Medical Policy
Policy Num: 02.001.054
Policy Name: Alcohol Injections for Treatment of Peripheral Neuromas
Policy ID: [02.001.054] [Ac / B / M- / P-] [2.01.97]
Last Review: July 07, 2023
Next Review: July 20, 2024
Related Policies : 07.001.117 Ablation Procedures for Peripheral Neuromas
Population Reference No. |
Populations |
Interventions |
Comparators |
Outcomes |
1 |
Individuals:
|
Interventions of interest are:
|
Comparators of interest are:
•Surgical excision |
Relevant outcomes include:
• Symptoms • Resource utilization • Treatment-related morbidity |
Morton neuroma is a common and painful compression neuropathy of the dorsal foot that is also referred to as intermetatarsal neuroma, interdigital neuroma, interdigital neuritis, and Morton metatarsalgia. Morton neuroma is usually treated with conservative measures, surgery, or minimally invasive procedures. Alcohol injection is a minimally invasive alternative to open surgery to treat Morton neuroma. Alcohol causes chemical neurolysis through dehydration, necrosis, and precipitation of the treated area, ultimately destroying the lesion after multiple injections.
For individuals who have Morton neuroma who receive intralesional alcohol injection(s), the evidence includes retrospective case series. Relevant outcomes are symptoms, resource utilization, and treatment-related morbidity. The body of evidence is limited, consisting of case series reporting on the treatment response of patients with refractory Morton neuroma. The available series have generally reported that some patients experience pain relief and express satisfaction with the procedure. Some evidence has suggested that surgery after failed cases of alcohol injections is more complex and challenging than in untreated patients due to the presence of fibrosis. There is a lack of controlled trials comparing alcohol injections with alternative therapies, and there are no controlled studies comparing outcomes for alcohol injections with those for surgery in surgical candidates. The evidence is insufficient to determine the effects of the technology on health outcomes.
The objective of this evidence review is to determine whether the use of alcohol injections improves the net health outcome in individuals with Morton neuroma compared with conservative therapy or surgery.
Alcohol injections are considered investigational for treatment of Morton neuroma.
Please refer to the Codes table.
BlueCard/National Account Issues
BLUECARD/NATIONAL ACCOUNT ISSUES
State or federal mandates (eg, Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity.
Benefits are determined by the group contract, member benefit booklet, and/or individual subscriber certificate in effect at the time services were rendered. Benefit products or negotiated coverages may have all or some of the services discussed in this medical policy excluded from their coverage.
Neuroma
A neuroma is a growth or tumor consisting of nerve tissue that develops as part of a normal reparative process following nerve injury. The injury may be due to chronic irritation, pressure, stretch, poor repair of nerve lesions or previous neuromas, laceration, crush injury, or blunt trauma.1, Neuromas typically appear 6 to 10 weeks after trauma, with most presenting within 1 to 12 months after injury or surgery. They may gradually enlarge over 2 to 3 years and may or may not be painful. Pain from a 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 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 neuropathic pain in residual limb pain, postthoracotomy, postmastectomy, and postherniorrhaphy pain syndromes. They may coexist with phantom pain or can predispose to it.
Morton Neuroma
Morton neuroma is a common and painful compression neuropathy of the common digital nerve of the foot that may also be referred to as interdigital neuroma, interdigital neuritis, or Morton metatarsalgia.1,2,3, It is histologically characterized by perineural fibrosis, endoneurial edema, axonal degeneration, and local vascular proliferation. Thus, some investigators do not consider Morton neuroma to be a true neuroma; instead, they consider it to be an entrapment neuropathy occurring secondary to compression of the common digital nerve under the overlying transverse metatarsal ligament. The incidence and prevalence of Morton neuroma are not clear, but it appears 10-fold more often in women than in men, with an average age at presentation of around 50 years.4,
The pain associated with Morton neuroma is usually throbbing, burning, or shooting, localized to the plantar aspect of the foot. It is typically located between the 3rd and 4th metatarsal heads, although it may appear in other proximal locations.1,2, The pain may radiate to the toes and can be associated with paresthesia. The pain can be severe, and the condition may become debilitating to the extent that patients are apprehensive about walking or touching their foot to the ground. It is aggravated by walking in shoes with a narrow toe box or high heels that cause excessive pronation and excessive forefoot pressure; removal of tight shoes typically relieves the pain.
