Medical Policy: 07.01.73 

Original Effective Date: January 2017 

Reviewed: January 2018 

Revised: January 2018 

 

Benefit Application:

Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

 

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.

 

Description:

Ablative procedures such as radiofrequency ablation, cryoneurolysis and chemical neurolysis of the nerves has been proposed as a treatment for several different types of pain. It has been used to treat a number of pain syndromes such as trigeminal neuralgia, cervical and lumbar facet joint pain and headache syndromes. This medical policy evaluates the evidence for ablative procedures to include radiofrequency ablation, cryoneurolysis and chemical neurolysis in peripheral sites distant from the cranium or spine. See also medical policies: 07.01.66 Ablative Treatments of Occipital Neuralgia, Chronic Headaches and Atypical Facial Pain; 07.01.41 Pulsed Radiofrequency; 07.01.58 Facet Joint Denervation.

 

Ablative procedures including radiofrequency ablation (RFA), cooled radiofrequency, pulsed radiofrequency, cryoneurolysis (cryoablation, cryotherapy, cryoanalgesia) and chemical neurolysis (chemodenervation) have been proposed as a treatment of the peripheral nerves to treat pain related to conditions including but not limited to the following: osteoarthritis, neuralgias/neuritis (intercostal neuralgia, inguinal neuralgia), peripheral neuromas and plantar fasciitis, for individuals that have not been effectively managed by pharmacologic or other alternative therapies.

 

Ablative Procedures

  • Radiofrequency ablation (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 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 (80 to 85°C). It is theorized that the thermal lesioning of the nerve destroys peripheral sensory nerve endings, resulting in the alleviation of pain. However, the results are typically not permanent as the nerves may regenerate which can cause the pain to return and may require the repetition of the RFA procedure to alleviate the pain.
  • Cooled radiofrequency is a newer technology that is a variation of conventional (standard) radiofrequency using a special device that uses a water cooled radiofrequency probe to ablate a larger lesion size and treat a larger area than standard RFA technology. Cooled radiofrequency applies more energy at the desired location without excessive heat diffusing beyond the area, causing less tissue injury away from the nerve. The goal for ablating the nerve is the same.
    • COOLIEF Cooled RF (radiofrequency) treatment (Haylard Health, Inc.) is a minimally invasive outpatient procedure that uses cooled radiofrequency energy to target the sensory nerves causing pain. COOLIEF circulates water through the device while heating nervous tissue to create a treatment area that is larger than conventional RF treatments. This combination targets the pain causing nerves without excessive heating, leading to pain relief. The procedure time varies depending on the treatment needed, the actual radiofrequency treatment time typically is less than 20 minutes. COOLIEF RF treatment is used in the treatment of hip and knee pain associated with osteoarthritis.
  • Pulsed radiofrequency treatment uses short bursts of radiofrequency current (temperature will not exceed 42°C), rather than continuous current (RFA). The mechanism for action of pulsed radiofrequency treatment is uncertain, but it is thought the heat is not enough to cause tissue coagulation or permanent damage to the nerve. If it does produce some degree of nerve destruction, it is thought to cause less damage than conventional (standard) RFA. Pulsed radiofrequency has been proposed as a possibly safer alternative to non-pulsed or continuous RFA in the treatment of variety pain syndromes.
  • Cryoneurolysis, also called cryoablation, cryotherapy or cryoanalgesia uses freezing temperatures to treat chronic pain of either sensory or motor nerves and uses a wide range of temperatures with treatment often occurring at temperature as cold as -196°C (liquid nitrogen coolant) or -20 to -140°C or colder (nitrous oxide coolant). Because peripheral nerve function is disrupted due to the destruction of the axon and myelin seath, the desired result provides pain relief until the nerve(s) regenerate. Cryodenervation has been used for patients with various types of pain including but not limited to post-herpatic neuralgia, intercostal pain, neuroma, and osteoarthritis.
    • The ioverao system (Myoscience, Inc) is a handheld device that delivers a controlled dosage of liquid nitrous oxide to the closed-end probes of the smart tip, which is then applied to specific targeted nerves. As this highly pressurized liquid travels from the handheld piece to the smart tip, it undergoes a phase change becoming very cold, drawing in heat energy from the surrounding tissue and forming a precise zone of cold at the targeted nerve. The gaseous nitrous oxide returns into the hand piece, leaving nothing behind in the body. This precise cold treatment causes a reversible nerve block based on a process called Wallerian degeneration. Pain is relieved as the signal is not able to conduct along the sensory nerves until the axon is regenerated. The nerve axon regenerates at the rate of about 1 mm per day, which provides a predictable indicator for restoration of nerve function.
  • Chemical Neurolysis (chemodenervation) is the use of a chemical using phenol, alcohol, glycerol or a hypertonic saline to cause destruction of nerve(s) by causing a temporary degeneration of the nerve(s) fibers to interrupt the transmission of nerve(s) signals for pain relief.

 

Osteoarthritis of the Knee

Osteoarthritis of the knee is a common cause of joint pain and disability. The treatment of osteoarthritis (OA) is directed towards reduction of symptoms 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), nutritional supplements (glucosamine, chondroitin); corticosteroid injections; and intra-articular viscosupplements. Operative treatments for symptomatic OA of the knee include arthroscopic lavage and cartilage debridement, osteotomy, and ultimately a total joint arthroplasty.

 

When an individual exhibits knee pain, the pain signals can be generated from the peripheral nerves innervating the knee including several branches of the genicular nerve, an ablative procedure to include radiofrequency ablation, cryoneurolysis and chemical neurolysis of the genicular nerves may be performed to restore function and alleviate knee pain as an alternative therapy.  Surgical treatment may not be an option for patients with multiple comorbidities, these ablative procedures have been proposed as an alternative for the treatment of chronic pain.

 

Radiofrequency Ablation

Based on review of the peer reviewed medical literature in regards to radiofrequency ablation (conventional RFA, pulsed radiofrequency or cooled radiofrequency) for the treatment of knee osteoarthritis, it includes seventeen total publications to include 5 small sized randomized controlled trials, although one involved diathermy radiofrequency ablation, 8 retrospective or prospective case series and 4 case reports. The literature also included a systematic review.

 

Choi et. al. (2011) investigated radiofrequency ablation (RFA) of the genicular nerve compared with sham procedure in 38 elderly patients with severe knee osteoarthritis pain lasting more than 3 months, and no response to conservative treatments. 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. VAS scores showed that the RF group had less knee joint pain at 4 (p<0.001) and 12 (p<0.001) weeks compared with the control group. Oxford Knee Scores showed similar findings (p<0.001). In the radiofrequency group 10/17 (59%), 11/17 (65%) and10/17 (59%) achieved at least 50% knee pain relief at 1,4 and 12 weeks, respectively. No patient reported a post-procedure adverse event during the follow-up period. The authors concluded RF neurotomy of genicular nerves leads to significant pain reduction and functional improvement in a subset of elderly chronic knee OA pain, and may be an effective treatment in such cases. However, further trials with large sample size and longer follow-up are warranted.

