height:2px; However, there is significant concern that this procedure has not undergone rigorous scientific investigation and therefore is experimental or unproven. he says. The treatment was designed to resolve pain and was administered to patients without motor weakness, whereas patients with acute paralysis caused by nerve root compression undergo surgery 24 to 48 hours after the onset of neurological deficit. The California Technology Assessment Forum (CTAF) conducted a technology review (2003) of IDET and concluded that IDET with the Radionics Radiofrequency system and with the Oratec IDET system did not meet CTAF technology assessment criteria. National Horizon Scanning Centre (NHSC). Saal JA, Saal JS. These investigators performed a literature review of in-vitro, in-vivo, and clinical studies. Pain Physician. Moreover, they stated that a prospective study comparing this new method with placebo should be conducted to confirm these initial results. The assessment concluded that, because only case series studies have been conducted to examine the efficacy of this procedure, it is considered investigational. The straight leg-raising test examined 3 months after treatment was negative. Intradiscal electrothermal therapy is minimally invasive and has a low complication rate and therefore might offer advantages over surgery. 2018;46(6):2461-2465. 2013;16(2 Suppl):SE25-SE54. Idk. One suggested differences only in pain and disability, while the best quality randomized controlled trial showed no differences. Press J to jump to the feed. 21. Outcome measures included the use of a VAS and the Roland-Morris Disability Questionnaire (RDQ), as well as X-ray and MRI (T2-quantification). The Nerve & Disc Institutes IntraDiscNutrosis. The Nerve & Disc Institute is owned by Solomon L. Cogan, D.C. 2022 The Nerve & Disc Institute. Moreover, these researchers stated that further studies with larger sample sizes and longer follow-ups are needed to continue to optimize the composition of PRP used to treat patients with lumbar disc disease. Anderson SR, Flanagan B. Discography. Other outcome measures were functional improvement, improvement of psychological status, and return to work. Nezer D, Hermoni D. Percutaneous discectomy and intradiscal radiofrequency thermocoagulation for low back pain: Evaluation according to the best available evidence. Physical activity, the use of analgesics, patients' satisfaction with the treatment results and patient's willingness to repeat the treatment were also evaluated. IDET was designed to reduce pain via two mechanisms: heat-induced changes in the structure of the collagen within the disc and ablation of the nerve endings in the outer third of the annulus. Two randomized controlled trials compared IDET to placebo. Zhang et al (2021) stated that during the last 10 years, various novel tissue engineering (TE) strategies have been developed to maintain, repair, and restore the biomechanical functions of the musculoskeletal system. 21 were here. Plasma disc decompression compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc herniation: A prospective, randomized, controlled trial. Both treatments resulted in rapid and statistically significant improvements over baseline in leg pain, back pain, RMDI, and EQ-5D that persisted in follow-up. Contact us to see if you qualify for treatment. Kristin and colleagues (2017) noted that stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. Summary. McCormick et al (2019) stated that no previous study has assessed the outcomes of cooled radiofrequency ablation (C-RFA) of the medial branch nerves (MBN) for the treatment of lumbar facet joint pain nor compared its effectiveness with traditional RFA (T-RFA). Their proprietary treatment protocol, IntraDiscNutrosis, helps enable your bodys natural abilities to HEAL your bad disc. Results from 5 RCTs investigating methylene blue injection, steroid injection, ramus communicans ablation, IDET and biacuplasty favored intervention over sham therapy. Thousands of patients just like you have found success at The Nerve & Disc Institute when all other treatments failed. ECRI (2007) determined that the evidence base for IEA for discogenic pain was rated low for quantity, quality, consistency and robustness. Acta Neurochir Suppl. 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. Shah RV, Lutz GE, Lee J, et al. All had chronic LBP for greater than 6 months, back pain exceeding leg pain, concordant pain on provocative discography, disc height greater than 50 % of control, and evidence of 1- or 2-level degenerative disc disease (DDD) without evidence of additional changes on magnetic resonance imaging. Sciatica, generally speaking, is caused by inflammation of the sciatic nerves which run from the spinal column down through each of the legs. Ceylan and colleagues (2019) noted that DDD is one of the main causes of LBP. In the cervical group it remained stable, while in the lumbar group VAS decreased even more during 36 months (p = 0.012); 1 patient had spinal surgery. 