| Coverage Policy Manual | |
| Policy #: | 1999016 |
| Category: | Surgery |
| Initiated: | June 1999 |
| Last Review: | August 2023 |
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| Annuloplasty, Percutaneous Intradiscal: Electrothermal (IDET), Radiofrequency (PIRFT) or Biacuplasty | |
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| Description: |
Electrothermal intradiscal annuloplasty therapies use radiofrequency energy sources to treat discogenic low back pain arising from annular tears. These annuloplasty techniques are designed to decrease pain arising from the annulus by thermocoagulating nerves in the disc and tightening annular tissue.
Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptom findings, in conjunction with radiologically confirmed degenerative disc disease.
Typical treatment includes conservative therapy with physical therapy and medication management, with potential for surgical decompression in more severe cases.
A number of electrothermal intradiscal procedures have been introduced to treat discogenic low back pain; they rely on various probe designs to introduce radiofrequency energy into the disc. It has been proposed that heat-induced denaturation of collagen fibers in the annular lamellae may stabilize the disc and potentially seal annular fissures. Pain reduction may occur through the thermal coagulation of nociceptors in the outer annulus.
With the intradiscal electrothermal annuloplasty procedure (IDET™, Oratec SpineCath System), a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. Using indirect radiofrequency energy, electrothermal heat is generated within the thermal resistive coil at a temperature of 90 degrees centigrade; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy with IDET™ include precise temperature feedback and control and the ability to provide electrothermocoagulation to a broader tissue segment than would be allowed with a direct radiofrequency needle. Annuloplasty using a laser-assisted spinal endoscopy kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty) has also been described.
Another procedure, referred to as percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), uses direct application of radiofrequency energy. With PIRFT, the radiofrequency probe is placed into the center of the disc, and the device is activated for only 90 seconds at a temperature of 70 degrees centigrade. The procedure is not designed to coagulate, burn, or ablate tissue. The Radionics RF Disc Catheter System has been specifically designed for this purpose.
A more recently developed annuloplasty procedure, referred to as intradiscal biacuplasty (Baylis Medical, Inc., Montreal, Canada) involves the use of 2 cooled radiofrequency electrodes placed on the posterolateral sides of the intervertebral annulus fibrosus. It is believed that by cooling the probes, a larger area may be treated than could occur with a regular needle probe.
Annuloplasty using a laser-assisted spinal endoscopy (LASE) kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty or PELA) has also been described.
Regulatory Status
A variety of radiofrequency coagulation devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA), some of which are designed for disc nucleotomy. In 2002, the Oratec Nucleotomy Catheter (ORATEC Interventions, Menlo Park, CA, acquired by Smith & Nephew in 2002) was cleared for marketing by FDA through the 510(k) process. The predicate device was the SpineCATH® Intradiscal Catheter, which received FDA clearance for marketing in 1999. The Radionics (a division of Tyco Healthcare group) Radiofrequency Disc Catheter System received marketing clearance by FDA through the 510(k) process in 2000. FDA product code: GEI.
In 2005, the Baylis Pain Management Cooled Probe was also cleared for marketing by FDA through the 510(k) process. It is intended for use “in conjunction with the Radio Frequency Generator to create radiofrequency lesions in nervous tissue.” FDA product code: GXI.
Note: This policy does not address DISC Nucleoplasty™, a technique based on a device offered by ArthroCare (Austin, TX). With the ArthroCare system, a bipolar radiofrequency device is used to provide lower energy treatment (Coblation®) to the intervertebral disc, which is designed to provide tissue removal with minimal thermal damage to collateral tissue. DISC Nucleoplasty is closer in concept to a laser discectomy in that tissue is removed or ablated in an effort to provide decompression of a bulging disc. DISC Nucleoplasty and laser discectomy are considered separately in policy No. 2001012.