 

Ikeuchi et. al. (2011) evaluated radiofrequency ablation (RFA) compared with local nerve block in a nonrandomized, open label and controlled study of patients complaining of refractory anteromedial knee pain associated with radiological osteoarthritis (moderate or severe) were included. They were assigned to one of two groups: those receiving radiofrequency thermocoagulation (N=18) or those receiving nerve block (N=17), depending on the time period that they were referred to the clinic. Radiofrequency current or local anesthetics was applied to the medial retinacular nerve and the infrapatellar branch of the saphenous nerve. Western Ontario McMaster Universities Osteoarthritis Index Score, pain visual analog scale (VAS), and patient’s global assessment were assessed with minimum follow-up of 6 months. The Western Ontario McMaster Universities Osteoarthritis Index Score were lower in the RF group (worse function) throughout the trial including the baseline period, and showed no benefit of treatment. Pain VAS score 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 patient’s global assessment (p=0.126). The only adverse effect mentioned was hypesthesia, which occurred only in RF patients, and remitted within two to six weeks. The authors concluded some patients were able to benefit from radiofrequency treatment, even if its effective period is limited. Radiofrequency application is a promising treatment to alleviate refractory anteromedial knee pain with osteoarthritis. Further experience and technical improvements are needed to establish its role in the management of knee osteoarthritis.

 

Bellini et. al. (2015) treated 9 patients using cooled RFA of the genicular nerve and the follow-up was extended to one, three, six and twelve months using Pain Visual Analogue Scale (VAS), patient global assessment and the Western Ontario McMaster Universities OA index (WOMAC). The study subjects comprised elderly patients with chronic knee pain (knee pain of at least moderate intensity on most days for > 3 months), radiologic tibio-femoral osteoarthritis and did not respond to conservative treatments including physiotherapy, oral analgesics, and intra-articular injections or steroids.  They were not candidates for invasive treatments due to comorbidities. VAS scores improved from a baseline mean of 8 to 2, 2.3, 2.1, 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. No adverse events of treatment were mentioned. The authors concluded, our research has some limits. One is the small number of patients and secondly, the follow-up was limited to 12 months. Even given these limitations, our results suggest cooled RF neurotomy of genicular nerves has the potential to significantly improve pain, function, and satisfaction, with the possibility of probing a larger tissue lesion than classical RF neurotomy. Moreover, cooled RF can be used in patients in whom an invasive procedure is not recommended. The decreases of chronic pain and medication usage, along with improvement in quality of life and high degree of satisfaction, may justify the use of cooled RF in a broader population.

 

Bhatia et. al. (2016) completed an evidence-based narrative review regarding radiofrequency procedures to relieve chronic knee pain. Chronic knee pain from osteoarthritis or following arthroplasty is a common problem. A number of publications have reported analgesic success of radiofrequency (RF) procedures on nerves innervating the knee, but interpretation is hampered by lack of clarity regarding indications, clinical protocols, targets and longevity of benefit from radiofrequency (RF) procedures. The following medical literature databases were reviewed for publications on RF procedures on the knee joint for chronic pain: MEDLINE, EMBASE, Cochrane Central Register for Controlled Trials, Cochrane Database of Systematic Reviews, and Google Scholar up to August 9, 2015. Data on scores for pain, validated scores for measuring physical disability, and adverse effects measured at any time point after 1 month following the interventions were collected, analyzed, and reported in this narrative review. Thirteen publications on ablative or pulsed radiofrequency treatments of innervation of the knee joint were identified. A high success rate of these procedures in relieving chronic pain of the knee joint was reported at 1 to 12 months after the procedures, but only 2 of the publications were randomized controlled trials. There was evidence for improvement in function and a lack of serious adverse events of RF treatments. The authors concluded that radiofrequency treatments on the knee joint (major or periarticular nerve supply or intra-articular branches) have the potential to reduce pain from osteoarthritis or persistent post-arthroplasty pain. Ongoing concerns regarding the quality, procedural aspects, and monitoring of outcomes in publications on this topic remain. Randomized controlled trials of high methodological quality are required to further elaborate the role of these interventions in this population.

 

In 2017 the COOLIEF Cooled RF FDA approval for the treatment of osteoarthritis of the knee was based on Halyard Health Inc. sponsored study which was a prospective, multi-center randomized clinical trial that included 151 patients over 12 months with primary effectiveness at six months and 12 months. The study found: in 74.1% of the cooled RF patient group, pain was reduced by at least 50 percent at six months and maintained in over 65.4% of those patients for a full 12 months post procedure; at baseline 67.1% of the cooled RF group and 62.7% of the steroid injection group reported symptoms of severe arthritis; Six months post-procedure only 5.2% of the cooled RF group reported the same severity level versus 37.3% of patients treated with steroid injections as measured by the Oxford Knee Score. The Oxford Knee Score is a validated outcomes instrument designed to assess function and pain associated with the knee; in addition the cooled RF patient group’s Oxford Knee Score remained low for 12 months with only 11.5 percent reporting severe symptoms at that point. The author concluded that COOLIEF Cooled RF provides more lasting relief than steroid injections for patients suffering from chronic osteoarthritis knee pain.

 

Gupta, et. al. (2017) completed a systematic review aimed to analyze published studies on radiofrequency ablation (conventional, pulsed or cooled radiofrequency) for patients suffering from osteoarthritis of the knee and patients post total knee arthroplasty who have developed refractory disabling chronic knee pain. The systematic review aimed to provide an overview of the current knowledge regarding variations in procedures, nerve targets, adverse events and temporal extent of clinical benefit. The results showed seventeen publications were identified in the search, including articles investigating conventional, pulsed, or cooled radiofrequency ablation. These studies primarily targeted either the genicular nerves or used an intraarticular approach. Of the studies, 5 were small-sized randomized controlled trials, although one involved diathermy radiofrequency ablation. There were 8 retrospective or prospective case series and 4 case reports. Utilizing the strength of evidence grading, there is a low level of certainty to suggest a superior benefit between targeting the genicular nerve, an intraarticular approach, or targeting the larger nerves such as femoral and tibial nerves. Utilizing the strength of evidence grading, there is a low level of certainty in supporting the superiority of any specific RFA procedure modality. The majority of the studies report positive patient outcomes, but the inconsistent procedural methodology, inconsistent patient assessment measures, and small study sizes limit the applicability of any specific study to clinical practice. The authors concluded overall, the studies showed promising results for the treatment of severe chronic knee pain by radiofrequency ablation at up to one year with minimal complications. Numerous studies, however, yielded concerns about procedural protocols, study quality, and patient follow-up. Radiofrequency ablation can offer substantial clinical and functional benefit to patients with chronic knee pain due to osteoarthritis or post total knee arthroplasty.

