A prospective cohort design or a non-randomized prospective design is used with a biased control. "Younger patients do better. The most common side effects at 24 hours post-procedure was soreness at the needle insertion site (76 %), new numbness and tingling (26 %), increased intensity of pre-procedure back pain (15 %), and new areas of back pain (15 %). Leidenberger T, Winkel A, Philipp C, et al. A 67-year old woman with a history of intradiscal O2-O3 chemonucleolysis developed numbness and weakness in her right upper and bilateral lower extremities followed by urinary retention. Int Orthop. Recently, an agent inducing chemical dissolution of the nucleus pulposus using condoliase has been approved as a novel intradiscal treatment for LDH. Less than 50 % of the authors selected cohort of patients reported symptomatic improvement at 1-month follow-up. Moreover, these researchers stated that although intradiscal MB injection appeared to be a safe and effective treatment for discogenic LBP, the clinical benefits for patients with discogenic LBP need to be further appraised in larger samples and more in-depth studies. So, what is IntraDiscNutrosis? Furthermore, this study was retrospective. VAX-D lowers that pressure to negative levels by creating a partial vacuum that can retract the disk. Randomized controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for chronic discogenic back pain. 2021 Dec 9 [Online ahead of print]. Moreover, they stated that although conclusions from several studies favor intervention over sham, it is unclear whether these interventions confer stable long-term benefit. Spinal stenosis can cause a number of annoying symptoms that can get worse over time. Well, let's start with what it is not. American Spinal Decompression Association: "Spinal Decompression Therapy.". .strikeThrough { Coblation technology was used in 50 patients, who had radicular leg pain due to contained disc herniation or focal protrusion, from 2005 to 2008. For patients with disc herniation requiring surgery, microsurgical sequestrectomy is the treatment of choice, while discectomy is obsolete. Each patient was examined before the procedure (baseline) and at 1, 3, 6, and 12 months after the procedure, using the VAS score for pain, the ODI score to measure degree of disability, and estimate QOL for those with pain; this coincided with scores on the Neuropathic Pain Questionnaire (DN4) for differential diagnoses. What Is Nonsurgical Spinal Decompression? Ren DJ, Liu XM, Du SY, et al. Interventional Procedures Consultation Document. The quality of many of the other studies is disappointing and the lack of sufficient documentation of adverse events and long term outcomes is disconcerting. Recommendations were based on the criteria developed by Guyatt et al. Even a large, protruding disk can be retracted where it's supposed to be," he says. Combination of ultra-purified stem cells with an in situ-forming bioresorbable gel enhances intervertebral disc regeneration. The authors reported that no serious adverse events in either arm of the study occurred, without defining serious adverse events. They noted that there is strong in-vitro evidence that supports the use of intradiscal PRP for discogenic LBP. } 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. These researchers stated that the main drawbacks of this study were its small sample size (n = 33) as well as its retrospective design, which led to problems in obtaining long-term, follow-up data. These preliminary findings need to be validated by well-designed studies. } } IDET Information. These researchers stated that additional studies are needed to identify which subset of patients with discogenic LBP are most likely to experience the highest and most consistent benefits from this minimally invasive autologous therapy, and how effective this therapy is when compared to control therapies. 2019;49(2):519-524. Available at: http://www.nucleoplasty.com/dph/information/temperature_comparison_nuc_IDET.pdf. J Neurosurg Spine. U.S. Food and Drug Administration (FDA), Center for Devices and Radiologic Health (CDRH). 