Effective January 1, 2007, there are 2 CPT category I codes specific to this procedure:
22526: Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level
22527: 1 or more additional levels (List separately in addition to code for primary procedure)
Prior to 2007, the procedure was coded with the following CPT category III codes:
0062T: Percutaneous intradiscal annuloplasty, any method, unilateral or bilateral including fluoroscopic guidance; single level
0063T: one or more additional levels (list separately in addition to 0062T for primary procedure)
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Policy/ Coverage: |
Effective August 2012
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty [IDET], percutaneous intradiscal radiofrequency thermocoagulation [PIRFT] or intradiscal biacuplasty) for the treatment of chronic discogenic back pain does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
For members with contracts without primary coverage criteria, percutaneous annuloplasty (e.g., intradiscal electrothermal annuloplasty [IDET], percutaneous intradiscal radiofrequency thermocoagulation [PIRFT] or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates.
Radiofrequency thermocoagulation or intradiscal electrothermal therapy (IDET) is a contract exclusion in group contracts issued on or after July 1, 2004.
Effective prior to August 2012
Intradiscal electrothermal therapy (IDET) is not covered based on benefit certificate Primary Coverage Criteria. Intradiscal electrothermal therapy fails to meet Primary Coverage Criteria because the available scientific evidence is in conflict or the subject of continuing debate.
Intradiscal electrothermal therapy (IDET) is a contract exclusion in group contracts issued on or after July 1, 2004.
For members with Individual Contracts without primary coverage criteria, IDET is considered investigational and is not covered. Investigational services are an exclusion in the member benefit certificate.
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| Rationale: |
This policy is being revised to address various different intradiscal annuloplasty therapies including percutaneous intradiscal electrothermal annuloplasty (IDET), radiofrequency intradiscal radiofrequency thermocoagulation (PIRFT) and intradiscal biacuplasty.
As with any therapy for pain, a placebo effect is anticipated, and thus randomized placebo-controlled trials are necessary to investigate the extent of the placebo effect and to determine whether any improvement with annuloplasty exceeds that associated with a placebo. Therefore, evidence reviewed for this policy focuses on randomized controlled trials (RCTs).
In 2007, a systematic review of intradiscal electrothermal annuloplasty (IDET) and percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) was published that followed the criteria recommended by the Cochrane Back Review Group (Urrutia, 2007). Four randomized and 2 nonrandomized studies, totaling 283 patients, were included in the review (the key studies are described below). The report concluded that the available evidence does not support the efficacy or effectiveness of IDET or PIRFT and that these procedures are associated with potentially serious side effects.
A 2012 systematic review by some of the same authors identified 3 RCTs and one observational study that met their criteria on thermal annular procedures (Helm, 2012). No new controlled trials were identified. The included evidence was found to be fair for IDET and poor for discTRODE and biacuplasty procedures regarding whether they are effective in relieving discogenic low back pain. Out of the 2 randomized studies that evaluated IDET, (Pauzka, 2004) (Freeman, 2005) one showed weak evidence of effectiveness, and the other one, which reported no improvement in either the active or sham treatment group, was rejected for methodologic shortcomings. The single randomized trial with the discTRODE device that was included in the review was considered to be a high-quality study that showed lack of efficacy (Kvarstein, 2009). There were no high-quality studies that evaluated the efficacy of biacuplasty, although it was noted that this procedure is being investigated in 2 ongoing randomized controlled trials.
A number of other systematic reviews that focused on related issues have come to various different conclusions about the efficacy of these procedures. Freeman and Mehdian reported that the evidence for IDET was mixed and that the evidence showed that PIRFT was ineffective for discogenic back pain (Freeman, 2008). Levin concluded that IDET was modestly effective for discogenic pain in carefully selected patients (Levin, 2009). Helm et al. concluded that the literature was limited, but supported that IDET led to significant benefit in approximately half of appropriately chosen patients and that there was minimal evidence for the efficacy of intradiscal biacuplasty (Helm, 2009).
