Discogenic Low Back Pain

Discogenic low back pain is a common, multifactorial pain syndrome that involves low back pain without radicular symptoms 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 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 and that pain reduction may occur through the thermal coagulation of nociceptors in the outer annulus.

Some electrothermal intradiscal procedures are briefly described next.

With the intradiscal electrothermal annuloplasty procedure, 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°C; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy with intradiscal electrothermal annuloplasty 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.

Percutaneous intradiscal radiofrequency thermocoagulation uses direct application of radiofrequency energy. With percutaneous intradiscal radiofrequency thermocoagulation, 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°C. The procedure is not designed to coagulate, burn, or ablate tissue. The Radionics Radiofrequency Disc Catheter System has been specifically designed for this purpose.

Intradiscal biacuplasty uses 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 kit to coagulate the disc granulation tissue (percutaneous endoscopic laser annuloplasty) 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 the bipolar radiofrequency device (Coblation®; ArthroCare, Austin, TX, acquired by Smith & Nephew, 2014). With the coblation system, a bipolar radiofrequency device is used to provide lower energy treatment 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 to provide decompression of a bulging disc. Disc nucleoplasty and laser discectomy are considered in 'Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty)' (Policy #077 in the Treatment Section).

Related Policies

• Automated Percutaneous and Endoscopic Discectomy (Policy #019 in the Surgery Section)
• Decompression of the Intervertebral Disc Using Laser Energy (Laser Discectomy) or Radiofrequency Coblation (Nucleoplasty) (Policy #077 in the Treatment Section)

FIDE-SNP Coverage:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the

[RATIONALE: This policy was created in 1999 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through February 11, 2020. This review is based in part on TEC Assessments from 2002 and 2003.^1,2,

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 one 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.

Intradiscal Electrothermal Annuloplasty
Clinical Context and Therapy Purpose

The purpose of percutaneous intradiscal electrothermal annuloplasty in patients who have discogenic back pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does intradiscal electrothermal annuloplasty improve the net health outcome in patients with discogenic back pain?

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

Patients

The relevant population of interest is patients with discogenic back pain.

Interventions

The therapy being considered is percutaneous intradiscal electrothermal annuloplasty, which is administered by an orthopedist or orthopedic surgeon in an outpatient clinical setting.

Comparators

Relevant comparators are conservative management and surgical spinal decompression, which are administered and managed by orthopedists and orthopedic surgeons.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Based on available literature, follow-up of at least 6-12 months is recommended.

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
Randomized Controlled Trials

Pauza et al (2004)^3, published the results of an RCT evaluating intradiscal electrothermal annuloplasty (referred to as intradiscal electrothermal therapy in Pauza) in patients with discogenic low back pain, which was the focus of discussion in the 2003 TEC Assessment. The trial included 64 patients with low back pain of more than 6 months in duration who were randomized to intradiscal electrothermal annuloplasty or a sham procedure. Visual analog scale scores for pain were reduced by an average of 2.4 cm in the intradiscal electrothermal annuloplasty group compared with 1.1 cm in the sham group, a statistically significant difference between groups (p=0.045). The mean change in the Oswestry Disability Index score was also significantly greater for the intradiscal electrothermal annuloplasty group than for the sham group. Improvements in the 36-Item Short Form Health Survey (SF-36) bodily pain subscale score were slightly higher for the intradiscal electrothermal annuloplasty group. The trial also reported the percent change in visual analog scale scores more than 2.0 cm, which is greater than the minimal clinically significant improvement of 1.8 to 1.9. When the visual analog scale score was dichotomized in this way, a relative risk of 1.5 was observed with a 95% confidence interval of 0.82 to 2.74. While this single-center trial was well-designed with respect to randomization, clear description of the intervention, and use of valid and reliable outcomes measures, it does not permit conclusions about the relative effects of intradiscal electrothermal annuloplasty and placebo, and it is unclear whether intradiscal electrothermal annuloplasty achieves clinically and statistically significant improvements in measures of pain, disability, or quality of life.

