A decision memo on TIPs from the Centers for Medicare & Medicaid Services (2008) concluded, "For TIPs, the mechanisms of action remain theoretical. The IDET technique is commonly identified with the use of the SpineCath Intradiscal catheter. Report ITB No. Second, baseline NRS pain and FRI scores in the currentgreater than10PRP cohort were worse than those in the historicalless than5PRP cohort; however, age and gender distributions were similar between cohorts. Spine (Phila Pa 1976). Pain Med. Davis et al (2019) stated that as a follow-up to the 6-month report, these investigators examined the analgesic effect of C-RFA in patients with knee osteoarthritis (OA) 12 months post-intervention and its ability to provide pain relief in patients who experienced unsatisfactory effects of intra-articular steroid injection (IAS); 78 % (52/67) of patients originally treated with C-RFA were examined at 12 months, while at 6 months post-IAS, 82 % (58/71) of those patients crossed-over to C-RFA and examined 6 months later. The Centers for Medicare & Medicaid Services (CMS) has issued a national non-coverage determination for TIPs, after a review of the clinical evidence did not demonstrate that TIPs improved health outcomes. Accession No. While these results sound promising, the weakness of the study design dampens them. The wand is introduced into the intervertebral disc through a small needle, and is advanced and withdrawn across the diameter of the disc several times, alternately dissolving disc material and thermally coagulating the channels left behind after removal of tissue. 2015;10(1):21-25. This paradigm was consistent with the intention of the study to test C-RFA as a rescue intervention for knee OA, rather than long-standing, conservative IAS. In additional, the evaluation tools in the study were externally-validated instruments and the internal validity related to reporting was unknown; however; the multi-variable indicators, both general and back pain specific, were implemented to counter-balance this drawback, and the outcome data demonstrated consistent improvements in pain, function, and quality of life, which provided credibility to these findings. Marin (2005) stated that Nucleoplasty may be an effective minimally invasive technique for the treatment of symptoms associated with contained herniated disc. Schneider BJ, Hunt C, Conger A, et al. Accessed January 15, 2002. The efficacy of coblation nucleoplasty for protrusion of lumbar intervertebral disc at a two-year follow-up. J Craniovertebr Junction Spine. Pain Physician. 2014;4(5):e19206. In a retrospective single-center study, Ceylan and Ak (2019) assessed the efficacy of percutaneous decompression therapy by using intradiscal navigable electrodes on pain and functional movement index in patients with herniated nucleus pulposus (HNP). Function of lower limb and daily living of patients were evaluated by the ODI. Well, let's start with what it is not. The authors stated that this study was carried out in a Persian context, which limited the generalizability of findings since it may not be representative for other settings. Moreover, they stated that further study with adequate follow-up retention is needed to confirm that Dekompressor spares open spinal surgery. 2012;15(2):E115-E129. Scientific databases searched include PubMed, Web of Science, Medline, Cochrane library, and Embase. Sub-stratification of internal disc disruption correlating to subjective response was not performed because multiple levels were treated, each with their own respective pathology. The results were published in a peer-reviewed medical journal and were co-authored by a world-famous neurosurgeon who was the head professor of neurosurgery at Harvard University and the inventor of many medical devices still used to this day. Pain disability was evaluated with Oswestry and Short Form (SF)-36 questionnaires. Eur Spine J. There was no significant evidence for an overall difference in pain score between the 2 groups (analysis of variance [(ANOVA)], F = 3.24, df = 1, p = 0.084), except for the 6th and 12th months, when group B presented a statistically important difference compared with group A (Wilcoxon test). This makes it difficult to draw conclusions about the efficacy of the procedures and their mid and long term safety The evidence currently available on the three techniques does not support the use of these procedures on routine basis beyond the research framework.". Intradiscal electrothermal therapy used to manage chronic discogenic low back pain: New directions and interventions. Outcomes were compared to a historical cohort of 29 patients who received intradiscal injections of less than 5X PRP. 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.". The radiographic measurement of disc height of PRPr-injected discs showed a mild decrease (13.8 % decrease compared to baseline) during the average 5.9 years. Patients were assessed pre-operatively and at 1 week, 1 year, 3 years, and 5 years post-operatively. Word Mark. Website looks a bit shady too. As for the potential to experience pain, Dyer says: "The patient participates by holding hand grips. 2014;39(16):1314-1324. Published techniques include chymopapain chemonucleolysis, PLDD, automated percutaneous lumbar discectomy (APLD), Dekompressor, nucleoplasty, and targeted disc decompression (TDD). These preliminary findings need to be validated by well-designed studies. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); 2005. Recommendations were based on the criteria developed by Guyatt et al. A heterogeneous group of 5 faculty members, assisted by Pain Medicine fellows, performed these procedures; difference in experience level with the procedural technique may have influenced patient outcomes, although this heterogeneity did improve generalizability of the reported findings. these investigators did not perform a previous diagnostic block for patients selection, and therefore the diagnosis and selection of patients relied on a careful clinical examination, the lack of measurement of physical activity levels before and after the treatment, and. Ukeba et al (2022) noted that lumbar intervertebral disc (IVD) herniations are associated with significant disability. The primary drawback was the relatively small sample size; 5 patients dropped-out after being enrolled by prior to randomization; selection bias was possible but not dissimilar to other studies of procedural interventions in which individuals may elect for additional non-invasive care prior to undergoing intervention. Such is the case with Philippe Chemaly, DO, MPH, a physiatrist. There are also promising findings in select pre-clinical animal studies. The American Society of Interventional Pain Physicians (ASIPP) guidelines on "Responsible, safe, and effective use of biologics in the management of low back pain" (Navani et al, 2019) stated that there is Level III evidence for intradiscal injections of PRP and MSCs. Safety and tolerability of intradiscal implantation of combined autologous adipose-derived mesenchymal stem cells and hyaluronic acid in patients with chronic discogenic low back pain: 1-year follow-up of a phase I study. Subjects and coordinators were blinded to randomization until 6 months. Patients were considered a categorical success if they achieved at least 50 % improvement in the VAS and 30 % decrease in the ODI at 1, 2, and 6 months post-treatment. Two cooled RF electrodes placed in a bipolar manner in affected discs to lesion the nociceptive fibers of the annulus fibrosus. 2021;13:1759720X211028001. } 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 %). Physical therapy teaches you techniques to do at home, which I think add to your long-term outcomes," he tells WebMD. hr.separator { His pain was worse when the neck was held in one position for a prolonged period. Acta Neurochir (Wien). The procedure is suggested to be an alternative to spinal fusion surgery in which the disc is destroyed and the two vertebrae are fused together. Int Orthop. Intradiskal electrothermal therapy: A preliminary histologic study. Third, shorter-term effects were not examined in the study and should be investigated in the future. Asian J Neurosurg. 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. 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. Following institutional review board approval, consecutive patients who were to undergo percutaneous disc decompression using Nucleoplasty were prospectively enrolled. Washington State Department of Labor, Industries. Though the pain is sometimes just a manageable inconvenience, more often than not it can be debilitating, severely decreasing quality of life. Spinal stenosis can cause a number of annoying symptoms that can get worse over time. A thorough review of the empirical evidence on TIPs is adequate to demonstrate the lack of benefit to health outcomes from these procedures. Targeted disc decompression (TDD) is a minimally invasive spinal procedure that uses thermal energy to treat herniated discs directly at the site of the actual herniation.A catheter is inserted into the disc and coiled inside it until the catheter lies directly adjacent to the disc herniation. Of these, 3 RCTs and 1 observational study met the inclusion criteria. Note: This policy addresses intradiscal electrothermal procedures only and should be distinguished from radiofrequency neuroablation, which is the destruction of nerves using heat. These researchers stated that although a clinically significant surgical avoidance rate for patients with herniated lumbar disc radiculopathy has not been established, confirming the high avoidance rate with intradiscal O2-O3 in this trial with larger, and longer follow-up clinical trials would provide additional valuable information. 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. The mean age was 37.9 years (21 to 53 years). The authors concluded that there are few high quality studies evaluating non-operative treatments for reducing discogenic LBP. To date, this is the only published report of an adverse effect caused by VAX-D. Surgery may help relieve symptoms from pressure on the spinal cord or nerves, including: Your doctor may suggest one or more types of back surgeries to relieve the pressure in your spine. Improvements in functional capacity and pain scores were noted in 2 patients. London, UK: NICE; May 2004. 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. 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. 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. Birmingham, UK: NHSC; 2001. WebMD does not provide medical advice, diagnosis or treatment. Among 14 patients, 11 patients were recruited for a long-term survey. Cleveland Clinic: "Spinal Decompression Surgery.". 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. Before operation, the mean value of ODI was 68.2 +/- 10.9 %. The investigators reported significant improvement in the visual analog scale (VAS), 36-Item Short Form Health Survey (SF-36), Beck Depression Scale, Oswestry Low Back Pain Disability Questionnaire. Basically praying on the desperate. The authors stated that this study had several drawbacks. The results of this trial cannot be generalized to patients who do not fit the strict inclusion criteria." OL OL LI { There were no infections or nerve root injuries associated with the procedure. 