Intradiscal Electrothermal Annuloplasty (IDET™)
Pauza and colleagues published the results of a randomized study, (Pauza, 2004) which was the focus of discussion in the 2003 TEC Assessment. The study included 64 patients with low back pain of greater than 6 months’ duration who were randomly assigned to receive either IDET™ or a sham procedure. Visual analogue scale (VAS) pain was reduced by an average of 2.4 cm in the IDET group, compared with 1.1 cm in the sham group, a significant difference between groups (p=0.045). The mean change in the Oswestry Disability Scale (ODS) was also significantly greater for the IDET group compared with the sham group. The improvement on the Short Form (SF)-36 Bodily Pain subscale was nearly significantly higher for the IDET group. The authors stated that per-protocol analyses were conducted, which excluded data from 8 patients, 5 from the IDET group and 3 from the sham group. One patient died, 1 was lost to follow-up, 1 had unsatisfactory electrode placement, 1 had post-treatment bone fracture, and 2 had new injuries unrelated to low back pain and were excluded due to compensation claims or opioids. Besides failing to perform intent-to-treat analyses, there are additional concerns about statistical methods used by Pauza et al. (Pauza, 2004) The report noted that the analysis of SF-36 Role Physical scores adjusted for differences at baseline, but whether the comparison used adjustment and statistical techniques was not specified. The technique for comparing group scores on continuous variables was described only as a t test, suggesting simple comparison of mean change at follow-up. More appropriate techniques for comparing changes between groups include analysis of covariance and repeated measure analysis of variance. The comparison of means on the VAS for pain and the ODS for disability do not readily reveal how often patients achieve a clinically significant improvement. Minimally significant improvement in VAS has been estimated at 1.8–1.9 cm, and by this estimate, the mean change in VAS of 2.4 cm for IDET would be considered clinically significant. However, a small number of extreme values can influence this measure. The study also reported the percentage with a change in VAS of more than 2.0 cm, which is greater than the minimally clinically significant improvement of 1.8–1.9. When the VAS is dichotomized in this way, a relative risk of 1.5 is observed with a 95% confidence interval (CI) of 0.82–2.74. In summary, the Pauza et al. trial is well-designed with respect to randomization, clear description of intervention, and use of valid and reliable outcomes measures. However, this single-center trial does not permit conclusions about the relative effects of IDET and placebo. The study did not conduct intent-to-treat analysis, and it is unclear whether IDET achieves clinically and statistically significant improvements in measures of pain, disability, and quality of life.
A second double-blinded randomized sham-controlled trial (RCT) was published by Freeman et al. in 2005 (Freeman, 2005). This trial enrolled patients with chronic discogenic low back pain, marked functional disability, magnetic resonance imaging (MRI) evidence of degenerative disc disease, and failure of conservative management. Planned enrollment was for 75 patients; however, the trial was stopped early due to slower than expected recruitment after 57 patients (38 IDET, 19 placebo) had been enrolled. Follow-up was for 6 months, and the outcome measure was successful treatment response, as defined by all of the following: 1) no neurologic deficit; 2) an increase on the Low Back Outcome Score (LBOS) of at least 7 points; and 3) improvements in the SF-36 physical functioning and bodily pain scales of at least 1 standard deviation. The authors reported that IDET™ was no more effective than sham stimulation on any of the outcomes. No subject in either group achieved a successful treatment response, as defined previously. There were no differences between the IDET and sham groups on the LBOS, the Oswestry Disability Index (ODI), the SF-36 subscales, the Zung Depression Index (ZDI), or the Modified Somatic Perception Questionnaire (MSPQ). There were no serious adverse events reported in either group.
In another controlled study, comparison of 21 electrothermal (IDET) and 21 radiofrequency procedures found significant improvements in a majority of IDET patients but not in matched radiofrequency-treated patients at 1-year follow-up; the study did not have a placebo-control group (Kapural, 2005).
Evidence-based guidelines from the American Society of Interventional Pain Physicians in 2007 concluded that the evidence is moderate for management of chronic discogenic low back pain with IDET (Boswell, 2007). Complications include catheter breakage, nerve root injuries, post-IDET disc herniation, cauda equina syndrome, infection, epidural abscess, and spinal cord damage.