Freeman et al (2005) reported on an industry-sponsored, double-blinded, sham-controlled randomized trial evaluating intradiscal electrothermal annuloplasty (referred to as intradiscal electrothermal therapy in this report) in patients with chronic discogenic low back pain, marked functional disability, magnetic resonance imaging evidence of degenerative disc disease, and failure of conservative management. ^4, Both the active intradiscal electrothermal annuloplasty and sham groups had an intradiscal catheter that was navigated to cover at least 75% of the posterior annulus. Planned enrollment based on power analysis was for 75 patients; however, the trial was stopped early due to slower than expected recruitment after 57 patients (38 intradiscal electrothermal annuloplasty, 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 of at least 7 points; and (3) improvements in the 36-Item Short Form Health Survey (SF-36) physical functioning and bodily pain subscales scores of at least 1 standard deviation. No subject in either group achieved a successful treatment response. Outcomes were similar between the intradiscal electrothermal therapy and sham groups on the Low Back Outcome Score (38.31 vs. 37.45), Oswestry Disability Index score (39.77 vs. 41.58), 36-Item Short Form Health Survey (SF-36) subscale scores (35.10 vs. 30.40), the Zung Depression Index score (41.39 vs. 40.82), and the Modified Somatic Perception Questionnaire score (8.67 vs. 8.6), respectively. None of the subgroup analyses showed statistically or clinically significant differences in study outcomes. No serious adverse events were reported in either group.

Section Summary: Intradiscal Electrothermal Annuloplasty

Two RCTs on intradiscal electrothermal annuloplasty have reported conflicting results, with one finding a benefit for intradiscal electrothermal annuloplasty and the other no benefit. The most recent RCT identified was from 2005. No recent literature on intradiscal electrothermal annuloplasty has been identified.

Percutaneous Intradiscal Radiofrequency Annuloplasty
Clinical Context and Therapy Purpose

The purpose of percutaneous intradiscal radiofrequency annuloplasty in patients who have discogenic back pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does percutaneous intradiscal radiofrequency annuloplasty improve the net health outcome in patients with discogenic back pain?

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

Patients

The relevant population of interest is patients with discogenic back pain.

Interventions

The therapy being considered is percutaneous intradiscal radiofrequency annuloplasty, which is administered by an orthopedist or orthopedic surgeon in an outpatient clinical setting.

Comparators

Relevant comparators are conservative management and surgical spinal decompression, which are administered and managed by orthopedists and orthopedic surgeons.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Based on available literature, follow-up of at least 6-12 months is recommended.

Study Selection Criteria

Methodologically credible studies were selected using the principles described in the first indication.

Review of Evidence
Randomized Controlled Trials

There is relatively little published data on percutaneous intradiscal radiofrequency thermocoagulation. Barendse et al (2001) reported on a double-blind trial that randomized 28 patients with chronic low back pain to percutaneous intradiscal radiofrequency thermocoagulation or a sham-control group.^5, The primary outcome was the percentage of success at 8 weeks, as measured by changes in pain level, impairment, Oswestry Disability Index scores, and analgesics taken. At the end of 8 weeks, there were 2 treatment successes in the sham group and 1 in the treatment group. Trialists concluded that percutaneous intradiscal radiofrequency thermocoagulation was no better than placebo in reducing pain and disability.

Kvarstein et al (2009) published a 12-month follow-up from an RCT of intra-annular radiofrequency thermal disc therapy using the discTRODE probe. ^6, 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 groups. Two patients from each group reported an increase in pain.

Section Summary: Percutaneous Intradiscal Radiofrequency Annuloplasty

Two sham-controlled randomized trials showed no evidence of a benefit with percutaneous intradiscal radiofrequency thermocoagulation. One found that only 1 of 14 patients was considered a treatment success. The other was terminated after blinded interim analysis showed no trend to benefit compared with sham.

Intradiscal Radiofrequency Biacuplasty
Clinical Context and Therapy Purpose

The purpose of intradiscal radiofrequency biacuplasty in patients who have discogenic back pain is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this policy is: Does intradiscal radiofrequency biacuplasty improve the net health outcome in patients with discogenic back pain?

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

Patients

The relevant population of interest is patients with discogenic back pain.

Interventions

The therapy being considered is intradiscal radiofrequency biacuplasty, which is administered by an orthopedist or orthopedic surgeon in an outpatient clinical setting.

Comparators

Relevant comparators are conservative management and surgical spinal decompression, which are administered and managed by orthopedists and orthopedic surgeons.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Based on available literature, follow-up of at least 6-12 months is recommended.

Study Selection Criteria

Methodologically credible studies were selected using the principles described in the first indication.