2014;4(5):e19206. Magalhaes FN, Dotta L, Sasse A, et al. Significant pain relief was noted, as opposed to pre-operative pain, at 1, 3, 6, and 12 months after the procedure according to each patient's self-evaluation (p = 0.01). IntraDiscNutrosis repairs this mechanism so your body can heal. Are You Ready for Relief? Desai MJ, Kapural L, Petersohn JD, et al. The study's glaring problem? Injections of cBMA were offered as a therapeutic option for qualified patients based upon clinical evaluation, the refractory and somewhat degenerative nature of their condition, and the relative absence of effective conservative rehabilitation strategies to avoid surgical intervention. Trademark Application Details. An example of a device used for this procedure is the Acutherm Decompression Catheter, which is used in conjunction with the Electrothermal 20S Spine System. From these, these researchers identified 11 RCTs from which data analysis was performed. Available at: http://www.nucleoplasty.com/dph/information/vijay_sing_poster_for_IITS.pdf. Adelaide, SA: Adelaide Spine Clinic; April 18, 2001. California Technology Assessment Forum (CTAF). } The results of the meta-analysis indicated that the effects of intradiscal MB injection between pre-operation and post-operation on DLBP were statistically significant based on the 3-month VAS or NRS (weighted mean difference [WMD] = 3.61; 95 % CI: 2.46 to 4.76; p < 0.05) and ODI (WMD = 24.64, 95 % CI: 12.07 to 37.21, p < 0.05), the 6-month VAS or NRS (WMD = 2.95; 95 % CI: 1.20 to 4.71; p < 0.05) and ODI (WMD = 23.21, 95 % CI: 12.89 to 33.53, p < 0.05), and the 12-month VAS or NRS (WMD = 3.19; 95 % CI: 0.99 to 5.40; p < 0.05) and ODI (standard mean difference [SMD] = 29.51, 95 % CI: 20.60 to 38.42, p < 0.05). Standard treatment is microsurgical sequestrectomy with direct visualization of the spinal canal; while treatment innovations include minimally invasive intradiscal interventions (e.g., chemonucleolysis, manual and automated disc decompression, laser disc decompression, nucleoplasty and thermal anular RF techniques with posterolateral access to the intervertebral disc). 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. Our patients have been in your shoes. 2009;34(10):1078-1093. Acute prevertebral abscess secondary to intradiscal oxygen-ozone chemonucleolysis for treatment of a cervical disc herniation. York, UK: University of York; June 16, 2010. A technology assessment by the California Technology Assessment Forum (CTAF, 2002) concluded that Nucleoplasty percutaneous disc decompression does not meet CTAF's assessment criteria. Healthcare Insurance Board/College voor zorgverzekeringen (CVZ). Ina prospective, multi-center, randomized, controlled trial, Gersztenand colleagues (2010)assessed clinical outcomes with percutaneous plasma disc decompression (PDD) as compared with standard care using fluoroscopy-guided trans-foraminal epidural steroid injection (TFESI) over the course of 2 years. Gerszten PC, Welch WC, King JT Jr. Quality of life assessment in patients undergoing nucleoplasty-based percutaneous discectomy. r/Minnesota is what YOU make it! Among patients undergoing TFLA, 70.3 % (n = 26) reported pain relief (NRS scores less than 50 % of baseline) at post-treatment 6 months, versus 58.1 % (n = 25) of those undergoing IDRA. 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). Park CH, Lee KK, Lee SH. 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. The quality of evidence on effectiveness of intradiscal biologics was very low. Kallewaard et al (2010) noted that various interventional treatment strategies for chronic discogenic LBP unresponsive to conservative care include reduction of inflammation, ablation of intradiscal nociceptors, lowering intra-nuclear pressure, removal of herniated nucleus, and radiofrequency ablation of the nociceptors. 2016;16(4):405-412. The investigators identified 6 studies that met inclusion criteria, involving a total of 283 patients. First, the follow-up durations were variable, due to the retrospective nature of the study. A Minnesota Health Technology Advisory Committee Technology Assessment of IDET (2001) concluded: "While the initial data are promising, large randomized controlled trials are needed to determine safety, cost, effectiveness, and long-term outcome. Lu and colleagues (2014) carried out a systematic evaluation of the literature to examine current non-operative management for the treatment of discogenic LBP. 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. Montreal, QC: Agence d'Evaluation des Technologies et des Modes d'Intervention en Sante (AETMIS); July 2005. There are also promising findings in select pre-clinical animal studies. There were4 patients who underwent conventional microdiscectomy. However, the authors stated that prospective, RCTs with higher quality of evidence are needed to confirm effectiveness and risks, and to determine ideal patient selection for this procedure. 