiofrequency (RF) treatment is a variation of nerve RFA using a special device that applies more energy at the desired location without excessive heat diffusing beyond the area, causing less tissue injury away from the nerve. The goal of ablating the nerve is the same.
For the indications assessed in this policy, nerve RFA should be distinguished from RF energy applied to areas other than the nerve to cause tissue damage. Some patients have been treated for plantar fasciitis with a fasciotomy procedure using a RF device. This procedure does not ablate a specific nerve.
Nerve RFA is also distinguished from pulsed RF treatment, which has been investigated as a treatment for different types of pain. The mechanism of action of pulsed RF treatment is uncertain, but it is thought not to destroy the nerve (Chua, 2011). If it does produce some degree of nerve destruction, it is thought to cause less damage than standard RFA. Some studies refer to pulsed RF treatment as ablation.
Types of Radiofrequency Ablation:
Cryoneurolysis
Cryoneurolysis is being investigated to alleviate pain in knee osteoarthritis and to manage pain following total knee arthroplasty. Temperatures of -20 degrees to -100 degrees Celsius 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.
The iovera System
The iovera treatment is powered by the Focused Cold Therapy delivery system, a handheld device which harnesses the unique properties of cryotherapy to target peripheral nerves and block pain. Highly pressurized liquid nitrous oxide travels through the handpiece to the closed end needles of the Smart Tip, where it undergoes a phase change and becomes very cold. This phase change forms a precise cold zone in the tissue causing a temporary nerve block.
Genicular Artery Embolization (GAE)
Osteoarthritic inflammation is accompanied by the growth of new blood vessels from existing ones. Sensory nerves grow along the new blood vessels. Mechanical stimulation of these nerves may contribute to osteoarthritic pain. The embolization procedure is intended to cause the death of the nerves via prevention of blood flow. A catheter is inserted through the femoral artery to the genicular arteries, and an embolic agent is injected to block blood flow.
Regulatory Status
A number of radiofrequency (RF) generators and probes have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process.
Although cryoablation equipment (e.g., IceRod CX cryoablation probe, IceEDGE 2.4, VisualICE) have received U.S. Food and Drug Administration (FDA) 510(k) marketing clearance, none appear to be specifically indicated for treatment of peripheral nerve pain.
In 2013, the Cryo-Touch IV (iovera; Myoscience) was cleared for marketing by FDA through the 510(k) process (K123516). Predicate devices were the Cryo-Touch II (K102021) and CryoTouch III (K120415).
In 2014, the iovera system (Myoscience, Inc) received 510K clearance from the U.S. Food and Drug Administration (FDA). It is cleared to be used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by application of cold to selected site for blocking of pain. The iovera device is not indicated for the treatment of central nervous system tissue.
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% or more reduction in pain) to a diagnostic genicular nerve block."
Radiofrequency and Cryoneurolysis Devices:
Coding
See CPT/HCPCS section.
Thermal, Electrical, and Radiofrequency ablation are considered neurolytic agents by CPT.
CPT instructs that pulsed radiofrequency is reported with an unlisted code.
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Policy/ Coverage: |
Effective April 22, 2026
Thermal ablation of peripheral nerves and genicular artery embolization to treat pain (e.g., Plantar Fasciitis, Knee Pain, Sacroiliac Pain, and Other Conditions) is considered
not Medically Necessary and is not covered or is investigational
for any indication or circumstance. Not Medically Necessary or
investigational services are Plan exclusions.
Click the following link to view the InterQual® criteria:
https://prod.ds.interqual.com/service/connect/transparency?tid=27b0a724-ca06-4b22-846b-598b8dae52fc
Effective November 15, 2025 to April 21, 2026
Does Not Meet Primary Coverage Criteria Or Is Not Covered For Contracts Without Primary Coverage Criteria
Radiofrequency Ablation of Peripheral Nerves
Radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis, knee osteoarthritis, sacroiliac joint pain, occipital neuralgia, cervicogenic headache, and all other indications does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness.
For members with contracts without Primary Coverage Criteria, radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis, knee osteoarthritis, sacroiliac joint pain, occipital neuralgia, cervicogenic headache, and all other indications is considered Not Medically Necessary or is investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cryoablation or Cryoneurolysis of Peripheral Nerves
Cryoneurolysis of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness.
For members with contracts without Primary Coverage Criteria, cryoneurolysis of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache is considered Not Medically Necessary or is investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cryoablation or cryoneurolysis (e.g. focused cold therapy, Iovera cryoanalgesia/cryoneurolysis) of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness.
For members with contracts without Primary Coverage Criteria, cryoneurolysis (e.g. focused cold therapy, Iovera cryoanalgesia/cryoneurolysis) of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty is considered Not Medically Necessary or is investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Genicular Artery Embolization
Genicular artery embolization for the treatment of knee pain does not meet member benefit certificate Primary Coverage Criteria that there be scientific evidence of effectiveness.
