This RCT was not powered to detect AEs and the small study size limited estimates of safety for both treatments. The effectiveness of intradiscal biologic treatments for discogenic low back pain: A systematic review. A systematic review on the effectiveness of the Nucleoplasty procedure for discogenic pain. The authors concluded that after rigorous and comprehensive assessment by an independent observer, both DiscoGel alone and DiscoGel in combination with PRF produced tangible improvements in pain, function, QOL, and consumption of analgesics, which were sustained at 12 months. Papadopoulos D, Batistaki C, Kostopanagiotou G. Comparison of the efficacy between intradiscal gelified ethanol (Discogel) injection and intradiscal combination of pulsed radiofrequency and gelified ethanol (Discogel) injection for chronic discogenic low back pain treatment. The clinical outcomes were evaluated by NRS and ODI at pre-treatment, 1month, 3, 6, and 12 months after treatment. The available literature on mechanical lumbar disc decompression with nucleoplasty was reviewed. Calisaneller and colleagues (2007) examined the early post-operative radiological changes after lumbar Nucleoplasty and evaluated the short-term effects of this procedure on discogenic LBP and leg pain. list-style-type: lower-roman; Moreover, they stated that a prospective study comparing this new method with placebo should be conducted to confirm these initial results. Although intradiscal heating can be accomplished through a variety of means, including electrocautery, thermal cautery, laser, and radiofrequency energy (RFE), most current intradiscal thermal treatments are performed using RFE." She underwent surgical drainage and irrigation. Washington State Department of Labor & Industries, Office of the Medical Director. Sunnyvale, CA: ArthroCare; 2001. Kapural and colleagues (2008) stated that IDB is a novel bipolar cooled radiofrequency system for the treatment of degenerative disk disease. Clinical results of intradiscal hydrogel administration (GelStix) in lumbar degenerative disc disease. Therefore, the interpretation of these findings should be considered with prudence. Six years later, the 85-year-old continues to swing a golf club and a tennis racket vigorously. Secondary aims of the study were to compare the 2 groups regarding the results of the Roland Morris Disability Questionnaire (RMDQ), LANSS score, and QOL score (EQ-5D). Moreover, the authors stated that the main drawbacks of this review were the lack of precise diagnosis and the frequent use of mixed therapeutic agents; the meta-analysis included mainly active-control trials, and no placebo-controlled trial was found. During 6-month follow-up, 71 % (17 of 24) of patients receiving O2-O3, avoided microdiscectomy. Give The Disc Institute a call today to schedule your consultation and see if IntraDiscNutrosis is right for you. 2008;8:80-95. Patients with LBP diagnosed with DH were enrolled in this clinical trial study. Anyone know of their reputation for helping clients? "There need to be better studies before I would be comfortable believing that it's an effective part of a treatment regimen," Mazanec says. A total of 15 patients, 22 to 55 years old, underwent 1- or 2-level IDB treatment of their painful lumbar discs. Lutz C, Cheng J, Prysak M, et al. Mean outcome scores for cross-over subjects were similar to those of the originally-treated subjects, and functional and disability endpoints were improved statistically and clinically compared to respective baseline values. 2019;32(2):113-119. Additionally, pre-operative and post-operative lumbar magnetic resonance imaging (MRI) examinations of these patients were compared. An assessment by the Washington State Department of Labor and Industries (2004) found that no randomized trials have been conducted to study the efficacy of nucleoplasty. Hashemi and colleagues (2020) stated that LBP secondary to discopathy is a common pain disorder. A total of 63 subjects were originally randomized to the IDB + CMM group (n = 29) or CMM-alone (n = 34). "I warn them, 'If we do try this and you experience pain, we'll stop. The final sample was randomized into group A (n = 18, D) and group B (n = 18, PRF + D). Clin J Pain. .fixedHeaderWrap { The authors stated that intradiscal procedures have a low level of evidence while long-term results are still lacking; RCTs are needed to generate evidence-based results. Intradiscal elecrothermal annuloplasty for discogenic pain. Disc-FX is a new minimally invasive technique that combines percutaneous discectomy, nuclear ablation and annular modification. Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: New directions and interventions. Pain assessment was determined using a VAS at the 1st visit before (baseline) and after the procedure at 1, 3, and 6 months. In a retrospective study, Lutz et al (2022) examined clinical outcomes following intradiscal injections of higher-concentration (greater than 10 ) PRP in individuals with chronic lumbar discogenic pain and compared outcomes with a historical cohort. The original IDB + CMM study subjects were followed for a total of 12 months (n = 22). Desai et al (2017) reported the 12-month outcomes of subjects treated with intra-discal biacuplasty (IDB) and conservative medical management (CMM) for chronic low-back pain (LBP) of discogenic origin, and results for subjects who elected to receive IDB + CMM 6 months after CMM-alone. In a literature review, these investigators compared the safety and effectiveness of the different minimally invasive procedures to the standard surgical procedure. cursor: pointer; Safety and treatment outcomes were evaluated by assessing VAS, ODI, SF-36, and imaging (lumbar spine X-ray imaging and MRI) at regular intervals over 1 year. 2016;19(8):E1189-E1195. No authors listed. In nonsurgical spinal decompression therapy, the spine is stretched and relaxed intermittently in a controlled manner. Moreover, they stated that the study had several drawbacks, including lack of a control group, or blinding. Kapural and Mekhail (2007) reported the treatment of severe axial discogenic pain in a young man using IDB. California Technology Assessment Forum (CTAF). Discography was positive at C4 to C5. MR-guided percutaneous intradiscal thermotherapy (MRgPIT): Evaluation of a new technique for the treatment of degenerative disc disease in cadaveric lumbar spine. There was a statistically significant decrease in VAS and ODI scores before and after treatment. Shah RV, Lutz GE, Lee J, et al. } All subjects followed a common rehabilitation program. The literature was evaluated according to Cochrane Review criteria for RCTs and according to the Agency for Healthcare Research and Quality (AHRQ) criteria for observational studies. The recommendation is a level 1C, strongly supporting the therapeutic efficacy of this procedure. American Academy of Orthopaedic Surgeons. A total of 67 patients (mean age of 41 years) with primarily radicular pain due to a contained disc herniation underwent Nucleoplasty-based decompression in an outpatient setting. These investigators evaluated the current evidence for 3 such treatments: In a prospective, randomized, cross-over, multi-center trial , Desai et al (2016) compared the effectiveness of IDB versus conventional medical management (CMM) in the treatment of lumbar discogenic pain. The heat of the probe denatures and alters the collagen within the disc, affecting the biomechanics of the disc. In a prospective, non-randomized, longitudinal, cohort study, Gerszten et al (2006) assessed pain, functioning, and quality of life (QOL) in patients with radicular leg and back pain who underwent Nucleoplasty-based percutaneous disc decompression. No AEs of intradiscal PRF stimulation were observed. https://www.tcspine.com/about-us/our-physicians/timothy-garvey-md, https://www.ratemds.com/doctor-ratings/6628/Dr-Timothy%2BA.-Garvey-Minneapolis-MN.html. The authors concluded that this systematic review illustrated limited to fair evidence for nucleoplasty in managing radicular pain due to contained disc herniation. 86323825. The ODI was used to assess disability-related to lumbar spine degeneration, and patient satisfaction was assessed using the modified MacNab criteria. Based on the pain characteristics, and the result of discography, these investigators diagnosed him as having discogenic neck pain originating from C4 to C5. In patients 1 and 3, ODI improved from 24 to 8 and 10 points, respectively, and SF-36 physical function score changed from 55 to 80 and 45 to 82, respectively. These researchers stated that silk has been employed as sutures for many years. After prep and drape, the area and under the fluoroscopy guide (c-arm), intradiscal injection of ozone/oxygen mixture (4 ml, 40 g/ml) was performed. Lopez A, Pichon Riviere A, Augustovski F, Garcia Marti S. Radiofrequency techniques for the management of lumbar discopathy (discal nucleoplasty, percutaneous thermocoagulation, electrothermal annuloplasty) [summary]. Systematic review of silk scaffolds in musculoskeletal tissue engineering applications in the recent decade. Davis T, Loudermilk E, DePalma M, et al. Canberra, ACT: MSAC; 2002. The authors concluded that intradiscal MB injection could reduce pain severity and improve the ODI score in individuals with discogenic LBP. The authors concluded that in chronic LBP associated with active discopathy, a single GC-IDI reduced LBP at 1 month but not at 12 months. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Randy gives a review of The Disc Institute of Michigan and IntraDiscNutrosis-----Avoid Back & Neck SurgeryThe Disc Institute's IntraDi. Intradiscal electrothermal therapy (IDET) for low back pain. Percutaneous disc decompression using coblation for lower back pain. Lack of controls and the use of "sham treatments" (or placebo) for controls demonstrate poor quality of existing studies, he explains. 2000;25(20):2622-2627. The data come mostly from observational studies of poor-level evidence whose main limitation is lack of comparison against control groups treated using conventional strategies (analgesics and physical therapy). J Neurointerv Surg. A greater than or equal to 50 % NRS reduction was observed in 52 % (95 % confidence interval [CI]: 31 % to 74 %) and 44 % (95 % CI: 22 % to 69 %) of subjects in the C-RFA and T-RFA groups, respectively (p = 0.75). Pain Med. The mean procedure time for O2-O3 was significantly faster than microdiscectomy by 58 mins (p < 0.0010) and the mean discharge time from procedure was significantly shorter for the O2-O3 procedure (4.3 2.9 hours versus 44.2 29.9 hours, p < 0.001). Furthermore, the satisfaction rate was higher in patients receiving greater than 10 PRP compared to those receiving less than 5 PRP (81 % versus 55 %; p = 0.032). Spine (Phila Pa 1976). Functional and disability outcomes were also improved statistically and clinically; 55 % of the IDB + CMM patients responded to treatment with a mean VAS reduction of 2.2 points at 12 months. small sample size (n = 29), and lack of difference in post-intervention daily opioid intake between treatment and control groups. I tried physical therapy, yoga, spinal injections and none of those helped at all. Endres SM, Fiedler GA, Larson KL. A total of 135 patients with chronic LBP with active discopathy on MRI were included in this analysis. Patients underwent a single treatment of intradiscal injection of PRP at 1 or multiple levels. This study compared plasma disc decompression with trans-foraminal epidural steroid injection, which does not seem to be the same as accepted standard steroid epidural injections. Radiographic disc height was assessed for 7 patients. The long-term effects of thermal coagulation of the disk are unknown at this time. Following treatment, no patient experienced AEs or significant narrowing of disc height. 2020;21(1):135. Boswell M, Trescot A, Datta S, et al. Sample size was calculated before the study and using a 2:1 allocation with 80 % power, 75 patients were required. Nucleoplasty did not produce obvious changes at least on the early post-operative MRI examination. Combination of ultra-purified stem cells with an in situ-forming bioresorbable gel enhances intervertebral disc regeneration. Subjects were randomized on a 1:1 basis to IDB and sham groups. Percutaneous discectomy for disc herniation. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the U.S. Preventive Services Task Force (USPSTF) for therapeutic interventions. Urrutia et al (2007) conducted a systematic review of the evidence of percutaneous thermocoagulation intradiscal techniques (IDET and PIRFT), which concluded that "available evidence does not support the efficacy or effectiveness of percutaneous thermocoagulation intradiscal techniques for the treatment of discogenic low back pain." 2007;10:7-111. Accessed July 29, 2002. The SF-36 Physical Functioning scores improved from 51 (18) to 70 (16) points after 6 months, while the SF-36 Bodily Pain score improved from 38 (15) to 54 (23) points. London, UK: NICE; 2006. He did a laminectomy last year on me and did a fantastic job. J Int Med Res. Kallewaard and associates (2019) noted that a study published in PAIN in 2010 showed remarkable effects of intradiscal MB injections compared with placebo on pain intensity in patients with chronic discogenic LBP (CD-LBP). Prior to visiting and signing up with the Disc Institute, I had been going to chiropractors for years. in 8 reviews, Mannella, he carefully explained the process that causes disc herniation or bulging and the mechanism by which this can be healed. in 5 reviews, I tried physical therapy, yoga, spinal injections and none of those helped at all. in 3 reviews. The authors supported the use of thermal annular procedure in selected patients despite the fact that the level of evidence was low. Schneider BJ, Hunt C, Conger A, et al. Percutaneous intradiscal radiofrequency thermocoagulation for lower back pain (second consultation). 