2019;44:499506. Systematic review of the effectiveness of thermal annular procedures in treating discogenic low back pain. Any other treatment (sham or active) was considered for comparative studies. The authors concluded that fluoroscopy-guided infiltrations of intervertebral discs and facet joints with PRGF in patients with chronic LBP resulted in significant pain reduction assessed by VAS. Secondary outcome measures were improvements in functional status. Two patients could not be contacted. Despite its use at various centers around the country, there are few published clinical studies that assess the efficacy of this procedure. All clinical symptoms except for the sensory deficit in the left leg were relieved. The studies utilized sophisticated random . 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 .. At 6-month follow-up, visual analog scale pain scores decreased from 5 cm to 1 cm, Oswestry disability scores improved from 14 points (28 % or moderate disability) to 6 points (12 % or minimal disability) and SF-36-PF (physical function) score changed from 67 to 82. Bhagia et al (2006) reported the short-term side effects and complications after percutaneous disc decompression utilizing Coblation technology (Nucleoplasty). Case Rep Orthop. Only subjective outcomes from case series and one non-randomized trial have been reported. IntraDiscNutrosis program; Koren Specific Technique; Manipulation for infant colic; Manipulation for internal (non-neuromusculoskeletal) disorders (Applied Kinesiology); Manipulation Under Anesthesia (see CPB 0204 - Manipulation Under General Anesthesia ); Moire Contourographic Analysis; Network Technique; Neural Organizational Technique; Multiple minimally invasive therapeutic modalities have been proposed; however, to-date no study has compared PLDD with intradiscal injection of radiopaque gelified ethanol (DiscoGel). Her symptoms did not respond to intravenous antibiotics alone; MRI of the cervical region revealed an extensive SEA anterior to the spinal cord, spinal cord myelopathy due to anterior compression by the lesion, and a pre-vertebral abscess extending from C2 to T1. The INTRADISCNUTROSIS CERTIFIED trademark is filed in the Medical & Beauty Services & Agricultural Services category with the following description: Trained to provide medical services, namely, performing IntraDiscNutrosis and other non-surgical treatments General Information Trademark Statements Classification Information Trademark Owner History While the current study provided encouraging feasibility data regarding intradiscal stem cell treatment and suggested some clinical benefit of the SVF therapy in degenerative disc patients, these investigators stated that a true evaluation of safety and effectiveness would require larger phase II/III studies. The authors stated that this retrospective analysis had obvious drawbacks such as the lack of a control group, possible regression to mean, and incomplete patient data at certain time-points. There is no down time, no pain during the procedure, and no side effects. Secondary measures noted were reports of complications and the Quality Index scores of each study that was evaluated. 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. Searching for alternatives, Reiner discovered vertebral axial decompression therapy (VAX-D), a relatively new, noninvasive form of traction-like therapy for low back pain. Thousands of patients just like you have found success at The Nerve & Disc Institute when all other treatments failed. 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. 2017;8(1):262. Cervical stenosis can also cause neck pain and problems with balance. "Look for places that do VAX-D with physical therapy. Reuters Health, May 8 2002. Itcould be an alternative to procedures like fusion or disc replacement. "When the pain is gone, that doesn't mean the fracture is completely healed. Diemen, The Netherlands; CVZ; 2000. Spine. Subjects were then monitored for adverse events (AE), range of motion (ROM), VAS, present pain intensity (PPI), ODI, BDI, Dallas Pain Questionnaire (DPQ) and SF-12 scores over a 6-month period; safety events were followed for 12 months. .strikeThrough { Intradiscal electrothermal therapy is used to treat patients with chronic, nonspecific low back pain attributed to degenerative disc disease and who met the criteria for interbody fusion surgery. The mean pre-operative VAS score was 6.95 (range of 3.0 to 10.0) and the mean post-operative VAS scores at 24 hours, 3 months and 6 months were 2.46 (range of 0 to 8.0), 4.0 (range of 0 to 10.0) and 4.53 (range