| Coverage Policy Manual | |
| Policy #: | 2001012 |
| Category: | Radiology |
| Initiated: | June 2001 |
| Last Review: | August 2023 |
|
|
|
|||||||||||
| Laser or Radiofrequency Treatment, Chronic Back Pain | |
|
|
|
| Description: |
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 variety of minimally invasive techniques have been investigated as treatment of low back pain related to disc disease. Techniques can be broadly divided into those designed to remove or ablate disc material, and thus decompress the disc, and those designed to alter the biomechanics of the disc annulus. The former category includes chymopapain injection, automated percutaneous lumbar discectomy, laser discectomy, and, most recently, disc decompression using radiofrequency energy, referred to as a disc Nucleoplasty.
A variety of different lasers have been investigated for laser discectomy, including YAG (yttrium aluminum garnet), KTP (potassium titanyl phosphate), holmium, argon, and carbon dioxide lasers. Due to differences in absorption, the energy requirements and the rates of application differ among the lasers. In addition, it is unknown how much disc material must be removed to achieve decompression. Therefore, protocols vary by the length of treatment, but typically the laser is activated for brief periods only.
Radiofrequency coblation uses bipolar low-frequency energy in an electrical conductive fluid (eg, saline) to generate a high-density plasma field around the energy source. This creates a low-temperature field of ionizing particles that break organic bonds within the target tissue. Coblation technology is used in a variety of surgical procedures, particularly related to otolaryngology. The disc nucleoplasty procedure is accomplished with a probe mounted using a radiofrequency coblation source. The proposed advantage of coblation is that the procedure provides for controlled and highly localized ablation, resulting in minimal damage to surrounding tissue.
Vertebral body endplates have been proposed as a source of lower back pain, caused by intraosseous nerves. The basivertebral nerve enters the posterior vertebral body and sends branches to the superior and inferior endplates. Vertebrogenic pain, transmitted via the basivertebral nerve, has been purported to occur with endplate damage or degeneration.
The Intracept Intraosseous Nerve Ablation System is a recently developed specialized radiofrequency ablation device which has been granted US Food and Drug Administration (FDA) approval strictly for destruction of the basivertebral nerve of the L3-S1 vertebrae. It is proposed as a treatment option for low back pain.
Regulatory Status
A number of laser devices have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for incision, excision, resection, ablation, vaporization, and coagulation of tissue. Intended uses described in FDA summaries include a wide variety of procedures, including percutaneous discectomy. Trimedyne received 510(k) clearance in 2002 for the Trimedyne® Holmium Laser System Holmium: Yttrium, Aluminum Garnet (Holmium:YAG), in 2007 RevoLix Duo™ Laser System, and in 2009 Quanta System LITHO Laser System. All were cleared, based on equivalence with predicate devices for percutaneous laser disc decompression/discectomy, including foraminoplasty, percutaneous cervical disc decompression/discectomy, and percutaneous thoracic disc decompression/discectomy. The summary for the Trimedyne® system states that indications for cervical and thoracic decompression/discectomy include uncomplicated ruptured or herniated discs, sensory changes, imaging consistent with findings, and symptoms unresponsive to 12 weeks of conservative treatment. Indications for treatment of cervical discs also include positive nerve conduction studies. FDA product code: GEX.
In 2001, the Perc-D SpineWand™ (ArthroCare) was cleared for marketing by FDA through the 510(k) process. FDA determined that this device was substantially equivalent to predicate devices. It is used in conjunction with the ArthroCare Coblation® System 2000 for ablation, coagulation, and decompression of disc material to treat symptomatic patients with contained herniated discs. Smith & Nephew acquired ArthroCare in 2014; as of 2017, Smith & Nephew has not provided any information about coblation devices specific to spine surgeries on its website. FDA product code: GEI.
