Description:　
Laser energy (laser discectomy) and radiofrequency (RF) coblation (nucleoplasty) are being evaluated for decompression of the intervertebral disc. For laser discectomy under fluoroscopic guidance, a needle or catheter is inserted into the disc nucleus, and a laser beam is directed through it to vaporize tissue. For disc nucleoplasty, bipolar RF energy is directed into the disc to ablate tissue. These minimally invasive procedures are being evaluated for the treatment of discogenic back pain.

For individuals who have discogenic back pain or radiculopathy who receive laser discectomy, the evidence includes systematic reviews of observational studies. Relevant outcomes are symptoms, functional outcomes, and treatment-related morbidity. While numerous case series and uncontrolled studies have reported improvements in pain levels and functioning following laser discectomy, the lack of well-designed and conducted controlled trials limits interpretation of reported data. The evidence is insufficient to determine the effect of the technology on health outcomes. 

For individuals who have discogenic back pain or radiculopathy who receive disc nucleoplasty with RF coblation, the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and treatment-related morbidity. For nucleoplasty, there are 2 RCTs in addition to several uncontrolled studies. These RCTs are limited by the lack of blinding, an inadequate control condition in 1 trial, and inadequate data reporting in the second. The available evidence is insufficient to permit conclusions concerning the effect of these procedures on health outcomes due to multiple confounding factors that may bias results. High-quality randomized trials with adequate follow-up (at least 1 year), which control for selection bias, the placebo effect, and variability in the natural history of low back pain, are needed. The evidence is insufficient to determine the effect of the technology on health outcomes. 

Background
Discogenic Low Back Pain
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.

Treatment
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.

Techniques that alter the biomechanics of the disc (disc annulus) include a variety of intradiscal electrothermal procedures discussed in evidence review 7.01.72.

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 (e.g., 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.

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 Inc. 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. FDA product code: GEI.

Policy:
Laser discectomy and radiofrequency coblation (disc nucleoplasty) are investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY as techniques of disc decompression and treatment of associated pain.   

Policy Guidelines
Coding
See the Codes table for details.

Benefit Application
BlueCard^®/National Account Issues
State or federal mandates (e.g., FEP) may dictate that all devices approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational and, thus, these devices may be assessed only on the basis of their medical necessity.

Rationale  
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Laser Discectomy
Clinical Context and Therapy Purpose
The purpose of decompression of the intervertebral disc using laser discectomy for patients with discogenic back pain or radiculopathy is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does decompression of the intervertebral disc using laser discectomy improve the net health outcome in patients with discogenic back pain or radiculopathy?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with discogenic back pain or radiculopathy.

Interventions
The therapy being considered is laser discectomy.

Comparators
The following therapies are currently being used to make decisions about laser discectomy: conservative management such as physical therapy and medication, epidural steroid injection, and the potential for conventional discectomy or surgical decompression in severe cases.

The optimal comparators are conservative therapy with a sham control, epidural steroid injection, or conventional discectomy.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, and treatment-related morbidity. Laser discectomy has a fairly extensive literature describing different techniques using different lasers.

Follow-up would ideally be ≥ 1 year.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
4. Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Singh et al. (2013) updated their systematic review of current evidence on percutaneous laser disc decompression.^1,2 The authors selected 17 observational studies. Due to the lack of RCTs, meta-analysis could not be conducted, and evidence was considered limited, as rated using U.S. Preventive Services Task Force criteria. A Cochrane review (2007) of surgical interventions for lumbar disc prolapse included 2 comparative studies on laser discectomy that were reported as proceedings and abstracts.³ Reviewers concluded that clinical outcomes following automated discectomy and laser discectomy “are at best fair and certainly worse than after microdiscectomy, although the importance of patient selection is acknowledged.”

