A single RCT evaluating PRP reported positive outcomes but had significant methodological flaws. Derby et al (2008) stated, "The goals of thermal disc treatments are to remove unwanted tissue such as herniated discs, create a seal to limit expression of matrix components, shrink collagen tissue, and destroy nociceptors. In a literature review, these investigators compared the safety and effectiveness of the different minimally invasive procedures to the standard surgical procedure. The primary outcome measure was pain relief of at least 6 months. Kwak and Chang (2018) stated that despite medication, exercise, and medical intervention, many patients complain of persistent discogenic neck pain. The authors stated that a potential limitation of the study was that the surgical procedure was left to the discretion of participating surgeons and traditional open microdiscectomy procedures were employed at the sites. Pain Med. The mean VAS scores were 7.14 0.64 at baseline and 2.48 0.63 at 12 months (p < 0.001). So, what is IntraDiscNutrosis? All of these interventions aim at relieving pressure from compressed nerve roots by mechanical ablation, chemical dissolution, evaporation or coagulation of disc tissue. The authors concluded that this case report was the 1st to suggest that intradiscal condoliase injection could be a useful and novel conservative therapeutic option for the treatment of post-operative rec-LDH. 12009104465. Procedure-related adverse events, including injection site pain, increased leg or back pain, weakness, and light-headedness, were observed in 5 patients in the PDD group (7 events) and 7 in the TFESI group (14 events). USPTO Trademarks The Disc Institute Of America, Llc Intradiscnutrosis Application #86323825. An update of the systematic assessment of mechanical lumbar disc decompression with nucleoplasty. The primary outcomes were treatment success defined as at least 30 % reduction in pain intensity and the Patients' Global Impression of Change 6 months after the intervention. Accessed January 15, 2002. Interested In learning more? Intradiscal PRF on the C4 to C5 intervertebral disc was performed under C-arm fluoroscopy. A total of 42 cases of protruded lumbar intervertebral disc treated by coblation Nucleoplasty followed-up for 2 years were analyzed. small sample size (n = 29), and lack of difference in post-intervention daily opioid intake between treatment and control groups. Allan E. Dyer, MD, PhD, who developed VAX-D, explains how the treatment "fixes" herniated disks, a frequent cause of lower back pain: "Your bones are separated by a cushion. Thousands of patients just like you have found success at The Nerve & Disc Institute when all other treatments failed. Thousands of patients just like you have found success at The Nerve & Disc Institute when all other treatments failed. IntraDiscNutrosis is a completely unique form of treatment that turns on the disc's self-repair process: it is not physical therapy, chiropractic care, pain management, or spinal surgery. These investigators included 84 patients with CD-LBP of which 14 (35 %) in the MB plus lidocaine group showed treatment success compared with 11 (26.8 %) in the control group who received placebo plus lidocaine (p = 0.426); 27 % of all subjects treated with MB stated that their overall health improved much or very much (Patients' Global Impression of Change), versus 25.6 % in the placebo group (p = 0.958). Secondary outcome measures included treatment "responders", defined as the proportion of subjects with a 2-point or 30 % decrease in VAS scores. Other secondary measures included changes from baseline to 6-months in: Kumar and colleagues (2014) stated that back pain due to lumbar disc disease is a major clinical problem. 2006) reported that the diagnosis of internal disc disruption was surrounded by controversy and that the effect of IDET was not well understood. In 2002 Oratec was acquired by Smith & Nephew. The treatment options range from physiotherapy to fusion surgery. This treatment will take around 12 weeks to complete. Desai MJ, Kapural L, Petersohn JD, et al. The intervertebral discs, which serve as cushions between the vertebrae, are composed of cartilage with a gelatinous-like center called the nucleus pulposus. However, randomized controlled studies are required to know with more precision the role of this procedure. The eligibility of the articles was evaluated by 2 reviewers according to pre-specified inclusion