Rates of Lumbar Radiofrequency Ablation on The Rise Despite Controversial Efficacy Data

Peer Reviewed

The total number of lumbar radiofrequency ablation (RFA) sessions performed in a large commercially insured population increased by approximately 131% between 2007 and 2016. The number of lumbar facet injections increased by 25% during this same period, a portion of which is attributable to the growth in RFA, the study researchers noted in the June issue of The Spine Journal.

Use of RFA to treat facet-mediated chronic low back pain is controversial, with some studies showing “large-magnitude, durable improvements in pain and functional limitation, but other studies demonstrating limited benefit of this treatment,” the study researchers explained.

spinal injection performed using fluoroscopyData suggests there may be an increase in use of diagnostic medial branch blocks and subsequent lumbar RFA. Photo Source: 123RF.com.

“Currently, there is limited data from high quality randomized controlled trials (RCTs) to demonstrate the efficacy of lumbar RFA,” explained senior author Janna L. Friedly, MD. “While there is some promising data from uncontrolled studies (primarily observational studies), RCTs are the gold standard for determining treatment efficacy. Despite this lack of RCT evidence, use of RFA and associated costs are steadily increasing over time as our study shows.”

“Our data suggest that there may be an increase in the use of diagnostic medial branch blocks and subsequent lumbar RFA versus an increase in use of therapeutic facet joint steroid injections, for which the efficacy data is even weaker and there are now insurance restrictions on their use,” Dr. Friedly told SpineUniverse. “In addition, it appears that a larger percentage of people who undergo lumbar RFA are having two or more diagnostic medial branch blocks prior to having RFA, which may improve patient selection for the procedure, but also increase the associated costs. Further studies will be needed to clarify the impact that these findings have on patient outcomes.”

Retrospective Cohort Study

The researchers retrospectively reviewed data from the IBM/Watson MarketScan Commercial Claims and Encounters Databases from 2007 to 2016. During this period, 165,734 out of 149,831,011 patients underwent lumbar RFA, and 501,273 patients received lumbar facet injections.

The total number of lumbar RFA procedures per 100,000 enrollees per year increased by approximately 131%—from 49 to 113 per 100,000 patients (Figure). The number of facet injection procedures increased by 25%—from 201 to 251 procedures per 100,000 patients (Figure). The overall cost for RFA procedures rose 12%—from $94,570 to $266,680 per 100,000 enrollees—and the cost of lumbar facet injections rose by 5%—from $257,280 to $396,580 per 100,000 enrollees.

The researchers noted an increasing trend in the number of patients who received two lumbar facet injection procedures prior to undergoing RFA—from 51% to 59%. This increase “may reflect physicians using more rigorous pre-RFA selection criteria.”

Bar chart shows total number of lumbar RFA sessions and lumbar facet joint procedures in 2006 and 2016Figure. Total number of lumbar RFA sessions and lumbar facet injection procedures performed in 2006 and 2016 in a large, commercially insured population. Source: Starr et al. Spine J. 2019;19(6):1019-1028.

Preventing Inappropriate Use of Radiofrequency Ablation

“Clearly, it is important to select patients carefully for this procedure and the majority of patients with symptoms of low back pain are not appropriate for lumbar RFA,” Dr. Friedly said. “Although there is still some controversy and lingering questions about how to best select patients for this procedure, most would agree that a careful history, physical examination, and at least one diagnostic medial branch block are essential in selecting people for lumbar RFA. In addition, it is important to recognize that there are a variety of alternative non-interventional treatments available to treat chronic low back pain, even when it is suspected facet-mediated pain.”

Study Limitations

“I think it is important to recognize that there are limitations to what we can conclude with claims-based data as we don’t have patient reported outcomes, but this data represents what is actually happening across the country so we can’t ignore these trends that we are observing,” Dr. Friedly said. “I think it is also important to note that we still don’t know with certainty how effective lumbar RFA is—there is a lack of data and the commonly cited data to support their use is very biased. This doesn’t mean that lumbar RFA is not effective for a subset of patients with facet-mediated pain, but it means that we have not yet proven that they are effective and there is concerning data that suggests that they are potentially being overused and adding to the high costs associated with treating low back pain.”

Unanswered Questions Regarding RFA

“There is a desperate need for a high-quality sham-controlled randomized controlled trial to determine the efficacy of lumbar RFA for facet-mediated pain,” Dr. Friedly said. The few randomized trials that have been done in the past are fraught with serious methodological issues that limit our ability to draw unbiased conclusions from them. Observational studies and uncontrolled studies are not sufficient to determine the efficacy of a pain intervention given the high placebo response associated with these types of treatments.”

