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Efficacy of Radiofrequency Neurotomy in Chronic Low Back Pain: A Systematic Review and Meta-Analysis

Authors Janapala RN , Manchikanti L , Sanapati MR , Thota S, Abd-Elsayed A, Kaye AD, Hirsch JA

Received 10 June 2021

Accepted for publication 3 August 2021

Published 10 September 2021 Volume 2021:14 Pages 2859—2891

DOI https://doi.org/10.2147/JPR.S323362

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Krishnan Chakravarthy



Rajesh N Janapala,1 Laxmaiah Manchikanti,2– 4 Mahendra R Sanapati,5,6 Srinivasa Thota,5 Alaa Abd-Elsayed,7 Alan D Kaye,8,9 Joshua A Hirsch10

1School of Medicine and Health Sciences, George Washington University, Washington, DC, USA; 2Pain Management Centers of America, Paducah, KY, USA; 3Anesthesiology and Perioperative Medicine, University of Louisville, Louisville, KY, USA; 4Department of Anesthesiology, School of Medicine, LSU Health Sciences Center, Shreveport, LA, USA; 5Pain Management Centers of America, Evansville, IN, USA; 6Anesthesiology and Research, School of Medicine, LSU Health Sciences Center, Shreveport, LA, USA; 7UW Health Pain Services, and Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA; 8Departments of Anesthesiology and Pharmacology, Toxicology, and Neurosciences, LSU Health Sciences Center, Shreveport, LA, USA; 9Ochsner Shreveport Hospital and Pain Clinic Feist-Weiller Cancer Center, Shreveport, LA, USA; 10Neurointerventional Radiology and Spine, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA

Correspondence: Laxmaiah Manchikanti
Pain Management Centers of America, 67 Lakeview Drive, Paducah, KY, 42001, USA
Tel +1 270 554 8373
Fax +1 270 554 8987
Email [email protected]

Purpose: The objective of the systematic review and meta-analysis is to evaluate the efficacy of radiofrequency neurotomy as a therapeutic lumbar facet joint intervention.
Patients and Methods: Utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist, a systematic review and meta-analysis was performed. A comprehensive literature search of multiple data sources from 1966 to September 2020 including manual searches of bibliography of known review articles was performed. The inclusion criteria were based on the selection of patients with chronic low back pain with diagnosis confirmed based on controlled diagnostic blocks and with the publication of at least 6 months of results of appropriate outcome parameters. Quality assessment of the trials was performed with Cochrane review criteria and interventional pain management techniques-quality appraisal of reliability and risk of bias assessment (IPM-QRB). The level of evidence of effectiveness is classified at five levels ranging from Level I to Level V. The primary outcome measure was a significant reduction in pain, eg, short term (up to 6 months) and long term (more than 6 months). The secondary outcome measure was an improvement in functional status.
Results: A total of 12 randomized controlled trials (RCTs) met the inclusion criteria for evaluating the efficacy of lumbar radiofrequency neurotomy. Radiofrequency neurotomy showed Level II evidence for efficacy for both the short term and long term.
Conclusion: This systematic review of the assessment of the efficacy of radiofrequency neurotomy in managing chronic low back pain was based on the inclusion of 12 RCTs with a diagnostic block and at least 6 months of follow-up results that showed Level II evidence for both short-term and long-term improvement.

Keywords: diagnostic facet joint nerve blocks, facet joint pain, facet joint nerve blocks, randomized trials, radiofrequency neurotomy, systematic review, meta-analysis

Introduction

Chronic axial low back pain, with or without extremity pain is one of the major causes of disability and escalating health care costs.1–7 In fact, morbidity and chronic disability now account for nearly half of the US health burden, despite substantial progress and improvement in overall health.6,7 In addition, among the 30 leading diseases and injuries contributing to years lives with disability in 2010 in the United States, low back pain ranked number one. Further, Dieleman et al1,2 showed an escalating spending pattern of low back and neck pain increasing from $87.6 billion in 2013 to $134.5 billion in 2016, with more than 53.5% increase between 2013 and 2016.