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. While these results sound promising, the weakness of the study design dampens them. 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). Outcomes measures were recorded at baseline and 6 months and included the VAS, low back pain outcome score (LBOS), Oswestry Disability Index (ODI), SF-36, Zung Depression index, the modified somatic perception questionnaire, sitting tolerance, work tolerance, medication, and the presence of any neurologic deficit. Dyer tells his patients to engage only in walking during the month-long recovery process. The relevant literature for Nucleoplasty was identified through a search of the following databases: PubMed, Ovid Medline, and the Cochrane library, and by a review of the bibliographies of the included studies. 2018;97(16):e0509. Discs can become damaged so that they bulge or tear. This in turn, helps promote movement of water, oxygen, and nutrient-rich fluids into the disks so they can heal. According to the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) System, the evidence supporting use of intradiscal MSCs and PRP is very low quality. There were no statistically significant differences between the groups in ODI reduction of greater than 40 %. The authors concluded that patients were pleased with the treatment results. These preliminary findings need to be validated by well-designed studies. Available at:http://www.laurushealth.com/healthnews/reuters/ NewsStory0508200212.htm. PubMed, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) were searched for clinical studies evaluating non-operative methods of treating discogenic back pain that were published between 2000 to 2012. Pain relief and functional improvement were the primary outcome measures. During the 2-year follow-up, 25 (56 %) of the patients in the PDD group and 11 (28 %) of those in the TFESI group remained free from having a secondary procedure following the study procedure (log-rank p = 0.02). For the purpose of analysis, the maximum allowable daily dose for that opioid was calculated and utilized. Ex-vivo, ablating with 5 W induced histological denaturation of collagen at the dorsal annulus, correlating with a rise in temperature to at least 60 C. Any case studies, results, endorsements, or testimonials presented on this page reflect the personal experience and opinions of the individual patient and do not prove our treatment works. American Spinal Decompression Association: "Spinal Decompression Therapy.". 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). A total of 20 patients with chronic LBP and a positive 1-level pressure-controlled provocation discography were randomized to either intra-annular PIRFT or intra-annular sham treatment. Furthermore, there were multiple psychosocial influences on the use, misuse, and prescribing habits of opioid medications that could have affected the ability to accurately reflect this variable. Saal JA, Saal JS. Electrothermal intradiscal therapies (also referred to as thermal intradiscal procedures [TIP]) are percutaneous spinal procedures that are designed to treat back pain utilizing heat that is applied to the disc or disc wall (annulus). Accessed January 15, 2002. Lumbar stenosis can cause back pain and extreme leg pain or cramping. Patients with a history of chronic LBP and DDD of the lumbar spine who met inclusion and exclusion criteria were recruited between December 2010 and January 2012. Two actively treated and2 sham-treated patients reported increased pain levels, and in both groups a higher number was unemployed after 12 months. In all procedures, NRS and ODI scores were significantly decreased over time. Dont settle for living every day in pain. Accessed January 15, 2002. An assessment of radiofrequency techniques (nucleoplasty, percutaneous thermocoagulation, and electrothermal annuloplasty) by the Institute for Clinical Effectiveness and Health Policy (Lopez et al, 2005) reached the following conclusions: "Radiofrequency techniques are new technologies and little information is published about them. European guidelines for the management of chronic nonspecific low back pain. Intervertebral disc biacuplasty for the treatment of lumbar discogenic pain: Results of a six-month follow-up. IDET Information. 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. J Spinal Disord. Available at: http://www.nucleoplasty.com/dph/information/brian_blue_case_study.pdf. However, the outcomes and cost of IDET have not been compared with those of fusion and chronic pain management. Needle artefacts and contrast-to-noise ratios (CNR) of 6 interactive sequences (PD-, T1-, T2w TSE, T1-, T2w GRE, bSSFP) with varying echo-times (TE) and needle orientations to the main magnetic field (B0) were analyzed. Ther Adv Musculoskelet Dis. Intradiscal glucocorticoid injection for patients with chronic low back pain associated with active discopathy: A randomized trial. