Several minimally invasive techniques have been explored as a treatment of low back pain secondary to disc disease. These techniques can be broadly divided into those designed to alter the biomechanics of the disc annulus (e.g., the intradiscal electrothermal therapy [IDET], percutaneous intradiscal radiofrequency thermocoagulation [PIRFT], and intradiscal biacuplasty procedures) which are addressed in this document, or those techniques that are designed toremove or ablate disc material and thus decompress the disc (e.g., percutaneous lumbar discectomy, laser discectomy and disc decompression using radiofrequency energy, referred to as a DISC nucleoplasty™).

Note: Please see the following related document for percutaneous automated lumbar discectomy, laser discectomy and DISC nucleoplasty information:

• SURG.00071 Percutaneous and Endoscopic Spinal Surgery

Intradiscal electrothermal therapy  (IDET™) using the Smith and Nephew Endoscopy SpineCath^® System, describes a percutaneous intradiscal annuloplasty procedure using a navigable catheter to provide targeted thermal energy within the disc annulus to treat chronic low-back pain related to degenerative disc disease. IDET is not designed to coagulate, burn or destroy the disc material. IDET is also sometimes referred to as intradiscal electrothermal annuloplasty.

Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) describes a minimally invasive procedure in which radiofrequency energy is directly applied to the disc material for 90 seconds at a temperature of 70 degrees centigrade. Similar to IDET, this procedure does not ablate the disc material, but instead alters the biomechanics of the disc or destroys the nociceptive pain fibers.

Intradiscal biacuplasty uses two internally cooled radiofrequency probes placed on the posterolateral sides of the intervertebral annulus fibrosus with the goal of ablating the neurons that generate pain sensations. It is proposed that by cooling the probes a larger area may be treated than with a regular needle probe. Like IDET and PIRFT, biacuplasty is not designed to coagulate, burn or destroy the disc material.  The procedure is designed to reduce chronic back pain caused by the intervertebral discs.

Investigational and Not Medically Necessary:

Percutaneous intradiscal electrothermal coagulation, also known as intradiscal electrothermal annuloplasty or the IDET™ procedure, is considered investigational and not medically necessary.

Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) is considered investigational and not medically necessary.   

Intradiscal biacuplasty is considered investigational and not medically necessary.

Intradiscal Electrothermal Coagulation Procedure (IDET)
In 2004, Pauza et al conducted a randomized trial to compare the efficacy of IDET to a placebo treatment.  Of the 260 individuals found to be potentially eligible for the procedure, 64 s were selected with 37 undergoing the IDET procedure and 27 being subjected to a sham procedure.  Principal outcome measures were based on pain and disability which were assessed using a visual analog scale for pain, the Short Form (SF-36), and the Oswestry disability scale.  Both groups demonstrated improvements, but mean improvements in disability, depression and pain were considerably greater in the group treated with IDET.  The authors concluded that while nonspecific factors associated with the procedure contributed to some degree to the apparent efficacy of IDET, its efficacy cannot be attributed wholly to a placebo effect.  While the authors suggest IDET may be a worthwhile surgical procedure, it is important to note the study contained several methodological flaws including the absence of the intention-to-treat analysis and missing results of 8 of 64 (12.5%) participants.  The absence of such documentation has the potential to skew the findings of the study, making the validity of the results questionable.

In 2005, Freeman and colleagues conducted a study on subjects with discogenic back pain and annular tears who failed to improve in spite of conservative treatment.  The study was carried out with 38 participants undergoing IDET and 19 receiving the sham procedure.  Tools to determine outcome included several subjective measures including the Low Back Outcome Score (LBOS), the Oswestry Disability Index (ODI) and the Short Form Questionnaire (SF-36).  A successful outcome was defined as: (1) No neurological deficit, (2) Improvement in the LBOS of greater than 7 points, and (3) Improvement in the physical function and bodily pain section of the SF-36 form of at least greater than one standard deviation.  No one in either arm of the study met the criteria for a successful outcome.  The findings of this study suggest that while IDET appears to be a safe procedure with no permanent complications, there is no significant benefit of IDET over the placebo.

An industry funded meta-analysis by Appleby and colleagues (2006) analyzed the peer-reviewed published literature on IDET from 1998 to 2005.  While the authors concluded that the pooled results of the literature provided evidence of the safety and efficacy of the IDET procedure, of the 18 studies reviewed, only one was randomized and many were retrospective. 

The literature regarding IDET is dominated by case series of individuals with varying lengths of follow-up.  The few randomized controlled clinical trials that have been published provide conflicting conclusions.  More well designed randomized controlled trial studies are needed in order to control for any placebo effect and clearly determine if IDET is a beneficial surgical procedure for individuals with chronic discogenic back pain.

Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT)
In 2001, Barendse and colleagues carried out a small, prospective, double-blind sham controlled randomized trial to assess the clinical effectiveness of percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) for reducing pain, physical impairment and functional disability due to chronic discogenic low back pain.  Participants in the radiofrequency treatment group (n = 13) received a 90-second 70 degree centigrade lesion of the intervertebral disc.  The subjects in the control group (n = 15) underwent the same procedure, but without use of radiofrequency current.  Both the treating physician and the participants were blinded to the group assignment.  Physical impairment, rating of pain, the degree of disability, and quality of life were assessed by a blinded investigator prior to the beginning of treatment.  At the end of eight weeks, visual analog scores for pain, global perceived effect, and the Oswestry disability scale did not reveal differences between the two groups.  The authors concluded that PIRFT is not effective in reducing chronic discogenic low back pain. 

In 2003, Ercelen and colleagues conducted a prospective randomized variable dose trial to evaluate the efficacy of PIRFT.  Provocative discography was used to diagnose discogenic pain and to locate the discs to be treated in 60 subjects with chronic low back pain.  From this group, 39  were randomly selected and divided into two groups.  In the first group, intradiscal radiofrequency energy was applied for 120 seconds and in the second group for 360 seconds, both at 80 degrees centigrade.  Participants were evaluated using a visual analogue scale for pain relief and functional improvement.  Pain and functional status were evaluated prior to and immediately after treatment, and at one and two weeks, and at one, three, and six months after the procedure.  There were no statistical differences in functional improvement and pain relief between the two groups (P > 0.05), and at 6 months there was no difference between before and after measures in either treatment group. 

Kvarstein et al (2009) studied twenty subjects in a randomized, controlled, double blinded trial comparing PIRFT to sham treatment for chronic discogenic low back pain. Both groups underwent insertion of the RF probe by the treating physician. A separate operator controlled delivery of RF therapy, thus blinding the participants as well as the treating physician to treatment or sham. The primary outcome measure was a change in pain intensity. Secondary outcome measures were subject's categorical impression of change in experienced pain; health-related quality of life; functional ability. The primary outcome, a change in pain intensity was not statistically significant. However, differences in the participants' impressions of changes in experienced pain were statistically significant. The remaining outcome measures were not statistically significant. The authors found that at twelve months, a high number of subjects had increased pain and concluded that the evidence was inconsistent and showed no benefit from PIRFT.

The small and limited number of studies that have been published on PIRFT provide conflicting conclusions.  Larger and well designed randomized controlled trial studies are needed to establish a durable and clinically significant outcome benefit of PIRFT in the treatment of discogenic back pain.

Chou et al (2009) developed an evidence based guideline for the American Pain Society (APS). Their findings for both IDET and PIRFT were:

• There is good or fair evidence from randomized trials that PIRFT thermocoagulation is not effective.
• There is insufficient (poor) evidence from randomized trials (conflicting trials, sparse and lower quality data, or no randomized trials) to reliably evaluate other interventional therapies, which include IDET.

Biacuplasty
There is very limited published peer-reviewed scientific literature regarding intradiscal biacuplasty.  Kapural and colleagues (2007) reported a single case study of an individual who underwent intradiscal biacuplasty as a treatment of severe discogenic pain.  In this study, the authors indicated this to be the first published report on intradiscal biacuplasty.  Kapural and colleagues (2008b) also reported on one small pilot study (n = 13) in which participants who underwent biacuplasty demonstrated improved pain and functional capacity at 6-month follow-up.  In a letter to the editor, Kapural (2008a) reported that improvements in pain control and function persisted even at 12 months after the procedure.  At this time, the available published evidence is insufficient to permit conclusions regarding the safety and efficacy of biacuplasty.

The intervertebral disc is often a primary source of chronic back pain.  Disc problems are usually due to injury, wear and tear or age.  Pain may be from the disc itself (discogenic pain) or from disc herniation or prolapse resulting in pressure on nearby nerve roots.  Discs are basically shock absorbers, whose content is 70-90% water.  Each disc begins to lose water and its shock absorber effect beginning in the late teens.  All discs degenerate as we age but it is only when a degenerated or bulging disc causes pain that it then becomes problematic.  When a disc degenerates to such an extent, or a small tear develops in the outer third of the disc, portions of the disc can move out near the area of the spinal nerves.  This can put pressure on a nerve root and causes the condition known as sciatica (pain radiating down the leg). 