Chronic persistent low back pain lasting longer than 1 year is reported in 25% to 60% of the patients.3–5 Overall prevalence of low back pain over a period of 1 year time frame ranged from 22% to 65% with an estimated lifetime occurrence of 11% to 84%.3,4 Among the multiple modalities utilized in managing facet joint pain, interventional techniques with facet joint interventions have been shown to be critically important with continued ongoing discussions on effectiveness, indications and medical necessity, selection of patients for therapeutic interventions, and finally utilization patterns with extensive literature.3,4,8

In addition, the COVID-19 pandemic and the opioid epidemic have affected all aspects of human life, especially those of chronic pain sufferers.3,4,17,22–28 The pandemic has resulted in reduced access with modifications in treatment modalities, with increased psychological stressors, and suffering.4,17,22–28 The use of interventional techniques for the treatment of spinal pain increased exponentially until 2009, at which point utilization began to decrease.8–12 Among these, facet joint interventions showed an overall 1.9% annual increase from 2009 to 2018 compared to 17% annual increases from 2000 to 2009.8,9,11 The analysis of expenditures for facet joint interventions in Medicare population11 also showed an increase in expenditures of 79% from 2009 to 2018 in the form of total costs for facet joint interventions; however, the inflation-adjusted costs with 2018 US dollars showed an overall increase of 53% with an annual increase of 4.9%. Further, lumbar facet joint injection procedures increased by 37% from 2009 to 2018, whereas lumbar radiofrequency neurotomy procedures increased by 169%. Compared to the Medicare population which increased by 30.1% from 2009 to 2018, the total number of patients undergoing facet joint interventions increased by 65.1% with an annual increase rate of 5.7%. In contrast, epidural procedures12 showed a decrease of inflation-adjusted costs overall 2%, whereas prior to inflation adjustment, total expenditures increased by 14.6% or an annual increase of 1.5%. Further, the number of patient visits and services demonstrated a decline for epidural procedures compared to Medicare growth of population, in contrast to facet joint interventions. In addition, expenditures of epidural interventions showed declines.12

Significant debate in reference to effectiveness and efficacy, utilization patterns, and indications and medical necessity of interventional techniques in general and facet joint interventions in particular, including radiofrequency neurotomy procedures continues among patients, clinicians, researchers, and payors.3,4,8–12,18–22,28–37

Advanced diagnostic techniques like imaging and controlled diagnostic blocks point to multiple structures including facet joints, sacroiliac joints, intervertebral discs, and nerve roots as a possible origin of chronic low back pain.3,38–47 The diagnosis of a lumbar facet joint as the cause of chronic pain cannot be accurately established by history, physical, or imaging alone.3,38–47 The diagnosis by controlled diagnostic blocks has been shown to be reasonably accurate.3,38–40,46,47 However, the prevalence of “pure” lumbar zygapophysial joint pain in patients with chronic low back pain with placebo controlled diagnostic blocks and 100% pain relief as the criterion standard has been shown to be 15%, with acute pain model.45 In this manuscript, the authors have excluded any patients who have had longer relief than a few hours. In contrast, with a philosophical paradigm shift from an acute to a chronic pain model, Manchikanti et al46 have shown a prevalence rate of 34.1% and false-positive rate of 49.8% in chronic low back pain, utilizing controlled comparative local anesthetic blocks with a criterion standard of 80% pain relief. Currently, intraarticular injections, facet joint nerve blocks, and radiofrequency neurotomy are used for therapeutic management.3,39,40 However, the evidence continues to be variable with discordant opinions in systematic reviews.3,39,40,48–50

This systematic review and meta-analysis of randomized controlled trials (RCTs) of radiofrequency neurotomy in managing chronic low back pain is sought to provide updated evidence.

Methods

A systematic review and meta-analysis was performed based on methodological and reporting quality of systematic reviews as described by Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA).51,52

The objective of this systematic review and meta-analysis, therefore was to assess the efficacy and effectiveness of radiofrequency thermoneurolysis in managing chronic low back pain of facet joint origin.

Studies Included

Randomized controlled trials (RCTs).

Participants Included

Patients with low back pain for at least 3 months’ duration. Studies with inadequate or lack of response to conservative therapies including non-steroidal anti-inflammatory drugs (NSAIDs), exercise regimens, physical therapy, and other conservative therapies and at least 6 months of follow-up were included. Studies with inclusion of acute causes of low back pain such as trauma, fractures, malignancies were excluded. Patients diagnosed with a single or double diagnostic block were included.

