DESCRIPTION
Intradiscal annuloplasty therapies use energy sources to thermally treat discogenic low back pain arising from annular tears. Thermal annuloplasty techniques are designed to decrease pain arising from the annulus and enhance its structural integrity.
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.
With the intradiscal electrothermal annuloplasty procedure a navigable catheter with an embedded thermal resistive coil is inserted posterolaterally into the disc annulus or nucleus. The catheter is then snaked through the disc circuitously to return posteriorly. Using indirect radiofrequency energy, electrothermal heat is generated within the thermalresistive coil at a temperature of 90 degrees centigrade; the disc material is heated for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy with IDET™ include precise temperature feedback and control and the ability to provide electrothermocoagulation to a broader tissue segment than would be allowed with a direct radiofrequency needle.
Another procedure, referred to as percutaneous intradiscal radiofrequency thermocoagulation (PIRFT), uses direct application of radiofrequency energy. With PIRFT, the radiofrequency probe is placed into the center of the disc, and the device is activated for only 90 seconds at a temperature of 70 degrees centigrade. The procedure is not designed to coagulate, burn, or ablate tissue.
A more recently developed annuloplasty procedure, referred to as intradiscal biacuplasty, involves the use of two 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.
Examples of devices used for these procedures include the SpineCath® / Oratec SpineCath System, and the Radionics RF Disc Catheter Electrode System®.
POLICY
Intradiscal annuloplasty (e.g., intradiscal electrothermal annuloplasty, percutaneous intradiscal radiofrequency thermocoagulation, or intradiscal biacuplasty) for the treatment of chronic discogenic back pain is considered investigational.
IMPORTANT REMINDER
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ADDITIONAL INFORMATION
Published scientific evidence in the form of well-designed studies in peer-reviewed journals regarding the use of percutaneous annuloplasty for the treatment of chronic discogenic pain is lacking. There is insufficient evidence to permit conclusions regarding the use of this technology compared to established alternative treatments.
SOURCES
American Society of Interventional Pain Physicians. (2009, July). Comprehensive evidence-based guidelines for interventional techniques in the management of chronic spinal pain. Retrieved October 20, 2009 from http://www.painphysicianjournal.com/2009/july/2009;12;699-802.pdf. (1,082 articles and/or guidelines reviewed)
Andersson, G. B., Mekhail, N. A., & Block, J. E. (2006, July). Treatment of intractable discogenic low back pain. A systemic review of spinal fusion and intradiscal electrothermal therapy (IDET). Pain Physician, 9 (3), 237-248.
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2010). Percutaneous intradiscal electrothermal annuloplasty and percutaneous intradiscal radiofrequency thermocoagulation (7.01.72). Retrieved July 12, 2011 from BlueWeb. (18 articles and/or guidelines reviewed)
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, April). Thermal intradiscal procedures (TIPS) (NCD 150.11, p. 2-76 to 2-77). Ingenix.
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2009, March). Intradiscal electrothermal annuloplasty for discogenic pain. Retrieved October 16, 2009 from ECRI institute. (17 articles and/or guidelines reviewed)
Hayes. Medical Technology Directory. (2010, February). Intradiscal electrothermal therapy (IDET). Retrieved July 13, 2011 from www.Hayesinc.com/subscribers. (56 articles and/or guidelines reviewed)
Helm II, S., Hayek, S.M., Benyamin, R. & Manchikanti, L. (2009). Systematic review of the effectiveness of thermal annular procedures in treating discogenic low back pain. Pain Physician, 12 (1), 207-232. (Level 1 Evidence; Independent Study)
Institute for Clinical Systems Improvement (ICSI). (2009, November). Health care guideline: Assessment and management of chronic pain. Retrieved July 13, 2011 from http://www.icsi.org/pain__chronic__assessment_and_management_of_14399/pain__chronic__assessment_and_management_of__guideline_.html. (150 articles and/or guidelines reviewed)
Kloth, D.S., Fenton, D.S., Andersson, G.B. & Block, J.E. (2008). Intradiscal electrothermal therapy (IDET) for the treatment of discogenic low back pain: patient selection and indications for use. Pain Physician, 11 (5), 659-668.
National Institute for Clinical Excellence. (2009, November). Percutaneous intradiscal electrothermal therapy for lower back pain: Guidance. Retrieved July 13, 2011 from http://guidance.nice.org.uk/IPG319/Guidance/pdf/English.
ORIGINAL EFFECTIVE DATE: 8/1/2000
MOST RECENT REVIEW DATE: 9/22/2011
ID_BA
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