The Intracept Intraosseous Nerve Ablation System “is intended to be used in conjunction with radiofrequency (RF) generators for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least 6 months duration that has not responded to at least 6 months of conservative care”. FDA reviewed the device and issued a substantially equivalent designation in August 2017 (K170827). FDA product code: GXI.
|
|
|
|
|
Policy/ Coverage: |
Effective August 2021
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Laser discectomy and radiofrequency coblation (disc nucleoplasty) as techniques of disc decompression and treatment of associated pain does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, laser discectomy and radiofrequency coblation (disc nucleoplasty) as techniques of disc decompression and treatment of associated pain is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Radiofrequency ablation to the basivertebral nerve for the relief of chronic low back pain (intraosseous nerve ablation) (eg Intracept Intraosseous Nerve Ablation System) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation to the basivertebral nerve for the relief of chronic low back pain (intraosseous nerve ablation) (eg Intracept Intraosseous Nerve Ablation System) is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
Effective Prior to August 2021
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Radiofrequency ablation to the basivertebral nerve for the relief of chronic low back pain (intraosseous nerve ablation) (eg Intracept Intraosseous Nerve Ablation System) does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, radiofrequency ablation to the basivertebral nerve for the relief of chronic low back pain (intraosseous nerve ablation) (eg Intracept Intraosseous Nerve Ablation System), is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
Effective Prior to February 2019
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain is considered investigational. Investigational services are an exclusion in the member certificate of coverage.
|
|
|
|
| Rationale: |
Disc Nucleoplasty is a relatively new technology. Key studies and controlled studies evaluating this technology are discussed below.
Bokov and colleagues reported a non-randomized cohort study comparing nucleoplasty and microsurgery in 2010 (Bokov, 2010). Inclusion criteria were evidence of nerve root compression, pain resistant to conservative treatment including selective nerve root blocks during at least 1 month with VAS equal to or greater than 40/100 and disability equal to or greater than 40% on the Oswestry Disability Index (ODI). Only patients with mild motor and sensory deficits were included in the study. Patients undergoing nucleoplasty received pretreatment questionnaires and testing and were divided into those with a disc protrusion (< 5 mm; n=24; 6-9 mm, n=22) or a disc extrusion (n=27). The patients with disc extrusion chose nucleoplasty despite a total annulus disruption. Patients were examined at 1, 3, 6, 12, and 18 months with VAS for pain and ODI. A satisfactory result was defined as a 50% decrease in VAS and a 40% decrease in ODI, and the rates of satisfactory and unsatisfactory responses were compared between nucleoplasty and microdiscectomy (n=65). There were no significant differences in outcomes for patients with a disc protrusion equal to or less than 5 mm versus 6-9 mm, and these groups were combined. For all patients with a disc protrusion treated with nucleoplasty, satisfactory results were obtained in 36 (78%, 95% confidence interval [CI]: 66-90%). For the microdiscectomy group, a satisfactory result was observed in 61 patients (94%, 95% CI: 85-98%). For patients with a disc extrusion, nucleoplasty had a significantly higher rate of unsatisfactory results; clinically significant improvements were observed in 12 cases (44%), and 9 patients (33%) with disc extrusion treated with nucleoplasty subsequently underwent microdiscectomy for exacerbation of pain. These results support the conclusion that nucleoplasty is not as effective as microdiscectomy for disc extrusion. Prospective controlled trials are needed to evaluate efficacy and time for recovery in patients with disc protrusion.
In 2009, Birnbaum reported a series of 26 patients with cervical disc herniation (29 discs) treated with disc nucleoplasty who had 2 years of follow-up (Birnbaum, 2009). He compared their outcomes with a group of 30 patients who received conservative treatment. It does not appear that patients were randomly assigned to either treatment group but that the control patients were randomly chosen. Conservatively treated patients received perineural injections with bupivacaine and prednisolone acetate during the first week of treatment. Baseline VASs were 8.4 in the control group and 8.8 in the nucleoplasty group. At 1 week, scores were 7.3 and 3.4, respectively, and at 24 months, 5.1 and 2.3, respectively. No other outcome data were provided.