For members with contracts without Primary Coverage Criteria, genicular artery embolization for the treatment of knee pain is considered Not Medically Necessary or is investigational and is not covered. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective September 2020 – November 14, 2025
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation of peripheral nerves to treat pain for all other indications (including but not limited to sacroiliac joint pain) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain for all other indications (including but not limited to sacroiliac joint pain) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation or cryoneurolysis of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation or cryoneurolysis of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cryoablation or cryoneurolysis (eg focused cold therapy, Iovera
® cryoanalgesia/cryoneurolysis) of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, cryoneurolysis (eg focused cold therapy, Iovera
® cryoanalgesia/cryoneurolysis) of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to September 2020
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation of peripheral nerves to treat pain for all other indications (including but not limited to sacroiliac joint pain) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain for all other indications (including but not limited to sacroiliac joint pain) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cryoablation or cryoneurolysis (eg focused cold therapy, Iovera ® cryoanalgesia/cryoneurolysis) of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, cryoneurolysis (eg focused cold therapy, Iovera ® cryoanalgesia/cryoneurolysis) of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to December 2019
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation of peripheral nerves to treat pain for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain for all other indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cryoablation or cryoneurolysis (eg focused cold therapy, Iovera ® cryoanalgesia/cryoneurolysis) of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, cryoneurolysis (eg focused cold therapy, Iovera ® cryoanalgesia/cryoneurolysis) of peripheral nerves to treat pain associated with knee osteoarthritis or total knee arthroplasty is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to September 2019
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation of peripheral nerves to treat pain for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain for all other indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with occipital neuralgia or cervicogenic headache is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cryoablation of peripheral nerves (eg. focused cold therapy) to treat pain associated with knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, cryoablation of peripheral nerves (eg. focused cold therapy) to treat pain associated with knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to April 2019
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation of peripheral nerves to treat pain for all other indications does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain for all other indications is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cryoablation of peripheral nerves (eg. focused cold therapy) to treat pain associated with knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, cryoablation of peripheral nerves (eg. focused cold therapy) to treat pain associated with knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to September 2018
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Cryoablation of peripheral nerves (eg. focused cold therapy) to treat pain associated with knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, cryoablation of peripheral nerves (eg. focused cold therapy) to treat pain associated with knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to July 2018
Radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation of peripheral nerves to treat pain associated with plantar fasciitis or knee osteoarthritis is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
This policy includes indications for heel pain due to plantar fasciitis and knee pain due to osteoarthritis (OA). Radiofrequency ablation (RFA) of other peripheral nerves is not addressed herein.
Because of the variable natural history of plantar fasciitis and knee OA and the subjective nature of the outcome measures, randomized controlled trials (RCTs) are needed to determine whether outcomes are improved with interventions for pain. Trials should include a homogenous population of patients with a defined clinical condition, use standardized outcome measures when possible, and define a priori the clinically significant magnitude of response.
The most clinically relevant outcome measures for pain treatments are measures of pain severity and functional limitations. Pain is a subjective, patient-reported measure. Therefore, pain outcomes require quantifiable pre- and post-treatment measures. Pain is most commonly measured with a visual analog scale (VAS). Quantifiable pre- and posttreatment measures of functional status are also used, such as 12-Item Short-Form Health Survey (SF-12) and SF-36.
Plantar Fasciitis
Several case series and 1 RCT were identified that evaluated RFA for treatment of chronic heel pain. In all studies, radiofrequency (RF) treatment used constant RF application with intent to ablate the nerve endings. Some studies used a specific pretreatment test to select subjects in whom pretrial testing was hypothesized to predict trial treatment success. For example, Erken et al performed trial injections of local anesthetic at a specific location (Erken, 2014).
Patients who responded were considered eligible for treatment. In a study by Cione et al, a sensory conduction threshold test was performed (Cione, 2009).
Patients with abnormal results were eligible for treatment. In some studies, the procedure required the patient to be conscious and respond to the sensation of electrical stimuli to locate the proper site for ablation. In other studies, the patient was under general anesthesia and the site for ablation was determined by other means.
Landsman et al reported the only randomized study of RFA (Landsman, 2013).
Seventeen patients were enrolled in a double-blind crossover trial, with crossover to the alternative treatment at 4 weeks. Patients must have failed at least 3 prior types of treatments, have had pain for more than 3 months, and rated pain at least 6 on a 0-to-10 VAS. The sham treatment consisted of all aspects of the actual RFA procedure, which included stimulation of sensory nerves in an awake patient, except for the delivery of RF energy at the final step. Outcomes assessed weekly were a pain VAS reported at the first step in the morning, average pain level, and peak pain level.
In a graphic presentation of results, patient pain levels for all 3 outcomes decreased after RFA but showed minimal change after sham. At 4 weeks, change in first-step pain was 5.00 in the RF group versus 1.33 in the sham group (p=0.30), change in average pain was 4.06 in the RF group versus 0.8 in the sham group (p=0.047), and change in peak pain was 5.33 in the RF group versus 1.80 in the sham group (p=0.048). After patients crossed over from sham to RFA, there was a steep drop in all pain outcomes. The maximum follow-up assessment was at 16 weeks and appears to show similar pain levels throughout the follow-up period.
The largest case series with the longest follow-up is by Cozzarelli et al. This study reported on 12-year follow-up of 82 patients who had undergone RFA for heel pain (Cozzarelli, 2010).
Patients had undergone RFA between 1994 and 1995 and had been interviewed at 5, 10, and 12 years postprocedure. Baseline pain levels before the procedure were recalled retrospectively at the time of the follow-up interviews. Of 99 patients potentially eligible to be interviewed, the study evaluated 82 patients. The results are presented without statistical testing. It appears that 73 of 82 patients reported being pain-free at 12 years. Of the pain-free patients, they rated their preprocedure pain at a mean of 7.1 on a 0-to-10 pain VAS.
Cione et al reported a retrospective case series of 75 patients treated with RFA (Cione, 2009).
Patients who underwent RFA between 2000 and 2003 were surveyed in 2004 to assess pre-procedure and current pain status. In this study, the actual number of treated patients is unknown, and pre-procedure pain status was assessed only at the follow-up survey. Median pre-procedure pain VAS was 9 (range, 2-10) and the postprocedure pain VAS was 1 (range, 0-8; p<0.001).
Erken et al reported on 2-year follow-up of 36 feet in 29 patients who underwent RFA for heel pain (Erken, 2014).
All patients had heel pain for at least 6 months and had failed at least 2 conservative treatments. Outcomes assessed included a pain VAS and the American Orthopedic Foot and Ankle Society Scale (AOFAS) scores assessed at baseline, 1 month, 1 year, and 2 years. Average VAS scores of patients were 9.2 before treatment, 1.2 at 1 month, 1.5 at 1 year, and 1.5 at 2 years. In addition, 85.7% of the patients rated their treatment as successful or very successful at 1- and 2-year follow-ups. Mean AOFAS scores (score range, 1-100) in 20 patients were 66.9 before treatment, 95.2 at 1 month, 93 at 1 year, and 93.3 at 2 years. Discomfort after the procedure in some patients resolved within 3 months.
Liden et al published a retrospective case series of 22 patients treated with RF nerve ablation (Liden, 2009).