Review of Evidence
Randomized Controlled Trials

Kapural et al (2013), Desai et al (2016), and colleagues have published several studies on the use of transdiscal radiofrequency annuloplasty using 2 transdiscal probes (biacuplasty) in patients with discogenic lower back pain, including a 2013 industry-sponsored, phase 1, double-blind RCT and a 2016 RCT. ^7,8,9,10,

Kapural et al (2013) conducted the phase 1 RCT. ^7,Of the 1894 patients screened, 1771 (94%) did not meet inclusion criteria. Sixty-four subjects consented and were enrolled. Outcome measures were the SF-36 physical functioning subscale (0-100), a numeric rating scale for pain (0-10), and the Oswestry Disability Index (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), numeric rating scale (-2.19 vs. -0.64), and Oswestry Disability Index (-7.43 vs. 0.53) scores. Mean SF-36 and numeric rating scale scores were considered to be clinically significant, but mean Oswestry Disability Index 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 groups.

Kapural et al (2015) reported on the unblinded 12-month follow-up from this phase 1 trial.^8, Improvements continued through 12 months, with a change from baseline to posttreatment of 47.0 to 68.9 (of 100) on the SF-36 physical functioning subscale (p<0.01) and 7.1 to 4.4 (of 10) on the numeric rating scale (p<0.01). Although the change in numeric rating scale score was statistically significant, the magnitude of the decrease was modest, and a final numeric rating scale score (4.4) remained high. The change in Oswestry Disability Index score (from 40.37 at baseline to 32.44 at 12 months) was also modest (p=0.05). Opioid usage did not decrease significantly (53.47 mg at baseline to 34.07 mg at follow-up, p=0.23).

Desai et al (2016) randomized 63 patients with lumbar discogenic pain diagnosed by provocation discography to intradiscal biacuplasty plus conservative medical management (n=29) or medical management alone (n=34).^9, Another 234 patients were scheduled for diagnostic discography but did not meet inclusion criteria. The primary outcome (the mean reduction in visual analog scale 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 visual analog scale 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. Other limitations of this industry-sponsored trial were 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. ^10, Mean 12-month change in visual analog scale 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. Visual analog scale score improved from 7.0 to 4.7 (p<0.001) in the crossover group, and 55% were considered to be responders.

Section Summary: Intradiscal Radiofrequency Biacuplasty

Two industry-sponsored RCTs have assessed use of biacuplasty to treat chronic low back pain. In one, only 6% of subjects screened met the strict inclusion and exclusion criteria for the study. Significant differences in outcomes were observed at 6 months, but not at 1 month or 3 months, and the definition of successful treatment appears to have been post hoc. In the second multicenter RCT, 63 patients met inclusion criteria, which included a positive result on provocation discography. There was a significant treatment effect for the primary outcome measure, but not the secondary outcome measures. This trial was not sham-controlled, and it was not reported whether it was adequately powered. Additional sham-controlled trials in a broader population of patients are needed to determine the effect of this treatment with greater certainty.

Summary of Evidence

For individuals who have discogenic back pain who receive intradiscal electrothermal annuloplasty, the evidence includes a small number of randomized controlled trials (RCTs). Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Two RCTs on intradiscal electrothermal annuloplasty reported conflicting results, with one reporting benefit for intradiscal electrothermal annuloplasty and the other reporting no benefit. Further study in a sham-controlled trial with a representative population of patients is needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have discogenic back pain who receive intradiscal radiofrequency annuloplasty, the evidence includes 2 RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Neither RCT found evidence of benefit with the treatment. More sham-controlled trials are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have discogenic back pain who receive intradiscal biacuplasty, the evidence includes 2 industry-sponsored RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. One trial reported significant improvements at 6 months post-treatment, but not at 1 and 3 months. The other trial also showed a significant reduction in visual analog scale scores at 6 months that appeared to continue to the 12 month follow-up; however, it is unclear whether this trial was sufficiently powered. More sham-controlled trials are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements
American Society of Interventional Pain Physicians

A 2013 review of the evidence informing American Society of Interventional Pain Physicians guidelines found limited-to-fair evidence for intradiscal electrothermal therapy (IDET; another term for intradiscal electrothermal annuloplasty) and biacuplasty and limited evidence for percutaneous intradiscal radiofrequency thermocoagulation.^11, These guidelines updated 2007 guidelines, which concluded that the evidence was moderate for management of chronic discogenic low back pain with IDET.^12, Complications included catheter breakage, nerve root injuries, post-IDET disc herniation, cauda equina syndrome, infection, epidural abscess, and spinal cord damage. The evidence for percutaneous intradiscal radiofrequency thermocoagulation was limited, with complications similar to IDET.^12,

National Institute for Health and Care Excellence

A 2016 guidance update by the National Institute for Health and Care Excellence (NICE) indicated that the evidence on safety and efficacy of percutaneous intradiscal radiofrequency thermocoagulation for low back pain was “limited” and should only be used by “special arrangement”.^13,