A prospective study from 2007 assessed outcomes in 52 consecutive patients treated with radiofrequency nucleoplasty of lumbar discs (Mirzai, 2007). Included in the study were patients younger than 60 years of age with radicular pain that was resistant to at least 3 months of conservative treatment, combined with magnetic resonance imaging (MRI) evidence of small and medium-sized herniated discs (less than 6 mm) that correlated with the patient’s symptoms. Patients with a disc height of less than 50% of adjacent discs, severe degenerated or fractured disc material, or evidence of extruded disc herniation were excluded. Independent assessment at 2 weeks, 6 months, and 1 year (94% follow-up) found a decrease in VAS pain scores from 7.5 to 2.1, a change from 42 to 21 on the ODI, and a reduction or complete stopping of use of analgesics in 94% of patients.
Cuellar et al. reported accelerated degeneration after failed nucleoplasty in 2010 (Cuellar, 2010). Of 54 patients referred for persistent pain after nucleoplasty, 28 patients were evaluated by MRI to determine the source of their symptoms. The total number of procedures performed could not be determined. VAS for pain in this cohort was 7.3. At a mean follow-up of 24 weeks (range, 6 to 52) after nucleoplasty, no change was observed between the baseline and postoperative MRI for increased signal hydration, disc space height improvement, or shrinkage of the preoperative disc bulge. Of 17 cervical levels treated in 12 patients, 5 (42% of patients) appeared to show progressive degeneration at treated levels. Of 17 lumbar procedures in 16 patients, 4 (15% of patients) showed progressive degeneration. Overall, a total of 26% of the patients in this series showed progressive degeneration at the treated level less than 1 year after nucleoplasty. The proportion of discs showing progressive degeneration out of the total nucleoplasty procedures performed cannot be determined from this study. It is also unknown whether any morphologic changes occur after nucleoplasties that were considered to be successful. Additional study of this potential adverse effect of nucleoplasty is needed.
Additionally, reports of 4 case series of patients receiving disc nucleoplasty were found. Li and colleagues report on a prospective study of 126 patients from China with contained cervical disc herniations who underwent nucleoplasty. VAS pain scores were significantly improved at 1, 3, 6, and 12 months’ follow-up (Li, 2008). Two smaller studies also report statistically significant reduction in pain. Calisaneller et al report on 29 patients who had lumbar nucleoplasty. Mean pre-operative VAS score was 6.95, and postoperative scores were 2.45, 4.0, and 4.53 at 24 hours, and 3 and 6 months, respectively (Calisaneller,2007). In a retrospective study from a U.S. center of 22 patients with 12 months of follow-up after lumbar nucleoplasty, statistically significant improvement on measures of pain, functional status, and medication use were reported (Yakovlev, 2007). Al-Zain and colleagues report outcomes for 69 patients for whom 12-month data were available from a cohort of 96 patients who underwent nucleoplasty for back pain and/or radiating pain in the lower extremities. (Seven patients were lost to follow-up, 11 were excluded due to secondary disc sequestration at the treated segment or elsewhere, and data for 8 patients is available only up to 6 months.) Seventy-three percent (73%) of patients improved more than 50% in early postoperative VAS score; this was reduced to 61% of patients at 6 months and to 58% after 1 year (Al-zain, 2008).
Practice Guidelines published in 2009 by the American Society of Interventional Pain Physicians (Manchikanti, 2009) report U.S. Preventive Services Task Force (USPSTF) report Level II-3 evidence for disc nucleoplasty in managing predominantly lower extremity pain due to contained disc herniation and state that there is no evidence available for axial low back pain. The guidelines make a weak recommendation for radiofrequency disc nucleoplasty in managing radicular pain due to contained disc herniation. No recommendation for nucleoplasty is given regarding managing axial low back pain.
Summary
While numerous case series and uncontrolled studies report improvements in pain and functioning following nucleoplasty, the lack of well-designed and conducted controlled trials limits interpretation of reported data. Questions remain about the safety and efficacy of this treatment. Reconsideration of the policy position awaits randomized trials with adequate follow-up (at least 1 year) that control for selection bias, the placebo effect, and variability in the natural history of low back pain.
