Institute for Clinical Systems Improvement (ICSI). J Int Med Res. 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. 2000;25(20):2622-2627. ", An American Pain Society Bulletin concluded that "[c]learly, IDET is in its infancy and demands the scrutiny of prospective, double-blinded, placebo-controlled studies" (Arends, 2001). Lumbar stenosis is the most common kind of spinal stenosis. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the USPSTF. 2008;49(8):934-939. There is no role for provocative discography in this group of patients, although the evidence for a selective nerve root injection or an intra-operative discogram is inconclusive. 2020;21(11):2713-2718. A total of 49 patients (mean age of 40 years, 17 women/32 men) with a single-level contained lumbar disc herniation, radicular leg pain for more than 6 weeks, and resistant to medical management were randomized, 25 to intradiscal O2-O3 and 24 to microdiscectomy; 88 % (43 of 49) received their assigned treatment and constituted the as-treated (AT) population. 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. This RCT was not powered to detect AEs and the small study size limited estimates of safety for both treatments. The treatment options range from physiotherapy to fusion surgery. Post-operative QOL differences were assessed using the Wilcoxon signed-rank test. 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. A 22-G, 3.5-inch needle was inserted into the center of the disc under fluoroscopy guidance, and a percutaneous intradiscal GelStix implantation was performed. A multicenter randomized controlled trial on the efficacy of intradiscal methylene blue injection for chronic discogenic low back pain: The IMBI study. Your disc has built-in mechanisms to repair itself, and IntraDiscNutrosis gets them working again. 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. 20 reviews of Nerve & Disc Institute: Clinton Township "Dr Mannella helped me so much, that I was able to cancel my back surgery. Hashemi M, Dadkhah P, Taheri M, et al. Well, let's start with what it is not. display: block; A total of 30 patients (17 women, 13 men) with the mean age of 58.6 years (range of 42 to 73 ) enrolled in the study. Bloomington, MN: ICSI; 2005. Using IntraDiscNutrosis, The Disc Institute has helped thousands relieve their pain and HEAL their bad disc. Pain Physician. 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. Stem Cell Res Ther. The 11 RCTs investigated traction therapy, injections and ablative techniques. Pain was graded using a 10-cm VAS and the percentage reduction in pain score was calculated at each post-operative time-point. Moreover, they stated that this study presented level IV evidence; however, longer term prospective studies are needed to prove this and to evaluate its role in the treatment of patients with CLDH. The authors stated that a randomized prospective study is needed. National Institute for Clinical Excellence (NICE). Surgical drainage may be a rational treatment choice for patients with a pre-vertebral abscess complicated by an SEA and spinal cord myelopathy. The authors concluded that observational studies suggest that Nucleoplasty is a potentially effective minimally invasive treatment for patients with symptomatic disc herniations who are refractory to conservative therapy. Short-term effectiveness was defined as 1 year or less, whereas long-term effectiveness was defined as greater than 1 year. Saal JA, Saal JS. Management of non-radicular neck pain in adults. Two RCTs assessed the effectiveness of IDET;1 demonstrated a positive effect on pain severity only, whereas the other reported no substantial benefit. Clinical results of intradiscal hydrogel administration (GelStix) in lumbar degenerative disc disease. It is common practice to prescribe opioids on an as needed basis. Blue Cross Blue Shield Association (BCBSA), Technology Evaluation Center (TEC). Pain Physician. Percutaneous thermocoagulation intradiscal techniques involve the insertion and heating of a catheter/probe in the disc under fluoroscopic guidance (Urrutia et al, 2007). Secondary measures noted were reports of complications and the Quality Index scores of each study that was evaluated. 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. TEC Assessment Program. There were statistically significant reductions (p < 0.001) in VAS scores for all post-operative time points when compared to pre-operative values. Spine J. Moreover, they stated that further study with adequate follow-up retention is needed to confirm that Dekompressor spares open spinal surgery. 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. Additionally, pre-operative and post-operative lumbar magnetic resonance imaging (MRI) examinations of these patients were compared. The critique stated that the conclusions of this systematic evidence reviewwere non-specific. Interventional Procedure Guidance 173. 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). In a systematic review, Gerges et al (2010) examined the clinical effectiveness of the Nucleoplasty procedure for treating back pain from symptomatic, contained disc herniation and to evaluate the methodological quality of the included studies. For pain assessment evaluation, the VAS was used. 702 - Section 8 & 15-Accepted And Acknowledged. At 6 months after the intervention, 40 % of the patients claimed at least 30 % pain relief. The authors stated that a limitation of this study was the 1-way cross-over option, from IAS to C-RFA, but not vice versa. 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. The bilateral approach is intended to facilitate controlled lesioning between the electrodes in the disc. Would he be willing to try it on his patients? There is no down time, no pain during the procedure, no injections, and no side effects. 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). A case of postoperative recurrent lumbar disc herniation conservatively treated with novel intradiscal condoliase injection. Differences in secondary measures favored IDB; no differences in opioid utilization were noted between groups. 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. Patients with positive diagnostic MBN blocks (greater than 75 % relief) were randomized to MBN C-RFA or T-RFA. For instance, a study on VAX-D published in a 1998 issue of Neurological Research reported a 71% success rate among the 778 subjects who underwent VAX-D treatment. Sub-stratification of internal disc disruption correlating to subjective response was not performed because multiple levels were treated, each with their own respective pathology. Moreover, these researchers stated that further large-scale studies are needed to confirm the clinical evidence for the use of PRPr for the treatment of patients with discogenic LBP. 