Patients in this study had heel pain for at least 6 months and had failed at least 2 conservative treatments. The outcome measure used was a pain VAS. Mean pain VAS decreased from 8.12 to 3.26 1 week after treatment. At a mean follow-up duration of 8 months, pain VAS scores decreased to 1.5, 2.0, and 2.1 at 1 month, 3 months, and 6 months postprocedure. Adverse events noted were minor and transient in most cases. One adverse event was called persistent post-static dyskinesia, which probably represents nonresponse to treatment.
Section Summary: Plantar Fasciitis
Case series studies and 1 randomized, double-blind trial are consistent with improvement of pain after RFA of the sensory nerves for patients with heel pain due to plantar fasciitis. However, several case series have methodologic weaknesses. In 2 of the case series, all pain assessments were performed retrospectively, including pretreatment pain assessment. The single randomized trial enrolled few subjects and, due to crossover at 4 weeks, randomized comparisons only evaluate outcomes to 4 weeks. To be more confident in the efficacy of this treatment, further studies with larger samples and longer follow-up are necessary. The safety of the procedure cannot be fully evaluated in the small samples studied so far.
Knee Osteoarthritis
Four studies of RFA for knee OA pain were identified. Two studies were case series, 1 study was a non-randomized comparison to nerve block, and 1 study was a randomized double-blind trial. One of the case series used pulsed RF treatments to a broad area of the knee, and indicated that the procedure was nonablative. Treatment in this study should be considered different from treatment in the other studies. In the only RCT, Choi et al investigated RFA of the genicular nerve compared with a sham procedure in 38 patients with chronic knee pain who had not responded to other treatments (Choi, 2011).
Before randomization into the study, patients underwent diagnostic genicular nerve blocks with local anesthetic. If patients experienced a decrease in numeric pain scale scores of at least 50% for more than 24 hours, they underwent RFA or a sham procedure. Outcome measures included a pain VAS, Oxford Knee Score, and a global assessment. The Oxford Knee Score is scaled between 12 and 60, with 12 representing the best outcome. At 1, 4, and 12 weeks, pain scores in the RF group decreased from 78 to 40 (visual estimation). The control group decreased significantly at 1 week, but then returned to baseline at 4 and 12 weeks. Ten participants in the RF group achieved at least 50% reduction in knee pain at 12 weeks versus 0 in the control group. No participants reported any adverse events during the follow-up period.
Ikeuchi et al evaluated RFA compared to local nerve block in a nonrandomized study of patients with refractory anteromedial knee pain (Ikeuchi, 2011).
Based on date of treatment, patients received either RFA of the sensory nerves to the medial knee or a nerve block using local anesthetic. Outcome measures included the Western Ontario McMaster Universities Osteoarthritis index (WOMAC) score, pain VAS, and patient global assessment. WOMAC scores were lower in the RF group (worse function) throughout the trial including the baseline period, and showed no benefit of treatment. Pain VAS showed a group by time interaction consistent with a treatment benefit of RFA, but there was no statistically significant difference in pain VAS score at 6 months. There was no significant difference in patients’ global assessment (p=0.126). The only adverse effect mentioned was hypoesthesia, which occurred only in RF patients, and remitted within 2 to 6 weeks.
The 2 case studies identified were very small. In one, Bellini et al treated 9 patients with chronic knee pain using cooled RFA of the genicular nerve (Bellini, 2015).
Patients had previously not responded to physical therapy, analgesics, hyaluronic acid, or steroid injections. They were not candidates for invasive treatments due to comorbidities. Outcome measures included a pain VAS and WOMAC scores. VAS scores improved from a baseline mean of 8 to 2, 2.3, 2.1, and 2.2 at 1, 3, 6, and 12 months after treatment, respectively. WOMAC scores improved from a baseline mean of 88 to 20, 22, 21, and 20 at the same assessment intervals. All posttreatment means were statistically significant compared with baseline. No adverse effects of treatment were mentioned.
Vas et al used pulsed RF treatment to 10 patients with OA (Vas, 2014).
The authors stated that they considered their procedure nonablative, and given the type and field of treatment in this study, this treatment should be considered different from the others reviewed in this section. Treatment was applied to several nerves associated with knee sensation and motor function, including the saphenous, tibial, and common peroneal nerves. Mean WOMAC scores changed from 46 at baseline to 55 and 67 at 3 and 6 months, respectively. Pain scores during activity changed from 7.7 at baseline to 5.3 and 3.3 at 3 and 6 months, respectively. Patients underwent customized physical therapy program during the follow-up period in this study.
Section Summary: Knee Osteoarthritis
The evidence of RFA for knee pain consists of 2 case series, 1 nonrandomized comparison, and 1 RCT. Treatments given differ slightly across studies and may not be comparable. One study used cooled RFA, another study used pulsed RF to several nerves in the knee, and another study treated only nerves associated with anteromedial knee pain. The most rigorous study evaluated 38 patients and observed outcomes over a 12-week follow-up period. To be more confident in the efficacy of this treatment, further studies with large samples and longer follow-up are necessary. The safety of the procedure cannot be fully evaluated in the small samples studied so far.
Summary of Evidence
The evidence for radiofrequency ablation of peripheral nerves in individuals who have plantar fasciitis includes case series studies and 1 randomized controlled trial (RCT). Relevant outcomes include symptoms and functional outcomes. The case series generally have small sample sizes, and many have methodologic deficiencies such as retrospective assessment of pain. The single RCT evaluated only 17 patients, and randomized outcomes could only be assessed out to 4 weeks posttreatment. Although the studies report that radiofrequency ablation reduces heel pain, the quality of the evidence is poor. The evidence is insufficient to determine the effects of the technology on health outcomes.
The evidence for radiofrequency ablation of peripheral nerves in individuals who have knee osteoarthritis includes case series studies and 1 RCT. Relevant outcomes include symptoms and functional outcomes. The method of radiofrequency treatment varied between studies. Some case series showed improvement in symptoms with treatment. The single randomized trial had a small sample size of 38 and assessed outcomes out to 12 weeks. Although this trial showed improvement in pain at 12 weeks, these results are insufficient to draw conclusions about treatment efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.
