Description　
Neural therapy involves the injection of a local anesthetic such as procaine or lidocaine into various tissues such as scars, trigger points, acupuncture points, tendon and ligament insertions, peripheral nerves, autonomic ganglia, the epidural space and other tissues to treat chronic pain. Neural therapy has been proposed for other chronic illness syndromes such as allergies, infertility, tinnitus, depression, and chronic bowel problems. When the anesthetic agent is injected into traditional acupuncture points, this treatment may be called neural acupuncture.

For individuals who have chronic pain or illness 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. 

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.

Policy
Neural therapy is considered INVESTIGATIONAL for all indications.

Policy Guidelines
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.

Coding
Please see the Codes table for details.

Rationale 
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 1 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.

Clinical Context and Therapy Purpose
The purpose of neural therapy in patients with chronic pain 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 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 review.

Populations
The relevant population of interest is individuals who have chronic pain or other chronic illnesses (e.g., allergies, infertility, tinnitus, multiple sclerosis, depression, and chronic bowel problems).

Interventions
The therapy being considered is injection of local anesthetics (e.g., procaine, lidocaine) for neural therapy.

Comparators
The comparators currently being used include standard medical management, injection of other substances such as normal saline or corticosteroids, or exercise-based modalities.

Outcomes
The outcomes of interest are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

Study Selection Criteria
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.

Review of Evidence
Randomized Controlled Trials
Boluk Senlikci et al. (2021) conducted a single center, randomized, nonblinded, controlled trial in Turkey that compared neural therapy (20 mL of local anaesthetic, 1:100 mixture of 10 mg/mL procaine) plus a hand rest and thumb spica splint (n = 20) or a hand rest and thumb spica splint alone (n = 19) in patients with De Quervain tenosynovitis.² Although the Duruoz Hand Index (DHI) score was lower in the neural therapy group at 1 month (8.94 vs 16.61; p = .009), scores were similar at 12 months (8.83 vs 12.66; p = .252). Key limitations of this trials include that the important outcomes of quality of life and function were not addressed and that the study was unblinded.

Altinbilek et al. (2019) conducted a multicenter, randomized controlled trial that compared neural therapy (with lidocaine 0.5%) plus exercise (n = 42) to exercise alone (n = 30) in patients with fibromyalgia.³ At 6 weeks, visual analogue pain scale (p = 0.038) and Beck Depression Scale (p = 0.049) scores were significantly reduced with neural therapy compared to the control group. At 10 weeks, there were no significant differences among groups in pain, quality of life, functional status, or depression or anxiety scores.

A randomized controlled trial by Nazlikul et al. (2018) compared the efficacy of neural therapy (6 sessions, n = 51) plus stretching to stretching alone (n = 51) in patients with low back pain due to piriformis syndrome.⁴ At the end of treatment, visual analogue pain scale (6.3 ± 7.5 vs 37.2 ± 10.4; p < 0.01) and Oswestry Disability Index (range 0 to 100; 15.2 ± 8.5 vs 32.2 ± 11.9; p < 0.01) scores were significantly improved with neural therapy compared to stretching alone.

Montenegro et al. (2015) conducted a randomized controlled trial to compare the effect of trigger point injection (with lidocaine 0.5%, once weekly for 4 weeks) to ischemic compression physical therapy (PT) followed by transcutaneous electrical nerve stimulation (given 4 times weekly for 4 weeks) in 30 women with chronic pelvic pain and abdominal wall trigger points.⁵ The trial was stopped early after results showed superiority in the trigger point injection group. Clinical response (defined as visual analogue pain scale reduction of at least 50% or significant subjective improvement in daily life activities) was significantly better in the trigger point injection group compared to the PT group at 1 week after treatment (80% vs 40%; p = 0.018), 4 weeks after treatment (80% vs 40%; p = 0.018), and 12 weeks after treatment (73.3% vs 13.3%; p = 0.00006). Differences in visual analogue pain scores were significant between groups at weeks 4 and 12 (both p < 0.01).

Nonrandomized Trials
A retrospective cohort study by Batur et al. (2020) compared the effect of neural therapy (with lidocaine 1%) and PT among 60 women with fibromyalgia, both in combination with a home exercise regimen.⁶ Efficacy after 4 weeks was evaluated with a visual analogue pain scale, Short Form 36 (SF-36) scores, and Fibromyalgia Impact Questionnaire (range 0 to 100) scores. Visual analogue scale (mean 3.70 ± 2.21 versus 5.10 ± 1.68; p = 0.003) and Fibromyalgia Impact Questionnaire (mean 40.73 ± 18.39 versus 46.00 ± 15.97; p = 0.008) scores were significantly reduced with neural therapy compared to PT. Several SF-36 subscores were significantly improved with neural therapy compared to PT including physical functioning (p = 0.046), energy/fatigue (p = 0.005), emotional well-being (p = 0.02), bodily pain (p = 0.047), and general health (p = 0.013).