Observational Studies
Tassi et al. (2006) compared outcomes from 500 patients who had discogenic pain and herniated discs treated using microdiscectomy (1997 – 2001 by 6 surgeons) with 500 patients treated using percutaneous laser disc decompression (2002 – 2004 by a single surgeon).⁴ Patients with sequestered discs were excluded. This retrospective review found that the hospital stay (6 days vs. 2 days), overall recovery time (60 days vs. 35 days), and repeat procedure rates (7% vs. 3%), all respectively, were shorter or had lower rates in the laser group than in the microdiscectomy group. No statistical comparisons were provided. The percentage of patients with overall good/excellent outcomes (Macnab criteria measuring pain and function) was found to be similar in both groups (85.7% vs. 83.8%, respectively) at the 2-year assessment; quantitative outcome measures were not reported.

Other than the comparative studies previously mentioned, the evidence for laser discectomy is limited to case series. Choy (2004) published the largest series, which included 1,275 patients treated with 2,400 procedures (including cervical, thoracic, lumbar discs) over 18.5 years, with an overall success rate using the Macnab criteria of 89%.⁵ Menchetti et al. (2011) retrospectively reviewed 900 patients treated with laser discectomy for herniated nucleus pulposus.⁶ The success rate using Macnab criteria at a mean of 5 years (range, 2 – 6 years) was 68%. Visual analog scale scores for pain decreased from 8.5 preoperatively to 2.3 at the 3-year follow-up but increased to 3.4 at the 5-year follow-up. There was a correlation between fair/poor results and subannular extrusion; 40% of these cases were treated with microsurgery after 1 to 3 months.

Section Summary: Laser Discectomy
Evidence on decompression of the intervertebral disc using laser energy consists of observational studies. Given the variable natural history of back pain and the possibility of placebo effects with this treatment, observational studies are insufficient to permit conclusions concerning the effect of this technology on health outcomes.

Disc Nucleoplasty With Radiofrequency Coblation
Clinical Context and Therapy Purpose
The purpose of decompression of the intervertebral disc using radiofrequency coblation for patients with discogenic back pain or radiculopathy is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does decompression of the intervertebral disc using disc nucleoplasty with radiofrequency coblation improve the net health outcome in patients with discogenic back pain or radiculopathy?

The following PICO was used to select literature to inform this review.

Populations
The relevant populations of interest is individuals with discogenic back pain or radiculopathy.

Interventions
The therapy being considered is disc nucleoplasty with radiofrequency coblation.

Comparators
The following therapies are currently being used to make decisions about laser discectomy: conservative management such as physical therapy and medication, epidural steroid injection, and the potential for conventional discectomy or surgical decompression in severe cases.

The optimal comparators are conservative therapy with a sham control, epidural steroid injection, or conventional discectomy.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, and treatment-related morbidity.

Follow-up would ideally be ≥ 1 year.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.
2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
3. To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
4. Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
Manchikanti et al. (2013) identified an RCT (described below) and 14 observational studies on disc nucleoplasty (radiofrequency coblation) that met inclusion criteria for their systematic review; the authors concluded that the evidence was limited to fair.⁷

Randomized Controlled Trials
Gerszten et al. (2010) conducted an industry-sponsored, unblinded, multicenter RCT, included in the above systematic review, that compared coblation nucleoplasty with 2 epidural steroid injections.⁸ Ninety patients were initially randomized (46 to the coblation nucleoplasty arm and 44 to the epidural steroid injections arm). The intention-to-treat analysis was defined on the basis of 85 patients (45 in the nucleoplasty group and 40 in the epidural steroid injections group) who ultimately underwent the assigned intervention. All patients had previously had an epidural steroid injection at 3 weeks to 6 months with no relief, temporary relief, or partial relief of pain. The primary outcome was pain reduction assessed by visual analog scale score. At the 6-month follow-up, the mean improvement in visual analog scale scores for leg pain, back pain, Oswestry Disability Index scores, and 36-Item Short-Form Health Survey (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, Oswestry Disability Index, and SF-36 scores. The proportion of patients in each group with unresolved symptoms requiring a secondary procedure during the first 6 months of the trial did not differ between groups (27% for nucleoplasty vs. 20% for epidural steroid). At 1-year follow-up, secondary procedure rates increased to 42% of the nucleoplasty group and to 68% of the steroid group. All patients who requested a secondary procedure were cared for as considered appropriate by the study investigator. For the epidural steroid injections and coblation nucleoplasty groups, respectively, secondary procedures that were pursued included additional epidural steroid injections (5 and 13 patients), other radiofrequency ablation (2 and 2), coblation nucleoplasty (20 and 0), microdiscectomy (2 and 4), and lumbar interbody fusion (0 and 1).

