Intradiscal annuloplasty therapies use energy sources to thermally treat discogenic low back pain arising from tears in the tough outer wall, or annulus of the spinal disc. Thermal annuloplasty procedures are done under fluoroscopy and are intended to decrease low back pain and enhance the structural integrity of the disc.
With the intradiscal electrothermal annuloplasty procedure, a navigable catheter is inserted posterolaterally into the disc. The catheter is then navigated through the disc to the desired position. Using indirect radiofrequency energy, heat is generated to a temperature of 90 degrees centigrade (195’F) for up to 20 minutes. Proposed advantages of indirect electrothermal delivery of radiofrequency energy include precise temperature feedback, and heat-induced shrinkage of collagen fibers to seal annular fissures without excessive damage and thermocoagulate nerve tissue, thereby stabilizing the disc and reducing pain.
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 Intracept® Intraosseous Nerve Ablation System, Oratec SpineCath®, discTRODE™, Radionics RF Disc Catheter System® and Baylis Pain Management Cooled Probe.
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.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
There is insufficient evidence to determine effectiveness of these technologies compared to established alternative treatments.
BlueCross BlueShield Association. Evidence Positioning System. (5:2019). Percutaneous intradiscal electrothermal annuloplasty, radiofrequency annuloplasty, and biacuplasty (7.01.72) Retrieved July 30, 2019 from https://www.evidencepositioningsystem.com. (15 articles and/or guidelines reviewed)
Centers for Medicare & Medicaid Services. CMS.gov. NCD for thermal intradiscal procedures (TIPs) (150.11). Retrieved December 2, 2015 from https://www.cms.gov.
Desai, M., Kapural, L., Petersohn, J., Vallejo, R., Menzies, R, Creamer, M., & Gofeld, M. (2017). Twelve-month follow-up of a randomized clinical trial comparing intradiscal biacuplasty to conventional medical management for discogenic lumbar back pain. Pain Medicine, 18 (4), 751-763. Abstract retrieved October 2, 2017 from PubMed database.
Helm, S., Simopoulos, T., Stojanovic, M., Abdi, S., El Terany, M. (2017). Effectiveness of thermal annular procedures in treating discogenic low back pain. Pain Physicintraian, 20 (6), 447-470. Abstract retrieved October 2, 2017 from PubMed database.
Kapural, L., Vrooman, B., Sarwar, S., Krizanac-Bengez, L., Rauck, R., Gilmore, C., et al. (2015). Radiofrequency intradiscal biacuplasty for treatment of discogenic lower back pain: a 12-month follow-up. Pain Medicine, 16 (3), 425-431. Abstract retrieved August 2, 2018 from PubMed database.
National Institute for Health and Care Excellence. (2016, January). Percutaneous electrothermal treatment of the intervertebral disc annulus for low back pain and sciatica. Retrieved October 2, 2017 from www.nice.org.uk/guidance/ipg544.
National Institute for Health and Care Excellence. (2016, January). Percutaneous intradiscal radiofrequency treatment of the intervertebral disc nucleus for low back pain. Retrieved October 2, 2017 from www.nice.org.uk/guidance/ipg545.
Park, C.H., Lee, K.K., & Lee, S.H. (2019). Efficacy of transforaminal laser annuloplasty versus intradiscal radiofrequency annuloplasty for discogenic low back pain. Korean Journal of Pain, 32 (2), 113-119. (Level 4 evidence)
ORIGINAL EFFECTIVE DATE: 8/1/2000
MOST RECENT REVIEW DATE: 9/26/2019
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