of 0 to 10.0), respectively. Spine. Analgesic consumption was reduced or stopped in 90 % of cases after 1 year. Subjects and coordinators were blinded to randomization until 6 months. These include: You are fully clothed during spinal decompression therapy. Sunnyvale, CA: ArthroCare; 2001. The authors concluded that the safety of intradiscal O2-O3 therapy requires further assessment; high-dose intravenous antibiotics should be initiated empirically at the earliest possible stage of pre-vertebral and epidural abscesses. Treatment patients reported a reduction of 16mg daily intake of opioids at 6 months; however, the results were not statistically different from sham patients. Press question mark to learn the rest of the keyboard shortcuts. Having been through the slow and painful recovery from back surgery once before, he dreaded another round. Int Orthop. 2016;41(13):1065-1074. A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy -- a 12-month follow-up. Reg Anesth Pain Med. If other measures don't work, your doctor may suggest surgical spinal decompression for bulging or ruptured disks, bony growths, or other spinal problems. Pain Physician. Short-term effectiveness was defined as 1 year or less, whereas long-term effectiveness was defined as greater than 1 year. Int Orthop. Indeed, it is conceivable that an inter-group difference may have been observed if outcomes had been examined beyond 6 months. 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. Images of the subject's lumbar region showed significant enlargement of the disk protrusion after VAX-D, requiring emergency surgery. padding: 15px; Patients with and without a greater than or equal to 50 % improvement from baseline of leg pain at 3 months after injection were defined as responders and non-responders, respectively. Dreyfuss P, Marquardt C, Tencer A, Alexander E. Cervical intradiscal radiofrequency lesioning: A feasiblity study. Asample aliquot of BMC was characterized by flow cytometry and colony-forming unit-fibroblast (CFU-F) assay to determine progenitor cell content. Korean J Pain. padding-bottom: 4px; Dont give up! 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. Looks like just another Chiro office offering something called "IntraDiscNutrosis," which has not been tested or found to be a viable form of treatment by any study. color: #FFF; IP073. Coblation ablates tissue via a low-temperature, molecular dissociation process to create small channels within the disc. Kapural et al (2010) reported the effects of intradiscal biacuplasty in the treatment of thoracic discogenic pain in 3 patients. Data from ArthroCare using cadaveric models shows that IDET generates substantially higher tissue temperatures within the nucleus and superior endplates of the vertebral disc than the Nucleoplasty procedure. Website looks a bit shady too. A preliminary report. 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. In anarrative review, Helm et al (2009)evaluated the effectiveness of thermal annular procedures (TAPs) in reducing LBP in patients with intradiscal disorders. "For those patients who did report benefits, the benefit was very short lived. During 6-month follow-up, 71 % (17 of 24) of patients receiving O2-O3, avoided microdiscectomy. Spine (Phila Pa 1976). Study Summary. Endres SM, Fiedler GA, Larson KL. Only 5.1 % patients were not satisfied with the treatment and 10.2 % would not repeat the treatment if needed. Experts discuss the effectiveness of a back pain treatment that offers an alternative to surgery. intradiscnutrosis what is it Ceylan A, Asik I, Ozgencil GE, Erken B. FTC 16 CFR Part 255 Compliance Statement: Results not typical. He always leaves surgery as the absolute last resort. The cross-over group demonstrated improvements in pain and functional capacity (p < 0.0001). Shah RV, Lutz GE, Lee J, et al. You may be unable to think of little else except finding relief. Canadian Coordinating Office of Health Technology Assessment (CCOHTA). Give Light and the People Will Find Their Own Way. --> 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. For this systematic review, a total of 43 studies were identified. Third, shorter-term effects were not examined in the study and should be investigated in the future. 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From back surgery once before, he dreaded another round double-blind controlled trial of percutaneous intradiscal radiofrequency thermocoagulation for discogenic! Was reduced or stopped in 90 % of the study to be validated by well-designed }...