Background

The practice of neural therapy is based on the belief that energy flows freely through the body. It is proposed that injury, disease, malnutrition, stress, and scar tissue disrupt this flow, creating disturbances in the electrochemical function of tissues and energy imbalances called “interference fields.” Injection of a local anesthetic is believed to re-establish the normal resting potential of nerves and flow of energy. Alternative theories include fascial continuity, the ground (matrix) system, and the lymphatic system.^1,

There is a strong focus on treatment of the autonomic nervous system, and injections may be given at a location other than the source of the pain or location of an injury. Neural therapy is promoted mainly to relieve chronic pain. It has also been proposed to be helpful for allergies, hay fever, headaches, arthritis, asthma, hormone imbalances, libido, infertility, tinnitus, chronic bowel problems, sports or muscle injuries, gallbladder, heart, kidney, or liver disease, dizziness, depression, menstrual cramps, and skin and circulation problems.

Regulatory Status

Neural therapy is a procedure and, as such, is not subject to regulation by the U.S. Food and Drug Administration.

Related Policies

• Prolotherapy (Policy #063 in the Treatment Section)
• Autonomic Nervous System Testing (Policy #085 in the Medicine Section)
• Intravenous Anesthetics for the Management of Chronic Pain and Depression (Policy #035 in the Drugs Section)

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

Policy Guidelines: (Information to guide medical necessity determination based on the criteria contained within the policy statements above.)

Neural therapy should be distinguished from the use of peripherally injected anesthetic agents for nerve blocks or local anesthesia. The site of the injection for neural therapy may be located far from the source of the pain or injury. The length of treatment can vary from 1 session to a series of sessions over a period of weeks or months.


[RATIONALE: This policy was created in 2012 and has been updated regularly with searches of the MEDLINE database. The most recent literature update was performed through September 23, 2019.

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, two 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.

Neural Therapy

Neural therapy is an alternative medicine modality that was developed in Germany and is most commonly reported in Europe. Most of the literature on neural therapy consists of non-English-language publications.

Clinical Context and Therapy Purpose

The purpose of neural therapy in patients who have chronic pain or illness is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does the use of neural therapy improve the net health outcome in patients with chronic pain or illness?

The following PICO was used to select literature to inform this policy.

Patients

The relevant population of interest is individuals with chronic pain or illness.

Interventions

The therapy being considered is neural therapy.

Comparators

The following practice is currently being used to treat chronic pain or illness: standard medical management.

Outcomes

The general outcomes of interest are improvements in functional outcomes and reductions in pain or illness as well as medication use. Follow-up varies by indication and by the number of injections required. Treatment may require a single or series of anesthetic injections over weeks or months.

Randomized Controlled Trials

Hui et al (2012) reported a nonblinded randomized controlled trial of complementary and alternative medicine for chronic herpes zoster-related pain.^2, The 59 patients included in the trial had a confirmed diagnosis of herpes zoster of at least 30 days in duration (median, 4.8 months; range, 1 month to 15 years) and with at least moderate postherpetic neuralgia pain (≥4 on a 10-point Likert scale). The therapy included 3 weeks of neural therapy (injection of 1% procaine at up to 6 points along the affected dermatome) along with other therapies from traditional Chinese medicine (i.e., acupuncture, cupping and bleeding, Chinese herbs) and meditation. A wait-list control group received the same treatment beginning 3 weeks after randomization. Intention-to-treat analysis of pain scores at 3 weeks showed significant improvement in the complementary and alternative medicine group (baseline, 7.5; posttreatment, 2.3), with little change in the wait-list control group (baseline, 7.8; 3 weeks, 7.2). A reduction in pain of at least 50% was observed in 66.7% of patients in the treatment group compared with 8.7% in the control group. In the 56% of patients who responded to a questionnaire after 1 to 2 years, 78.8% reported continued relief of pain. Interpretation of the results is limited by the multiple interventions provided and the possibility of a placebo effect in this nonblinded study.

One English-language report by Gibson and Gibson (1999) described a small double-blind, randomized, placebo-controlled crossover trial in 21 patients with multiple sclerosis.^3, Anesthetic or saline was injected at acupuncture points in the ankle and at 14 or 15 points around the circumference of the head. Patients received 2 injections of anesthetic or saline in the first week; in the second week, all patients received anesthetic injections. At the end of the first week, 8 of 11 patients in the active treatment group and 1 of 10 in the placebo group had improved in 1 or more functions on the Kurtzke scale. Therapy was continued as needed for up to 3.5 years, with long-term improvements being reported in over 50% of patients.