2012 Update
A literature search was conducted through September 2012. There were no new randomized trials, practice guidelines, position statements or other publications identified that would prompt a change in the coverage statement.
A search of the online site www.clinicaltrials.gov in June 2012 identified two studies listed as completed and one study listed as status unknown. An industry-sponsored randomized controlled trial of nucleoplasty compared to conservative care (NCT00940810) is listed with an estimated enrollment of 46 patients with completion expected November 2011. There were no publications provided.
Another industry-sponsored sham-controlled randomized trial on nucleoplasty is listed as completed as of March 2008 (NCT00124774). No publications from this trial have been identified.
2013 Update
A literature search was conducted using the MEDLINE database through September 2013. No new information was identified that would prompt a change in the coverage statement. The following is a summary of the key identified literature.
A 2013 systematic review by Manchikanti et al. identified 1 RCT and 14 observational studies on nucleoplasty that met inclusion criteria, concluding that evidence on nucleoplasty was limited to fair (Manchikanti, 2013).
Randomized Controlled Trials
An industry-sponsored RCT from 2010 was an unblinded multi-center comparison of coblation nucleoplasty versus 2 epidural steroid injections (Gerstzen, 2010). The 85 patients included in the study had a focal disc protrusion and had failed conservative therapy. In addition, all patients had received an epidural steroid injection 3 weeks to 6 months previously with no relief, temporary relief, or partial relief of pain. At the 6-month follow-up, the mean improvement in VAS for leg pain, back pain, the Oswestry Disability Index (ODI), and Short Form (SF)-36 subscores were significantly greater in the nucleoplasty group. A greater percentage of patients in the nucleoplasty group also had a minimum clinically important change for leg pain, back pain, ODI and SF-36 scores. A similar percentage of patients (27% of the nucleoplasty group and 20% of the epidural steroid group) had unresolved symptoms and received a secondary procedure during the first 6 months of the study. At 1-year follow-up, secondary procedure rates increased to 42% of the nucleoplasty group and 68% of the steroid group. By the 2-year follow-up, 44% of the nucleoplasty group and 73% of patients in the steroid group had secondary procedures, including 20 patients who had crossed over from steroid treatment to nucleoplasty.
A 2012 unblinded RCT from Asia compared nucleoplasty with conservative treatment in 64 patients (Chitragran, 2012). VAS at 15 days after treatment was reduced from a baseline of about 9 to about 5. The nucleoplasty group was reported to have a reduction in pain and medication use compared to conservatively treated controls at 1, 3, 6, and 12 months following treatment, although the data were not presented in this brief report. Comparison of MRI at baseline and after treatment showed a decrease in the bulging of the disc from 5.09 mm to 1.81 mm at 3 months after nucleoplasty.
Ongoing Clinical Trials
A search of the online site www.clinicaltrials.gov in June 2013 identified 1 new trial from Europe that will compare nucleoplasty with pulsed radiofrequency of the nerve or dorsal root ganglion (DRG) (NCT01797172). Thirty-eight patients will be enrolled with completion expected in 2014.
Two recent trials are listed as completed but no publications have been identified:
2014 Update
A literature search conducted through July 2014 did not reveal any new information that would prompt a change in the coverage statement.
2015 Update
A literature search conducted through July 2015 did not reveal 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.
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. The key identified literature is summarized below.
De Rooij et al compared the effects of percutaneous cervical nuceloplasty and anterior cervical discectomy in 48 patients with cervical radicular pain due to a single-level contained soft-disc herniation (de Rooij, 2020). The primary outcome measure was arm pain intensity as measured by a visual analog scale. Overall, a statistically significant interaction between the groups on arm pain intensity and the secondary outcome of SF-36 item pain, in favor of anterior cervical discectomy, was noted at 3 months. There was also a trend for more improvement of arm pain in favor of anterior cervical discectomy at 12 months, with no statistical interactions on the secondary outcomes observed. Of note, the trial was discontinued before reaching the required sample size as enrollment into the trial was low.