Diagnosis
Although a host of imaging methods are used to diagnosis Morton neuroma, including plain radiographs, magnetic resonance imaging, and ultrasonography, objective findings are unique to this condition and are primarily used to establish a clinical diagnosis.1, Thus, a patient's toes often show splaying or divergence. Patients may describe the feeling of a "lump" on the foot bottom or a feeling of walking on a rolled-up or wrinkled sock. Clinical examination with medial and lateral compression may reproduce the painful symptoms with a palpable "click" on interspace compression (Mulder sign).5,
Treatment
Management of patients diagnosed with Morton neuroma typically starts with conservative approaches, such as the use of metatarsal pads in shoes and orthotic devices that alter supination and pronation of the affected foot.3, These approaches are aimed at reducing pressure and irritation of the affected nerve. They may provide relief, but they do not alter the underlying pathology. There is little evidence supporting the effectiveness or comparative effectiveness of these practices.[267] In a case series, Bennett et al (1995) evaluated a 3-stage protocol of private practice patients (N=115) who advanced from stage I (education plus footwear modifications, and a metatarsal pad) to stage II (steroid injections with local anesthetic or local anesthetic alone) and into stage III (surgical resection) if treated while in stages I and II did not bring relief within 3 months.6, Overall, 97 (85%) of 115 patients believed that pain had been reduced with the treatment program. However, twenty-four (21%) patients eventually required surgical excision of the nerve and 23 (96%) of those had satisfactory results.
Ablation Techniques
Alternative approaches to treat refractory Morton neuroma include minimally invasive procedures aimed at in situ destruction, including intralesional alcohol injections.2 Dehydrated ethanol has been shown to inhibit nerve function in vitro, has high affinity for nerve tissue, and causes direct damage to nerve cells via dehydration, cell necrosis, and precipitation of protoplasm, leading to neuritis and a pattern of Wallerian degeneration. Technically, ethanol is a sclerosant that causes chemical neurolysis of the nerve pathology but is considered an ablative procedure for this evidence review. The use of ultrasound guidance during this procedure has been shown to increase surgical accuracy, improve outcomes, and shorten procedure duration.
Alcohol injection for Morton neuroma is a surgical procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.
This evidence review was created in April 2015 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through April 24, 2021. Please refer to policy # 07.001.117 for pertinent information. This policy has been placed in Sunset Status. Sunset Date: July, 2022.
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function-including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.
Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.
The purpose of intralesional alcohol injection therapy for patients who have Morton neuroma is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The question addressed in this evidence review is: Does use of alcohol injections improve health outcomes for patients with Morton neuroma compared with conservative therapy or surgery?
The following PICO was used to select literature to inform this review.
The relevant population of interest is individuals with Morton neuroma.
The therapy being considered is an intralesional injection of alcohol.
The following therapies are currently being used: conservative therapy (eg, rest, metatarsal supports) and surgical excision.
The general outcomes of interest are reduction in pain, improvement in function, and patient satisfaction.
Patients are followed within 1 to 2 weeks after an injection to determine pain reduction and patient satisfaction. Additional injections may occur in subsequent 1 to 2 months to achieve the level of desired pain reduction for the patient.
Methodologically credible studies were selected using the following principles:
To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
Studies with duplicative or overlapping populations were excluded.
No randomized controlled trials or nonrandomized interventional trials were identified. Several published case series have used alcohol injections to treat Morton neuroma. Summaries of these series appear in Table 1.
Treatment in all the case series consisted of injections of alcohol combined with an anesthetic (eg, lidocaine or bupivacaine). Injections were repeated at 2-week intervals, if symptoms persisted. On average, across studies, each patient received approximately 4 injections. Ultrasound guidance was used in all of the series described in Table 1. Outcomes were patient-reported and consisted of various measures of pain and satisfaction.
The largest series identified was reported by Pasquali et al (2015), who described a retrospective 2-center case series of 508 patients who received ultrasound-guided alcohol injection from 2001 to 2012 for Morton neuroma.7, Eligible patients presented with 2nd or 3rd web space symptoms and had failed 3 months of conservative treatment with insoles and nonsteroidal anti-inflammatory drugs. Patients were injected with a 50% alcohol plus mepivacaine solution, with a mean of 3 injections (range, 1-4 injections) per neuroma. Pain at the Morton neuroma site was assessed on a visual analog scale (VAS) ranging from 0 to 10, by local adverse reactions at 1 week postprocedure (0 = no reaction; 1 = minimal swelling, pain, redness; 2 = significant swelling, pain redness), and patient-reported satisfaction. Pain scores improved from a mean preinjection VAS score of 8.7 to a mean postinjection score of 3.6 at 1 year (change in VAS score, p<0.001). At 1 year postinjection, 74.5% of patients were completely satisfied with the procedure. Fifty (9.3%) feet eventually required operative excision.