An industry-funded meta-analysis and systematic review were published that support the use of IDET (Andersson, 2006) (Appleby, 2006). However, the quality of the studies included in these reviews was poor; 14 of the 18 studies reviewed did not have appropriate controls.
Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT)
There is relatively minimal published data on PIRFT. In 2001, Barendse and colleagues reported on a double-blind trial that randomly assigned 28 patients with chronic low back pain to undergo PIRFT or to a sham control group (Barendse, 2001). The primary outcome was the percentage of success at 8 weeks, as measured by changes in pain level, impairment, ODS, and analgesics taken. At the end of 8 weeks, there were 2 treatment successes in the sham group compared to one in the treatment group. The authors concluded that PIRFT was not better than the placebo procedure in reducing pain and disability.
In 2009, Kvarstein and colleagues published 12-month follow-up from an RCT of intra-annular radiofrequency thermal disc therapy using the discTRODE™ probe from Radionics (Kvarstein, 2009). Recruitment was discontinued when blinded interim analysis of the first 20 patients showed no trend toward overall effect or difference in pain intensity between active and sham treatment at 6 months. At 12 months, there was a reduction from baseline pain but no significant difference between the 2 groups. Two patients from each group reported an increase in pain. Although this controlled study did not find evidence for a benefit of PIRFT, it may not have been powered to detect a small or moderate effect of the procedure.
Evidence-based guidelines from the American Society of Interventional Pain Physicians in 2007 found the evidence for radiofrequency posterior annuloplasty (PIRFT) to be limited, with complications similar to IDET (catheter breakage, nerve root injuries, post-IDET disc herniation, cauda equina syndrome, infection, epidural abscess, and spinal cord damage) (Boswell, 2007).
Biacuplasty
One case report of transdiscal radiofrequency annuloplasty using 2 transdiscal probes (biacuplasty) was identified in 2007; the authors indicate this to be the first publication with this procedure (Kapural, 2007). In 2010, investigators from Turkey published a case series of 15 patients treated with biacuplasty (Karaman, 2010). No published RCTs were identified.
Practice Guidelines and Position Statements
Evidence-based guidelines from the American Society of Interventional Pain Physicians concluded that the evidence is moderate for management of chronic discogenic low back pain with IDET™ (Boswell, 2007). Complications include catheter breakage, nerve root injuries, post-IDET disc herniation, cauda equina syndrome, infection, epidural abscess, and spinal cord damage. The evidence for radiofrequency posterior annuloplasty (PIRFT) was reported to be limited, with complications similar to IDET.
The United Kingdom’s National Institute for Health and Clinical Excellence (NICE) guidance, published in 2004, indicates that the current evidence on safety and efficacy of percutaneous intradiscal percutaneous radiofrequency thermocoagulation for lower back pain does not appear adequate to support its use (NICE, 2004).
NICE guidance on electrothermal annuloplasty was updated in 2009 (NICE, 2009). NICE considers current evidence on the safety and efficacy of percutaneous intradiscal electrothermal therapy for low back pain to be inconsistent. NICE recommends that this procedure only be used with special arrangements for clinical governance, consent, and audit or research.
Ongoing Clinical Trials
A search of the online site ClinicalTrials.gov in June 2012 identified two industry-sponsored studies on biacuplasty.
• NCT00750191 is a small Phase I randomized double-blind placebo-controlled trial of transdiscal radiofrequency annuloplasty using 2 transdiscal probes by the same principal investigator as in the 2007 report above (Kapural, 2007). The study is currently recruiting with an estimated enrollment of 64 subjects and completion expected in 2012.
• NCT01263054 is a manufacturer-sponsored Phase IV randomized, multi-center, open-label clinical trial comparing disc biacuplasty with the TransDiscal system versus medical management for discogenic lumbar back pain. The study was scheduled to begin in December 2010 with an estimated enrollment of 136 subjects. Final data collection for the primary outcome measure is expected in 2012, with study completion in 2013.