Interventions Included

Radiofrequency neurotomy performed under radiological imaging (fluoroscopy, computed tomography (CT), or magnetic resonance imaging (MRI)) were included while blind and ultrasound-guided interventions were excluded.

Outcome Measures Included

The primary outcome measure was pain relief. The secondary outcome measure was an improvement in functional status. The outcomes of less than 6 months of management were considered short term and 6 months or longer were considered long term.

Literature Search

A comprehensive literature search was conducted to include randomized control trials published from all countries and in all languages. Searches were performed from the following sources without language restrictions.

  1. PubMed from 1966 https://pubmed.ncbi.nlm.nih.gov/
  2. Cochrane Library https://www.cochranelibrary.com/
  3. Google Scholar https://scholar.google.com/
  4. US National Guideline Clearinghouse (NGC) https://www.ahrq.gov/gam/index.html
  5. Clinical Trials https://www.clinicaltrials.gov/
  6. Previous systematic reviews and cross-references
  7. All other sources including non-indexed journals and abstracts

The search period was from 1966 through September 2020.

Search Strategy

The search strategy emphasized chronic low back pain treated with lumbar facet joint interventions. The search terms included: (((((((((((spinal pain, chronic low back pain) OR chronic back pain) OR facet joint pain) OR lumbosciatic pain) OR postlaminectomy) OR lumbar surgery syndrome) OR zygapophysial)) AND ((((((facet joint) OR zygapophyseal) OR zygapophysial) OR medial branch block OR intraarticular injection OR radiofrequency neurotomy) OR radiofrequency ablation.

Inclusion and Exclusion Criteria

RCTs studying radiofrequency neurotomy with at least 6 months of follow-up were included in this study. No observational studies were included. Only the trials with appropriate diagnosis established by at least one diagnostic block were included. Studies without an appropriate diagnosis, non-randomized studies, non-systematic reviews, case series, and case reports were excluded.

Data Collection and Analysis

Two review authors independently, established search criteria, searched the literature, and extracted data from the selected studies. Disagreements between the two reviewer authors were resolved by a third author.

Methodological Quality Assessment

RCTs were assessed for their quality or risk of bias methodologically with Cochrane review criteria (Table 1)53 and Interventional Pain Management techniques–Quality Appraisal of reliability and Risk of Bias Assessment (IPM-QRB) (Table 2).54

Table 1 Sources of Risk of Bias and Cochrane Review Rating System

Table 2 Item Checklist for Assessment of Randomized Controlled Trials of IPM Techniques Utilizing IPM – QRB

Risk of Bias of Individual Studies

Trials that met the inclusion criteria and scored at least 9 of 13 using Cochrane review criteria were considered high quality, while trials scoring 5–8 were considered of moderate quality. Trials that scored less than 5 were considered of low quality and were excluded from the analysis.

Trials meeting the inclusion criteria were also assessed with IPM-QRB criteria.54 Studies scoring 32–48 were considered of high quality, those scored 16–31 were of moderate quality and those that scored below 16 were considered of low quality and were excluded from the analysis.

Methodological quality of the trials was assessed by two authors, independently in an unblinded manner. If a discrepancy occurred, a third author was involved to resolve the conflict. When an issue of conflict of interest was raised in reviewing the manuscript (regarding authorship), the involved authors were not allowed to review those manuscripts for quality assessment.

Outcome Measures

An outcome is considered clinically significant if a reduction of 3 points on Visual Analog Scale (VAS) or Numeric Rating Scale (NRS), or at least 50% reduction in pain and improvement in the functional status. A positive study is said to be clinically significant and effective indicating that the primary outcome should be statistically significant at a P-value ≤0.05.

Analysis of Evidence

The evidence was analyzed utilizing qualitative and quantitative evidence synthesis. Quantitative evidence synthesis was performed utilizing conventional meta-analysis and a single-arm meta-analysis.

Qualitative Analysis

The qualitative analysis of the evidence was performed based on best-evidence synthesis, modified and collated using multiple criteria, including the Cochrane Review criteria and United States Preventive Services Task Force (USPSTF) criteria as illustrated in Table 3.55 The analysis was conducted using five levels of evidence ranging from strong to opinion- or consensus-based. The results of best evidence as per grading were utilized. At least two of the review authors independently, in a standardized manner, analyzed the evidence. Any disagreements between reviewers were resolved by a third author and consensus was attained. If there were any conflicts of interest (eg, authorship), the reviewers of interest were recused from assessment and analysis.