and exclusion criteria, after which an independent reviewer carried out data extraction and a 2nd independent reviewer validated the data obtained. There is no pain during treatment, no side effects, and no need to take downtime or recovery time off of work. } The authors concluded that coblation Nucleoplasty may have satisfactory clinical outcomes for treatment of protruded lumbar intervertebral disc for as long as 2-year follow-up, but longer-term benefit still needs verification. Blue B. Nucleoplasty case report. These positive results should be validated in placebo-controlled randomized trials and studies that compare IDET with alternative treatments. } One suggested differences only in pain and disability, while the best quality randomized controlled trial showed no differences. Azulay N, Forgerit M, Alava EG, et al. Ultra-purified stem cells with an in situ-forming bioresorbable gel for enhancement of intervertebral disc regeneration. The Nerve & Disc Institutes IntraDiscNutrosis. Subjects were asked regarding their NRS scores, ODI scores, and progression to secondary treatment. There were statistically significant reductions (p < 0.001) in VAS scores for all post-operative time points when compared to pre-operative values. Streitparth F, Disch AC. Between-group comparison of NRS scores after 2 follow-ups were not statistically different (p = 0.62); however, the ODI score in DiscoGel was statistically lower (p = 0.001); 6 cases (16.67 %) from each group reported undergoing surgery after the follow-up period, which was not statistically different. The non-parametric Friedman statistical test was used to determine the possible differences between baseline and different follow-up time-points on pain reduction after treatment. In two randomized, independent medical research studies conducted by Dr. Paul Thomlinson (an external, third-party Ph.D. research scientist specializing in health care evaluation), patients who had received care at The Disc Institute were studied to evaluate the effectiveness and long-term results of IntraDiscNutrosis by The Disc Institute .. No intra-operative and post-operative complications were reported. Before or after therapy, you may have other types of treatment, such as: Ask your doctor whether or not you are a good candidate for nonsurgical spinal decompression. ECRI Institute Emerging Technology (TARGET) Evidence Report. Though the pain is sometimes just a manageable inconvenience, more often than not it can be debilitating, severely decreasing quality of life. This technique utilizes the Bialys TransDiscal System. Pain assessment was determined using a VAS at the 1st visit before (baseline) and after the procedure at 1, 3, and 6 months. Fourth, this study did not contain control subjects. display: none; This trial included 37 patients who received intradiscal injections of higher-concentration (greater than 10 ) PRP and had post-procedure outcomes data (visual numerical scale pain score, Functional Rating Index [FRI], and NASS Patient Satisfaction Index). New and Emerging Technology Briefing. There was a statistically significant decrease in VAS and ODI scores before and after treatment. More importantly, the procedure demonstrated a strong safety profile with no SAEs or complications linked to the therapy. No complications were observed. Does VAX-D really work? No major AEs occurred in either treatment group. An historical perspective. Using IntraDiscNutrosis, The Disc Institute has helped thousands relieve their pain and HEAL their bad disc. The theory is that this process creates a negative intradiscal pressure (pressure within the disc itself), which is thought to have two potential benefits: Pulls the herniated or bulging disc material back into the disc Percutaneous thermocoagulation intradiscal techniques involve the insertion and heating of a catheter/probe in the disc under fluoroscopic guidance (Urrutia et al, 2007). The primary outcome measure was mean pain reduction at 6 months. Two actively treated and2 sham-treated patients reported increased pain levels, and in both groups a higher number was unemployed after 12 months. Intradiscal electrothermal therapy (IDET), also known as intradiscal electrothermal annuloplasty (IDTA) or IEA, is a minimally invasive surgical procedure that uses a catheter and a flexible electrode that is inserted into the affected disc in order to heat the entire posterior edge of the annulus. Tired of the constant, nagging pain