 

Summary

Based on review of the peer reviewed medical literature in regards to radiofrequency ablation to include conventional RFA, pulsed radiofrequency or cooled radiofrequency for the treatment of knee osteoarthritis  includes seventeen total publications to include 5 small sized randomized controlled trials, although one involved diathermy radiofrequency ablation. There were 8 retrospective or prospective case series and 4 case reports. The literature also included a systematic review. Some studies may have shown promising results, however, numerous studies yielded concerns about procedural protocols, study quality, small study sizes and patient follow-up which limit the applicability of any specific study to clinical practice. Further randomized clinical trials (RCTs) are needed to determine the efficacy of radiofrequency ablation (conventional, pulsed or cooled) to include studies with larger sample sizes, longer follow periods and double-blinding to establish the overall effectiveness of these procedures and to compare their outcomes against one another. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Cryoneurolysis (Cryoanalgesia, Cryotherapy, Cryoablation)

Knee osteoarthritis (OA) patients spend 50% of post diagnosis time receiving conservative, nonsurgical treatments, as total knee arthroplasty (TKA) is typically reserved for patients with end stage disease due to the limited lifespan of implants and associated risks. The use of low-risk minimally invasive therapies to treat chronic knee pain associated with osteoarthritis have been recommended to include cryoneurolysis.

 

Cyroneurolysis involves the technique of blocking peripheral nerve ending through freezing. Percutaneous application of low temperatures (-20°C to -100 °C) to peripheral nerves cause Wallerian degeneration, in which the nerve structure and conduction are disrupted while the structural elements of the nerve bundle remain intact, allowing for complete regeneration and functional recovery of the nerve. The nerve axon is able to regenerate along the previously established path to eventually reinnervate the sensory receptor. It is proposed that cyroneurolysis of sensory peripheral nerves can provide pain relief for a variety of chronic pain conditions, however, most studies have not been randomized controlled trials (RCTs).

 

Radnovich et. al. (2017) reported on a randomized, double blinded, sham-controlled, multicenter trial with a 6 month follow-up in patients with mild to moderate knee osteoarthritis, to evaluate the efficacy and safety/tolerability of cryoneurolysis for reduction of pain symptoms associated with knee osteoarthritis. The patients were randomized 2:1 to cryoneurolysis targeting the infrapatellar branch of the saphenous nerve (IPBSN) or sham treatment. Cryoneurolysis was administered using the ioverao device and the sham treatment consisted of cryoneurolysis using the ioverao device but did not allow a freezing zone to form and had no therapeutic effect. The primary endpoint was the change from baseline to Day 30 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score adjusted by baseline score and site. Secondary endpoints, including Visual Analogue Scale (VAS) pain sore and total WOMAC score, were tested in pre-defined order. A total of 180 patients were enrolled (active treatment n=121 and sham treatment n=59). Compared to the sham group, patients who received active treatment had a statistically significant greater change from baseline in the WOMAC pain subscale score at Day 30 (P=0.0004), day 60 (P=0.0176) and day 90 (P=0.0061). Among patients who continued to have a benefit at day 120 and day 150, respectively, those who received active treatment had statistically significant lower WOMAC pain score at day 150 but not day 180 than those who received sham treatment. Most expected side effects were mild in severity and resolved within 30 days. The incidence of device or procedure related adverse events was similar in the two treatment groups with no occurrence of serious or unanticipated adverse side effects. Several limitations should be noted. Although allocation to treatment group was initially well  concealed, patients began to more accurately guess their treatment group assignment based on their response to treatment over time, which may have affected patient-reported outcomes and biased results in favor of active treatment. There is a lack of consensus about how OA treatment responders should be defined. The study was conducted at multiple sites with different investigators applying treatment, lending greater weight to the robustness and generalizability of results, the trial should be replicated to ensure reproducibility of findings. The authors concluded cryoneurolysis of infrapatellar branch of the saphenous nerve (IPBSN) resulted in statistically significant decreased knee pain and improved symptoms compared to sham treatment for up to 150 days, and appeared safe and well tolerated.

 

In 2016, Dasa et. al. completed a retrospective chart review of 100 patients who underwent total knee arthroplasty (TKA) to assess the value of adding perioperative cryoneurolysis to a multimodal pain management program. The treatment group consisted of the first 50 patients consecutively treated after the practice introduced perioperative (five days prior to surgery) cryoneurolysis as part of its standard pain management protocol. The control group consisted of the 50 patients treated before cryoneurolysis was introduced. Outcomes included hospital length of stay (LOS), post-operative opioid requirements, and patient reported outcomes of pain and function. A significant lower proportion of patients in the treatment group had a LOS of ≥ 2 days compared with the control group (6% vs 67%, p < 0.0001) and required 45% less opioids during the first 12 weeks of surgery. The treatment group reported a statistically significant reduction in symptoms at the six and 12 week follow-up compared with the control group and within-group significant reductions in pain intensity and pain interference at two and six week follow-up, respectively. This study had several limitations, including its retrospective, nonrandomized and lack of blinding of patients and investigators, which may have biased results and limits the generalizability of findings. Selection bias may have influenced results as the control group was comprised of the first 50 patients with complete WOMAC responses treated prior to the initiation of preoperative cryoneurolysis. These patients may have been different from less compliant patients who did not complete the questionnaire and were excluded from the control group. In addition, differences between the control and treatment groups may be attributable to history or other confounding factors, rather than the study intervention. Because the treatment group underwent TKA more recently than the control group, and there has been a trend towards reducing post-operative LOS in the U.S, it is possible that the shorter LOS observed in the treatment group may be an artifact of history. The authors concluded perioperative cryoneurolysis in combination with multimodal pain management may significantly improve outcomes in patients undergoing TKA. Promising results from the preliminary retrospective study warrant further investigation of this novel treatment in prospective, randomized trials.

 

A retrospective chart review of 48 patients, 24 patients undergoing total knee arthroplasty (TKA) prior to March 31, 2014 comprised the control group and 24 patients undergoing TKA following cryoneurolysis comprised the cryoneurolysis treated (Cryo) group. It was hypothesized that a pre-operative cryoneurolytic block 5 days prior to surgery would decrease TKA postoperative pain. Subjects in the treated group received a cryoneurolysis treatment to the infrapatellar branch of the saphenous nerve (ISN) and the anterior femoral cutaneous nerve (AFCN) five days prior to TKA. Subjects in the control group received standard pre-operative care. Patient reported outcome measures were collected using the KOOS, Oxford Knee Score, SF12 and PROMIS scales at baseline (pre-cryoneurolysis), and at the 2, 6 and 12 weeks postoperative visits.  KOOS Pain score demonstrates that patients in the Cryo group had KOOS pain scores that were significantly higher (a higher KOOS Pain score indicates less knee pain) (p < 0.05) than those of the control group at both 6 and 12 weeks post-operation. The average difference in KOOS Pain score between the two groups at 6 and 12 weeks post-operation were 11.2 and 13.4 respectively. There were no significant differences in average scores for all additional outcomes measures (KOOS, Oxford Knee Score, SF12, and PROMIS) for any of the follow-up time points. The authors concluded cryoneurolysis to block the ISN and AFCN prior to the TKA appears to be an effective method for reducing postoperative narcotic use and length of hospital stay. Additional research is required to further establish this method as a viable preoperative practice for patients undergoing TKA.