Chitragran et al. (2012) published results of an unblinded RCT conducted in Asia that compared nucleoplasty with conservative treatment in 64 patients.⁹ Visual analog scale scores at 15 days after treatment were reduced by 4 points from baseline (9 to 5). The nucleoplasty group was reported to have a reduction in pain and medication use compared with conservatively treated controls at 1, 3, 6, and 12 months posttreatment, although the data were not presented. Comparison of magnetic resonance images at baseline and after treatment showed a decrease in disc bulging from 5.09 mm to 1.81 mm at 3 months after nucleoplasty.

De Rooij et al. (2020) 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.¹⁰ Tables 1 and 2 summarize the key characteristics and results of this trial. 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. Tables 3 and 4 discuss study relevance and design/conduct limitations.

Table 1. Summary of Key RCT Characteristics

Study	Countries	Sites	Dates	Participants	Interventions
					Active	Comparator
de Rooij et al. (2020)10	The Netherlands	5	2012 – 2018	48	Percutaneous cervical nucleoplasty (n = 24)	Anterior cervical discectomy (n = 24)

RCT: randomized controlled trial.

Table 2. Summary of Key RCT Results

Study	Arm Pain Intensity (measured with VAS)	Neck Pain Intensity (measured with VAS)	Satisfaction after Treatment (measured by GPE questionnaire)	Disability due to Neck Pain (measured by Neck Disability Index)
de Rooij et al. (2020)10	ITT analysis	ITT analysis	ITT analysis	ITT analysis
Percutaneous cervical nucleoplasty (mean; 95% CI)	Baseline: 53.1 (43.8-62.4) 1 week: 38.4 (26.3-50.5) 3 months: 35.7 (24.1-47.2) 12 months: 31 (19.9-42.1)	Baseline: 60.1 (50.8-69.4) 1 week: 46.7 (35.5-57.9) 3 months: 37.1 (26.3-49.3) 12 months: 35.0 (24.1-45.9)	1 week: 2.95 (2.37-3.55) 3 months: 2.60 (1.92 to 3.28) 12 months: 3 (2.36-3.64)	Baseline: 61.88 (56.17 to 67.59) 3 months: 49.09 (40.4-57.76) 12 months: 46.13 (37.35-54.91)
Anterior cervical discectomy (mean; 95% CI)	Baseline: 58.9 (49.7-68.3) 1 week: 41.9 (29.6-54.3) 3 months: 24.3 (12.7-35.9) 12 months: 21.3 (10-32.6)	Baseline: 59.9 (50.1-69.9) 1 week: 48.9 (50.5-70.4) 3 months: 26.0 (13.9-38.0) 12 months: 24.7 (13.5-35.8)	1 week: 2.46 (1.83 to 3.06) 3 months: 1.97 (1.26 to 2.67) 12 months: 2.27 (1.62 to 2.92)	Baseline: 67.7 (61.99-73.41) 3 months: 49.79 (41.12-58.48) 12 months: 46.35 (37.57-55.13)

CI: confidence interval: GPE: global perceived effect; ITT: intention-to-treat; RCT: randomized controlled trial; VAS: visual analog scale.