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. 2019;49(6):1634-1639. The authors concluded that these findings suggested that IDB is safe and effective; and indicated that IDB may fill an important niche as a minimally-invasive therapy to treat discogenic LBP in carefully selected patients. Canberra, ACT: MSAC; 2002. 2022;2022:3656753. 2010;26(4):354-357. Systematic review of silk scaffolds in musculoskeletal tissue engineering applications in the recent decade. Efficacy and durability of radiopaque gelified ethanol in management of herniated discs. Plymouth Meeting, PA: ECRI; June 2007. Even a large, protruding disk can be retracted where it's supposed to be," he says. At 6-months patients in the CMM-alone group were eligible for cross-over if desired. In a letter to the editor regarding the afore-mentioned study by Magalhaes et al (2012), Rahimi-Movaghar and Eslami (2012) stated that "In order to investigate the maximum effectiveness of ozone therapy in these different methods, we recommend an accurate, multicenter, double blind, randomized controlled trial be undertaken to achieve the best evidence in patients with herniated intervertebral discs". Cervical stenosis can also cause neck pain and problems with balance. Furthermore, the late addition of the amendment to collect X-rays at the final visit limited the ability to capture data on a large portion of the patients enrolled. 2016;17(6):1010-1022. The report describes a severe complication suffered by a patient during VAX-D treatment. The IDET technique is commonly identified with the use of the SpineCath Intradiscal catheter. A Cochrane systematic review (Gibson, 2005) concluded that the effectiveness of IDET remained unproven. An assessment by the National Institute for Clinical Excellence (2004) concluded: "Current evidence on the safety and efficacy of percutaneous disc decompression using Coblation for lower back pain does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Systematic review of IDB identified1 pilot study. Montreal, QC: Agence d'Evaluation des Technologies et des Modes d'Intervention en Sante (AETMIS); July 2005. 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). Park CH, Lee KK, Lee SH. Pain Med. The quality of evidence for improvement in pain or function after a Nucleoplasty procedure is Level II-3. The literature search yielded 3,063 results, 37 studies were identified for full-text review, and 12 met established inclusion criteria for review. Pain Pract. Waltham, MA: UpToDate; reviewed April 2020. Int Orthop. A prospective cohort design or a non-randomized prospective design is used with a biased control. PIRFT does not ablate the disc material but instead alters the biomechanics of the disc or destroys nociceptive pain fibers. Patients with positive diagnostic MBN blocks (greater than 75 % relief) were randomized to MBN C-RFA or T-RFA. There are no randomized studies of its effectiveness, no animal research regarding the long term effects of disc heating, and no evidence of long-term safety. 2016;16(4):405-412. Percutaneous nucleoplasty using coblation technique for the treatment of chronic nonspecific low back pain: 5-year follow-up results. Intradiscal platelet-rich plasma injection for chronic discogenic low back pain: Preliminary results from a prospective trial. Nucleoplasty is designed to avoid the substantial thermal injury risks of Intradiscal Electrothermal Annuloplasty (IDET), because Nucleoplasty produces lower temperatures within the disc annulus. Kapural L, Vrooman B, Sarwar S, et al. list-style-type: upper-alpha; Pain Med. The main drawback of this review was a paucity of literature with randomized trials. Itcould be an alternative to procedures like fusion or disc replacement. The authors concluded that nucleoplasty has been shown to be a safe and minimal-access procedure. Study Summary. At 1 month after the intervention, the percentage of responders (LBP intensity less than 40) was higher in the GC-IDI group (36 of 65 [55.4 %]) than the control group (21 of 63 [33.3 %]) (absolute risk difference, 22.1 percentage points [95 % CI: 5.5 to 38.7 percentage points]; p = 0.009). A total of 33 subjects were selected to be treated with intradiscal MBI. In a review on "Effectiveness of thermal annular procedures in treating discogenic low back pain", Helm et al (2012) stated that the evidence is fair for IDET and poor for discTRODE and biacuplasty procedures regarding whether they are effective in relieving discogenic LBP. Foot Pain: Are You Putting Your Best Foot Forward? Pain Pract. No intra-operative and post-operative complications were reported. OL LI { Success was defined a priori as a composite measure: no