 

Makovtich et. al. reported on a case report for painful stiffness following total knee arthroplasty using cryoablation of the infrapatellar branch of the saphenous nerve. Injury to the infrapatellar branch of the saphenous nerve can result of knee trauma or iatrogenic (complication) causes during a total knee arthroplasty. Patients may complain of poorly localized, sharp and burning anteromedial knee pain especially with movement. Cyroablation of the IPBSN creates a reversible second degree nerve injury, which results in a conduction block that provides prolonged pain relief. A 75 year old woman presented with persistent knee pain and stiffness at 3 months post TKA despite 33 sessions of physical therapy. She reported a functional decline with disturbed sleep as well as a constant sharp, anterior knee pain (10/10) with a dull leg ache, all of which worsened with movement. Her x-rays demonstrated a well-fixed and aligned TKA without identifiable pathology for the knee pain. On exam she exhibited an antalgic gait with a flexed knee posture. Patient underwent consultation with PM&R and Orthopaedics, after the PM&R evaluation the consensus was to attempt cryoablation of the IPBSN prior to manipulation surgery. Cryoablation of the nerve (temp -22 °C to -88 °C) was performed at locations both proximal and distal to the bifurcation of the IPBSN using ioverao cryotherapy system. The patient reported a pain score of 0/10 at 15 minutes post procedure and she allowed aggressive manipulation of the knee and was able to ambulate in the clinic without pain. At 10 weeks post treatment the patient reported that she was pain-free and could actively participate in aggressive home exercises. Her active knee range of motion improved from 15 degrees to 105 degrees. Concluded that cryoablation of the IBSN should be considerd in patients with refractory anterolateral knee pain after TKA.

 

Summary

Based on review of the peer reviewed medical literature, the literature includes one randomized controlled trial, retrospective study and a case report. While these studies may have shown promising results, further prospective randomized clinical trials (RCTs) with larger sample sizes and longer follow up periods are needed to further establish that cryoneurolysis (cryoanalgesia, cryotherapy, cryoablation) is viable in the treatment of chronic pain associated with osteoarthritis of the knee and as a preoperative and postoperative practice undergoing TKA. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Chemical Neurolysis

Osteoarthritis is a common source of pain in the hips and knees, there is a significant impact on mobility. A joint replacement is a remedy for many patients, but comorbidities may prevent this as an option. Chemical neurolysis (phenol, alcohol, glycerol) may be an option to provide pain relief and maintain mobility. Chemical neurolysis causes nerve destruction and has a local anesthetic effect on smaller nerve fibers.

 

Based on review of the peer reviewed medical literature the evidence is very limited, no controlled studies were identified on the use of chemical neurolysis (phenol, alcohol, glycerol) of the treatment of osteoarthritis of the knee. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Osteoarthritis of the Hip

Osteoarthritis of the hip is a common condition that many people develop during middle age or older, though it may occur in younger people too. Osteoarthritis can occur in any joint in the body, but most often develops in weight-bearing joints, such as the hip. Osteoarthritis develops slowly and the pain it causes worsens over time and there is no cure. Osteoarthritis has no single specific cause, but there are certain factors that may increase an individual’s risk for developing to include: increasing age, family history of osteoarthritis, previous injury to hip joint, obesity, and improper formation of the hip joint at birth, a condition known as developmental dysplasia. Osteoarthritis can still develop despite not having any of these risk factors. In osteoarthritis of the hip joint, the hip joint gradually wears away over time. As the cartilage wears away, it becomes frayed and rough and the protective joint space between the bones decreases. This can result in bone rubbing on bone. To make up for the lost cartilage, the damaged bones may start to grow outward and form bone spurs (osteophytes). The most common symptoms of hip osteoarthritis is pain around the hip joint. Over time, painful symptoms may occur more frequently, including during rest or at night. Additional symptoms may include: pain in the groin or thigh that radiates to the buttocks or knee, pain that flares up with vigorous activity, stiffness in the hip joint that makes it difficult to walk or bend, locking or sticking of the joint and a grinding noise (crepitus) during movement caused by loose fragments of cartilage and other tissues interfering with the smooth motion of the hip, and decreased range of motion in the hip that affects the ability to walk and may cause a limp.  The treatment of osteoarthritis (OA) is directed towards reduction of symptoms and improve function. Nonsurgical treatment includes lifestyle modifications: minimizing activities that aggravate the condition, such as climbing stairs, switching from high impact activities to lower impact activities, losing weight can reduce stress on the hip joint, resulting in less pain and increased function; physical therapy; assistive devices (cane, crutches, walker); medications (acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids either orally or injected into the painful joint. Surgical treatment may include osteotomy, hip resurfacing or total hip arthroplasty.

 

When an individual exhibits hip pain, the pain signals can be generated from the peripheral nerves innervating the hip including the femoral and obturator nerves, an ablative procedure using radiofrequency ablation (conventional, pulsed or cooled); chemical neurolysis or cryoneurolysis (cold) of these nerves may be performed to restore function and alleviate hip pain as an alternative therapy. Surgical treatment may not be an option for patients with multiple comorbidities, these ablative procedures have been proposed as an alternative for the treatment of chronic hip pain.

 

Radiofrequency Ablation

Rivera et. al. (2012) completed a prospective study of 18 patients with chronic hip pain with several contraindications for total hip arthroplasty (THA). Predenervation diagnosis was osteoarthritis in 16 patients and prolonged post-operative hip pain in 2 (1 THA, 1 Girdlestone). The hip pain was treated by percutaneous radiofrequency lesioning of the sensory branches of the obturator and femoral nerves. Six month follow-up data revealed a statistically significant decrease in Visual Analog Scale (VAS) scores and Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) scores, and a statistically significant increase of Harris Hip Score. Before radiofrequency and at 6 month follow-up, mean VAS scores were 9.52 (range 7-10; standard deviation 0.79) and 6.35 (range 3-10; standard deviation 2.17), respectively; mean Harris Hip Scores were 28.64 (range 19-41; standard deviation 6.98) and 43.88 (range 23.71; standard deviation 16.38), respectively; and mean WOMAC scores were 75.70 (range 92-59; standard deviation 9.70) and 63.70 (range 78-44; standard deviation 11.37), respectively. All values were statistically significant (P<.05) for Student’s t test and Wilcoxon signed-rank test. Eight patients reported ≥ 50% pain relief at 6 month follow-up. No side effects were reported. The authors concluded the use of this technique for hip pain control is controversial. In our experience, percutaneous radiofrequency lesioning of the sensory branches of the nerves innervating the hip joint can be an option for patients with intractable hip pain.

