Coverage Policy Manual
Policy #: 2011079
Category: Medicine
Initiated: December 2011
Last Review: October 2018
  Neural Therapy

Description:
Neural therapy involves the injection of a local anesthetic such as procaine or lidocaine into scars, trigger points, acupuncture points, tendon and ligament insertions, peripheral nerves, autonomic ganglia, the epidural space, and other tissues to treat chronic pain and illness. When the anesthetic agent is injected into traditional acupuncture points, this treatment may be called neural acupuncture.
 
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 reestablish the normal resting potential of nerves and flow of energy. Alternative theories include fascial continuity, the ground (matrix) system, and the lymphatic system (Frank, 1999).
 
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.
 

Policy/
Coverage:
Neural therapy or neural acupuncture for the treatment of chronic pain and illness does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, neural therapy or neural acupuncture for the treatment of chronic pain and illness is considered investigational.  Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Note: 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 one session to a series of sessions over a period of weeks or months.
 
 

Rationale:
This policy was created with a search of the MEDLINE database through October 2011. 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.
 
One English language report from 1999 describes a small double-blind, randomized placebo-controlled cross-over trial in 21 patients with multiple sclerosis (Gibson, 1999). 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 one 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. At the time of publication, the authors reported having treated more than 300 patients with multiple sclerosis with this approach.
 
In a case series from 1990, Arnér and colleagues reported prolonged relief of neuralgia after regional anesthetic blocks in 25 of 38 patients (Arner, 1990). All patients had neuralgia due to nerve injury (endogenous entrapment or surgical or accidental trauma) with a mean pain duration of 3.8 years (range, 6 months to 12 years). All patients had a demonstrable sensory deficit or sensory hyperfunction within the cutaneous territory supplied by the injured nerve measured by quantititative sensory testing (QST). None of the patients had the classical type of complex regional pain syndrome (previously called reflex sympathetic dystrophy). Each patient received a series of 2-23 blocks (median 5.2 blocks) of bupivacaine. Sixteen patients experienced subjective improvement for weeks to months after the series of blocks, but a second series of blocks was effective in only 7 of these patients. Four of the 7 reported sustained improvement after 1-4 years. Thirty of the 38 patients did not experience long-lasting pain relief and were subsequently treated with transcutaneous electrical nerve stimulation (TENS). The authors concluded that nerve blocks with local anesthetics rarely provide long-term, complete relief of neuralgia.
 
In 2011, Schmittinger and colleagues reported a case of brainstem hemorrhage following neural therapy for decreased libido (Schmittinger, 2011).  
 
Summary
Neural therapy is an alternative medicine modality that involves the injection of a local anesthetic into various tissues to treat chronic pain and illness. There are few English language reports, and the available evidence is insufficient to permit conclusions concerning the health benefit of this procedure.
 
2012 Update
A literature search was done on PubMed through September 2012.  There was no new information identified that would prompt a change in the coverage statement.
 
2013 Update
A literature search was conducted using the MEDLINE database through September 2013. There was no new information identified that would prompt a change in the coverage statement. One RCT was identified.
 
In 2012, Hui and colleagues reported a non-blinded randomized controlled trial of complementary and alternative medicine (CAM) for chronic herpes zoster-related pain (Hui, 2012). The 59 patients included in the trial had a confirmed diagnosis of herpes zoster of at least 30 days in duration (median of 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, and Chinese herbs) and meditation. A wait-list control group received the same treatment beginning 3 weeks after randomization. Intent-to-treat analysis of pain scores at 3 weeks showed significant improvement in the CAM group (baseline: 7.5, post-treatment: 2.3), with little change in the waitlist 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 1-2 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 non-blinded study.
 
2014 Update
A literature search conducted through March 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
One ongoing randomized control clinical trial (NCT02087462) was identified that is a multicenter RCT with 3 groups to determine the effectiveness and health economic evaluation of the electroacupuncture for sciatica due to intervertebral disc displacement in a population of adults aged 18-65. 324 participants who meet the inclusion criteria will be randomly allocated into 3 different groups, namely electroacupuncture group, electroacupuncture & traction group, electroacupuncture & traction & oral medication group.
 
All participants will receive six-week treatment, the participants in electroacupuncture group will receive electroacupuncture only, electroacupuncture & traction group will receive both electroacupuncture and traction, and in electroacupuncture & traction & oral medication group all of the three therapies are adopted.
 
The statistical analysis will be conducted by a third party who is masked to the allocation of participants.
 
2014 Update
A literature search conducted through November 2014 did not reveal any new information that would prompt a change in the coverage statement.
 
2015 Update
A literature search conducted through November 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Egli and colleagues reported on a series of 280 patients with chronic severe pain who had failed conventional medical measures (Elgi, 2015).  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, physiotherapy, osteopathy or chirotherapy. After an average of 9.2 treatments (range, 1 to 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.
 
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in November 2015 did not identify any ongoing or unpublished trials that would likely influence this review.
 
2017 Update
A literature search conducted using the MEDLINE database through November 2017  did not reveal any new information that would prompt a change in the coverage statement.
 
2018 Update
A literature search was conducted through September 2018.  There was no new information identified that would prompt a change in the coverage statement.   

References: Arner S, Lindblom U, Meyerson BA et al.(1990) Meyerson BA et al. Prolonged relief of neuralgia after regional anesthetic blocks. A call for further experimental and systematic clinical studies. Pain 1990; 43(3):287-97.

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

Frank BL(1999) Neural therapy. Phys Med Rehabil Clin North Am 1999; 10(3):573-82, viii.

Gibson RG, Gibson SL.(1999) Neural therapy in the treatment of multiple sclerosis. J Altern Complement Med 1999; 5(6):543-52.

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

Schmittinger CA, Schar R, Fung C et al.(2011) Brainstem hemorrhage after neural therapy for decreased libido in a 31-year-old woman. J Neurol 2011; 258(7):1354-5.


Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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