Summary
There is limited evidence on the efficacy of intradiscal thermal annuloplasty, consisting of a small number of RCTs and case series. The two RCTs on IDET report different results, with one reporting benefit for IDET and the other reporting no benefit. Systematic reviews of the available evidence have generally found limited to no evidence to support a role for radiofrequency annuloplasty or biacuplasty. This evidence is insufficient to conclude that these procedures improve health outcomes.
2013 Update
A literature search conducted through July 2013 did not reveal any new information which would prompt a change in the coverage statement.
A 2013 review of the evidence for American Society of Interventional Pain Physicians guidelines found limited to fair evidence for intradiscal electrothermal annuloplasty (IDET) and biacuplasty and limited evidence for percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) (Manchikanti, 2013).
Kapural and colleagues published a 2013 industry-sponsored small Phase I double-blind RCT (NCT00750191) on the use of transdiscal radiofrequency annuloplasty using 2 transdiscal probes (biacuplasty) (Kapural, 2013. Out of 1,894 patients who were screened, 1,771 (94%) did not meet inclusion criteria. Sixty-four subjects were consented and enrolled in the study. Outcome measures were the SF-36 physical functioning subscore (0-100), the numerical rating scale (NRS) for pain (0-10), and the ODI (0-100). There were no significant differences between the groups at 1 month or 3 months. At 6 months, the biacuplasty group showed a significantly greater change from baseline for the SF-36 (15.0 vs. 2.63), NRS (-2.19 vs. -0.64) and ODI (-7.43 vs. 0.53). Mean SF-36 and NRS scores were considered to be clinically significant, but mean ODI scores did not achieve the minimally important difference of 10 points. With clinical success defined post-hoc as a 15-point increase in physical function together with a greater than 2 point decrease in pain, 30% of biacuplasty patients and 3% of sham-treated patients were considered successful. There was no significant difference in opioid use between the 2 groups.
Ongoing Clinical Trials
A search of the online site ClinicalTrials.gov in July 2013 identified two industry-sponsored studies on biacuplasty.
• NCT00750191 is a small Phase I randomized double-blind placebo-controlled trial of transdiscal radiofrequency annuloplasty using 2 transdiscal probes by the same principal investigator as in the 2007 report above (Kapural, 2007). The study has been completed but no publications were identified.
• NCT01263054 is a manufacturer-sponsored Phase IV randomized, multi-center, open-label clinical trial comparing disc biacuplasty with the TransDiscal system versus medical management for discogenic lumbar back pain. The study was scheduled to begin in December 2010 with an estimated enrollment of 136 subjects. Final data collection for the primary outcome measure is expected in 2012, with study completion in 2013.
2014 Update
A literature search conducted using the MEDLINE database through July 2014 did not reveal any new information to prompt a change in the coverage statement.
2015 Update
A literature search using the MEDLINE database conducted through July 2015 did not identify any new information that would prompt a change in the coverage statement.
2017 Update
A literature search conducted through July 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
In the 2016 RCT by Desai and colleagues, 63 patients with lumbar discogenic pain diagnosed by provocation discography were randomized to intradiscal biacuplasty plus conservative medical management (n=29) or medical management alone (n=34) (Desai, 2016)(a). Another 234 patients were scheduled for diagnostic discography but did not meet inclusion criteria. The primary outcome (the mean reduction in VAS score for pain at 6 months) was significantly greater in the biacuplasty group (-2.4) than in the medical management group (-0.56; p=0.02). The secondary outcomes were not statistically significant, which included the proportion of responders, defined as a 2-point or 30% decrease in VAS scores, which was achieved in 50% of the biacuplasty group compared to 18% of controls (p=0.073). Investigators did not report whether the trial was adequately powered. Another limitation of this industry-sponsored trial was the lack of a sham control and patient blinding, which could contribute to a placebo effect in the subjective pain outcomes.