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
Recent publications have been reviewed (Koreckij, 2021; Macadaeg, 2020; Fishchenko, 2021; Boody, 2022; McCormick, 2022; McCormick, 2022; DeVivo, 2020; McCormick, 2022; Conger, 2022; Loan, 2021; Conger, 2022; Mekhail, 2022; Urits, 2021; Conger, 2021; Michalik, 2021; Tieppo, 2021; Schnapp, 2022; Huang, 2022; Sayed, 2022; Falowski, 2022; Tieppo Francio, 2021; Eshraghi, 2022; Beall, 2022) and the review does not prompt a change in the coverage statement.
August 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. The key identified literature is summarized below.
In 2022, the International Society for the Advancement of Spine Surgery published updated guidelines on intraosseous basivertebral nerve ablation (Lorio, 2022). The guideline was informed by a systematic review which included 2 randomized controlled trials (RCTs) and additional single-arm studies. The guideline authors concluded that intraosseous ablation of the basivertebral nerve from the L3 through S1 vertebrae may be considered medically indicated for individuals with chronic low back pain when all the following criteria are met:
Chen et al conducted an open-label, case-control, single-center study in China in individuals with cervical herniated intervertebral disc and cervical radiculopathy treated with nucleoplasty (n=71) compared to conventional treatment (n=21) (Chen, 2022). The nucleoplasty group demonstrated significantly greater changes from baseline in pain scores measured by the visual analog scale at 1-month post-operation (p<.001), 3 months post-operation (p<.001), and 6 months post-operation (p<.01) compared to conventional therapy. At 1 month post-operation, the nucleoplasty group also exhibited improved Oswestry Disability Index scores (p<.05) and Neck Disability Index scores (p<.05) compared to conventional therapy, but there was no difference between groups at 6 months follow-up. These results are limited by the small sample size, lack of randomization, and loss to follow-up of some participants at the 6-month point.
In 2012, the North American Spine Society (NASS) released clinical practice guidelines on the diagnosis and treatment of lumbar disc herniation with radiculopathy (NASS, 2012). NASS stated, "there is insufficient evidence to make a recommendation for or against the use of plasma disc decompression/nucleoplasty in the treatment of patients with lumbar disc herniation with radiculopathy."
|
|
|
|
| CPT/HCPCS: | |
|
|
|
| References: |
2000 Blue Cross Blue Shield Association Technology Evaluation Center Assessment; Tab 5. Al-Zain F, Lemcke J, Killeen T et al.(2008) Minimally invasive spinal surgery using nucleoplasty: a 1-year follow-up study. Acta Neurochir (Wien) 2008; 150(12):1257-62. Barendse GAM, van den Berg SGM, Kessels AHF, et al.(2001) Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain. Lack of effect from a 90-second 70 C lesion. Spine 2001; 26:287-292. Beall D, Macadaeg K.(2022) Intraosseous basivertebral nerve ablation 3-year effectiveness and safety results: a pooled cohort study of two prospective clinical trials. Lecture ASPN annual meeting; July 14-17, 2022. Becker S, Hadjipavlou A, Heggeness MH.(2017) Ablation of the basivertebral nerve for treatment of back pain: a clinical study. Spine J. 2017 Feb;17(2):218-223. doi: 10.1016/j.spinee.2016.08.032. Epub 2016 Sep 1. Birnbaum K.(2009) Percutaneous cervical disc decompression. Surg Radiol Anat 2009; 31(5):379-87. Boody B, Sperry B, Harper K, Macadaeg K, McCormick Z.(2022) The relationship between patient demographic and clinical characteristics and successful treatment outcomes following basivertebral nerve radiofrequency ablation: a pooled cohort study of three prospective clinical trials. Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S2–S13. Boswell MV, Trescot AM, et al.(2007) Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician, 2007; 10:7-111. Calisaneller T, Ozdemir O, et al.(2007) Six months post-operative clinical and 24 hour post-operative MRI examinations after nucleoplasty with radiofrequency energy. Acta Neurochir (Wien), 2007; 149:495-500. Chen CH, Chiu YP, Ji HR, et al.(2022) Analysis of the clinical and radiological outcomes of percutaneous cervical nucleoplasty: A case-control study. PLoS One. 2022; 17(12): e0278883. PMID 36508407 Chitragran R, Poopitaya S, Tassanawipas W.(2012) Result of percutaneous disc decompression using nucleoplasty in Thailand: a randomized controlled trial. J Med Assoc Thai 2012; 95 Suppl 10:S198-205. Conger A, Burnham T, Clark T, Teramoto M, McCormick Z.(2022) The effectiveness of intraosseous basivertebral nerve, ablation for the treatment of vertebrogenic low back pain: an updated systematic review with single arm metaanalysis. Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S50–S62. Conger A, Schuster NM, Cheng DS, Sperry BP, Joshi AB, Haring RS, Duszynski B, McCormick ZL.(2021) The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Neurotomy for the Treatment of Chronic Low Back Pain in Patients with Modic Changes: A Systematic Review. Pain Med. 2021 May 21;22(5):1039-1054. doi: 10.1093/pm/pnab040. PMID: 33544851. Conger A., Smuck M., Truumees E., Lotz J., DePalma M., McCormick Z.(2022) Vertebrogenic pain; a paradigm shift in diagnosis and treatment of axial low back pain. Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S63-S71. Cuellar VG, Cuellar JM, Vaccaro AR et al.(2010) Accelerated degeneration after failed cervical and lumbar nucleoplasty. J Spinal Disord Tech 2010; 23(8):521-4. de Rooij J, Harhangi B, Aukes H, et al.(2020) The Effect of Percutaneous Nucleoplasty vs Anterior Discectomy in Patients with Cervical Radicular Pain due to a Single-Level Contained Soft-Disc Herniation: A Randomized Controlled Trial. Pain Physician. Nov 2020; 23(6): 553-564. PMID 33185372 DeVivo AE, D’ Agostino G, D’ Anna G, Al Qatami H, Gil I, Ventura F, et. al.(2020) Intra-osseous basivertebral nerve radiofrequency ablation (BVA) for the treatment of vertebrogenic chronic low back pain. Neuroradiology. 2020;63:809-815. https://doi.org/10.1007/s00234-020-02577-8. Eshraghi Y, Shah J, Guirguis M.(2022) Novel Technologies in Interventional Pain Management. Phys Med Rehabil Clin N Am. Vol 33, Issue 2, May 2022: 533-552. https://www.sciencedirect.com/science/article/abs/pii/S1047965122000067?via%3Dihub Falowski, S, Sayed, D.(2022) Chapter 7: Back Pain: Vertebrogenic. In: Mostoufi, S.A., George, T.K., Tria Jr., A.J. (eds) Clinical Guide to Musculoskeletal Medicine. Springer, Cham. 2022:45-50. 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. 2018 May;27(5):1146-1156. doi: 10.1007/s00586-018-5496-1. Epub 2018 Feb 8. 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. 2019;13(2):110-119. 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. Eur Spine J. 2020 Aug;29(8):1925-1934. doi: 10.1007/s00586-020-06448-x. Epub 2020 May 25. PMID: 32451777. Fishchenko I V, Garmish AR, Kravchuk LD, Saponenko AI, Clinic CM.(2021) Radiofrequency ablation of the basivertebral nerve in the treatment of chronic low back pain: analysis of a small clinical series. Hir Pozvonochnika. 2021;18(3):61–7. Gerszten PC, Smuck M, Rathmell JP et al.(2010) Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: a prospective, randomized, controlled trial. J Neurosurg Spine 2010; 12(4):357-71. Gerszten PC, Welch WC, King JT.