of your spinal stenosis? Patients in the IDB group exhibited statistically significant improvements in physical function (p=0.029), pain (p=0.006), and disability (p=0.037) at 6-month follow-up as compared to patients who received sham treatment. The primary outcome was the proportion of individuals with greater than or equal to 50 % pain relief after intradiscal biologic injection at 6 months. A doctor operates the computer, customizing treatment to your specific needs. Isaac Z. Commonly called a "slipped disc," "blown," or "ruptured disc," a herniated disc occurs when the inner disc material leaks through the protective rings of the disc. Anyone know of their reputation for helping clients? Daste C, Laclau S, Boisson M, et al. The analysis of the VAS over time showed that at the end-point of the study (6 months), 91 % of patients showed an excellent score, 8.1 % showed a moderate improvement, and 1.2 % were in the inefficient score. 2011;3(3):288-292. These researchers were unable to confirm that intradiscal MB injections were better capable of significantly reducing pain in patients with CD-LBP 6 months after treatment compared with placebo. The authors stated, "We cannot recommend the use of intradiscal radiofrequency, electrothermal coagulation or radiofrequency denervation of the rami communicans for the treatment of either nonspecific or "discogenic" low back pain.". 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. A Cochrane systematic review (Gibson, 2005) concluded that the effectiveness of IDET remained unproven. IntraDiscNutrosis has a success rate of over 90%, backed by an independent, randomized medical research study. Report ITB No. } However, because of the lack of prospective randomized controlled clinical trials with adequate follow up demonstrating the effectiveness of IDET, the procedure is considered experimental and investigational and is not covered. With locations in Michigan, Minnesota, Pennsylvania, and North Carolina, The Disc Institute has one primary goal: to help you avoid #backsurgery If at any point in the session the patient experiences discomfort, releasing the handgrips immediately halts the treatment. Excellent or good patient satisfaction was achieved in 87.9 % of patients after 1 week, 72.4 % after 1 year, 67.7 % after 3 years, and 63.4 % at the last follow-up. The authors concluded that findings from this study suggested that clinical outcomes can be optimized by using PRP preparations that contain a higher concentration of platelets. } Original 510(k) clearance was obtained by Oratec Interventions, Inc., (Menlo Park, CA). Study Summary. Typically they're less obese, have less [spinal] degeneration going on, more abdominal strength and better flexibility," he says. those with a contained lumbar disc herniation (CLDH) (n = 12). Randy gives a review of The Disc Institute of Michigan and IntraDiscNutrosis-----Avoid Back & Neck SurgeryThe Disc Institute's IntraDi. What Are the Risks of Spinal Decompression Surgery? border-radius: 4px; Images of the subject's lumbar region showed significant enlargement of the disk protrusion after VAX-D, requiring emergency surgery. Urrutia G, Kovacs F, Nishishinya MB, Olabe J. Percutaneous thermocoagulation intradiscal techniques for discogenic low back pain. O2-O3 treatment performed as outpatient day surgeries, included a one-time intradiscal injection delivered at a concentration of 35 3 g/cc of O2-O3 by a calibrated delivery system. IntraDiscNutrosis reverses your problem and turns your situation around, allowing your discs to receive what they need to heal. To date, this is the only published report of an adverse effect caused by VAX-D. ICSI Medical Brief. The authors concluded that the findings of this study demonstrated that analgesia following C-RFA for OA knee pain could last for at least 12 months and could rescue patients who continue to experience intolerable discomfort following IAS. Of the patients who were followed-up at 8 years, 36 % (CI: 17 % to 55 %) had undergone surgery and the median satisfaction was "4" (interquartile range of 2 to 5). Status Refresh. An assessment of IDET prepared for the Ohio Bureau of Workers' Compensation (2004) concluded that "[t]he more recent medical literature has not found outcomes as good as those previously reported regardless of the measure used in the study" and that "[a]dditional outcomes studies are needed.". Categorical success rates were as follows: 1 month: 3/22=14 % (95 % CI: 0 % to 28 %), 2 months: 7/22=32 % (95 % CI: 12 % to 51 %), 6 months: 9/19=47 % (95 % CI: 25 % to 70 %). Reg Anesth Pain Med. The value at 1 week was 28.6 +/- 8.2 %; 1-year at 35.8 +/- 6.5 %; and 2-years at 39.4 +/- 5.8 %. No unanticipated adverse events (AEs) occurred. Subjects and coordinators were blinded to randomization until 6 months. The authors concluded that Nucleoplasty appears to be safe and effective; however, they noted that randomized, controlled studies are needed to further evaluate its long-term effectiveness. The heat of the probe denatures and alters the collagen within the disc, affecting the biomechanics of the disc. ", The State of Oregon Workman Compensation System (2001) reached similar conclusions regarding IDET: "IDET is a new procedure that is that is currently being promoted by some medical providers as an effective treatment for chronic low back pain. IntraDiscNutrosis repairs this mechanism so your body can heal. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain. In patient 1 VAS went from 7 to 8 cm claiming no improvements after the procedure. The median Quality Index score was 16 (range of 12 to 19), indicating adequate methodological quality of the available literature. The other techniques were supported mainly by observational studies and thus their scores range between 0 and 2B+/-. 2018;46(6):2461-2465. Anderson SR, Flanagan B. Discography. London, UK: NICE; May 2004. All rights reserved. London, UK: NICE; 2006. 2000;25(20):2601-2607. This RCT was not powered to detect AEs and the small study size limited estimates of safety for both treatments. All patients were managed in conjunction with the authors colleagues in the Neurosurgery Unit of Bellaria Hospital and the IRCCS Institute of Neurological Sciences, Bologna. Hashemi M, Poorfarokh M, Mohajerani SA, et al. Patients were selected on clinical criteria, MRI findings, and a positive provocative discogram. Since 2 RCTs are in progress on that procedure, assessment of biacuplasty may change upon publication of those studies. The authors concluded that Nucleoplasty-based percutaneous disc decompression in patients with symptomatic contained disc herniations is safe and improves QOL as measured by the SF-36, EQ5D, and VAS for pain,3 generic QOL outcome instruments. Washington State Department of Labor, Industries. McCormick ZL, Choi H, Reddy R, et al. The investigators reported that there were no intra- and post-operative complications, and significant improvements in patient functional capacity and pain scores were noted. Percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic low back pain. Published techniques include chymopapain chemonucleolysis, PLDD, automated percutaneous lumbar discectomy (APLD), Dekompressor, nucleoplasty, and targeted disc decompression (TDD). Azzazi and colleagues (2011)evaluated the safety and clinical outcome of Nucleoplasty in well-selected cases. Pain and FRI scores significantly improved by 3.4 2.5 and 46.4 27.6, respectively, at 18.3 13.3 months following intradiscal injections of great than 10 PRP (p < 0.001). 2022;58(3):428. The authors concluded that intradiscal O2-O3 chemonucleolysis for single-level lumbar disc herniations unresponsive to medical management, met the non-inferiority criteria to microdiscectomy on 6-month mean leg pain improvement. Tried everything she could and absolutely nothing has worked. ECRI (2007) determined that the evidence base for IEA for discogenic pain was rated low for quantity, quality, consistency and robustness. Because the patient has failed conservative treatments with oral analgesics and selective left L5 nerve root block, he requested intradiscal condoliase injection instead of revision surgery. The procedure involves placing a thermal catheter within an intervertebral disc via a 17-gauge introducer needle under fluoroscopic guidance and heating the tip to 90C over 13 minutes and maintaining that temperature for 4 minutes. Patient satisfaction was evaluated at the 12th month by a patient satisfaction scale (PSS). FTC 16 CFR Part 255 Compliance Statement: Results not typical. Press question mark to learn the rest of the keyboard shortcuts. 2005 - 2023 WebMD LLC. Pain Physician. Desai MJ, Ollerenshaw J, Harrison R, et al. These researchers observed no procedural complications or AEs; predictors for success were Pfirrmann grading of 2 or less and higher QOL mental component scores. 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