Of the 29 patients originally randomized to intradiscal biacuplasty, 22 (76%) were available for 12-month follow-up (Desai, 2016)(b). Mean 12-month change in VAS score was -2.2 (from 6.7 at baseline to 4.4 at 12 months, p=0.001). After 6 months, patients randomized to medical management were allowed to receive intradiscal biacuplasty and were followed for another 6 months; 25 of 34 patients crossed over. VAS score improved from 7.0 to 4.7 (p<0.001) in the crossover group, and 55% were considered to be responders.
ONGOING AND UNPUBLISHED CLINICAL TRIALS
A search of ClinicalTrials.gov in July 2017 did not identify any ongoing or unpublished trials that would likely influence this review.
2018 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2018. No new literature was identified that would prompt a change in the coverage statement.
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2019. No new literature was identified that would prompt a change in the coverage statement.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2021. No new literature was identified that would prompt a change in the coverage statement.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Fischgrund and colleagues conducted a randomized, double-blind, sham controlled study (SMART trial) of basivertebral nerve ablation using the Intracept system in 225 participants from the U.S. and Europe (Fischgrund, 2018). Patients had chronic isolated lumbar pain that had not responded to at least 6 months of nonoperative management. Additional study inclusion criteria were a minimum Oswestry Disability Index of 30 points (on a 100 point scale), a minimum visual analog scale of 4, and Modic type 1 or 2 changes at the vertebral endplates of the levels targeted for treatment. Treatment was limited to a minimum of 2 and a maximum of 3 consecutive vertebral levels from L3 to S1. The active treatment group (n=147) received radiofrequency and the sham group (n=78) underwent the same protocol for the same overall duration as the treatment group; however, the radiofrequency treatment was simulated. Patients were blinded to the group assignment for 1 year, at which time those in the sham arm were allowed to cross over, 57 (73%) of whom elected to do so and receive the Intracept treatment. The primary endpoint of the original study was comparative change in Oswestry Disability Index from baseline to 3 months, and in the intent-to-treat analysis there was no statistically significant difference in this outcome between groups at this time point. There was a difference between groups in the 3-month per protocol analysis (mean Oswestry Disability Index improved 20.5 and 15.2 points in the treatment and sham arms, respectively; p=.019). However, at the 12 month per protocol analysis, the difference in mean Oswestry Disability Index between groups was no longer statistically significant. Pain severity, measured by visual analog scale, was not significantly different between groups at 3 months (p=.083) but there was significantly greater improvement in the treatment group at 6 and 12 months.
The 24-month follow-up results were reported for the active treatment group from the SMART trial (Fischgrund, 2019). Of the per protocol population treated with ablation (treatment arm), 106 (83%) completed a 24-month follow-up visit. A durable Oswestry Disability Index mean improvement was observed (23.4 points). Data for Oswestry Disability Index outcomes were not available for the sham group because of the high crossover rate. Therefore, long-term comparative outcomes are not available.
Five-year results were reported for the 100 U.S. patients from the treatment arm from the original SMART trial who were available for follow-up (Fischgrund, 2020). Mean Oswestry Disability Index scores improved from 42.8 to 16.9 at 5 years, a reduction of 25.9 points. Mean reduction in visual analog scale score was 4.4 points (baseline 6.7, p<.001).
The INTRACEPT trial was an open-label RCT conducted at 20 U.S. sites (Khalil, 2019). A total of 140 patients with lower back pain of at least 6 months duration, with Modic Type 1 or 2 vertebral endplate changes between L3 and S1, were randomized to undergo radiofrequency ablation of the basivertebral nerve or continue standard care. Standard care consisted of pain medications, physical therapy, exercise, chiropractic treatment, acupuncture, and spinal injections; the specific treatment(s) administered were determined by the treating investigator in conjunction with the patient. Treatment of up to 4 vertebrae in non-consecutive levels from L3 to S1 was allowed. The primary study endpoint was change in Oswestry Disability Index at 3 months. A pre-planned interim analysis was undertaken when 60% of participants reached the 3-month follow-up (n=51 in the treatment group and n=53 in the standard care group) and reported statistically significant differences between groups on all patient-reported outcome measures, favoring the treatment group. The study was halted, and the individuals were allowed to cross over to the treatment arm. Study limitations include short term follow-up, lack of a sham group, and allowance of crossover at 3 months.