Table 3 Qualitative Modified Approach to Grading of Evidence of Therapeutic Effectiveness Studies

Meta-Analysis

For dual-arm meta-analysis, Review Manager software (Rev Man 5.3) was used (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark, 2008).

For single-arm meta-analysis, software Comprehensive Meta-analysis version 3.0 was used (Biostat Inc., Englewood, NJ).

For pain and improvement of function data, the studies were reported as the standardized mean differences (SMD) with 95% confidence intervals (CI).

Data were plotted by using forest plots to evaluate treatment effects. Heterogeneity was interpreted through I2 statistics.

Results

The flow diagram illustrates the search results and the final number of studies that were considered for inclusion (Figure 1).

Figure 1 Flow diagram illustrating the results of literature search conducted to evaluate lumbar radiofrequency thermoneurolysis.

The full manuscript was reviewed for 89 studies, out of which 15 RCTs56–70 were selected and 12 of them met the inclusion criteria to include in this systematic review. Three trials were excluded.57,58,70 Civelek et al57 was excluded due to lack of diagnostic blocks prior to providing radiofrequency denervation procedure. Cohen et al58 and van Tilburg et al70 was excluded due to short-term assessment of 3 months. Of the remaining 12 trials, 7 of them were active control trials,56,59,60,62–64,66 and the remaining 5 were placebo or sham control.61,65,67–69

Methodological Quality Assessment

The results of methodological quality assessment of the RCTs meeting the inclusion criteria carried out using Cochrane review criteria and IPM-QRB criteria are illustrated in Tables 4 and 5.

Table 4 Methodological Quality Assessment of Randomized Trials of Lumbar Facet Joint Radiofrequency Thermoneurolysis Utilizing Cochrane Review Criteria53

Table 5 Methodologic Quality Assessment of Randomized Trials of Lumbar Facet Joint Radiofrequency Thermoneurolysis Utilizing IPM – QRB Criteria54

Utilizing the Cochrane quality assessment and the previously established score ranges in the methods section of this study, 10 trials56,59,60,62–65,67–69 scored between 9 and 13, thus meeting our criteria of high-quality studies, while 2 trials61,66 scored between 5 and 8, thus said to be studies of moderate quality.

Based on the IPM-QRB criteria for randomized trials, 8 trials56,59,60,62–64,68,69 scored between 32 and 48, hence they are of high quality, while 4 trials61,65–67 scored between 16 and 31, thus are considered as moderate quality trials. Thus, only 8 trials met the criteria for high-quality with both instruments.56,59,60,62–64,68,69 This indicates the importance of IPM specific instruments in methodologic quality assessments.

Study Characteristics

Table 6 shows the study characteristics of all the included randomized trials.

Table 6 Study Characteristics of Randomized Controlled Trials Assessing Lumbar Radiofrequency Neurotomy

Analysis of Evidence

Qualitative Analysis

Table 7 shows the effectiveness of radiofrequency neurotomy. The included trials studied a total of 1049 patients, with 461 patients undergoing conventional radiofrequency neurotomy. Among these, in 10 positive trials, the total number of patients included were 717 with 296 undergoing conventional radiofrequency neurotomy. Among the two negative trials,61,68 a total of 332 patients were included with 165 undergoing radiofrequency neurotomy. Juch et al61 with low methodological quality and high risk of bias, included 125 of 251 patients with conventional radiofrequency neurotomy. Whereas, the second study by van Wijk et al68 included 81 patients with 40 patients undergoing conventional radiofrequency. Thus, a total of 165 patients were studied with conventional radiofrequency neurotomy with lack of improvement or considered negative; however, only van Wijk et al68 was sham controlled. Consequently, based on 12 studies, a total of 1049 patients were included with 461 undergoing radiofrequency neurotomy, with 296 of 717 showing positive results and 165 of 332 showing negative results. Among positive trials, the number of patients in each study varied from 16 to 45. Among the four sham controlled trials,64,65,68,69 one study was negative on both short-term and long-term follow-up,68 whereas two studies were positive,64,69 both for short and long term and one study was positive for only short-term.65

Table 7 Effectiveness of Lumbar Radiofrequency in Facet Joint Pain

Overall, based on the qualitative analysis, the level of evidence of efficacy is Level II with moderate evidence.