Tables 3 and 4 display notable limitations identified in each study.

Table 3. Study Relevance Limitations

Study	Populationa	Interventionb	Comparatorc	Outcomesd	Duration of Follow-upe
de Rooij et al. (2020)10	4. Inclusion by participating hospitals was limited as several patients preferred to be treated in their local hospital, resulting in the majority of patients coming from 2 sites			6. At 12 months, no significant interaction on any outcomes was seen, presumed due to trial being underpowered

The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 4. Study Design and Conduct Limitations

Study	Allocationa	Blindingb	Selective Reportingc	Data Completenessd	Powere	Statisticalf
de Rooij et al. (2020)10		1. Patients and interventionists were not blinded to treatment, increased risk of performance bias		2. Change in study intended to physiotherapy treatment arm. Withdrawn due to refusal of patients with prior unsuccessful physiotherapy	3. Trial did not accrue required sample size

The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Cohort Studies
Bokov et al. (2010) reported a nonrandomized cohort study comparing nucleoplasty with microdiscectomy.¹¹ Patients undergoing nucleoplasty were grouped into those with a disc protrusion (n = 46) or a disc extrusion (n = 27). Patients were rated at 1, 3, 6, 12, and 18 months for pain visual analog scale and Oswestry Disability Index scores. A satisfactory result was defined as a 50% decrease in visual analog scale score and a 40% decrease in Oswestry Disability Index score. For patients with a disc protrusion treated with nucleoplasty, satisfactory results were obtained in 36 (78%) patients. For patients with a disc protrusion treated with microdiscectomy, a satisfactory result was observed in 61 (94%) patients. For patients with a disc extrusion, nucleoplasty had a significantly higher rate of unsatisfactory results; clinically significant improvements were observed in 12 (44%) cases and 9 (33%) patients with disc extrusion treated with nucleoplasty subsequently underwent microdiscectomy for exacerbation of pain.

Birnbaum (2009) compared outcomes from a series of 26 patients who had cervical disc herniation treated using disc nucleoplasty with a group of 30 patients who received conservative treatment using bupivacaine and prednisolone acetate.¹² Baseline visual analog scale score was 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.

Cuellar et al. (2010) reported on an observational study evaluating accelerated degeneration after failed nucleoplasty.¹³ Of 54 patients referred for persistent pain after nucleoplasty, 28 patients were evaluated by magnetic resonance imaging to determine the source of their symptoms. Visual analog scale score for pain in this cohort was 7.3. At a mean follow-up of 24 weeks (range, 6 – 52 weeks) after nucleoplasty, no change was observed between baseline and postoperative magnetic resonance imaging results 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%) patients appeared to show progressive degeneration at treated levels. Of 17 lumbar procedures in 16 patients, 4 (15%) patients showed progressive degeneration. Overall, 32% of the patients in this series showed progressive degeneration at the treatment level less than 1 year after nucleoplasty. The proportion of discs showing progressive degeneration of the total nucleoplasty procedures performed cannot be determined from this study. It is also unknown whether any morphologic changes occurring after nucleoplasties were considered successful. Additional study of this potential adverse event of nucleoplasty is needed.

Section Summary: Disc Nucleoplasty With Radiofrequency Coblation
Three unblinded RCTs have assessed nucleoplasty. One was from Asia and compared nucleoplasty with conservative therapy. Another RCT was an industry-sponsored comparison of coblation nucleoplasty with epidural steroid injections in a group of patients who had already failed the control intervention. At 6-month follow-up, scores for pain and functional status were superior for the nucleoplasty group, but a similar percentage of patients in the 2 groups had unresolved symptoms and received a secondary procedure. In the observational phase of the trial (2-year follow-up), 50% of patients in the epidural steroid group crossed over to nucleoplasty. The manner in which alternative interventions were offered in the observational phase is uncertain. Overall, interpretation of these study results is limited. In the third unblinded, prospective RCT, nucleoplasty was compared to anterior cervical discectomy in patients with cervical radicular pain. Overall, no significant differences between the groups were observed at 1 year. Additionally, the RCT was terminated early as the enrollment rate was low, resulting in the study being underpowered. Results from a cohort study support the conclusion that nucleoplasty is not as effective as microdiscectomy for disc extrusion. Further prospective controlled trials comparing nucleoplasty with microdiscectomy are needed to evaluate efficacy and time to recovery in patients with disc protrusion. Notably, a case series reported accelerated degeneration after nucleoplasty. Adequate follow-up with magnetic resonance imaging is needed to determine if nucleoplasty accelerates disc degeneration.

