Surgery Section - Pulsed Radiofrequency for Facet Joint Denervation

IMPORTANT REMINDER

This Medical Policy has been developed through consideration of medical necessity, generally accepted standards of medical practice, and review of medical literature and government approval status.

Benefit determinations should be based in all cases on the applicable contract language. To the extent there are any conflicts between these guidelines and the contract language, the contract language will control.

The purpose of medical policy is to provide a guide to coverage. Medical Policy is not intended to dictate to providers how to practice medicine. Providers are expected to exercise their medical judgment in providing the most appropriate care.

DESCRIPTION

Percutaneous radiofrequency (RF) facet denervation is a procedure used to treat neck or back pain originating in facet joints.  Probe tip temperatures for thermal radiofrequency denervation reach 60°C and are intended to produce long-term pain relief through coagulation of tissue. Percutaneous radiofrequency denervation may be considered a standard of care for the treatment of chronic neck and back facet joint pain which has not responded to at least three months of conservative medical management. Pulsed radiofrequency is an alternative therapy being considered as a possible safer treatment to thermal percutaneous radiofrequency denervation. Pulsed radiofrequency consists of short bursts of electrical current of high voltage in the radiofrequency range but without heating the tissue enough to cause coagulation. Temperatures for pulsed radiofrequency do not exceed 42°C at the probe tip versus temperatures in the 60°s C reached in thermal radiofrequency denervation. In addition, with pulsed radiofrequency, tissues may cool between pulses. It is postulated that with pulsed radiofrequency denervation transmission across small unmyelinated nerve fibers is disrupted but not permanently damaged, while large myelinated fibers are not affected.

Note: This policy does not address conventional percutaneous radiofrequency facet denervation which may be considered medically necessary for the treatment of facet joint pain that is not responding to conservative treatments.

POLICY/CRITERIA

Pulsed radiofrequency denervation is considered investigational for the treatment of chronic spinal/back pain.

POSITION SUMMARY

The principal outcome for treatment of pain is symptom relief and improved functional level. Relief of pain is a subjective outcome that is typically associated with a placebo effect. Therefore blinded and randomized controlled trials (RCTs) are important to control for the placebo effect and determine its magnitude and to determine whether any treatment effect provides a significant advantage over the placebo.  In addition, trials comparing currently available treatments with pulsed radiofrequency (RF) therapy are important to determine the overall effectiveness of this therapy for the treatment of chronic facet joint pain.

A search of the MEDLINE database identified one small RCT comparing pulsed radiofrequency to placebo treatment. Van Zundert and colleagues randomized 23 patients (of 256 screened) with chronic cervical radicular pain. (1,2)Success was defined as at least 50% improvement on global perceived effect (GPE), at least 20% reduction in pain on visual analog scale (VAS), and reduced pain medication use measured 3 months after treatment. Nine of 11 patients in the treatment arm and 4 of 12 in the sham arm showed at least 50% improvement on GPE (P=0.03), and 9 of 11 in the treatment group and 3 of 12 in the sham group achieved at least 20% reduction in pain on VAS (P=0.02). At 6 month follow-up, more patients in the treatment group reduced their use of pain medication, but the difference was not significant. There was a trend toward more positive outcomes in the pulsed RF group on quality of life scores. The authors conclude that pulsed RF may provide pain relief for a limited number of carefully selected patients. These findings must be confirmed in larger studies before drawing conclusions regarding the efficacy of pulsed RF.

Two studies comparing conventional percutaneous RF and pulsed RF were identified in the literature review. Tekin and colleagues randomized sixty patients, 20 each to conventional RF, pulsed RF and a control group (local anesthetic only). (3) Outcome measures were pain on VAS and Oswestry Disability Index (ODI) scores. Mean VAS and ODI scores were lower in both treatment groups than in controls post treatment, however the reduction in pain was maintained at 6- and 12-month follow-up only in the conventional RF group. The number of patients not using analgesics and patient satisfaction were highest in the conventional RF group. A second randomized, double blind, prospective trial by Kroll and colleagues compared conventional radiofrequency denervation with pulsed radiofrequency for the treatment of lumbar back pain. (4) This trial reported no statistically significant difference in long-term VAS outcomes between those receiving conventional radiofrequency and those receiving pulsed radiofrequency. However a greater improvement over time in the VAS was noted within the conventional radiofrequency group compared to VAS over time within the pulsed RF group.

In summary, the available evidence is limited and inconclusive with regard to the use of pulsed radiofrequency denervation for the treatment of chronic facet joint pain. Larger, randomized controlled trials are needed to validate the long-term effectiveness of this strategy for the treatment of chronic facet joint pain.

References

1. BlueCross and BlueShield Association Medical Policy Reference Manual, Policy No. 7.01.116
2. Van Zundert J, Patijn J, Kessels A et al. Pulsed radiofrequency adjacent to the cervical root ganglion in chronic cervical radicular pain: a double-blind sham controlled randomized clinical trial. Pain 2007; 127(1-2):173-82
3. Tekin I, Merzai H, Ok G et al. A comparison of conventional and pulsed radiofrequency denervation in the treatment of chronic facet joint pain. Clin J Pain 2007; 23(6):524-9
4. Kroll HR, Kim D, Danic MJ et a1. A randomized, double-blind, prospective study comparing the efficacy of continuous versus pulsed radiofrequency in the treatment of lumbar facet syndrome. J Clin Anesth 2008;20(7):534-7

Cross References

None

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