Twelve-month follow-up results were reported from the INTRACEPT trial; after a median of 175 days post randomization, 92% of patients initially randomized to the standard care arm elected to receive early treatment with basivertebral nerve ablation (Smuck, 2021). Six-month results for the Oswestry Disability Index were significantly improved with basivertebral nerve ablation (n=66) compared to standard care (n=74) (least squares mean difference between groups, -24.5; 95% CI, -29.4 to -19.6; p=.0001). Improvements in the Oswestry Disability index and mean visual analog scale that were reported among patients initially treated with basivertebral nerve ablation were maintained throughout the 12-month study period, with reported reductions of -25.7±18.5 points, and -3.8±2.6 cm, respectively (p<.001 for both comparisons to baseline). However, comparative data were not available beyond 6 months due to the high rate of crossover.
In 2020, the International Society for the Advancement of Spine Surgery published guidelines on intraosseous ablation of the basivertebral nerve for relief of chronic low back pain (Lorio, 2020). The guidelines suggest that basivertebral nerve ablation is an appropriate treatment for chronic low back pain in select patients who meet the following additional criteria:
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through July 2023. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
Andersson GB, Mekhail NA, Block JE.(2006) Treatment of intractable discogenic low back pain: A systematic review of spinal fusion and intradiscal electrothermal therapy (IDET). Pain Physician, 2006; 9:237-48. Appleby D, Andersson G, Totta M.(2006) Meta-analysis of the efficacy and safety of intradiscal electrothermal therapy (IDET). Pain Med, 2006; 7:308-16. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC).(2002) Intradiscal electrothermal therapy for chronic low back pain. TEC Assessments 2002; Volume 17, Tab 11. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC).(2003) Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic low back pain. TEC Assessments 2003; Volume 18, Tab 19. Boswell MV, Trescot AM, Datta S et al.(2007) Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician 2007; 10(1):7-111. Cohen SP, Larkin T, Abdi S, et al.(2003) Risk factors for failure and complications of intradiscal electrothermal therapy: a pilot sutdy. Spine 2003; 28(00): 1142-7. Derby R, Eek B, Ryan DP.(1998) Intradiscal Electrothermal Annuloplasty. N Am Spine Society 1998; San Francisco. Desai MJ, Kapural L, Petersohn JD, et al (a).(2016) A prospective, randomized, multicenter, open-label clinical trial comparing intradiscal biacuplasty to conventional medical management for discogenic lumbar back pain. Spine (Phila Pa 1976). Jul 01 2016;41(13):1065-1074. PMID 26689579 Desai MJ, Kapural L, Petersohn JD, et al (b).(2016) Twelve-month follow-up of a randomized clinical trial comparing intradiscal biacuplasty to conventional medical management for discogenic lumbar back pain. Pain Med. Aug 27 2016. PMID 27570246 Fischgrund JS, Rhyne A, Franke J, et al.(2018) Intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. May 2018; 27(5): 1146-1156. PMID 29423885 Fischgrund JS, Rhyne A, Franke J, et al.(2019) Intraosseous Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: 2-Year Results From a Prospective Randomized Double-Blind Sham-Controlled Multicenter Study. Int J Spine Surg. Apr 2019; 13(2): 110-119. PMID 31131209 Fischgrund JS, Rhyne A, Macadaeg K, et al.(2020) Long-term outcomes following intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 5-year treatment arm results from a prospective randomized double-blind sham-controlled multi-center study. Eur Spine J. Aug 2020; 29(8): 1925-1934. 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