Policy title: Restorative Neurostimulation Therapy

Policy number: MA 1.034

Fecha de entrada en vigor: 8/1/2026

Política

Restorative neurostimulation therapy (ReActiv8) is considered investigational as there is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Esta política médica se aplica a los planes Medicare Advantage ofrecidos por Capital Blue Cross y sus subsidiarias.

Descripción/Antecedentes

Restorative neurostimulation for chronic lower back pain attributed to multifidus dysfunction

Restorative neuromodulation therapy (ReActiv8) uses an implanted device to deliver electrical stimulation to the nerves controlling the multifidus muscles of the lumbar spine. It is proposed that restorative neuromodulation reduces pain by triggering contractions of the multifidus muscles to restore neuromuscular control and help stabilize the spine. It is intended for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptom relief.

Regulatory status for restorative neurostimulation devices

In 2020, the ReActiv8 (Mainstay Medical) was FDA approved through the Premarket Approval (PMA) process (PMA P190021) for individuals with intractable chronic low back pain associated with multifidus dysfunction for whom available low back pain treatments do not provide sufficient or durable symptom relief. FDA Product Code: QLK

Fundamento

Resumen de la evidencia

For individuals who have chronic pain conditions including low back pain who receive restorative neurostimulation therapy (ReActiv8), the evidence includes 1 sham-controlled RCT (N = 204), 1 open-label RCT (N=203), 1 prospective single-arm trial (N = 53), and a case series (N = 44). Relevant outcomes are symptoms, functional outcomes, quality of life, and medication use. In the sham-controlled RCT, there was no difference between groups on the primary endpoint of treatment response at 120 days, defined as the composite of 30% or greater reduction in VAS and no increase in pain medications (57.1% intervention vs 46.6% sham; p =.1377). Prespecified secondary analyses of primary outcome data favored the intervention group, but clinical significance is unclear. An uncontrolled follow-up phase of the RCT reported continued improvement in pain scores through 3 years but results are at high risk of bias due to lack of a control group and high attrition. The open-label RCT showed statistically significant improvements in the treatment arm compared to the control arm in the primary and secondary outcomes. However, limitations included lack of blinding, imbalance in baseline depression between treatment and control arms, and greater clinical contact than standard management protocols in the treatment arm. Nonrandomized studies are limited by lack of blinding, no sham control, high attrition. and small sample sizes. Additional evidence from longer-term sham controlled RCTs is needed. Las pruebas son insuficientes para determinar que la tecnología da lugar a una mejora en el resultado neto para la salud.

Definiciones

N/D

Exención de responsabilidad

Las políticas médicas de Capital Blue Cross se utilizan para determinar la cobertura de tecnologías, procedimientos, equipos y servicios médicos específicos. Estas políticas médicas no constituyen un consejo médico y están sujetas a cambios según lo permita la ley o la evidencia clínica aplicable de las pautas de tratamiento independientes. Los proveedores que brindan tratamiento son individualmente responsables de los consejos médicos y el tratamiento de los miembros. Estas políticas no son una garantía de cobertura o pago. El pago de las reclamaciones está sujeto a la determinación del programa de beneficios del miembro y la elegibilidad en la fecha del servicio, y a la determinación de que los servicios son médicamente necesarios y apropiados. El procesamiento final de una reclamación se basa en los términos del contrato que se aplican al programa de beneficios de los miembros, incluidas las limitaciones y exclusiones de beneficios. Si un proveedor o miembro tiene alguna pregunta sobre esta política médica, debe comunicarse con Servicios para proveedores o Servicios para miembros de Capital Blue Cross.

Información de codificación

Nota: Esta lista de códigos no es exhaustiva y puede cambiar de vez en cuando según lo permita la ley o las pautas clínicas aplicables. La inclusión de un código en esta sección no constituye una garantía de cobertura o pago. Además, no todos los servicios cubiertos son elegibles para un reembolso por separado.

Se considera de investigación para microcirugía fisiológica linfática y, por lo tanto, no está cubierto.

Referencias

1. Gilligan C, Volschenk W, Russo M, et al. Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial. Neuromodulation. Enero de 2023; 26(1): 87-97. PMID 35088722
2. Gilligan C, Volschenk W, Russo M, et al. Three-Year Durability of Restorative Neurostimulation Effectiveness in Patients With Chronic Low Back Pain and Multifidus Muscle Dysfunction. Neuromodulation. Jan 2023; 26(1): 98-108. PMID 36175320
3. Gilligan C, Volschenk W, Russo M, et al. Five-Year Longitudinal Follow-Up of Restorative Neurostimulation Shows Durability of Effectiveness in Patients With Refractory Chronic Low Back Pain Associated With Multifidus Muscle Dysfunction. Neuromodulation. 2024;27(5):930-943. doi:10.1016/j.neurom.2024.01.006
4. Schwab F, Mekhail N, Patel KV, et al. Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction. Pain Ther. Feb 2025; 14(1): 401-423. PMID 39812968
5. Deckers K, De Smedt K, Mitchell B, et al. New Therapy for Refractory Chronic Mechanical Low Back Pain-Restorative Neurostimulation to Activate the Lumbar Multifidus: One Year Results of a Prospective Multicenter Clinical Trial. Neuromodulation. Enero de 2018; 21(1): 48-55. PMID 29244235
6. Thomson S, Chawla R, Love-Jones S, et al. Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort. Pain Ther. Dec 2021; 10(2): 1451-1465. PMID 34478115
7. Mitchell B, Deckers K, De Smedt K, et al. Durability of the Therapeutic Effect of Restorative Neurostimulation for Refractory Chronic Low Back Pain. Neuromodulation. Agosto de 2021; 24(6): 1024-1032. PMID 34242440
8. Ardeshiri A, Shaffrey C, Stein KP, et al. Real-World Evidence for Restorative Neurostimulation in Chronic Low Back Pain-a Consecutive Cohort Study. World Neurosurg. Dec 2022; 168: e253-e259. PMID 36184040
9. National Institute for Health and Care Excellence. 2022 Neurostimulation of lumbar muscles for refractory nonspecific chronic low back pain: Interventional Procedures Guidance. https://www.nice.org.uk/guidance/ipg739.
10. Lorio M, Lewandrowski KU, Coric D, Phillips F, Shaffrey CI. International Society for the Advancement of Spine Surgery Statement: Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting From Neuromuscular Instability. Int J Spine Surg. 2023;17(5):728-750. doi:10.14444/8525
11. Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain [published correction appears in J Pain Res. 2022 Dec 24;15:4075-4076. doi: 10.2147/JPR.S402370]. J Pain Res. 2022;15:3729-3832. Published 2022 Dec 6. doi:10.2147/JPR.S386879

Historial de políticas

• MA 1.161
• 03/02/2026 New policy to address Reactiv8 device as investigational.

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