Egli et al. (2015) reported on a series of 280 patients with chronic severe pain who had failed conventional medical measures.⁷ The most common reason for referral to the academic center in Europe was back pain, and more than two-thirds of patients had undergone PT, 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.

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.⁸ 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, comparability between groups at baseline and a placebo control.

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, multiple sclerosis, 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 randomized and nonrandomized trials. 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 that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
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.

American College of Obstetricians and Gynecologists
In 2020, the American College of Obstetricians and Gynecologists practice bulletin on chronic pelvic pain recommends trigger point injections (alone or in combination with other treatments) for improving pain and function in patients with myofascial chronic pelvic pain (Level A recommendation — based on good and consistent scientific evidence).⁹ In particular, trigger point injections may be effective for pelvic floor muscle spasm that is refractory to pelvic floor PT and medications. Injection at trigger points in the abdominal wall may be more effective than ischemic compression PT. Examples of medications that can be used for this type of injection include saline, anesthetics, steroids, or opioids; no medication is specifically recommended for or against and the guideline authors speculate that needle injection may itself account for some of the therapeutic effect. Symptom relief may occur rapidly after the first dose, but full benefit may require repeated doses.

American Academy of Neurology
In 2014, the American Academy of Neurology guideline on complimentary and alternative therapies for multiple sclerosis stated that there is insufficient evidence to support or refute the efficacy of neural therapy.¹⁰ Due to inadequate data, the guideline classifies neural therapy treatment as ‘unproven’ for this indication. The evidence reviewed was limited to a single Class III study (controlled study with independent outcome assessment) that evaluated the effect of neural therapy on disability in patients with all forms of multiple sclerosis.¹¹ Among 61 patients with various forms of multiple sclerosis, 69% had improved Expanded Disability Status Scores which were sustained in 29% of patients during long-term follow-up (2 to 3.5 years).

North American Spine Society
In 2020, the North American Spine Society guideline on the diagnosis and treatment of low back pain states that evidence is insufficient to make a recommendation for or against treatment with trigger point injections (Grade I recommendation — insufficient or conflicting evidence not allowing a recommendation for or against the intervention).¹² Neural therapy and local anesthetic injections are not specifically mentioned, but the guideline reviewed 1 randomized study (Level II evidence) that compared a single treatment with lidocaine, lidocaine combined with a steroid, a dry needle (acupuncture), and vapocoolant spray plus acupressure.¹³ After 2 weeks, pain was improved by 40% to 60% in all groups. Based on this study, the guideline authors concluded that outcomes are similar regardless of the medication used for the trigger point injection.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that may influence this review are listed in Table 1.

References: 

1. Frank BL. Neural therapy. Phys Med Rehabil Clin N Am. Aug 1999; 10(3): 573-82, viii. PMID 10516978
2. Altinbilek T, Terzi R, Basaran A, et al. Evaluation of the effects of neural therapy in patients diagnosed with fibromyalgia. Turk J Phys Med Rehabil. Mar 2019; 65(1): 1-8. PMID 31453538
3. Nazlikul H, Ural FG, Ozturk GT, et al. Evaluation of neural therapy effect in patients with piriformis syndrome. J Back Musculoskelet Rehabil. 2018; 31(6): 1105-1110. PMID 30010101
4. Montenegro ML, Braz CA, Rosa-e-Silva JC, et al. Anaesthetic injection versus ischemic compression for the pain relief of abdominal wall trigger points in women with chronic pelvic pain. BMC Anesthesiol. Dec 01 2015; 15: 175. PMID 26628263
5. Balevi Batur E, Atan T. Neural therapy for fibromyalgia: myth or improving quality of life?. Int J Clin Pract. Sep 21 2020: e13719. PMID 32955788
6. 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
7. 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. 2013; 10(3): 431-5. PMID 24146471
8. American Association of Orthopaedic Medicine. Neural Therapy. 2013; http://www.aaomed.org/Neural-therapy. Accessed September, 2020.
9. Learman LA, McHugh KW. Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. Mar 2020; 135(3): e98-e109. PMID 32080051
10. Yadav V, Bever C, Bowen J, et al. Summary of evidence-based guideline: complementary and alternative medicine in multiple sclerosis: report of the guideline development subcommittee of the American Academy of Neurology. Neurology. Mar 25 2014; 82(12): 1083-92. PMID 24663230
11. Gibson RG, Gibson SL. Neural therapy in the treatment of multiple sclerosis. J Altern Complement Med. Dec 1999; 5(6): 543-52. PMID 10630348
12. North American Spine Society. Diagnosis and treatment of low back pain. 2020. Accessed September 15, 2020.
13. Garvey TA, Marks MR, Wiesel SW. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain. Spine (Phila Pa 1976). Sep 1989; 14(9): 962-4. PMID 2528826

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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