neurologic deficit resulting from the procedure, an improvement in the LBOS of 7 or more points, and an improvement in the SF-36 subscales of bodily pain and physical functioning of greater than 1 standard deviation from the mean. Curr Rev Pain. These researchers stated that high quality explanatory trials are needed to better examine the true effectiveness of these treatments. INTRADISCNUTROSIS The Disc Institute Of America, Llc. Clinically meaningful improvements (more than 30 % decrease from baseline) in VAS and RDQ were identified in 91 % of patients at final survey. No major AEs occurred in either treatment group. Six months following continuous CMM-alone treatment, subjects in this study group were allowed to "cross-over" to IDB + CMM (n = 25); and followed for an additional 6 months. SEE IF YOU QUALIFY The authors concluded that the findings of this study suggested that GelStix treatment was useful in pain relief in patients with lumbar DDD from the 1st month of treatment. Spine. IDET study information sheet. Ong D, Chua NH, Vissers K. Percutaneous disc decompression for lumbar radicular pain: A review article. Kuhelj D, Dobrovolec A, Kocijancic IJ. ", 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. OL OL LI { Pain Physician. Furthermore, an UpToDate review on "Subacute and chronic low back pain: Nonsurgical interventional treatment" (Chou, 2020) does not mention hydrogel as a management option. The mean ODI score before intervention was 81.25 %, which was reduced to 41.14 % in the DiscoGel group and 52.86 % in the PLDD group after 12 months, which was statistically significant. York, UK: University of York; June 16, 2010. Multiple minimally invasive therapeutic modalities have been proposed; however, to-date no study has compared PLDD with intradiscal injection of radiopaque gelified ethanol (DiscoGel). The authors concluded that although previously published short- and medium-term outcomes after percutaneous nucleoplasty appeared to be satisfactory, the long-term follow-up results showed a significant decline in patient satisfaction over time. Third, MRIs were not taken for the subjects of the long-term follow-up survey; thus, MRI evaluation would be needed to evaluate the extent of disc degeneration itself. Some people turn to spinal decompression therapy -- either surgical or nonsurgical. First, it was a retrospective, short-term follow-up study that included only 42 patients and did not include a statistical power analysis. Kumar and colleagues (2017) stated that adipose tissue-derived mesenchymal stem cells (AT-MSCs) offer potential as a therapeutic option for chronic discogenic LBP because of their immunomodulatory functions and capacity for cartilage differentiation. Intradiscal biacuplasty uses two internally water-cooled radiofrequency probes to lesion nociceptors in the intervertebral disc. Pain Physician. 2009;12(1):207-232. There were no complications associated with the procedure and continued improvements were observed over time. These researchers evaluated a new MR-compatible applicator system for MRgPIT in an open 1.0-T MRI-system. Gibson JA, Waddell G. Surgery for degenerative lumbar spondylosis. The pain reduction after the PRGF-Endoret injections showed a statistically significant drop from 8.4 1.1 before the treatment to 4 2.6, 1.7 2.3, and 0.8 1.7 at 1, 3, and 6 months after the treatment, respectively, with respect to all the time evaluations (p < 0.0001) except for the pain reduction between the 3rd and 6th month whose significance was lower (p < 0.05). The grading of recommendation was 1C for intradiscal ozone therapy and 1B for paravertebral ozone therapy. The medical notes of 33 patients, admitted for nucleoplasty between June 2006 and September 2007, were reviewed retrospectively. The principal outcome measures were physical function, pain, disability, and opioid usage. The Disc Institute of Pittsburghs innovative IntraDiscNutrosis program is a medical breakthrough for people suffering with bulging discs, herniated discs, degenerative discs, stenosis, sciatica, and other disc-related problems. The chymopapain chemonucleolysis has the most publications, but it is also accompanied by the most significant adverse complications and so it is scored as a 2B+/-. Rate and therefore might offer advantages over surgery identified with the procedure continued... For the treatment results open 1.0-T MRI-system are you Putting your best foot Forward for paravertebral ozone therapy... Primary outcome measures were physical function, pain, disability, and in both groups a higher number unemployed! Other outcome measures were functional improvement, improvement of psychological status, and 12 established. Idet have not been compared with fluoroscopy-guided transforaminal epidural steroid injections for symptomatic contained lumbar disc:... 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