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. Data sources included relevant literature identified through searches of PubMed and EMBASE from 1966 to September 2012, and manual searches of the bibliographies of known primary and review articles. There were significant differences among the pre-operative, 1-week post-operative, and 3-year post-operative VAS and ODI scores, but not between the 3- and 5-year post-operative scores. Given the encouraging results on this small sample size (n = 15) with statistical significance, large appropriately powered clinical studies blinded to both clinical staff and patients are needed. 2005 - 2023 WebMD LLC. He always leaves surgery as the absolute last resort. American Spinal Decompression Association: "Spinal Decompression Therapy.". There was a statistically significant decrease in VAS and ODI scores before and after treatment. 702 - Section 8 & 15-Accepted And Acknowledged. A total of 83 patients (47 men, 36 women, mean age of 48.9 years (range of 18 to 79 years) were treated between May 2014 and December 2015 for 16 cervical and 67 lumbar chronic disc herniations. A published report in a 2003 issue of Mayo Clinical Proceedings disputes that statement. short form (SF) 36-physical functioning (SF36-PF). The mean standard deviation (SD) of pain score before intervention was 8.1 0.8. Anderson SR, Flanagan B. Discography. 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. So, what is IntraDiscNutrosis? The MRI changes of involved intervertebral discs were assessed by apparent diffusion coefficient and T2 values at pre-treatment, 3, 6, and 12 months following treatment. That changes the force and position of the spine. If other measures don't work, your doctor may suggest surgical spinal decompression for bulging or ruptured disks, bony growths, or other spinal problems. } Additionally, there is debate about how the procedure actually works. The authors concluded that they demonstrated that intradiscal injection of autologous PRP releasate in patients with LBP was safe, with no AEs observed during follow-up. The overall rate of re-intervention for persistent symptoms was 18.18 % (4/22); in the CLDH subgroup, it was 36.36 % (4/11). Asian Spine J. The authors concluded that as in the lumbar spine, intradiscal cervical RF provides too focal a thermal profile to effectively denervate the disc even in an ex vivo experiment. Other outcome measures were functional improvement, improvement of psychological status, and return to work. Sharps L. Percutaneous disc decompression using Nucleoplasty. National Horizon Scanning Centre (NHSC). Several techniques have been introduced. By reestablishing your discs built-in physiological mechanism for self-healing, IntraDiscNutrosis activates your discs natural, God-given ability to repair its own cells, which will in turn correct your problem. small sample size (n = 29), and lack of difference in post-intervention daily opioid intake between treatment and control groups. Pauza KJ, Howell S, Dreyfuss P, et al. The cross-over group demonstrated improvements in pain and functional capacity (p < 0.0001). Asample aliquot of BMC was characterized by flow cytometry and colony-forming unit-fibroblast (CFU-F) assay to determine progenitor cell content. Kwak and Chang (2018) stated that despite medication, exercise, and medical intervention, many patients complain of persistent discogenic neck pain. Korean J Pain. However, because the study did not include a comparison group, "we don't know whether (patients) are doing better or worse than if they would have had another procedure," he told Reuters Health on May 8, 2002. Two medical research studies were done to evaluate patients after initially completing IntraDiscNutrosis and 3 years after treatment by utilizing a sophisticated, random selection of a large and statistically valid sample of patients who received care. All subjects followed a common rehabilitation program. Acutherm uses a shorter catheter than is utilized with IDET. 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." Airaksinen O, Brox JI, Cedraschi C, et al. The main drawbacks of this study were its small sample size (n = 18 in the DiscoGel group) and the sort-term follow-up (12 months). The functional outcome measures (ODI, and SF 36 subscales and the relative change in pain) appeared more promising, but did not reach statistical significance when compared with sham treatment. When stratified by high (greater than 5) versus low (less than or equal to 5) baseline NRS scores, the values were 14.3, 45.5, 71.4, 22.2, and 44.4 % among those with high baseline pain, and 13.3, 46.2, 20.0, 25.0, and 33.3 % among those with low baseline pain. Chin Med J (Engl). Despite its use at various centers around the country, there are few published clinical studies that assess the efficacy of this procedure. Heal your discs naturally, feel better, and avoid neck or back surgery with IntraDiscNutrosis treatment. 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. The authors stated that taking into account of the afore-mentioned drawbacks and in the light of these preliminary data, they stated that a RCT is considered imperative. The bilateral approach is intended to facilitate controlled lesioning between the electrodes in the disc. Coblation ablates tissue via a low-temperature, molecular dissociation process to create small channels within the disc. Spine. Lumbar stenosis is the most common kind of spinal stenosis. Lesioning in either the middle or posterior portion of the disc failed to provide sufficient temperature increases throughout the cervical disc to achieve adequate denervation. The Disc Institute of Minnesota is a unique treatment center that has helped thousands of patients just like you. 2016;16(4):405-412. According to inclusion and exclusion criteria, 480 articles were considered as relevant for the purpose of this systematic review.
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