(2006) Quality of life assessment in patients undergoing nucleoplasty-based percutaneous discectomy. J Neurosurg Spine. 2006; 4:36-42. Huang J, Delijani K, Jones J, Di Capua J, El Khudari H, Gunn AJ, Hirsch J.(2022) Basivertebral Nerve Ablation. Semin Intervent Radiol. 2022 Jun 30;39(2):162-166. doi: 10.1055/s-0042-1745794. PMID: 35782000; PMCID: PMC9246496. Karasek M, Bogduk N.(2000) Twelve-month follow-up of a controlled trial of intradiscal thermal annuloplasty for back pain due to internal disc disruption. Spine 2000; 25(20):2601-7. Khalil JG, Smuck M, Koreckij T, et al.(2019) A prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Spine J. 2019 Oct;19(10):1620-1632. doi: 10.1016/j.spine.2019.05.598. Epub 2019 Jun 20. PMID: 31229663. Kim HS, Adusl N, Yudoyono F, Paudel G, et al.(2018) Transforaminal Epiduroscopic Basivertebral Nerve Laser Ablation for Chronic Low Back Pain Associated with Modic Changes: A Preliminary Open-Label Study. Pain Res Manag. 2018 Aug 14;2018:6857983. doi: 10.1155/2018/6857983. eCollection 2018. Koreckij T, Kreiner S, Khalil JG, et al.(2021) Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 24-Month treatment arm results. N Am Spine Soc J. Dec 2021; 8: 100089. PMID 35141653 Li J, Yan DL, Zhang ZH.(2008) Percutaneous cervical nucleoplasty in the treatment of cervical disc herniation. Eur Spine J 2008; 17(21):1664-9. Loan, A.J. and Kieser, D.C.(2021) Intraosseous Radiofrequency Ablation of the Basivertebral Nerve in Chronic Low Back Pain: A Meta-Analysis. Open Journal of Radiology, 11, 81-90. Lorio M, Clerk-Lamalice O, Beall DP, et al.(2020) International Society for the Advancement of Spine Surgery Guideline-Intraosseous Ablation of the Basivertebral Nerve for the Relief of Chronic Low Back Pain. Int J Spine Surg. Feb 2020; 14(1): 18-25. PMID 32128298 Lorio M, Clerk-Lamalice O, Rivera M, et al.(2022) ISASS Policy Statement 2022: Literature Review of Intraosseous Basivertebral Nerve Ablation. Int J Spine Surg. Dec 2022; 16(6): 1084-1094. PMID 36266051 Macadaeg K, Truumees E, Boody B, Pena E, Arbuckle A., Gentile, J, et al.(2020) A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. NASSJ 2020;3(100030). E-pub 18 Sept 2020. https://doi.org/10.1016/j.xnsj.2020.100030. Manchikanti L, Derby R, Benyamin RM et al.(2009) A systematic review of mechanical lumbar disc decompression with nucleoplasty. Pain Physician 2009; 12(3):561-72. Manchikanti L, Falco FJ, Benyamin RM et al.(2013) An update of the systematic assessment of mechanical lumbar disc decompression with nucleoplasty. Pain Physician 2013; 16(2 Suppl):SE25-54. Masala S, Massari F, et al.(2007) Nucleoplasty in the treatment of lumbar diskogenic back pain: one year follow-up. Cardiovasc Intervent Radiol, 2007; 30:426-32. McCormick Z, Conger A, Smuck M, Lotz J, Hirsch J, Hickman C, et al.(2022) Magnetic resonance imaging characteristics associated with treatment success from basivertebral nerve ablation: an aggregated cohort study of multicenter prospective clinical trials data. Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S34–S49. McCormick Z, Sperry B, Boody B, Hirsch JA, Conger A, Harper K, et al.(2022) Pain Location and Exacerbating Activities Associated with Treatment Success Following Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trial Data. Pain Medicine, 23(S2), 2022, S14–S33 McCormick ZL.(2022) Vertebrogenic Pain: A Phenomenon Driving New Understanding of Chronic Axial Low Back Pain. Pain Medicine, Volume 23, Issue Supplement_2, August 2022, Pages S1. Mekhail N.