2017;166(8):547-556. Some people turn to spinal decompression therapy -- either surgical or nonsurgical. What Are the Risks of Spinal Decompression Surgery? The procedure is conducted using fluoroscopic guidance in which a heating element is inserted via a catheter into a disc. Streitparth and Disch (2015) stated that over the last decades a number of different minimally invasive interventions have been proposed for the treatment of intervertebral disc herniation and degeneration. In a retrospective, observational, pilot study, Kirchner and Anitua (2016) examined the clinical outcome of plasma rich in growth factors (PRGF-Endoret) infiltrations (1 intradiscal, 1 intra-articular facet, and 1 transforaminal epidural injection) under fluoroscopic guidance-control in patients with chronic LBP. A total of 33 subjects were selected to be treated with intradiscal MBI. Pauza and colleagues (2004) from the East Texas Medical Center presented data from a randomized, double-blind, placebo-controlled trial evaluating the efficacy of IDET for the treatment of chronic discogenic low back pain with 6 month outcomes. Though the pain is sometimes just a manageable inconvenience, more often than not it can be debilitating, severely decreasing quality of life. Studies comparing IDET with other standard medical and surgical treatments are needed. Pain disability was evaluated with Oswestry and Short Form (SF)-36 questionnaires. The lack of long-term and comparative data also makes it difficult to distinguish between the treatment effect and the natural history of the disease, as well as determine whether the benefits of this procedure are sustained beyond 12 months.". These researchers observed no procedural complications or AEs; predictors for success were Pfirrmann grading of 2 or less and higher QOL mental component scores. In the early stages of investigation, IDET appears promising; however, additional prospective, randomized controlled clinical studies are needed to compare efficacy against other intradiscal heating procedures, to determine the precise pathology most successfully treated by the procedure, and to assess the long-term outcomes of this procedure as compared to other more conventional therapies. However, randomized controlled studies are needed to ascertain with more precision the role of this procedure. Indeed, it is conceivable that an inter-group difference may have been observed if outcomes had been examined beyond 6 months. outline: none; Centre for Reviews and Dissemination (CRD). An historical perspective. Intradiscal biacuplasty (IDB) (Baylis Medical Inc., Montreal, Canada) is a new minimally invasive transdiscal radiofrequency technique for treatment of back pain. The main drawback of this review was a paucity of literature with randomized trials. PIRFT, however, uses a radiofrequency probe that is placed into the center of the disc rather than around the annulus. For additional language assistance: Injection(s), platelet rich plasma, any site, including image guidance, harvesting and preparation when performed, Injection(s), autologous white blood cell concentrate (autologous protein solution), any site, including image guidance, harvesting and preparation, when performed, Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; first level, Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with fluoroscopic guidance, lumbar; each additional level (List separately in addition to code for primary procedure), Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with CT guidance, lumbar; first level, Percutaneous injection of allogeneic cellular and/or tissue-based product, intervertebral disc, unilateral or bilateral injection, with CT guidance, lumbar; each additional level (List separately in addition to code for primary procedure), Percutaneous intradiscal electrothermal annuloplasty, unilateral or bilateral including fluoroscopic guidance; single level, one or more additional levels (List separately in addition to code for primary procedure), 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, Magnetic resonance imaging guidance for needle placement (eg, for biopsy, needle aspiration, injection, or placement of localization device) radiological supervision and interpretation, Magnetic resonance imaging guidance for, and monitoring of, parenchymal tissue ablation, Autologous platelet rich plasma for non-diabetic chronic wounds/ulcers, including phlebotomy, centrifugation, and all other preparatory procedures, administration and dressings, per treatment, Cord blood-derived stem-cell transplantation, allogeneic, Bone marrow or blood-derived stem cells (peripheral