 

Chye et. al. (2015) completed a prospective comparative study of 29 patients with chronic hip pain that were divided into two groups, pulsed radiofrequency (PFR) and conservative treatment. Fifteen patients received PRF of the articular branches of the femoral or obturator nerves, and 14 patients received conservative treatment. Visual Analog Scale (VAS) score, Oxford Hip Scores (OHS) and pain medications were used for outcome measurement before treatment and at 1 week, 4 weeks, and 12 weeks after treatment. Results at 1 week, 4 weeks and 12 weeks after treatment initiation, improvements in VAS were significantly greater with PRF. Improvements in OHS were significantly greater in the PRF group at 1 week, 4 weeks and 12 weeks. Patients in the PRF group also used less pain medications, Eight subjects in the conservative treatment group switched to the PRF group after 12 weeks and six of them had > 50% improvement. The authors concluded pulsed radiofrequency (PRF) of the articular branches of the femoral and obturator nerves offers a treatment option with good outcomes for patients suffering from chronic hip pain. When compared with conservative treatment, it offers greater pain relief and can augment physical functioning. Although this study produced promising results, caution is advised in drawing conclusions from this single study. Controlled, randomized investigations with longer observation periods are necessary to further clarify the role of pulsed radiofrequency (PRF) in the treatment of chronic hip pain.

 

In 2018 Bhatia, et. al. completed an evidence-based narrative review regarding radiofrequency procedures to relieve chronic hip pain. Chronic hip pain from osteoarthritis and other degenerative conditions is a common problem. A few publications have recently reported analgesic success of radiofrequency (RF) procedures on nerves innervating the hip, but interpretation is hampered by lack of clarity regarding indications, clinical protocols, anatomic targets, and longevity of benefit from RF procedures. For this evidence based narrative review the following medical literature databases for publications on RF procedures on the hip joint for chronic pain: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Google Scholar through February 28, 2017. Existing knowledge on innervation of the hip joint was synthesized. Data on analgesic and functional outcomes and adverse effects measured at any time points following the interventions were also collected, analyzed and reported in this narrative review. Fourteen publications on ablative RF treatments of innervation of the hip joint were identified. A high success rate of these procedures in relieving chronic pain of the hip joint was reported at 8 days to 36 months after the procedures, but none of the publications were randomized controlled trials. There was evidence for improvement in function and a lack of serious adverse events of RF treatments. The authors concluded radiofrequency treatments for the sensory innervation of the hip joint have the potential to reduce pain secondary to degenerative conditions. Ongoing concerns remain regarding the anatomic targets, as well as quality, procedural aspects, and monitoring outcomes in publications on this topic. Randomized controlled trials of high methodological quality are required to further elaborate the role of these interventions in this population.

 

Summary

Based on review of the peer reviewed medical literature the literature is limited regarding radiofrequency ablation (conventional, pulsed and cooled) for the treatment of osteoarthritis of the hip. Although studies may have shown promising results, further randomized clinical trials (RCTs) are needed to determine include studies with larger sample sizes, longer follow periods and double-blinding to establish the overall effectiveness of these procedures and to compare their outcomes against one another. The evidence is insufficient to determine the effects of this technology on net health outcomes and therefore is considered investigational.

 

Cryoneurolysis (Cryoanalgesia, Cryotherapy, Cryoablation)

Based on review of the peer reviewed medical literature the evidence is very limited, no controlled studies were identified on the use of cryoneurolysis (cryoablation, cryotherapy, cryoanalgesia) to treat osteoarthritis of the hip. Most studies are related to osteoarthritis of the hip and cryoneurolysis. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Chemical Neurolysis

Osteoarthritis is a common source of pain in the hips and knees, there is a significant impact on mobility. A joint replacement is a remedy for many patients, but comorbidities may prevent this as an option. Chemical neurolysis (phenol, alcohol, glycerol) of the obturator nerve may be an option to provide pain relief and maintain mobility. Chemical neurolysis causes nerve destruction and has a local anesthetic effect on smaller nerve fibers.

 

Based on review of the peer reviewed medical literature the evidence is very limited, no controlled studies were identified on the use of chemical neurolysis (phenol, alcohol, glycerol) of the treatment of osteoarthritis of the hip. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Intercostal Neuralgia

Intercostal neuralgia refers to a neuropathic condition involving the intercostal nerves, manifesting as intense dysesthetic pain, e.g. sharp, shooting or burning in quality radiating around the chest wall. Intercostal nerves are peripheral nerves that run along with the vascular bundle on the inferior surface of each rib. The pain usually begins at the posterior axillary line and radiates anteriorly into the distribution of the affected intercostal and sub costal nerves. Deep inspiration or movement of the chest wall may increase the pain of intercostal neuralgia slightly but much less compared with the pain.

 

Intercostal neuralgia occurs due to a number of reasons such as nerve entrapment, a traumatic or iatrogeneic (caused by a complication) neuroma, persistent nerve irritation, or herpes zoster. The pain of the intercostal neuralgia is the result of a damage or inflammation of the intercostal nerves and can be localized in one or more of the intercostal spaces. Although it is commonly seen and recognized in patients with chronic chest wall pain after thoracotomy, intercostal neuralgia has been reported in patients after breast and abdominal surgery, trauma and infection. There are several treatment options available, including systemic medications, topical or invasive nerve blocks, cryoablation and radiofrequency ablation (conventional and pulsed).

 

A definite treatment protocol is yet to be suggested for patients with intercostal neuralgia, as the efficacy of the proposed treatments is difficult to evaluate. Small sample sizes, difficulty in assigning control groups, and ambiguous outcome parameters are the main factors that affect the outcome. The initial choice of therapy should be guided by the patient’s comorbidities, adverse effects of drugs and patient preference. Based on the findings of the pain questionnaires, additional diagnostics and/or multidisciplinary treatment interventional pain treatment may be considered that includes radiofrequency ablation and cryoablation (cryoneurolysis). Radiofrequency ablation to include pulsed radiofrequency has generated interest in the treatment of neuropathic pain. Cryotherapy (cyroneurolysis) involves another way of interrupting the peripheral nerve’s ability to transmit pain by freezing it. Cyrotherapy has been used on neuromas and the involved intercostal nerves.

 

Radiofrequency Ablation

Radiofrequency ablation to include pulsed radiofrequency ablation has been studied in the treatment of chronic intercostal neuralgia pain. Based on review of the literature which includes retrospective and prospective studies and case series/case reports, there is very limited evidence in the literature. Most studies are limited in patient size and of limited long term follow-up. There is a need for further double blinded randomized trials to further elicit the efficacy of radiofrequency ablative therapy in the treatment of chronic intercostal neuralgia pain. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Cryoneurolysis

Cryoneurolysis (cryoanalgesia, cryotherapy, cryoablation) the use of cold to provide analgesia has been utilized for the treatment of chronic intercostal neuralgia pain. The effectiveness of this therapy is dependent on proximity of the probe to the nerve, size of the probe, rate and duration of freezing and temperature of the tissues in proximity to the probe. Based on review of the literature which includes retrospective and prospective studies and case reports, the literature shows mixed results. While some studies have shown promising results of reduced pain, numerous studies yielded concerns about study quality, small study sizes and patient follow-up. Further randomized clinical trials (RCTs) to include prospective double blinding randomized controlled studies with larger sample sizes and longer follow periods are needed to determine the efficacy of cyroablation (cryodenervation) in the treatment of chronic intercostal neuralgia. The evidence is insufficient to determine the effects of the technology on net health outcomes.