Practice Guidelines and Position Statements
The American College of Foot and Ankle Surgeons issued a guideline on the treatment of heel pain in 2010 (Thomas, 2010).
Bipolar radiofrequency is listed as a third tier option for patients who have failed other treatments. It was given a grade C recommendation, meaning that this treatment option is supported by either conflicting or level IV (expert opinion) evidence.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through February 2018. No new literature was identified that would prompt a change in the coverage statement.
2019 Update
A literature search was conducted through September 2019. There was no new information identified that would prompt a change in the coverage statement.
2020 Update
Knee Osteoarthritis
Hunter et al reported 12 to 24-month follow-up of a subset of patients treated with RFA in the RCT by Davis et al (Hunter, 2020). There were 42 patients randomized to RFA and 41 randomized to the control group who crossed over to RFA at 6 months who qualified for follow-up at participating sites. Of the 83 potential participants, 15 had additional procedures (eg steroid injection, total knee arthroplasty, hyaluronic injection, repeat RFA) and were not included in the analysis, 35 (42.2%) could not be reached or declined to participate, and 33 (40%) consented for the study. Although 44% of patients who participated in follow-up maintained their improvement in pain scores, this was a small percentage of the patients who received treatment. Interpretation is limited due to the small number of patients and the potential for bias in this non-blinded study.
Chen et al reported another manufacturer-sponsored trial on cooled RFA for knee osteoarthritis (Chen, 2020). The investigators randomized 177 patients to RFA or a single injection of hyaluronic acid (Synvisc ONE). Although widely used, the efficacy of hyaluronic acid has not been supported by evidence (AAOS, 2020). Therefore, it might be considered a placebo treatment. Crossovers to RFA (n=68, 82.9%) were allowed at 6 months. A major limitation of this publication is that results were reported only for the 83% of control patients who crossed over; the authors noted that the remainder of the patients reported long-term pain relief from hyaluronic acid. An additional report of this trial is currently in press and may provide further detail to compare RFA and hyaluronic acid for patients with OA.
Occipital Neuralgia and Cervicogenic Headache
Kvarstein et al reported a double-blinded RCT of 52 patients who were treated with cryoneurolysis or injection of corticosteroid and local anesthetic in a tertiary pain clinic (Kvarstein, 2019).
The investigators noted a temporary benefit of both treatments for cervicogenic headache, but there was no additional benefit for the more invasive procedure. A possibility of adverse effects of repeated occipital cryoneurolysis were noted to include scar and neuroma formation and a risk of neuropathic pain.
Practice Guidelines and Position Statements
American College of Rheumatology and Arthritis Foundation
2019 Guidelines from the American College of Rheumatology and the Arthritis Foundation gave a conditional recommendation for radiofrequency ablation for the treatment of knee osteoarthritis (Kolasinski, 2020).
The recommendation was based on evidence of a potential analgesic benefit, but the studies used heterogeneous techniques and there was a lack of long-term safety data.
Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed below:
Ongoing
NCC03381248
A Prospective, Multi-center, Randomized, Clinical Trial Evaluating the Safety and Effectiveness of Using COOLIEF™ Cooled Radiofrequency Probe to Create Lesions of the Genicular Nerves and Comparing a Single Injection of Hyaluronic Acid in the Management of Knee Pain
Planned Enrollment: 177 Completion Date: Aug 2020
NCT03818022
Effectiveness of Preoperative Cryoneurolysis (Iovera) for Postoperative Pain Control in Total Knee Arthroplasty
Planned Enrollment: 100 Completion Date: Dec 2020
NCT02915120
Ultrasound-Guided Pulsed Radiofrequency Of The Genicular Nerves In The Treatment Of Patients With Osteoarthritis Knee Pain: Randomized, Double-Blind, Placebo-Controlled Trial
Planned Enrollment: 142 Completion Date: Dec 2020
NCT03774121
Cryoneurolysis for the Management of Chronic Pain in Patients With Knee Osteoarthritis; A Randomized Controlled Study
Planned Enrollment: 90 Completion Date: Dec 2021
NCT04145011
A Prospective, Multi-center, Randomized, Single Blind Clinical Trial Comparing COOLIEF* Cooled Radiofrequency to Conventional Radiofrequency Ablation of the Genicular Nerves in the Management of Knee Pain in an Osteoarthritic Patient Population
Planned Enrollment: 148 Completion Date: Jun 2022
Unpublished
NCT02260869
Efficacy of Cooled and Monopolar Radiofrequency Ablation of the Geniculate Nerves for the Treatment of Chronic Osteoarthritic Knee Pain
Planned Enrollment: 78 Completion Date: Jun 2019 (Completed)
NCT03628482
A Randomized Controlled Study to Compare Efficacy of Continuous Versus Pulsed Radiofrequency Treatment of Genicular Nerves to Alleviate Pain and Improve Functional Impairment in Patients With Advanced Osteoarthritis of the Knee
Planned Enrollment: 188 Completion Date: Aug 2019
NCT02925442
Comparison Between Cooled (C-RFA) and Standard (t-RFA) Radiofrequency Ablation, and Control for Pain Management Following Unilateral Knee Arthroplasty: A Double-Blinded, Parallel-Grouped, Placebo- Controlled Randomized Clinical Trial
Planned Enrollment: 150 Completion Date: Feb 2020
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Chen et al conducted a systematic review of RFA for the treatment of knee OA (Chen, 2021). The authors (including several affiliated with the American Academy of Orthopaedic Surgeons) identified 7 RCTs published through 2019 that met inclusion criteria. Quality of the studies was assessed based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology for risk of bias of randomization, allocation concealment, blinding, incomplete data, selective reporting, and other bias. Five of the trials were rated as high quality despite lack of blinding in most and moderate risk of bias for allocation concealment and other bias (Choi, 2011; Sari, 2018; Ray, 2018; Davis, 2018; El-Hakeim, 2018). Two were rated as moderate quality (Shen, 2017; Xiao, 2018). A majority of the studies were conducted outside of the U.S., with a number of participants ranging from 24 to 151. Techniques included RFA and cooled RFA. RFA was compared to non-treated controls or sham procedures, intra-articular corticosteroids, or hyaluronic acid. There was high heterogeneity due to the variability in comparators and outcome measures that limited meta-analysis, but analysis of the mean differences for the individual studies showed general agreement that RFA had a benefit on pain, function, and composite scores compared to the control treatments at 3 and 6 month follow-up.