Summary of Evidence
For individuals who have discogenic back pain or radiculopathy who receive laser discectomy, the evidence includes systematic reviews of observational studies. Relevant outcomes are symptoms, functional outcomes, and treatment-related morbidity. While numerous case series and uncontrolled studies have reported improvements in pain levels and functioning following laser discectomy, the lack of well-designed and -conducted controlled trials limits interpretation of reported data. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals who have discogenic back pain or radiculopathy who receive disc nucleoplasty with radiofrequency coblation, the evidence includes RCT s and systematic reviews. Relevant outcomes are symptoms, functional outcomes, and treatment-related morbidity. For nucleoplasty, there are 3 RCT s in addition to several uncontrolled studies. These RCT s are limited by the lack of blinding, an inadequate control condition in 1, inadequate data reporting in the second, and low enrollment with early study termination in the third. The available evidence is insufficient to permit conclusions concerning the effect of these procedures on health outcomes due to multiple confounding factors that may bias results. High-quality randomized trials with adequate follow-up (at least 1 year), which control for selection bias, the placebo effect, and variability in the natural history of low back pain, are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in Supplemental Information if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

National Institute for Health and Care Excellence
In 2016, NICE updated its guidance on laser lumbar discectomy for the treatment of sciatica.¹⁴ The guidance stated that current evidence “is inadequate in quantity and quality.”

Also in 2016, NICE also updated its guidance on percutaneous disc decompression using coblation for lower back pain and sciatica in 2016.¹⁵ NICE stated: “Current evidence on percutaneous coblation of the intervertebral disc for low back pain and sciatica raises no major safety concerns. The evidence on efficacy is adequate and includes large numbers of patients with appropriate follow-up periods.” The guidance also noted that the patient should be informed of the range of treatment options available.

American Society of Interventional Pain Physicians
In 2009, updated in 2013, the American Society of Interventional Pain Physicians issued practice guidelines on lumbar disc compression and chronic spinal pain.^16,17 The systematic reviews informing the 2013 guidelines found limited evidence for percutaneous laser disc decompression and limited to fair evidence for nucleoplasty.^2,7

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in March, 2022 did not identify any ongoing or unpublished trials that would likely influence this review.

References:  