 

Chemical Neurolysis

Chemical neurolysis is the use of a chemical using phenol, alcohol, glycerol or a hypertonic saline to cause destruction of nerve(s) by causing a temporary degeneration of the nerve(s) fibers to interrupt the transmission of nerve(s) signals for pain relief and has been proposed in the treatment of chronic intercostal neuralgia.

 

Based on review of the peer reviewed medical literature, the literature is limited on the use of chemical neurolysis for the treatment of chronic intercostal neuralgia. Randomized clinical trials (RCTs) are needed to determine the efficacy of chemical neurolysis for the treatment of chronic intercostal neuralgia to include studies with large sample sizes and longer follow periods to establish the overall effectiveness of this procedures compared to other alternative treatments. The evidence is insufficient to determine the effects of this technology on net health outcomes 

 

Inguinal Neuralgia

Chronic inguinal neuralgia involving the ilioinguinal and iliohypogastric nerves is a frequent complication of surgical procedures involving a lower abdominal incision such as hernia repair, appendicitis surgery, caesarean section and may also occur with trauma to the lower quadrant of abdomen or inguinal region. Chronic inguinal neuralgia is a chronic persistent pain in the pelvic and/or groin region caused by nerve dysfunction. Treatment modalities for inguinal neuralgia include nonsteroidal anti-inflammatory medications (NSAIDs), nerve block, nerve ablation, surgery, and nerve stimulation  Ablative procedures such as radiofrequency, cryoneurolysis and chemical neurolysis have been proposed as an alternative for the treatment of chronic inguinal neuralgia pain.

 

Radiofrequency Ablation

Based on review of the peer reviewed medical literature, the literature is limited to one randomized trial, retrospective studies and case series, for radiofrequency ablation (conventional and pulsed) for the treatment of chronic inguinal neuralgia.

 

In 2012, Kastler et. al. completed a retrospective study to evaluate and compare ilioinguinal and iliohypogastric radiofrequency neurolysis and local injection for the treatment of chronic inguinal neuralgia. Forty-two patients suffering from chronic inguinal pain refractory to specific medication were included. A total of 18 radiofrequency neurolysis (RFN) procedures (14 patients) and 28 injections (28 patients) were performed. Pain was assessed in both groups using Visual Analog Scale (VAS) scores measured immediately before and after the procedure at one, 3, 6, 9 and 12 months after the procedure. Mean duration of pain prior to the procedure and mean duration of pain relief were noted. Moreover, mean maximum early pain relief was assessed. All procedures were ambulatory under computed tomography (CT) guidance. Injections contained 1.5 mL of cortivazol and 3 mL of lidocaine-ropivacaine (30%-70%). Radiofrequency neurolysis was performed using a Neurotherm RF Generator. The mean age in both groups was 48.7 years. Forty-two patients presented with post-surgical inguinal pain which occurred after hernia repair. All included patients that had undergone previously unsuccessful pain therapies. Mean VAS scores were 7.72 in the RF group and 7.46 in the infiltration group. Maximum early pain relief did not statistically differ (77% in the RFN group and 81.5% in the injection group). Mean duration of pain relief was statistically significant (P=.005) in the RF group (12.5 months) compared to the infiltration group (1.6 months). Mean VAS scores during the year following the procedure were all significantly in favor of radiofrequency neurolysis management. Limitations of this study include small study samples and retrospective study. The authors concluded that radiofrequency neurolysis appears to be significantly more effective than local nerve infiltrations. It is a safe and effective treatment for chronic inguinal pain. Local steroid injection along with local injection of anesthetic should be used as a confirmation of ilioinguinal neuropathy before performing radiofrequency neurolysis.

 

In 2015, Makharita et. al. completed a randomized, double-blind controlled trial to evaluate the efficacy of pulsed radiofrequency in management of chronic inguinal neuralgia. Chronic inguinal neuralgia has been reported after inguinal herniorrhaphy, caesarean section, appendectomy and trauma to the lower quadrant of the abdomen or inguinal region. Twenty-one adult patients aged between 20 and 60 years were allocated into 2 groups. Group 1 received 2 cycles of pulsed radiofrequency (PRF) for each nerve root. In Group 2, after stimulation, the same time was spent to mimic PRF. Both groups received bupivacaine 25% plus 4mg dexamethasone in 2mL for each nerve root. Visual Analogue Scale (VAS) was assessed. Duration of the first block effective pain relief was reported. Repeated PRF blockade was allowed for any patient who reported a VAS > 30 mm in both groups during the one year follow-up period. The number and duration of blocks were reported and adverse effects were reported. Significantly longer duration of pain relief was noticed in Group 1 (P=0.005) after the first block, while the durations of pain relief of the second block were comparable (P=0.59). In Group 1 the second PRF produced pain relief from the twenty-forth week until the tenth month while in Group 2, pain relief was reported from the sixteenth week until the eighth month after the use of PRF. All patients in Group 2 received 3 blocks (the first was a sham PRF) during the one year follow-up period. Meanwhile, 2 PRF blocks were sufficient to achieve pain relief for patients in Group 1 except 4 patients who needed a third PRF block. No adverse events were reported. Limitations include small sample size and the study was not powered. The authors concluded for intractable chronic inguinal pain, pulsed radiofrequency represents a promising treatment modality. It is superior to local anesthetic and steroid injection. It provides pain relief for about 20 weeks and it can be repeated.

 

Summary

Based on review of the peer reviewed medical literature, the literature is limited to one randomized trial, retrospective studies and case series, for radiofrequency ablation (conventional and pulsed) for the treatment of chronic inguinal neuralgia. While these studies may have shown promising results, further prospective randomized clinical trials (RCTs) are needed to determine the efficacy of radiofrequency ablation (conventional, pulsed, cooled) to include studies with larger sample sizes, longer follow periods and double-blinding to establish the overall effectiveness of these procedures and to compare their outcomes against one another. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Cryoneurolysis and Chemical Neurolysis

Nerve ablation using cryoneurolysis (cryoablation, cryotherapy, cryoanalgesia) and chemical neurolysis (phenol or alcohol) have been proposed as an alternative treatment for the treatment or chronic inguinal neuralgia for patients who have failed other non-surgical management. There is little published evidence related to the use of cryoneurolysis and chemical neurolysis in the treatment of chronic inguinal neuralgia. Alcohol or phenol injection have been tried to reduce chronic inflammation and destroy the offending nerve ending(s). Cyroablation (cryoneurolysis) destroys the nerve fibers by coagulation at very low temperatures, have been shown to give some temporary pain relief. Typically following these procedures pain recurred due to nerve regeneration. Definitive evidence for their effectiveness is lacking. Further randomized clinical trials are needed to determine the effectiveness of cryoneurolysis and chemical neurolysis for the treatment of chronic inguinal neuralgia. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Plantar Fasciitis