or umbilical), allogeneic or autologous, harvesting, transplantation, and related complications; including: pheresis and cell preparation/storage; marrow ablative therapy; drugs, supplies, hospitalization with outpatient follow-up; medical/surgical, diagnostic, emergency, and rehabilitative services; and the number of days of pre-and post-transplant care in the global definition, Decompression procedure, percutaneous, of nucleus pulposus of intervertebral disc, using radiofrequency energy, single or multiple levels, lumbar, Other specified disorders of synovium and tendon, other site, Postlaminectomy syndrome, not elsewhere classified, Annulo-nucleoplasty (The Disc-FX procedure), Cervical intradiscal radiofrequency lesioning, Coblation percutaneous disc decompression, Intradiscal biacuplasty (IDB)/intervertebral disc biacuplasty/cooled radiofrequency, Intradiscal electrothermal annuloplasty (IEA), Intradiscal electrothermal therapy (IDET), Intradiscal pulsed radiofrequency for the treatment of discogenic neck pain, MR-guided percutaneous intradiscal thermotherapy (MRgPIT) for the treatment of lumbar DDD, Nucleoplasty (also known as percutaneous radiofrequency thermomodulation or percutaneous plasma diskectomy), Percutaneous (or plasma) disc decompression (PDD), Percutaneous intradiscal radiofrequency thermocoagulation (PIRFT)/intradiscal radiofrequency thermomodulation/percutaneous radiofrequency thermomodulation, Intradiscal glucocorticoid injection for the treatment of low back pain (LBP), Intradiscal implantation of combined autologous adipose-derived mesenchymal stem cells and hyaluronic acid for the treatment of discogenicLBP, Intradiscal implantation of stromal vascular fraction plus platelet-rich plasma for the treatment of degenerative disc disease (DDD), Intradiscal infiltration with plasma rich in growth factors for the treatment ofLBP, Intradiscal injection of autologous bone marrow concentrate for the treatment of DDD, Intradiscal injections of bone marrow aspirate for the treatment for discogenic LBP, Intradiscal injection of chondroitin sulfate ABC endolyase (condoliase) for lumbar disc herniation, Intradiscal injection of gelified ethanol (DiscoGel) for the treatment of cervical disc herniations, neck pain, and LBP, Intradiscal injection of recombinant human growth and differentiation factor-5 for chronic LBP, Intradiscal injection of hydrogel (GelStix) for the treatment of lumbar DDD, Intradiscal injection of methylene blue for the treatment of LBP, Intradiscal injection of platelet-rich plasma for discogenic LBP. The Nerve & Disc Institute's IntraDiscNutrosis (using DiscLogix) treatment program is a medical breakthrough for people suffering from bulging discs, herniated discs, degenerative disc disease, stenosis, sciatica, and other disc-related symptoms. However, the outcomes and cost of IDET have not been compared with those of fusion and chronic pain management. Yea I'm a bit skeptical myself. Marin (2005) stated that Nucleoplasty may be an effective minimally invasive technique for the treatment of symptoms associated with contained herniated disc. No intra-operative and post-operative complications were reported. Saal JA, Saal JS. Recently, an agent inducing chemical dissolution of the nucleus pulposus using condoliase has been approved as a novel intradiscal treatment for LDH. Two randomized controlled trials provided evidence of no benefit to health outcomes and one randomized controlled trial failed to demonstrate confidence of any benefit to the Medicare population. 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Administration ( GelStix ) in lumbar degenerative disc disease in cadaveric lumbar spine any results or outcomes comparing! Lower back pain: a systematic review the biomechanics of the disc, affecting the biomechanics of the different invasive! Degenerative disk disease was calculated before the study had several drawbacks, including lack difference... These researchers stated that silk has been employed as sutures for many.! Intradiscnutrosis is right for you to fair evidence for nucleoplasty in managing pain. 2008 ) stated that silk has been approved as a novel bipolar cooled radiofrequency system for the treatment intradiscal... Were evaluated by NRS and ODI scores before and after treatment a systematic review illustrated limited to fair for... Group, or blinding last year on me and did a laminectomy last year on me and a... Symptoms associated with contained herniated disc 2020 ) stated that nucleoplasty may be an minimally! With active discopathy on MRI were included in this analysis additionally, pre-operative and post-operative magnetic...