An independent study by Elawamy et al compared pulsed radiofrequency to a single injection of platelet-rich plasma in 200 patients with OA (NCT03886142) (Elawamy, 2021). VAS scores showed an improvement of 50% (from a score of 6 to 3) in both groups at 3 months, with values returning to a score of 5 by the sixth month. Scores on the Index of Severity for OA of the Knee were reduced from 7 at baseline to 4 at the third month, increasing to 5 at the sixth month. Twelve-month scores were not reported. Platelet-rich plasma is not considered a standard of care treatment for OA and there were a number of additional limitations in conduct and reporting of this study. Overall, the available studies have methodological limitations and the number of patients studied for this common condition is low.
In 2021, the Spine Intervention Society's Patient Safety Committee published an article on the safety of genicular nerve RFA (McCormick, 2021). The committee reviewed case reports of septic arthritis, pes anserine tendon injury, third-degree skin burn, and clinically significant hematoma and/or hemarthrosis with RFA of the genicular nerves, concluding that larger cohort studies are needed to determine the incidence of these complications for this emerging technology.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Kurtoglu et al reported the largest case series of standard RFA for plantar fasciitis (Kurtoglu, 2022). The retrospective study, conducted in Turkey, included 261 individuals with plantar heel pain for at least 6 months and at least 2 failed conservative treatments. Mean VAS (scale 0-10) was 8 (range 8-9) at baseline and 0 (range 0-7) at the final mean follow-up of 15 months (p<.001). At follow-up, 16 (6.1%) individuals felt the RFA procedure was unsuccessful.
The American Society of Pain and Neuroscience issued consensus guidelines using U.S. Preventive Services Task Force (USPSTF) grading criteria on the use of RFA to treat various pain conditions (Lee, 2021). The guidelines stated that genicular RFA may be used for the treatment of osteoarthritis-related and post-surgical knee joint pain (Grade B), and may be selectively offered for the treatment of occipital neuralgia pain when greater or lesser nerves have been identified as the etiology of pain via diagnostic blocks (Grade C).
2023 Update
An RCT with 180 individuals has compared cryoneurolysis with sham treatment in individuals who had knee OA. Cryoneurolysis resulted in a greater decrease in WOMAC pain, WOMAC total, and VAS score at 30 days compared with sham-treated controls. Subsequent measurements showed no significant benefit of cryoneurolysis on WOMAC score at 60 days or in VAS scores at 60 or 90 days. 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 yet to be resolved (Radnovich, 2017).
Additional 2023 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Liu et al performed a systematic review of RFA, pulsed RF, C-RFA, and RF thermocoagulation to either the genicular nerve or intra-articular nerves in patients with knee OA (Liu, 2022). The authors identified 15 RCTs which met their inclusion criteria. This assessment concluded that all studies had a low risk of bias for random sequence generation, 12 (80%) had a low risk of bias for allocation concealment, 6 (40%) had a low risk of bias for blinding of participants, and personnel as well as blinding of outcome assessment. A low risk of selective reporting was identified in 12 (80%) studies, and all studies were reported as having a low risk of other biases. No overall assessment of study quality was provided. The authors reported a mean pain score difference in favor of the radiofrequency group over the control group at 1 to 2 weeks (-1.72; 95% confidence interval [CI], -2.14 to -1.30), 4 weeks (-1.49; 95% CI, -1.76 to -1.21), 12 weeks (-1.83; 95% CI, -2.39 to -1.26), and 24 weeks (-1.96; 95% CI, -2.89 to -1.04); however, all these estimates had significant heterogeneity ranging from 66% to 97% (p<.00001). A subgroup analysis limiting the site of radiotherapy to the genicular nerve included 5 trials and found a weighted mean difference between RF and control of -1.64 (95% CI, -2.19 to -1.09; p<.001) with a high level of heterogeneity (I2, 84%; p<.001) at 1 to 2 weeks post-treatment. The mean difference in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores also favored the radiofrequency group over control groups at 4 weeks (-10.64; 95% CI, -13.11 to -8.17), 12 weeks (-6.12; 95% CI, -7.67 to -4.57), and 24 weeks (-10.89; 95% CI, -12.28 to -9.51). No significant heterogeneity was observed in the 4 and 12 week WOMAC score pooled estimates, but the evidence was limited to being pooled from 4 trials. The rate of adverse events appeared equivalent between groups when observed when pooling data from 13 RCTs (risk difference, 0.03; 95% CI, -0.01 to 0.06; p=.14) with no significant heterogeneity.