“In addition, further research is needed to determine the best diagnostic algorithm (ie, how to best select patients for this procedure), and what combinations of treatments and in what sequence are most effective to manage chronic low back pain for the best outcomes and most value,” she said.

Disclosures
Dr. Friedly has no relevant disclosures.

COMMENTARY

Gerard Malanga, MD
Board Certified in Physical Medicine & Rehabilitation, Pain Medicine, Sports Medicine
Clinical Professor, Physical Medicine & Rehabilitation
Rutgers School of Medicine-NJ Medical School
New Jersey Sports Medicine, LLC
New Jersey Regenerative Institute
Cedar Knolls, NJ

The article by Starr et al describes the ever-increasing use of radiofrequency ablation procedures of the lumbar spine with decreasing outcomes. As with every area of medicine, selecting who is most likely to benefit from RFA is of utmost importance. Dr. Friedly specifically notes this in her comments. Unfortunately, with RFA, we have taken a kernel of science and watered it down.

In the classic study on RFA by Dreyfuss et al, he screened approximately 400 patients and ultimately performed RFA on only 15 patients whose pain was relieved by controlled, diagnostic medial branch blocks of the lumbar zygapophysial joints.1 In these well-selected patients, at least 90% pain relief was found in approximately 60% of patients and most (87%) obtained at least 60% pain relief.

In 2014, the International Spine Intervention Society (ISIS) recommended ≥80% relief of the index pain “using either placebo or anesthetics with varying lengths of activity (ie, bupivacaine longer than lidocaine) with ≥80% relief of the index pain.”2 In addition, the ISIS recommends that the practitioner “identify the local anesthetic used and the expected duration of response for diagnostic purposes.” The second block using a different anesthetic is needed because there are a lot of placebo responses by doing a single block. And if those two things were proven, patients did extraordinarily well up to at least a year as noted in the Dreyfuss study.

Unfortunately, in the pain community there was a push to reduce the criteria for pain relief on diagnostic blocks to ≥50%. In many cases, clinicians only perform one block (instead of two) often citing lack of coverage by insurance providers for this. Thus, many physicians fail to follow guidelines that have been established with the greatest likelihood of success. Quickly, RFA began being performed on a lot of people who were not likely to benefit from it. The study by Starr et al also highlights an increased use of facet injections. Facet joint injections have been shown to be of little benefit, other than limited short-term benefit.

This data demonstrates a lack of incentives for selective, evidenced-based treatment. Many of the procedures were performed on multiple levels and bilaterally. While these may be necessary in a limited number of cases, RFA or injections of multiple lumbar spine facet joints is certainly not specific and unlikely to produce a true positive response. This practice drives costs with little benefit. It is not excusable to not use the best techniques that have been well-described by the current medical literature. It appears that physicians are driven to do procedures based on a variety of influences. Some, unfortunately, are economic or practice driven and not necessarily in the best interest of the patient.

The increased use of RFA and facet joint injections is also reflective of the current backswing from the “opioid crisis” with the rationale that it is a nonopioid treatment of pain. We must not forget that like all procedures, facet injections and RFA have risks that can cause a harm, and if used unnecessarily, wasted cost. As in most areas of medicine, few clinicians obtain outcomes measures for these procedures, and there is no penalty for providing ineffective treatments.

In terms of what alternatives can be offered: first, patients should be given positive messages. Rather than focusing on incidental findings on X-rays and MRI scans, they should be directed to the many self-empowering activities they can do (rather than being passive recipients of care).

Treatment should emphasize the role of exercise programs that patients can do on their own, controlling weight, stretching, biofeedback, and other cognitive behavioral treatments. Simple measures that include being aware of our thoughts and how stress can manifest in physical ailments is something that few people want to address but can provide great rewards for very little cost and without negative effects. Receiving treatments that are invasive, not evidence-based and unlikely to be of benefit should be avoided!

Disclosures
Dr. Malanga has no relevant disclosures.

References
1. Dreyfuss P, Halbrook B, Pauza K, Joshi A, McLarty J, Bogduk N. Efficacy and validity of radiofrequency neurotomy for chronic lumbar zygapophysial joint pain. Spine (Phila Pa 1976). 2000;25(10):1270-1277.

2. Bogduk N. ISIS Practice Guidelines for Spinal Diagnostic and Treatment Procedures. 2nd ed. San Francisco, CA: International Spine Intervention Society; 2014.

 

Updated on: 08/19/19
Continue Reading
Patterns in Back Pain Over Time: Who Recovers and Who Persists?
Janna L. Friedly, MD
Associate Professor of Medicine and Rehabilitation Medicine
University of Washington
Gerard Malanga, MD
Clinical Professor, Physical Medicine & Rehabilitation
Rutgers School of Medicine-NJ Medical School
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