The term intradiscal electrothermal annuloplasty (IDET™) using the Smith and Nephew Endoscopy (Andover, MA) SpineCath^® System specifically describes a minimally invasive annuloplasty procedure used to treat chronic low-back pain related to disc disease.  In an initial step, the pathogenic disc is identified using pressure-based discography.  A navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus.  The catheter is then advanced through the disc circuitously to return posteriorly.  Electrothermal heat is then generated with the thermal resistive coil; the disc material is heated for up to 20 minutes.  This outpatient procedure typically requires less than 30 to 40 minutes of recovery time.  The mechanism of action of pain relief is not known, but it is thought to be related to shrinkage of the collagen fibers within the annulus, or destruction of the adjacent nociceptive pain fibers.

Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT) differs from the IDET procedure in that radiofrequency energy is applied directly to the involved disc.  The radiofrequency probe is placed into the center of the disc instead of around the annulus.  The practitioner activates the probe and delivers radiofrequency energy into the center of the disc for 90 seconds at a temperature of 70 degrees centigrade.  As in IDET, the mechanism of action of pain relief is not precisely understood, but is thought to be related to a reduction of the pain receptor input by destroying the pain receptor fibers.

Biacuplasty uses radiofrequency energy to heat the nervous tissue while circulating water is used to cool the tissue that is adjacent to the disc.  The biacuplasty device, TransDiscal™ system, was developed by Baylis Medical Company Inc. (Montreal, QC Canada).  During the procedure, the individual is mildly sedated and the area to be treated anesthetized. Two probes are inserted into the disc through introducer needles and the disc is heated by radiofrequency waves. After approximately 15 minutes, the probes and needles are removed and a bandage is placed over the treatment site.  Biacuplasty is similar to PIRFT in that it uses radiofrequency energy and similar to IDET and PIRFT in that it is not designed to coagulate, burn or destroy the disc material.

Annulus: The hard, tough outer layer of the vertebral disc surrounding the center portion called the nucleus, which is a softer gel-like substance. 

Biomechanics: The study of the effects of internal and external forces on the human body in movement and rest.

Discogenic Pain: Pain generated by the disc itself which is externally intact, as opposed to disc prolapse or herniation which put pressure on nearby nerve roots.

Percutaneous: Through the skin (puncture as opposed to "open" surgical incision).

Radiofrequency: The use of electrodes to generate heat to alter tissue structure. 

Spine Anatomy: The spine is divided into three major sections: the cervical (neck), the thoracic (mid-back) and lumbar spine (lower back). These sections are made up of individual bones called vertebrae, which are the primary area of weight bearing and provide a resting-place for the discs, which act as shock absorbers between the vertebrae.

The following codes for treatments and procedures applicable to this document are included below for informational purposes.  Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy.  Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member. 

When services are Investigational and Not Medically Necessary:

Future ICD-10 coding (effective 10/01/2013)
A draft of ICD-10 Coding related to this document, as it might look today, is available for reference and comments at: Appendix 1: Future ICD-10 coding

Peer Reviewed Publications:

1. Appleby D, Anderson, G, Totta, M.  Meta-analysis of the efficacy and safety of intradiscal electrothermal therapy (IDET). Pain Med. 2006; 7(4):308-316.
2. 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. 2001; 26(3):287-292.
3. Biyani A, Andersson GBJ, Chaudhary H, An HS. Intradiscal electrothermal therapy: a treatment option in patients with internal disc disruption. Spine. 2003; 28(15S):S8-S14.
4. Cohen SP, Larkin T, Abdi S, et al. Risk factors for failure and complications of Intradiscal Electrothermal Therapy: a pilot study. Spine. 2003; 28(11):1142-1147.
5. Davis TT, Delamarter RB, Sra P, Goldstein TB. The IDET procedure for chronic discogenic low back pain. Spine. 2004; 29(7):752-756.
6. Derby R, Eek, B, Chen Y et al. Intradiscal electrothermal annuloplasty (IDET): a novel approach for treating chronic discogenic back pain. Neuromodulation. 2000; 3:82-88.
7. Ercelen O, Bulutcu E, Oktenoglu T, et al. Radiofrequency lesioning using two different time modalities for the treatment of lumbar discogenic pain: a randomized trial. Spine. 2003; 28(17):1922-1927.
8. Freedman BA, Cohen SP, Kuklo TR, et al, Intradiscal electrothermal therapy (IDET) for chronic low back pain in active duty soldiers: 2 year follow-up. Spine Journal. 2003; 3(6):502-509.
9. Freeman BJ, Fraser RD, Cain CM, Hall DJ, Chapple DC. A randomized, double-blind, controlled trial: intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Spine. 2005; 30(21):2369-2377; discussion 2378.
10. Kapural L, Hayek S, Malak O, et al. Intradiscal thermal annuloplasty versus intradiscal radiofrequency ablation for the treatment of discogenic pain: a prospective matched control trial. Pain Med. 2005; 6(6):425-431.
11. Kapural L. Intervertebral disk cooled bipolar radiofrequency (intradiskal biacuplasty) for the treatment of lumbar diskogenic pain: a 12-month follow-up of the pilot study. Pain Med. 2008a; 9(4):407-408.
12. Kapural L, Mekhail N. Novel intradiscal biacuplasty (IDB) for the treatment of lumbar discogenic pain. Pain Pract. 2007; 7(2):130-134.
13. Kapural L, Ng A, Dalton J, et al. Intervertebral disc biacuplasty for the treatment of lumbar discogenic pain: results of a six-month follow-up. Pain Med. 2008b; 9(1):60-67.
14. Kvarstein G, Måwe L, Indahl A,  et al. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy-a 12-month follow-up. Pain. 2009; 145(3):279-286.
15. Karasek M, Bogduk N. Twelve-month follow-up of a controlled trial of intradiscal thermal annuloplasty for back pain due to internal disc disruption. Spine. 2000; 25:2601-2607.
16. Lutz, et al. Treatment of chronic lumbar diskogenic pain with intradiskal electrothermal therapy: A Prospective Outcome Study. Arch Phys Medicine Rehabilitation. 2003; Vol 84.
17. McGraw JK, Silber JS.  Intradiscal electrothermal therapy for the treatment of discogenic back pain.  Appl Rad. 2001; 30(7):11-16.
18. Pauza KJ, Howell S., Dreyfuss P, et al. A randomized, placebo controlled trial of intradiscal electro-thermal therapy for the treatment of discogenic low back pain. Spine Journal. 2004; 4(1):27-35.
19. Pomerantz SR, Hirsch JA. Intradiscal therapies for discogenic pain. Semin Musculoskelet Radiol. 2006; 10(2):125-135.
20. Saal JA, Saal JS. Intradiscal electrothermal treatment for chronic discogenic low back pain. Spine. 2002; 27(9):966-974.
21. Saal JA, Saal JS. Intradiscal electrothermal treatment for chronic discogenic low back pain. A prospective outcome study with minimum 1 year follow up. Spine. 2000; 25:2622-2627.
22. Singh K, Ledet E, Carl A. Intradiscal therapy: a review of current treatment modalities. Spine. 2005; 30(17 Suppl):S20-S26.
23. Spruit M, Jacobs WCH. Pain and function after intradiscal electrothermal treatment (IDET) for symptomatic lumbar disc degeneration. Eur Spine J. 2002; 11:589-593.
24. Zhou Y, Abdi S. Diagnosis and minimally invasive treatment of lumbar discogenic pain--a review of the literature. Clin J Pain. 2006; 22(5):468-481.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Blue Cross Blue Shield Association. Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic low back pain. TEC Assessment, 2004; 18(19).
2. California Technology Assessment Forum (CTAF).  IDET intradiscal electrothermal therapy for the treatment of low back pain. October 8, 2003. Available at: http://www.ctaf.org/content/assessment/detail/551. Accessed on January 14, 2011.
3. Centers for Medicare and Medicaid Services. National Coverage Determination: Thermal Intradiscal Procedures (TIPs). NCD #150.11. Effective September 29, 2008. Available at: http://www.cms.hhs.gov/mcd/index_chapter_list.asp. Accessed on January 14, 2011.
4. Chou R, Atlas SJ, Stanos SP, Rosenquist RW. Nonsurgical interventional therapies for low back pain: A review of the evidence for an American Pain Society clinical practice guideline. Spine. 2009; 34(10):1078-1093.
5. Institute for Clinical Systems Improvement (ICSI). Assessment and management of chronic pain. January 14, 2011. Available at: http://www.icsi.org/pain__chronic__assessment_and_management_of_14399/pain__chronic__assessment
   _and_management_of__guideline_.html.   Accessed on January 14, 2011.
6. National Institute for Clinical Excellence (NICE). Percutaneous intradiscal electrothermal therapy for low back pain. November 2009. Available at: http://www.nice.org.uk/nicemedia/live/11055/46396/46396.pdf.   Accessed on January 14, 2011.
7. National Institute for Clinical Excellence (NICE). Percutaneous intradiscal radiofrequency thermocoagulation for lower back pain. August 2004. Available at: http://www.nice.org.uk/nicemedia/live/11115/31119/31119.pdf. Accessed on January 14, 2011.

Annuloplasty, Intradiscal Electrothermal
Annuloplasty, Intradiscal Radiofrequency
Baylis TransDiscal™ System
Biacuplasty
IDET™
Percutaneous Intradiscal Electrothermal Coagulation (IDET™)
Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT)
SpineCath^® System

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.