In 2016, NICE guidance on electrothermal annuloplasty was also updated.^14, NICE considered evidence on the efficacy of percutaneous intradiscal radiofrequency thermocoagulation for low back pain to be inconsistent and of poor quality, although no major safety concerns were identified. NICE recommended percutaneous intradiscal radiofrequency thermocoagulation only with special arrangements for clinical governance, consent, and audit or research.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in February 2020 did not identify any ongoing or unpublished trials that would likely influence this review.]
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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Percutaneous Intradiscal Electrothermal Annuloplasty, Radiofrequency Annuloplasty, and Biacuplasty
Percutaneous Intradiscal Electrothermal Annuloplasty and Percutaneous Intradiscal Radiofrequency Annuloplasty
Percutaneous Intradiscal Annuloplasty Procedures
Annuloplasty Procedures, Intradiscal
discTRODE RF Catheter Electrode System
IDEA (Intradiscal Electrothermal Annuloplasty)
IDET (Intradiscal Electrothermal Therapy)
Intradiscal Biacuplasty
Intradiscal Electrothermal Annuloplasty (IDEA)
Intradiscal Electrothermal Therapy (IDET)
Intradiscal Heating Procedure
Intradiscal Thermal Modulation (ITM)
ITM (Intradiscal Thermal Modulation)
Oratec SpineCath System
Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT)
PIRFT (Percutaneous Intradiscal Radiofrequency Thermocoagulation)
Radiofrequency Posterior Annuloplasty (RFA)
Radionics RF Disc Catheter System
RF Disc Catheter Electrode System
RFA (Radiofrequency Posterior Annuloplasty)
SpineCATH System
TransDiscal System
Biacuplasty

References:
1. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Intradiscal electrothermal therapy for chronic low back pain. TEC Assessments Apr 2002;Volume 17:Tab 11. PMID 11010675

2. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic low back pain. TEC Assessments. Nov 6 2003;Volume 18:Tab 19. PMID 15043079

3. Pauza KJ, Howell S, Dreyfuss P, et al. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Spine J. Jan-Feb 2004;4(1):27-35. PMID 14749191

4. Freeman BJ, Fraser RD, Cain CM, et al. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine (Phila Pa 1976). Nov 1 2005;30(21):2369-2377; discussion 2378. PMID 16261111

5. Barendse GA, van Den Berg SG, Kessels AH, et al. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain: lack of effect from a 90-second 70 C lesion. Spine (Phila Pa 1976). Feb 1 2001;26(3):287-292. PMID 11224865

6. Kvarstein G, Mawe L, Indahl A, et al. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy--a 12-month follow-up. Pain. Oct 2009;145(3):279-286. PMID 19647940

7. Kapural L, Vrooman B, Sarwar S, et al. A randomized, placebo-controlled trial of transdiscal radiofrequency, biacuplasty for treatment of discogenic lower back pain. Pain Med. Mar 2013;14(3):362-373. PMID 23279658

8. Kapural L, Vrooman B, Sarwar S, et al. Radiofrequency intradiscal biacuplasty for treatment of discogenic lower back pain: a 12-month follow-up. Pain Med. Mar 2015;16(3):425-431. PMID 25339501

9. Desai MJ, Kapural L, Petersohn JD, et al. 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

10. Desai MJ, Kapural L, Petersohn JD, et al. Twelve-month follow-up of a randomized clinical trial comparing intradiscal biacuplasty to conventional medical management for discogenic lumbar back pain. Pain Med. Apr 1 2017;18(4):751-763. PMID 27570246

11. 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-S283. PMID 23615883

12. Boswell MV, Trescot AM, Datta S, et al. Interventional techniques: evidence-based practice guidelines in the management of chronic spinal pain. Pain Physician. Jan 2007;10(1):7-111. PMID 17256025

13. National Institute for Health and Care Excellence. Percutaneous intradiscal radiofrequency treatment of the intervertebral disc nucleus for low back pain [IPG545]. 2016; https://www.nice.org.uk/guidance/ipg545. Accessed March 4, 2020.

14. National Institute for Health and Care Excellence. Percutaneous electrothermal treatment of the intervertebral disc annulus for low back pain and sciatica [IPG544]. 2016; https://www.nice.org.uk/guidance/IPG544. Accessed March 4, 2020.

15. Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Thermal Intradiscal Procedures (TIPs) (150.11). 2008; https://www.cms.gov/medicare-coverage-database/details/ncd- details.aspx?ncdid=324&ver=1. Accessed March 4, 2020.

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