Nonrandomized Trials

Egli et al (2015) reported on a series of 280 patients with chronic severe pain who had failed conventional medical measures.^4, The most common reason for referral to the academic center in Europe was back pain, and more than two-thirds of patients had undergone physical therapy (PT), osteopathy, or chirotherapy. After an average of 9.2 treatments (range, 1-40) in the first year, 126 patients reported that they were considerably better and 41 reported being pain-free. Of the 193 patients who were taking pain medications at the start of treatment, three-quarters had reduced pain medication or were taking no pain medication after 1 year.

A nonrandomized comparative study by Atalay et al (2013) compared neural therapy (n=33) with PT (n=27) for the treatment of chronic low back pain.^5, The average duration of symptoms before treatment was 13.78 months. Patients who had not previously been treated with PT were assigned to the PT group, and patients who had previously failed PT were assigned to the neural therapy group. PT consisted of exercises, hot pack, ultrasound, and transcutaneous electrical nerve stimulation over 15 sessions. Neural therapy consisted of anesthetic injection into scars, trigger points, and acupuncture points over 5 sessions. Outcome measurements included the visual analog score for pain, the Roland-Morris Disability Questionnaire for disability, the Nottingham Health Profile for quality of life, and the Hospital Anxiety Depression Scale for depression, anxiety, and quality of life. The neural therapy group exhibited greater disability and worse quality of life at baseline. Both groups improved over time, and there was greater improvement in the neural therapy group on some of the outcome measures. Interpretation of this study is limited due to lack of randomized treatment assignment, lack of comparability between groups at baseline, and lack of a placebo control.

Schmittinger et al (2011) reported on a case of brainstem hemorrhage following neural therapy for decreased libido.^6,

Summary of Evidence

For individuals who have chronic pain or illness (e.g., pain, allergies, hay fever, headaches, arthritis, asthma, hormone imbalances, libido, infertility, tinnitus, chronic bowel problems, sports or muscle injuries, gallbladder, heart, kidney, or liver disease, dizziness, depression, menstrual cramps, skin and circulation problems) who receive neural therapy, the evidence includes small randomized trials and a large case series. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. There are few English-language reports assessing the use of neural therapy for pain, and the available studies have methodologic limitations that preclude conclusions on efficacy. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION

Practice Guidelines and Position Statements

The American Association of Orthopaedic Medicine has described neural therapy on its website and provides a link for instructional courses on the procedure.^7,

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in October 2018 did not identify any ongoing or unpublished trials that would likely influence this review.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Neural Therapy
Neural Acupuncture

References:
1. Frank BL. Neural therapy. Phys Med Rehabil Clin N Am. Aug 1999;10(3):573-582, viii. PMID 10516978.

2. Hui F, Boyle E, Vayda E, et al. A randomized controlled trial of a multifaceted integrated complementary- alternative therapy for chronic herpes zoster-related pain. Altern Med Rev. Mar 2012;17(1):57-68. PMID 22502623.

3. Gibson RG, Gibson SL. Neural therapy in the treatment of multiple sclerosis. J Altern Complement Med. Dec 1999;5(6):543-552. PMID 10630348.

4. Egli S, Pfister M, Ludin SM, et al. Long-term results of therapeutic local anesthesia (neural therapy) in 280 referred refractory chronic pain patients. BMC Complement Altern Med. Jun 27 2015;15:200. PMID 26115657.

5. Atalay NS, Sahin F, Atalay A, et al. Comparison of efficacy of neural therapy and physical therapy in chronic low back pain. Afr J Tradit Complement Altern Med. Oct 2013;10(3):431-435. PMID 24146471.

6. Schmittinger CA, Schar R, Fung C, et al. Brainstem hemorrhage after neural therapy for decreased libido in a 31- year-old woman. J Neurol. Jul 2011;258(7):1354-1355. PMID 21286741.

7. American Association of Orthopaedic Medicine. Neural Therapy. 2013; http://www.aaomed.org/Neural-therapy. Accessed September, 2019.

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

There are no specific CPT codes for local anesthetics when injected in this fashion.

There are no specific HCPCS codes for local anesthetics when injected in this fashion.