Plantar fasciitis is one of the most common causes 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, and can impede activities of daily living. On physical examination firm pressure will elicit a tender spot over the medial tubercle of the calcaneus. The exact etiology is unclear, although repetitive injury is suspected. Possible risk factors for the development of plantar fasciitis include obesity, prolonged standing or jumping, flat feet and reduced ankle dorsiflexion. Although heel spurs often coexist with plantar fasciitis, it is unclear whether they have a causal role and may instead represent a secondary response to an inflammatory reaction. Most cases of plantar fasciitis are treated with conservative therapy, including stretching exercises for the plantar fascia and calf muscles; decreasing physical activities that are causative or aggravating ( running, jumping, dancing); avoiding the use of flat shoes or barefoot walking; prefabricated over the counter arch supports/heel cups; molded shoe inserts (orthotics); night splints; nonsteroidal anti-inflammatory drugs (NSAIDs); and injecting tender areas of the plantar region with glucocorticoids and a local anesthetic. Improvement may take up to 1 year in some cases.  Ablative procedures to include radiofrequency ablation, cryoneurolysis (cryoablation, cryoanalgesia, cryotherapy) and chemical neurolysis have been proposed as an alternative for the treatment of chronic heel pain associated with plantar fasciitis.

 

Radiofrequency Ablation

Several case series and an RCT (randomized controlled trial) were identified that evaluated radiofrequency ablation (RFA) for the treatment of chronic heel pain. In all studies, radiofrequency ablation (RFA) used constant radiofrequency application with the intent to ablate nerve endings.

 

Landsman et. al. (2013) reported the only randomized study of RFA. Seventeen patients were enrolled in a double-blind crossover trial, with crossover to the alternative treatment at 4 weeks. Patients must have failed a 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 in the heel region. It was observed that statistically significant improvement of plantar fasciitis in patients actively treated with radiofrequency ablation and no significant improvement in the sham-treated group. Those treated with sham subsequently demonstrated improvement after subsequent RFA treatment. The authors concluded using a prospective, randomized study with sham treatment and crossover, this study demonstrates the efficacy of radiofrequency ablation for the treatment of plantar fasciitis.

 

Erken et. al. (2014) reported on two year follow-up evaluating the results of radiofrequency ablation of the calcaneal branches of the inferior calcaneal nerve on 35 feet in 29 patients with plantar heel pain between 2008 and 2011. All of the patients who were treated had been complaining of heel pain for more than 6 months and had failed conservative treatment. All of the patients were evaluated using the average 10 point Visual Analog Scale (VAS) and the American Orthopedic Foot and Ankle Society Scale (AOFAS) scores assessed before treatment, as well as their 1 month, 1 year and 2 year follow-up after the procedure. The average VAS score of the feet was 9.2, 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-up. The 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. The authors concluded these findings suggest that radiofrequency ablation of the calcaneal branches of the inferior calcaneal nerve was an effective pain treatment option for chronic heel pain associated with plantar fasciitis that did not respond to other conservative treatment options.

 

The largest case series with the longest follow-up is by Cozzarelli et.al. (2010). This study reported on 12 year follow up of 82 patients who had undergone radiofrequency ablation (RFA) for heel pain. Patients had undergone RFA between 1994 and 1995 and had been interviewed at 5, 10 and 12 years post procedure. An evaluation of medical records was performed as a means of inclusion in this study. A standardized telephone interview was done, and subjectively scored responses of the patients were recorded and analyzed. Of 99 patients potentially eligible to be interviewed, the study evaluated 82 patients and 89% reported no recurrence of pain after 5, 10 and 12 years post procedure.

 

Cione et. al (2009) reported case series of 75 patients with recalcitrant plantar heel pain caused by calcaneal neuritis, treated with radiofrequency ablation. The median age of the cohort was 55 (range 24 to 83) years, 25 (33.3%) of the patients were male, 50 (66.7%) of the patients were female, and 15 (20%) of the patients were treated for bilateral heel pain caused by medial calcaneal neuritis. The median pre-procedure VAS score was 9 (range 2 to 10), whereas the post procedure VAS score was 1 (range 0 to 8). Five (6.7%) of the patients experienced recurrent heel pain, over a median follow-up duration of 18 months. Overall, 93.3% of the patients experienced satisfactory pain relief with radiofrequency lesioning for the treatment of recalcitrant plantar heel pain caused by medial calcaneal neuritis.

 

Liden et. al. (2009) published a retrospective case series of 22 patients treated with radiofrequency nerve ablation with a history of prolonged moderate to severe heel pain associated with plantar fasciitis to determine if ablation of sensory branch of the medial calcaneal nerve would result in symptomatic relief. Participants in this study were given subjective questionnaires and Visual Analog Scales (VAS) in order to rate their symptoms before and after the ablation using radiofrequency energy. The 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 post procedure. Adverse events were minor and transient in most cases. One adverse event was called persistent post-static dyskinesia which probably represents nonresponse to treatment. The authors concluded that the findings support radiofrequency nerve ablation may be considered as an alternative to repetitive corticosteroid injections or open surgical intervention for the treatment of recalcitrant plantar heel pain.

 

Summary

Radiofrequency ablation of peripheral nerves may be performed for the treatment of chronic heel pain associated with plantar fasciitis and the literature on the use of this is limited. The evidence for radiofrequency ablation of peripheral nerves in individuals who have plantar fasciitis includes case series studies and 1 randomized controlled trial (RCT). 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 post-treatment. Although the studies report that radiofrequency ablation reduces heel pain, the quality of the evidence is poor. Because of the variable natural history of plantar fasciitis and the subjective nature of the outcome measures, randomized clinical trials (RCTs) are needed to determine whether outcomes are improved with interventions for pain. Trials should include homogenous population of patients with defined clinical condition, use standardized outcome measures to include longer follow up periods and define clinically relevant outcome measures for pain treatments which includes measures of pain severity and functional limitations. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Cyroneurolysis (Cryoablation, Cryoanalgesia, Cryotherapy)

Cryoneurolysis (cryoablation, cryoanalgesia, cryotherapy) is a relatively new treatment modality using cold (freezing) for the treatment of plantar fasciitis who have failed prior conservative therapy. The most important aspect of this treatment modality is locating the exact area of heel pain as the target area for the tip of the cryoprobe is the central area of the greatest pain. The cryoneurolysis procedure provides ablation of the divisional branches of the medial calcaneal nerve medially and the branches of the lateral calcaneal nerve laterally.

 

Per review of the peer reviewed medical literature, the literature is limited related to cryoneurolysis and the treatment of plantar fasciitis. Prospective studies and retrospective case series/case reports were found, no randomized controlled trials were found. Some studies may have shown promising results in regards to decreased pain, however, study quality, small study sizes and patient follow-up limit the applicability of any specific study to clinical practice. Further randomized clinical trials (RCTs) are needed to determine the efficacy of cyroneurolysis (cryoablation, cryoanalgesia, cryotherapy) to include studies with larger sample sizes, longer follow periods and double-blinding to establish the overall effectiveness of this procedure and include comparative studies against other treatments. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Chemical Neurolysis

For patients with plantar fasciitis no published literature was identified in regards to patient receiving chemical neurolysis (alcohol, phenol, glycerol) for the treatment of this condition. The evidence is insufficient to determine the effects of this technology on net health outcomes.