Wu et al conducted a systematic review and network meta-analysis of multiple RFA modalities versus other treatments for osteoarthritis (OA) with a focus on short-term clinical outcomes through 6 months post-treatment (Wu, 2022). Twenty-one RCTs were identified that were eligible for inclusion. The evidence base consisted of 1818 individuals with a range of 24 to 260 participants across the included RCTs. Outcomes of interest included VAS Pain and WOMAC function scores as well as adverse events. The authors found that C-RFA has better efficacy for pain and function than conventional or pulsed modalities and that conventional RFA outperforms pulsed RFA. Visual analog scale (VAS) pain scores were reported in 16 studies at 3 months follow-up (n=1401). All interventions, with the exception of exercise, had significant improvement compared with placebo. In a ranked surface under the cumulative ranking curve (SUCRA) analysis, monopolar C-RFA of the genicular nerve ranked first in analgesia performance, followed by conventional monopolar RFA of the genicular nerve, intraarticular platelet-rich plasma injection (IAPRP), pulsed monopolar RFA of the genicular nerve, intraarticular anesthesia injection (IAA), intraarticular dextrose injection (IAD), intraarticular sodium hyaluronate injection (IAHA), pulsed monopolar RFA of the saphenous nerve, intraarticular corticosteroid injection, nonsteroidal anti-inflammatory drugs (NSAIDs). At 6 months, 10 trials reported on 1,021 individuals for VAS pain outcomes. All treatments, save NSAIDs, had a significantly decreased VAS score compared with exercise at 6 months follow-up. A SUCRA analysis showed that the best-performing intervention was conventional bipolar RFA of the genicular nerves (MD, -5.5; 95% CI, -4.3 to -6.7) followed by conventional monopolar RFA of the genicular nerves, pulsed monopolar intraarticular RFA, pulsed monopolar RFA of the genicular nerve, IACS, IAHA, IAPRP, and NSAIDs. WOMAC scores were reported in 14 studies (n=1091) at 3 months and by 9 studies (n=821) at 6 months follow-up. At 3 months, except for exercise, NSAIDs, and pulsed monopolar IPRFA, all treatments had a significant reduction in WOMAC scores compared to placebo. SUCRA analysis suggested the first rank intervention for improved knee performance at 3 months follow-up was cooled monopolar RFA of the genicular nerve followed by conventional bipolar RFA of the genicular nerve, pulsed monopolar intraarticular RFA, conventional monopolar RFA of the genicular nerve, pulsed monopolar intraarticular RFA plus IAPRP, IAA, pulsed monopolar RFA of the genicular nerves, pulsed monopolar IPRFA, IAS, and IAHHA. All interventions had a significant improvement in WOMAC scores at 6 months compared to exercise. SUCRA analysis showed the best performance for cooled monopolar RFA of the genicular nerve followed by conventional bipolar RFA of the genicular nerve, conventional monopolar RFA of the genicular nerve, pulsed monopolar RFA of the genicular nerve, IACS, IAHA, NSAIDs and exercise. The authors also reported that adverse events were recorded in 6 RCTs (n=836) and found 43 (8.3%) in the RFA groups, which were likely attributable to RFA; major adverse events included: pain (n=5), post-procedural pain (n=7), fall (n=5), stiffness (n=1) and swelling (n=2).
Lyman et al published an extension study to assess long-term outcomes through 24 months for participants in this trial who received RFA (Lyman, 2022). Of the initial 66 RFA patients who had 12 months follow-up, 36 signed the informed consent to participate in the extension study. Thirty-two of these participants completed 18 month follow-up and 27 completed 24 month follow-up; the primary reason for loss to follow-up was receiving another knee procedure. At baseline, the participants had a mean NRS of 6.8±0.8 which was reduced to 2.4 ± 2.5 (64% reduction) at 18 months and 3.4 ± 3.2 (51% reduction) at 24 months; a
≥ 50% improvement in NRS pain scores was experienced by 22 (69%) of patients at 18 and 17 (63%) at 24 months. Mean WOMAC scores at baseline for these participants were 64.4 ± 14.7, which were reduced by a mean of 34.7±27.5 (54%; p<0.0001 versus BL) and 24.8±32.8 (35%; p<0.0007) at 18 and 24 months respectively. No serious or non-serious adverse events related to cooled RFA were reported by the authors at 18 or 24 months post-treatment.
A single-center, double-blind RCT by Malaithong et al compared bipolar radiofrequency to a sham RFA procedure using low-level sensory stimulation in 64 individuals with OA (Thailand Clinical Trial Registration 20170130003) (Malaithong, 2022). Both treatment groups received genticular nerve blocks prior to RFA or sham procedure. The bipolar RFA and sham RFA treatment arms experienced significant improvements in pain at 12 months from baseline, but no differences between groups were observed. Similar findings were observed for WOMAC scores through 12 months follow-up as well as the Patient Global Improvement Index. Interpretation of this study is limited due to the small number of individuals enrolled.
Kapural et al reported a retrospective assessment of pain relief in 340 consecutive patients with chronic knee pain at a single center who were treated with either C-RFA (n=170) or conventional RFA (n=170) (Kapural, 2022). The mean age at treatment was 63 years in the C-RFA group and 61 years in the conventional RFA group; both treatment groups had similar levels of baseline VAS pain reported prior to nerve block (8.4 in the C-RFA group and 8.3 in the traditional RFA group). Included patients had at least one year of follow-up after treatment and were evaluated on short-term and long-term pain outcomes on the VAS and opioid use. The authors reported that at the first follow-up, approximately 4 to 6 weeks post-treatment, individuals in the C-RFA group had superior pain reduction on the VAS when compared to traditional RFA as well as significantly longer durability of pain relief. This reduction in pain, however, did not translate into a reduction in the usage of opioids from baseline which showed no significant differences in either treatment arm.
Mihalko et al reported a non-blinded single-center RCT of cryoneurolysis for individuals with OA planning to undergo TKA (Mihalko, 2021). Patients were randomized 1:1 to either cryoneurolysis targeting the superficial genicular nerves or standard of care treatment prior to receiving TKA. A significant reduction in the primary outcome of opioid consumption was not reported in the intention to treat (ITT) analysis, but PP analysis found that patients in the cryoneurolysis group had significantly lower opioid consumption 72 hours, 6 weeks, and 12 weeks post-discharge (p<.05). A significant reduction in pain from baseline was reported at 12 weeks post-discharge but not for earlier evaluated time points when analyzing the PP population. Improvements in the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) were noted from 72 hours to 12 weeks follow-up in the PP analysis (p<.0001). The authors noted an adverse event rate of 17% in the cryoneurolysis group and 35% in the standard of care comparator.
Lung et al reported a retrospective study of pain relief in 57 individuals with OA and chronic knee pain planning to undergo TKA at a single center who were treated with either cryoneurolysis of the anterior femoral cutaneous nerve (AFCN) or infrapatellar branch of the saphenous nerve (ISN) or conventional TKA without cryoneurolysis (Lung, 2022). Included patients had at least 1 year of follow-up after treatment and were assessed for the primary outcome of total opioid morphine milligram equivalents (MME) at 6 weeks post-treatment as well as VAS pain, knee injury and osteoarthritis scores (KOOS JR), and short form survey (SF12) outcome measures. No significant between group differences were found for the outcome of mean total MME during the inpatient stay or follow-up visits at 4 and 6 weeks post-treatment (p>.05). KOOS scores at 12 months follow-up (p=.007) favored the cryoneurolysis group over standard TKA controls, as did SF-12 mental scores (p=.01). However, between-group comparisons on these outcomes at other time points as well as SF12 physician scores and VAS pain at all time points reported, failed to reach significance. Complications were rare and appeared equivalent between groups.