Quantitative Analysis

Quantitative analysis was performed utilizing conventional dual-arm meta-analysis and single-arm meta-analysis. The data from all the RCTs providing appropriate criteria were included withsix trials qualifying for dual-arm meta-analysis in one of the categories; whereas, for single-arm meta-analysis 10 RCTs met criteria for inclusion.

Conventional Dual-Arm Meta-Analysis

Of the five placebo or sham controlled studies,61,65,67–69 two studies were not included due to lack of availability of appropriate data. Van Wijk et al68 provided only data at 3-month follow-up, whereas 6- and 12-month follow-up data were not available. van Kleef et al69 had data available only at 8-week point time with no data to be included in meta-analysis at 6 and 12 months of follow-up. Consequently, a comparative cumulative analysis of data from three RCTs that compared lumbar radiofrequency neurotomy using conventional radiofrequency ablation (CRFA) with sham procedure as the control group was performed as shown in Figure 2.

Figure 2 (A) Conventional dual-arm meta-analysis of pain relief of radiofrequency neurotomy vs sham control group at 6-month follow-up. (B) Conventional dual-arm meta-analysis of pain relief of radiofrequency neurotomy vs sham control group at 12-month follow-up.

Figure 2A shows short-term follow-up (6 months or less) data with inclusion of three trials.64,65,67 The cumulative analysis showed that radiofrequency neurotomy with CRFA reduced pain scores by 1.98 (with a 95% confidence interval between −0.5 and 4.47) compared to a sham procedure. However, it was not statistically significant with a P-value of 0.12.

For 12-month data, only two studies were available, which included Tekin et al67 and Juch et al61. Out of the five trials,61,65,67–69 only two trials61,67 were available with data to be included as shown in Figure 2B.

Overall, there were four sham-controlled trials described as placebo-controlled.64,65,68,69 Among these, a single study68 showed negative results for short- and long-term improvement. One study presented only short-term results with improvement at 6 months (65). Two studies showed short-term and long-term positive results.64,69 Thus, three of the four placebo-controlled trials showed positive results for short term and two of the four showed positive results for short and long term.

The results in this analysis were favoring CRFA at 12 months.

Conventional dual-arm analysis was also performed at 6 and 12 months for active control trials. Overall, six studies were included of the seven active-controlled trials available (Figure 3).

Figure 3 (A) Conventional dual-arm meta-analysis of pain relief of radiofrequency neurotomy of active control trials at 6 -month follow-up. (B) Conventional dual-arm meta-analysis of pain relief of radiofrequency neurotomy of active control trials at 12-month follow-up.

The analysis showed the results favoring CRFA at 6 months; however, the results were favoring the active control group at 12 months.

Functional status using Oswestry Disability Index (ODI) scores was reported in only two out of thefive5 trials61,67 at 6-month follow-up point as shown in Figure 4. At 12 months, functional status was assessed utilizing ODI in only in two studies.61,67

Figure 4 (A) Conventional dual-arm meta-analysis of functional status (ODI) of radiofrequency neurotomy vs sham control group at 6-month follow-up. (B) Conventional dual-arm meta-analysis of functional status (ODI) of radiofrequency neurotomy vs sham control group at 12-month follow-up.

Outcomes results of sham-controlled trials and active-controlled trials have been described in qualitative analysis.

Single-Arm Meta-Analysis

A single-arm cumulative analysis of the data from 10 RCTs, in which at least one arm of the study patients underwent radiofrequency neurotomy. The cumulative analysis was conducted between the initial and final pain VAS scores at 6 months follow-up in the CFRA arm of the studies.

In the single-arm cumulative analysis as shown in Figure 5A, CRFA reduced pain VAS score by 3.43 (with a 95% confidence interval between 2.66 and 4.19) at the end of 6 months follow-up. It was also statistically significant with a P-value of <0.00001.

Figure 5 (A) Single arm meta-analysis of pain relief of radiofrequency neurotomy at baseline vs at 6-month follow-up of active-controlled trials. (B) Single arm meta-analysis of pain relief of radiofrequency neurotomy at baseline vs at 12-month follow-up of active control trials.