(2022) Interventions for Chronic Axial Low Back Pain: Meta-Analysis. Lecture presented at American Society of Pain & Neuroscience Annual Conference, July 15, 2022, Miami, FL. Michalik A, Conger A, Smuck M, Maus TP, McCormick ZL.(2021) Intraosseous Basivertebral Nerve Radiofrequency Ablation for the Treatment of Vertebral Body Endplate Low Back Pain: Current Evidence and Future Directions. Pain Med. 2021 Jul 25;22(Suppl 1):S24-S30. doi: 10.1093/pm/pnab117. PMID: 34308955. Mirzai H, Tekin I, et al.(2007) The results of nucleoplasty in patients with lumbar herniated disc: a prospective clinical study of 52 consecutive patients. Spine J, 2007; 7:88-92. Mirzai H, Tekin I, Yaman O et al.(2007) The results of nucleoplasty in patients with lumbar herniated disc: a prospective clinical study of 52 consecutive patients. Spine J 2007; 7(1):88-92; discussion 92-3. North American Spine Society (NASS).(2012) Clinical guidelines for diagnosis and treatment of lumbar disc herniation with radiculopathy. 2012; https://www.spine.org/Portals/0/Assets/Downloads/ResearchClinicalCare/Guidelines/LumbarDiscHerniation.pdf. Accessed February 14, 2023. Percutaneous Intradiscal Radiofrequency Thermocoagulation for Chronic Discogenic Low Back Pain. 2002 Blue Cross Blue Shield Association Technology Evaluation Center Assessment. Radiofrequency ablation for chronic spinal pain. Hayes Technology Assessment 2004. Saal JA, Saal JS.(2000) Intradiscal electrothermal treatment for chronic discogenic low back pain: a prospective outcomes study with minimum 1-year follow-up. Spine 2000; 25(20):2622-7. Sayed D, Naidu RK, Patel KV, Strand NH, Mehta P, Lam CM, et al.(2022) Best Practice Guidelines on the Diagnosis and Treatment of Vertebrogenic Pain with Basivertebral Nerve Ablation from the American Society of Pain and Neuroscience. J Pain Res. 2022;15:2801-2819. https://doi.org/10.2147/JPR.S378544 Schnapp W, Martiatu K, Delcroix G.(2022) Basivertebral Nerve Ablation for the Treatment of Chronic Low Back Pain: A Scoping Review of the Literature. Pain Physician. 2022:E551-E562. Singh V, Piryani C, Liao K.(2003) Evaluation of percutaneous disc decompression using coblation in chronic back pain with or without leg pain. Pain Physician, 2003; 6:273-80. Smuck M, Khalil J, Barrette K, et al.(2021) Prospective, randomized, multicenter study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain: 12-month results. Reg Anesth Pain Med. Aug 2021; 46(8): 683-693. PMID 34031220 Tieppo Francio, V.; Gill, B.; Rupp, A.; Sack, A.; Sayed, D.(2021) Interventional Procedures for Vertebral Diseases: Spinal Tumor Ablation, Vertebral Augmentation, and Basivertebral Nerve Ablation—A Scoping Review. Healthcare 2021, 9, 1554. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8624649/ Tieppo FV, Sherwood D, Twohey E, Barndt B, Pagan-Rasodo R, Eubanks J, Sayed D.(2021) Developments in Minimally Invasive Surgical Options for Vertebral Pain: Basivertebral Nerve Ablation – A Narrative Review. JPR. 2021;14:1887-1907. Truumees E, Macadaeg K, Pena E, et al.(2019) A prospective, open-label, single-arm, multi-center study of intraosseous basivertebral nerve ablation for the treatment of chronic low back pain. Eur Spine J. 2019;28, 1594–1602. Urits I, Noor N, Johal AS, Leider J, Brinkman J, Fackler N, et al.(2021) Basivertebral Nerve Ablation for the Treatment of Vertebrogenic Pain. Pain Ther. 2021 Jun;10(1):39-53. doi: 10.1007/s40122-020-00211-2. Epub 2020 Oct 31. PMID: 33128702; PMCID: PMC8119576. www.oratec.com/products/spine/referencerev11.pdf. Yakovlev A, Tamimi MA, et al.(2007) Outcomes of percutaneous disc decompression utilizing nucleoplasty for the treatment of chronic discogenic pain. Pain Physician, 2007; 10:319-28. |
|
|
|
|
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
|