1. Singh V, Manchikanti L, Benyamin RM, et al. Percutaneous lumbar laser disc decompression: a systematic review of current evidence. Pain Physician. May-Jun 2009; 12(3): 573-88. PMID 19461824
2. Singh V, Manchikanti L, Calodney AK, et al. Percutaneous lumbar laser disc decompression: an update of current evidence. Pain Physician. Apr 2013; 16(2 Suppl): SE229-60. PMID 23615885
3. Gibson JN, Waddell G. Surgical interventions for lumbar disc prolapse. Cochrane Database Syst Rev. Apr 18 2007; (2): CD001350. PMID 17443505
4. Tassi GP. Comparison of results of 500 microdiscectomies and 500 percutaneous laser disc decompression procedures for lumbar disc herniation. Photomed Laser Surg. Dec 2006; 24(6): 694-7. PMID 17199468
5. Choy DS. Percutaneous laser disc decompression: an update. Photomed Laser Surg. Oct 2004; 22(5): 393-406. PMID 15671712
6. Menchetti PP, Canero G, Bini W. Percutaneous laser discectomy: experience and long term follow-up. Acta Neurochir Suppl. 2011; 108: 117-21. PMID 21107947
7. Manchikanti L, Falco FJ, Benyamin RM, et al. An update of the systematic assessment of mechanical lumbar disc decompression with nucleoplasty. Pain Physician. Apr 2013; 16(2 Suppl): SE25-54. PMID 23615886
8. Gerszten PC, Smuck M, Rathmell JP, et al. 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. Apr 2010; 12(4): 357-71. PMID 20201654
9. Chitragran R, Poopitaya S, Tassanawipas W. Result of percutaneous disc decompression using nucleoplasty in Thailand: a randomized controlled trial. J Med Assoc Thai. Oct 2012; 95 Suppl 10: S198-205. PMID 23451463
10. de Rooij J, Harhangi B, Aukes H, et al. 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
11. Bokov A, Skorodumov A, Isrelov A, et al. Differential treatment of nerve root compression pain caused by lumbar disc herniation applying nucleoplasty. Pain Physician. Sep-Oct 2010; 13(5): 469-80. PMID 20859316
12. Birnbaum K. Percutaneous cervical disc decompression. Surg Radiol Anat. Jun 2009; 31(5): 379-87. PMID 19190848
13. Cuellar VG, Cuellar JM, Vaccaro AR, et al. Accelerated degeneration after failed cervical and lumbar nucleoplasty. J Spinal Disord Tech. Dec 2010; 23(8): 521-4. PMID 21131800
14. National Institute for Health and Care Excellence (NICE). Epiduroscopic lumbar discectomy through sacral hiatus for sciatica [IPG570]. 2016; https://www.nice.org.uk/guidance/ipg570. Accessed March 10, 2022.
15. National Institute for Health and Care Excellence (NICE). Percutaneous coblation of the intervertebral disc for low back pain and sciatica [IPG543]. 2016; https://www.nice.org.uk/guidance/ipg543. Accessed March 11, 2022.
16. Manchikanti L, Derby R, Benyamin RM, et al. A systematic review of mechanical lumbar disc decompression with nucleoplasty. Pain Physician. May-Jun 2009; 12(3): 561-72. PMID 19461823
17. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. Apr 2013; 16(2 Suppl): S49-283. PMID 23615883
18. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Laser Procedures (140.5). 1997; https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=69&ncdver=1&DocID=140.5&bc=gAAAAAgAAAAAAA%3D%3D. Accessed March 11, 2022.
19. Centers for Medicare and Medicaid Services (CMS). National Coverage Determination (NCD) for Thermal Intradiscal Procedures (TIPs) (150.11). 2009;https://www.cms.gov/medicare-coverage-database/view/ncd.aspx?NCDId=324.
20.  

Coding Section

Code	Number	Description
CPT	62287	Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, any method, single or multiple levels, lumbar (e.g., manual or automated percutaneous discectomy, percutaneous laser discectomy)
	77002	Fluoroscopic guidance for needle placement
HCPCS	S2348	Decompression procedure, percutaneous, of nucleus pulposis of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar
ICD-10-CM		Investigational for all diagnoses
ICD-10-PSC	0R533ZZ	Destruction, percutaneous, cervical vertebral disc
	0R553ZZ	Destruction, percutaneous, cervicothoracic vertebral disc
	0R593ZZ	Destruction, percutaneous, thoracic vertebral disc
	0R5B3ZZ	Destruction, percutaneous, thoracolumbar vertebral disc
	0S523ZZ	Destruction, percutaneous, lumbar vertebral disc
	0S543ZZ	Destruction, percutaneous, lumbosacral disc
Type of Service	Surgery
Place of Service	Outpatient/Inpatient

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

History From 2024 Forward     

01012024  NEW POLICY

06/20/2024 Annual review, no change to policy intent