A meta-analysis published by Guimaraes et al reviewed multiple therapeutic interventions to relieve pain from plantar fasciitis (Guimaraes, 2023). A total of 8 studies of RFA were identified, but only 2 RCTs were included in the pooled analysis of RFA compared to a control group (n=117). The authors performed a dual assessment of the risk of bias of the included studies using the Cochrane Risk of Bias tool and found a low quality of evidence for RFA to relieve pain from plantar fasciitis. The pooled mean difference between groups for pain outcomes was -1.19 (95% CI, -3.54 to 1.15; p=.32), favoring the RFA group, but this estimate did not achieve statistical significance and had a high level of heterogeneity (I2, 84%).
Two double-blind sham-controlled randomized trials have assessed RFA for the treatment of chronic heel pain. Wu et al randomized 36 individuals to ultrasound-guided pulsed radiofrequency of the posterior tibial nerve (Wu, 2017). First step pain, average pain, and the AOFAS ankle-hindfoot score were assessed at baseline and at 1, 4, 8, and 12 weeks. Changes in VAS score in the sham group were modest (<1 on a 10-point VAS) and of short duration (statistically significant at weeks 1 and 4 but not weeks 8 and 12). The AOFAS ankle-hindfoot score was 60.55 at baseline and 60.05 at 12 weeks in the sham group. In the RFA group, VAS scores at weeks 1, 4, 8, and 12 were all significantly lower than baseline (p<.001), and the AOFAS ankle-hindfoot score increased from 55.5 to 87.6 (p<.001). The improvements in pain and function were greater in the RFA group than in the control group (p<.001 for all measures).
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2024. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A single-center, double-blind RCT by Ma et al compared RFA to usual care in patients over 50 years of age with moderate to severe knee OA (Ma, 2024). A total of 112 patients were randomized. Mean NRS scores were lower among patients in the RFA group at the 6-month follow-up (2.25 vs. 4.53; p<.01) as were worst NRS scores (3.27 vs. 5.42; p<0.01). WOMAC scores for pain and physical function were lower in patients receiving RFA; however, stiffness scores were similar between groups.
Mont et al evaluated the Innovations in Genicular Outcomes Registry (iGOR) for outcomes associated with preoperative cryoneurolysis prior to TKA (Mont, 2024). A total of 80 individuals who had received preoperative cryoneurolysis and 60 who had not were identified from 2021 to 2024. Results include:
2025 Update
Genicular Artery Embolization
Little et al reported 2-year follow-up results from a prospective pilot study evaluating genicular artery embolization in individuals with osteoarthritis of the knee (GENESIS) (Little, 2024). Forty-six patients (median age of 60) were treated with genicular artery embolization, 6 of which were not able to be embolized. Assessments were performed at baseline, 6 weeks, 3 months, and 1 year using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analogue Scale (VAS) (0-100 mm). Mean VAS improved from 58.63 at baselines to 37.7 at 2-years. KOOS were improved at each timepoint with associated reductions in analgesia use.28 participants completed the 2-year follow-up. Nine participants underwent knee replacement surgery. Adverse events included self-limiting skin discoloration (4 participants, self-limiting groin hematoma (1 participant), and deep-vein thrombosis due to immobilization (1 participant). The authors concluded that GAE using permanent microspheres is a safe intervention for mild-moderate knee OA with sustained efficacy at 2 years. The authors also recognized that the study was limited by a relatively small sample size and a lack of an experimental control group. Further controlled trials are needed to assess the placebo effect with GAE, optimal embolic materials, and identify the ideal patient population for GAE.
Bagla et al reported the results of a multicenter, single-blinded randomized trial which evaluated genicular artery embolization compared to a sham procedure for individuals with knee osteoarthritis (Bagla, 2022). 21 participants were enrolled with 14 randomized to receive genicular artery embolization and 7 randomized to sham. If after 1 month of treatment, a participant in the sham group reported less than minimal improvement in WOMAC and VAS measurements, they were allowed to crossover to treatment. At the 1-month follow-up time, none of the participants in the sham group demonstrated minimal clinically relevant improvement and all opted to undergo genicular artery embolization. There was a statistically significantly greater pain reduction in the treatment group than in the sham group at 1 month. Disability improvement was also significantly greater in the treatment group. Only minor adverse events were reported. Five subjects were excluded after increased analgesic use. Sensitivity analysis with all excluded patients confirmed significant improvements at 1 and 12 months. The study did not compare GAE to conservative treatments used for osteoarthritic knee pain.
Cusumano et al reported 2-year safety and effectiveness outcomes of a single-center, single-arm, prospective investigational device exemption (IDE) trial studying genicular artery embolization for treatment of symptomatic knee osteoarthritis (Cusumano, 2024). 40 patients were initially included in the study, and 2 patients were lost to follow-up. Primary endpoint was treatment effectiveness measured by WOMAC scores. Treatment success was defined as a 50% or more decrease in WOMAC relative to baseline. At 12 months, 27/40 participants (67.5%) were reported to have clinical success. At the 24-month assessment, 38 participants were available for analysis of which 47.4% reported 50% or more reduction in WOMAC scores. Adverse events occurred in the first 12 months following treatment and included groin hematoma (n=1), self-resolving focal skin ulceration (n=7) and asymptomatic small bone infarct on MRI (n=2). Seven of 25 (28.0%) patients had symptom recurrence between 12 and 24 months and were determined to be clinical failures. All treatment-related adverse events occurred within 12 months after GAE, without additional events after 12 months.
Epelboym et al published the results of a systematic review of GAE as a treatment of OA-related knee pain (Epelboym, 2023). The researchers used Embase, PubMed, and Web of Science to identify studies evaluating treatment of knee OA with GAE. Primary outcome measure was change in pain scale score at 6 months. 10 studies met inclusion criteria with a total of 351 treated knees included. Patients who underwent GAE demonstrated declines in VAS pain scores at 1 month, 3 months, 6 months, and 12 months.