Study | N | Treatment | Mean FU, mo | Results | Surgical FU, n (%) |
Perini et al(2016)8, | 220 | Alcohol, lidocaine | 19 | • Median NRS pain score improved from 9 to 3• 88.6% reported reductions in limitations of everyday activities• Reduction in neuropathic pain (100% to 45%)• No change in nociceptive pain (47% to 53%) | 14 (6) |
Pasquali et al(2015)7, | 508 | Alcohol, mepivacaine | 12 | • Mean VAS pain score improved from 8.7 to 3.6• 74.5% completely satisfied | 50 (9) |
Musson et al(2012)9, | 75 | Alcohol, bupivacaine | 14 | • Mean VAS pain score improved from 8.5 to 4.2• 32% complete symptom relief; 33% partial relief; 35% no relief | 17 (20) |
Hughes et al(2007)10, | 101 | Alcohol, bupivacaine | 12 | • Mean VAS pain score improved from 8 to 0• 84% "essentially pain free"; 8% "mild/moderate pain"; 8% "no difference" | 3 (3) |
Fanucci et al(2004)11, | 40 | Alcohol, carbocaine | 10 | • 21 completely satisfied; 9 satisfied with minor complications; 6 satisfied with major complications; 4 dissatisfied | 4 (10) |
FU: follow-up; NRS: numeric rating scale; VAS: visual analog scale.
Morgan et al (2014)12, reported on a systematic review that included the studies above published through February 2012 plus another by Dockery (1999)13, and compared the need for subsequent surgery after alcohol injections for Morton neuroma with or without ultrasound guidance. Reviewers concluded that use of ultrasound guidance for alcohol injections to treat Morton neuroma could reduce the need for subsequent surgery better than unguided treatments.
For individuals who have Morton neuroma who receive intralesional alcohol injection(s), the evidence includes retrospective case series. Relevant outcomes are symptoms, resource utilization, and treatment-related morbidity. The body of evidence is limited, consisting of case series reporting on the treatment response of patients with refractory Morton neuroma. The available series have generally reported that some patients experience pain relief and express satisfaction with the procedure. Some evidence has suggested that surgery after failed cases of alcohol injections is more complex and challenging than in untreated patients due to the presence of fibrosis. There is a lack of controlled trials comparing alcohol injections with alternative therapies, and there are no controlled studies comparing outcomes for alcohol injections with those for surgery in surgical candidates. The evidence is insufficient to determine the effects of the technology on health outcomes.
[ ] MedicallyNecessary | [X] Investigational |
In response to requests, input was received from 2 specialty societies and 5 academic medical centers while this policy was under review in 2015. Input was consistent that the use of alcohol injections to treat Morton neuroma is investigational.
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.
The Association of Extremity Nerve Surgeons issued practice guidelines (2020 ) which drew the following conclusions about alcohol injections.14, [ :
"The literature regarding alcohol injections is equivocal. There may be some short-term positive effect, but longterm effect is poor for this therapy. Some of the literature recommends using 30% alcohol solution to get effective results. However, new research has shown the use of 30% ethanol alcohol does not create any measurable change in the histology of nerve tissue. There is also moderate risk of necrosis of surrounding tissues.[60] As a general rule, we do not advocate the use of alcohol injections."
U.S. Preventive Services Task Force Recommendations
Not applicable.
There is no national coverage determination. In the absence of a national coverage determination, coverage decisions are left to the discretion of local Medicare carriers.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in April 2021 did not identify any ongoing or unpublished trials that would likely influence this review.
Codes |
Number |
Description |
CPT |
64632 |
Destruction by neurolytic agent, plantar common digital nerve |
HCPCS |
|
|
ICD-10-CM |
|
Investigational for all diagnoses |
|
G57.60-G57.63 |
Lesion of plantar nerve code range (include Morton metatarsalgia) |
ICD-10-PCS |
|
ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure. |
As per correct coding guidelines.
Date |
Action |
Description |
07/07/23 | Annual review | No changes since last year except for a paragraph added in Rationale Section for promotion of greater diversity and inclusion in clinical research of historically marginalized groups. |
07/11/22 | Annual review | This policy has been placed in Sunset Status. Please refer to policy # 07.001.117 for pertinent information. Policy is currently archived. |
07/13/21 | Annual review | Policy updated with literature review through April 24, 2021; references added. Policy statement unchanged. Potential for archive discussed. Need for policy affirmed. |
07/06/20 |
Annual review |
Policy updated with literature review through April 1, 2020, no references added. Policy statement unchanged. |
06/04/20 |
Annual review |
No changes |
06/22/19 |
Annual review |
Policy updated with literature review through April 1, 2019, no references added. Policy statement unchanged. Title changed to Alcohol Injections for Treatment of Peripheral Morton Neuromas. |
06/14/18 |
Annual review |
Policy updated with literature review through April 9, 2018; no references added; reference 19 updated. Policy statement unchanged. |
11/16/17 |
|
|
07/03/15 |
Created |
New policy |