Similarly, a single-arm cumulative analysis was done at 12 months follow-up, for which only five RCTs had the required data at 12 months (Figure 5B). The single-arm cumulative analysis showed that CRFA reduced pain VAS score by 3.68 (with a 95% confidence interval between 2.34 and 5.02) at the end of the 12-month follow-up. It was also statistically significant at a P-value of <0.00001.

Single-arm analysis was also performed on functional status with ODI scores at 6 and 12 months. Only two studies met inclusion criteria, both at 6 and 12 months. As shown in Figure 6, the data showed significant improvement in functional status at 6 and 12 months in CRFA group.

Figure 6 (A) Single-arm meta-analysis of functional status (ODI) of radiofrequency neurotomy at 6-month follow-up in sham control trials. (B) Single-arm meta-analysis of functional status (ODI) of radiofrequency neurotomy at 12 month follow-up in sham control trials.

The evidence of efficacy based on dual-arm and single-arm meta-analysis of CRFA with placebo controlled and active controlled trials, is Level II evidence (moderate), in improving pain and function for short-term and long-term follow-up.

Discussion

This systematic review and meta-analysis of randomized trials of efficacy of lumbar facet joint radiofrequency neurotomy procedures in managing chronic low back pain revealed Level II evidence for short-term effectiveness of 6 months or less and for long-term effectiveness of 6 months or longer. Out of the 12 trials56,59–69 included in this analysis, 6 trials56,64–67,69 demonstrated short- and long-term effectiveness, 4 trials59,60,62,63 revealed short-term effectiveness only, whereas 2 trials61,68 showed lack of effectiveness. The evidence analysis for efficacy was based on five sham-controlled trials,64,65,67–69 with one trial assessing short-term outcomes (65) and four trials assessing long-term outcomes.64,67–69 Among these, five sham-controlled trials, three of them showed positive long-term outcomes,64,67,69 whereas one trial showed only short-term positive outcomes.65 However, one trial68 showed negative results for both short term and long term. Consequently, among the five studies, three showed long-term improvement and four showed short-term improvement. These results were strengthened by active-controlled trials with single-arm meta-analysis. However, among the studies which showed negative results, Juch et al61 included 251 patients with 126 patients in the control group. Even though the study had a variety of limitations,71–78 it is considered as one of the important studies in the literature. A second high-quality trial also showed lack of significant improvement with radiofrequency neurotomy.68 Thus, even though results are seen and positive results were demonstrated in 10 trials, the total number of patients undergoing conventional radiofrequency neurotomy were 296 of 717. In contrast, among the two negative trials,61,68 162 of 332 patients underwent radiofrequency neurotomy. The negative studies were larger than any of the positive studies in inclusion of the number of patients included in the study. Consequently, the evidence is Level II with positive results among 10 of the 12 trials and 2 negative trials.

The results of the present analysis are similar but nonetheless different from other previously published systematic reviews and guidelines. The guidelines for facet joint interventions3 showed Level II evidence for radiofrequency neurotomy in the lumbar spine with inclusion of a total of 11 trials, with 2 of them showing lack of effectiveness. However, two of the studies included in the guidelines were not included in this systematic review. There are additional studies which were not included in the systematic review/guidelines3 and included in the present review. In the systematic review and guidelines (3), the authors utilized 11 trials with the same 2 trials showing negative results and 9 trials showing positive results, The guidelines included both active-control and sham-control trials similar to the present manuscript. Overall, the results agree with this publication. The results of two additional systematic reviews by the same authors39,40 were also similar to the present study.

There are other systematic reviews which provide discordant opinions. Maas et al50 showed lack of effectiveness. Schneider et al49 showed effectiveness in patients with 100% pain relief and utilizing a parallel needle placement with relief in approximately 57% of the patients. Lee et al,48 in a meta-analysis, concluded that conventional radiofrequency denervation resulted in a significant reduction in low back pain with positive results when compared with sham procedures over a period of 1 year. The analysis was performed in 231 patients from multiple studies undergoing denervation procedures. Leggett et al79 in an older systematic review analyzed six sham controlled RCTs performed between 1994 and 2008. They found high variability in selection criteria and outcomes with inconclusive effectiveness. In contrast, Poetscher et al80 also evaluated nine RCTs comparing the effect of radiofrequency treatment with other forms of treatment and with placebo and found that radiofrequency denervation was more effective than placebo and steroid injection. However, they concluded that evidence should be interpreted with caution.