October 2025 Update
Annual policy review completed with a literature search using the MEDLINE database through September 2025. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Taslakian et al reported on a systematic review and meta-analysis for genicular artery embolization (Taslakian, 2023). Review consisted of 10 groups with 9 studies, 270 patients, and 339 knees. Genicular Artery Embolization’s technical success was 99.7%. Over 12 months, the WMD ranged from -34 to -39 at each follow-up for VAS score [VAS score was
−37 (95% CI:
−44 to
−30) at 1 month (8 cohorts),
−34 (95% CI:
−41 to
−27) at 3 months (7 cohorts),
−39 (95% CI:
−48 to
−30) at 6 months (6 cohorts), and
−36 (95% CI:
−51 to
−22) at 12 months (5 cohorts)] and -28 to -34 for WOMAC [−28 (95% CI:
−34 to
−21) at 1 month (5 cohorts),
−29 (95% CI:
−31 to
−27) at 3 months (4 cohorts),
−30 (95% CI:
−34 to
−26) at 6 months (4 cohorts), and
−34 (95% CI:
−39 to
−30) at 12 months (2 cohorts)] Total score (all p less than 0.001). At 12 months, 78% met the MCID for VAS score; 92% met the MCID for WOMAC Total score, and 78% met the SCB for WOMAC Total score. Higher baseline knee pain severity was associated with greater improvements in knee pain. Over 2 years, 5.2% of patients underwent total knee replacement and 8.3% received repeat GAE. Adverse events were minor, with transient skin discoloration as the most common (11.6%). The limited evidence suggests that GAE is a safe procedure with improvement in knee OA. However, further studies are needed.
A study reported by Landers et al investigated the effects of transcatheter arterial embolization (TAE) on pain, function, and quality of life in people with early-stage symptomatic knee osteoarthritis (OA) compared to a sham procedure (Landers, 2023). 59 individuals with symptomatic Kellgren-Lawrence grade 2 knee OA participated. They were randomly allocated to TAE or a sham procedure. The intervention group underwent TAE of one or more genicular arteries. The control group received a blinded sham procedure. The primary outcome was knee pain at 12 months according to the Knee injury and Osteoarthritis Outcome Score (KOOS) pain scale. Secondary outcomes included self-reported function and quality of life (KOOS, EuroQol five-dimension five-level questionnaire (EQ-5D-5L)), self-reported Global Change, six-minute walk test, 30-second chair stand test, and adverse events. Subgroup analyses compared participants who received complete embolization of all genicular arteries (as distinct from embolization of some arteries) (n = 17) with the control group (n = 29) for KOOS and Global Change scores at 12 months. Continuous variables were analyzed with quantile regression, adjusting for baseline scores. Dichotomized variables were analyzed with chi-squared tests. Overall, 58 participants provided questionnaire data at 12 months. No significant differences were found for the primary and secondary outcomes, with both groups improving following the procedure. At 12 months, KOOS pain scores improved by 41.3% and 29.4% in the intervention and control groups, respectively. No adverse events occurred. Subgroup analysis indicated that the complete embolization group had significantly better KOOS Sports and Recreation, KOOS Quality of Life, and Global Change scores than the control group; 76.5% of participants who received complete embolization reported being moderately or much better compared to 37.9% of the control group. TAE might produce benefits above placebo, but only when complete embolization of all genicular arteries is performed. Further comparative studies are required before definitive conclusions regarding the effectiveness of TAE can be made.
A search of PubMed, EMBASE, Scopus, and Web of Science was conducted through March 2025 (Milhelm, 2025). Sham-controlled RCTs with adult participants with symptomatic knee osteoarthritis were included. The 3 studies had a total of 138 participants. Based on the research “GAE demonstrated short-term pain reduction, particularly in VAS scores, with one trial showing a significant improvement at 1 month (-50.8 vs -0.5). KOOS pain scores improved modestly across studies but lacked statistical significance. Functional outcomes were mixed; one trial reported significant improvement in WOMAC function, and another found enhanced quality of life in patients undergoing complete embolization. No serious adverse events occurred; minor complications such as catheter-site bruising were infrequent and self-limited.” It was concluded that “GAE appears to be a safe and minimally invasive treatment that may provide short-term symptomatic relief in select KOA patients. However, limited sample sizes, methodological variability, and short follow-up periods constrain definitive conclusions. Larger, standardized trials with longer follow-up are necessary to confirm efficacy and optimize patient selection.”
A study to determine efficacy of GAE compared with sham GAE for pain reduction was conducted on 58 adult participants with mild to moderate knee osteoarthritis who were not improving with conservative treatment (Tijmen, 2024). This was a double-blind randomized sham controlled trial that took place between June 2019 – December 2021. The main outcome was reduction of pain measured with the Knee Injury and Osteoarthritis Outcome Score pain subscale (0-100, with 0 representing the worst pain outcome and 100 the best) after 4 months. Results “From June 2019 to December 2021, 58 patients were included. 29 patients were randomised to the GAE group and 29 to the sham group. All participants completed the study. The mean pain reduction after 4 months was 21.4 (95% CI 13.9 to 28.8) for the GAE group and 18.4 points (95% CI 11.6 to 25.1) for the sham group. The between-group difference for the mean pain reduction was 3.0 (95% CI -7.1 to 13.0) with an estimated Cohen's d effect size of d = 0.15 (95% CI -0.37 to 0.66). Group allocation was not a significant contributor to pain reduction (p = 0.31). No serious adverse events (AEs) occurred. 23 mild AEs occurred in the GAE group and 5 in the sham group.” Authors concluded “We did not establish a clinical effect of GAE in patients with mild-to-moderate KOA as GAE produced a similar effect on pain reduction as a sham GAE procedure.”
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| References: |
American Academy of Orthopaedic Surgeons.(2013) Treatment of Osteoarthritis of the Knee: Evidence-based Guideline 2nd edition. 2013 https://www.aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-knee/osteoarthritis-of-the-knee-2ndeditiion- clinical-practice-guideline.pdf. Accessed July 28, 2020.
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