 

Peripheral Neuromas

A neuroma is a pathology of a peripheral nerve that develops as part of a normal reparative process. Neuromas may develop after injury to a nerve or as a result of chronic irritation, pressure, stretch, poor repair of nerve lesions or previous neuromas, laceration, crush injury or blunt trauma. Neuromas typically appear about 6 to 10 weeks after trauma with most presenting within 1 to 12 months after injury or surgery. They may gradually enlarge over a period of 2 to 3 years. And may or may not be painful. Pain from neuroma may be secondary to traction on the nerve by scar tissue, compression of the sensitive nerve endings by adjacent soft tissues, ischemia of the nervous tissue or ectopic foci of ion channels that elicit neuropathic pain. Patients may describe the pain as a low-intensity dull pain or intense paroxysmal burning pain, often triggered by external stimuli such as touch or temperature. Neuroma formation has been implicated as a contributor of neurpathic pain in residual limb pain, post-thoracotomy, post-mastectomy and post-herniorrhaphy pain syndromes. Management options for painful peripheral neuromas may include pharmacotherapy, steroid injection, chemical neurolysis, cryoablation and radiofrequency ablation.

 

Based on review of the peer reviewed medical literature the evidence is very limited, no controlled studies were identified on the use of ablative procedures (chemical neurolysis, cryoablation and radiofrequency ablation to include conventional, pulsed or cooled RF) to treat painful peripheral neuromas other than Morton neuromas. The evidence is insufficient to determine the effects of the technology on net health outcomes.    

 

Practice Guidelines and Position Statements

American College of Foot and Ankle Surgeons

In 2010, the American College of Foot and Ankle Surgeons issued a guideline on the treatment of heel pain. 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 either conflicting or level IV expert opinion evidence.

 

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.

 

In 2013, the ioverao 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 ioverao device is not indicated for the treatment of central nervous system tissue.

 

In 2017 the U.S. Food and Drug Administration (FDA) cleared for marketing COOLIEF cooled radiofrequency (Cooled RF) treatment for the relief of chronic moderate to severe knee pain caused by osteoarthritis (OA).

 

Prior Approval:

 

Prior approval is required

 

Policy:

  • See also Medical Policy 07.01.66 Ablative Treatments of Occipital Neuralgia, Chronic Headaches and Atypical Facial Pain
  • See also Medical Policy 07.01.41 Pulsed Radiofrequency
  • See also Medical Policy 07.01.58 Facet Joint Denervation

 

Ablative procedures of the peripheral nerves including but not limited to the following:

  • Radiofrequency ablation (RFA)
  • Cooled radiofrequency ablation to include but not limited to COOLIEF cooled RF (Haylord Health)
  • Pulsed radiofrequency ablation
  • Cyroneurolysis (cryoablation, cryotherapy, cryoanalgesia) to include but not limited to ioverao system (Myoscience, Inc)
  • Chemical neurolysis (alcohol, phenol, glycerol); and

also are considered investigational to treat pain for all indications, including but not limited to the following:

  • Chronic knee pain/Osteoarthritis of the knee
  • Chronic hip pain/Osteoarthritis of the hip
  • Plantar Fasciitis
  • Peripheral neuromas
  • Intercostal neuralgia
  • Inguinal neuralgia

 

Based on review of the peer review medical literature the evidence is limited and insufficient to determine the efficacy of these ablative procedures of the peripheral nerves to treat various types of pain.  Some studies may have shown promising results, however, numerous studies yielded concerns about procedural protocols, study quality, small study sizes and patient follow-up which limit the applicability of any specific study to clinical practice. Further prospective randomized clinical trials (RCTs) are needed to determine the efficacy of these ablative procedures to include studies with larger sample sizes, longer follow periods and double-blinding to establish the overall effectiveness of these procedures and to compare their outcomes against one another. The evidence is insufficient to determine the effects of this technology on net health outcomes and therefore is considered investigational.

 

Procedure Codes and Billing Guidelines:

To report provider services, use appropriate CPT* codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.

  • 64620 Destruction by neurlytic agent, intercostal nerve (destruction by a neurolytic agent may include chemical (e.g. alcohol, glycerol, phenol), cold, or radiofrequency techniques)
  • 64640 Destruction of neurolytic agent; other peripheral nerve or branch (destruction by neurolytic agent may include chemical (e.g. alcohol, glycerol, phenol), cold, or radiofrequency techniques)

 

Selected References:

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  • Arslan A, Koca TT, Utkan A, et. al. Tratment of chronic plantar heel pain with radiofrequency neural ablation of the first branch of the lateral plantar nerve and medial calcaneal nerve branches. J Foot Ankle Surg 2016 Jul-Aug;55(4):767-71. PMID 27073185
  • Crawford F, Thomson CE. Interventions for treating plantar heel pain. Cochran Database Syst Rev 2010 Jan 20;(1):CD000416. PMID 20091508
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  • Byas-Smith MG, Gulati A. Ultrasound guided intercostal nerve cryoablation. Anesth Analg 2006 Oct;103(4):1033-5. PMID 17000825
  • Moore W, Kolnick D, Tan J, et. al. CT guided percutaneous cryoneurolysis for post thoracotomy pain syndrome: early experience and effectiveness. Acad Radiol 2010 May;17(5):603-6. PMID 20227306
  • Calandria L. Cryoanalgesia for post-herpatic neuralgia: a new treatment. Int J Dermatol 2011 Jun;50(6):746-50. PMID 21595675
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  • Wu H, Groner J. Pulsed radiofrequency treatment of articular branches of the obturator and femoral nerves for management of hip joint pain. Pain Pract 2007 Dec;7(4):341-4. PMID 17986165
  • UpToDate. Post-Herpatic Neuralgia. Zahid H Bajwa M.D., Topic last updated February 13, 2017.
  • UpToDate. Treatment of Musculoskeletal Chest Pain. Kristine Phillips M.D., PhD, Peter H. Schur M.D., Topic last updated October 5, 2015.
  • UpToDate. Post-Herniorrhaphy Group Pain. Janina B. Bonwich M.D., FACS. Topic last updated April 17, 2017.
  • UpToDate. Overview of the Treatment of Chronic Non-Cancer Pain. Ellen WK Rosenquist M.D., Topic last updated November 30, 2017.
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  • Makharita M, Amr Y. Pulsed radiofrequency for chronic inguinal neuralgia. Pain Physician 2015;18:E147-E155
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Policy History:

  • January 2018 - Annual Review, Policy Revised
  • January 2017 - New Policy

Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

 

*CPT® is a registered trademark of the American Medical Association.