In this review, 40% of the trials (5 of 12) compared CRFA to sham procedures. The majority of the trials (7 of 12) compared them to other interventions or a different mode of radiofrequency ablation. Lakemeier et al59 compared CRFA with intraarticular facet joint steroid injections, but only studied short-term effectiveness. This trial showed a positive result for both conventional radiofrequency and intraarticular steroid injections in short term. Two trials56,67 compared conventional radiofrequency to pulsed radiofrequency ablation. In both the studies, conventional radiofrequency demonstrated positive results, while pulsed radiofrequency ablation showed limited effectiveness. One trial66 compared CRFA to endoscopic neurotomy. In this trial, both the groups showed positive results in short term and long term according to our established criteria. However, the effectiveness of endoscopic neurotomy lasted for over 2 years while it did not in the CRFA group. Overall, CRFA appears to be effective in both the short term and long term as an intervention in chronic low back pain of facet joint origin.

From the meta-analysis, though there was no statistical difference of pain VAS score between CRFA and sham procedure at 6 months follow-up, there was a trend towards CRFA being more effective than a sham procedure. These results might in part be related to the small sample sizes of the RCTs, with a cumulative sample size of just 160 patients with 80 in each arm. Thus, more studies with larger patient sample sizes should be conducted to establish the effectiveness of lumbar radiofrequency neurotomy. However, in single-arm analysis, the radiofrequency neurotomy using CRFA showed a statistically significant reduction in the pain VAS scores both at 6 months and 12 months follow-up compared to the baseline.

As with any systematic review and meta-analysis, the validity of this analysis is only as reliable as the validity of the primary studies. Although there were multiple studies in this meta-analysis the patient sample size was low in most of the primary studies.

Multiple issues have been highlighted in reference to the systematic reviews, specifically in interventional pain management,3,4,21,81–84 Significant controversy related to placebo and multiple issues related to meta-analysis of active control trials have been discussed. Manchikanti et al81 have shown sodium chloride solution injected into the epidural space is not a placebo. Similarly, they have shown epidural lidocaine is also not a placebo.26 In this assessment, local anesthetic was utilized during sham control. This can provide relief, which can be significant.3 Consequently, in a dual-arm meta-analysis, it is difficult to assess the role of effectiveness of conventional radiofrequency neurotomy when local anesthetic was utilized prior to sham neurolysis, as well as when an active control was utilized. This affects all placebo and sham control trials, as well as active control trials. None of the previous reviews have performed a single-arm analysis. It has been shown that is crucial to perform a single-arm analysis in multiple studies as expected in this systematic review and meta-analysis.3,4,26,27,81–84 Qualitative analysis demonstrated positive results with Level II evidence. Quantitative analysis also showed Level II evidence with dual-arm analysis. However, single-arm analysis meta-analysis showed clear superiority of conventional radiofrequency neurotomy compared to local anesthetic injection or other treatments including pulsed radiofrequency. Though not appreciated well, single-arm analysis is crucial in elucidating the effectiveness of both groups, whether it is local anesthetic converted into placebo or local anesthetic administered prior to sham procedure. Consequently, differences in conclusions may be the product of methodological differences between investigators.3,4,26,81–93

Conclusion

This systematic review provides evidence variable from Level II for short-term and long-term effectiveness of radiofrequency neurotomy, diagnosed with controlled diagnostic blocks. Overall, the evidence was adjusted to Level II based on the negative studies with large sample sizes.

Acknowledgments

The authors wish to thank Tonie M. Hatton and Diane E. Neihoff, transcriptionists, for their assistance in preparation of this manuscript.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Funding

There was no external funding in preparation of this manuscript.

Disclosure

Dr Abd-Elsayed is a consultant of Medtronic and Avanos and reports no other potential conflicts of interest for this work. Dr Hirsch is a consultant for Medtronic and Senior Affiliate Research Fellow at the Neiman Policy Institute and reports personal fees from Medtronic, Persica, and Relevant and grants from Neiman Health Policy Institute, outside the submitted work, and reports no other potential conflicts of interest for this work. All other authors report no conflicts of interest in this work.

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