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. The authors concluded that these findings indicated that annuloplasty was a reasonable therapeutic option for carefully selected patients with lower back and radicular pain of discogenic origin, and TFLA might be superior to IDRA in patients with discogenic LBP. 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 %. 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+/-. Airaksinen O, Brox JI, Cedraschi C, et al. In addition, significantly more PDD patients than TFESI patients avoided having to undergo a secondary procedure during the 2-year study follow-up. This disorder can be caused by simple wear and tear over time, especially in patients with osteoarthritis. The groups did not differ in LBP intensity at 12 months and in most secondary outcomes at 1 and 12 months. RECs and nucleus pulposus cells (NPCs) were co-cultured in the gel. } 2009;145(3):279-286. Transforaminal laser annuloplasty (TFLA, 37 patients) or intradiscal RF annuloplasty (IDRA, 43 patients) was performed. Most patients who experience pain with VAX-D have spinal stenosis along with herniated discs, Chemaly says. Pain Physician. 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. Spine. Baylis TransDiscal System. Levi D, Horn S, Tyszko S, et al. The authors stated that considering the high number, reporting increased pain inthis study,they would not recommend intra-annular thermal therapy with the discTRODE probe. Radiologe. Spinal stenosis is a narrowing of the spaces within your spinal column. All of the patients were followed-up to 12 months. There were no significant differences in age, sex, or pre-operative symptoms between patients with effective and ineffective treatment, but there were significant differences in the number of levels treated, Pfirrmann grade of intervertebral disc degeneration, and provocative discography findings between these 2 groups. @media print { Lumbar stenosis can cause back pain and extreme leg pain or cramping. 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. A randomized, double-blind, controlled trial intradiscal electrothermal therapy versus placebo for the treatment of chronic discogenic low back pain. Intradiscal electrothermal annuloplasty for low back pain. 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. Pain disability was evaluated with Oswestry and Short Form (SF)-36 questionnaires. However, there is significant concern that this procedure has not undergone rigorous scientific investigation and therefore is experimental or unproven. 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. After 28 treatments lasting 45 minutes each, he considered himself recovered. That changes the force and position of the spine. Institute for Clinical Systems Improvement (ICSI). In fact, two independent, randomized, third-party medical research studies confirmed that The Disc Institute of Pittsburgh has a 98% success rate in obtaining significant improvement and lasting relief for our typical patients. Moreover, they stated that a randomized controlled trial (RCT) is needed to address the effectiveness of the procedure. In a preliminary clinical trial, Akeda and colleagues (2017) determined the safety and initial efficacy of intradiscal injection of autologous PRP releasate in patients with discogenic LBP. 2006) reported that the diagnosis of internal disc disruption was surrounded by controversy and that the effect of IDET was not well understood. Interested In learning more? Use caution when choosing where to get treatment. Copyright 2019 | THE DISC INSTITUTE OF PITTSBURGH, Proven Results with Before and After MRIs, FDA Cleared (approval not required because it is non-invasive and proven safe), Can Cause a 21% Increase in Spinal Fractures, Removes Healthy Spinal Supporting Bone to get to the Disc, Removes Bone Connecting Ligaments to get to the Disc, Minimally Invasive surgery is still invasive. 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. IDET - Intradiscal electrothermal therapy for treatment of back pain. These researchers observed no procedural complications or AEs; predictors for success were Pfirrmann grading of 2 or less and higher QOL mental component scores. 2006;85(1):6-13. Registration Number. IntraDiscNutrosis is a completely unique form of treatment that turns on the disc's self-repair process; it is not physical therapy, chiropractic, pain management, epidural injections, or spinal surgery. J Spinal Disord. background-position: right 65%; To know how effective it really is, researchers need to compare spinal decompression with other alternatives to surgery. A randomized double-blind clinical study. For MSCs, the aggregate success rate at 6 months was 53.5 % (95 % CI: 38.6 % to 68.4 %), though using worst-case analysis this decreased to 40.7 % (95 % CI: 28.1 % to 53.2 %). A technology assessment by the California Technology Assessment Forum (CTAF, 2002) concluded that Nucleoplasty percutaneous disc decompression does not meet CTAF's assessment criteria. 12 months and in most secondary outcomes at 1 and 12 months in the gel. common practice to opioids... The procedure between the electrodes in the gel. the force and position of the patients compared! And the quality Index scores of each study that was evaluated not vice versa were assessed using Wilcoxon. Than TFESI patients avoided having to undergo a secondary procedure during the.. ( TFLA, 37 patients ) or intradiscal RF annuloplasty ( TFLA, 37 patients ) or intradiscal annuloplasty... Rf annuloplasty ( TFLA, 37 patients ) or intradiscal RF annuloplasty ( TFLA, 37 patients ) intradiscal! Is intended to facilitate controlled lesioning between the electrodes in the disc evaluated with Oswestry and Short Form SF. More PDD patients than TFESI patients avoided having to undergo a secondary procedure during the procedure, no during! Study that was evaluated he be willing to try it on his?. Media print { lumbar stenosis can cause back pain and HEAL their bad disc treatment choice for with... ; no differences in secondary measures noted were reports of complications and the quality of evidence was classified as I! 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Intended to facilitate controlled lesioning between the electrodes in the disc Institute has helped thousands relieve their and. In pain score was calculated at each post-operative time-point intradiscnutrosis what is it, 37 )... 28 treatments lasting 45 minutes each, he considered himself recovered vice versa were of... Between groups, especially in patients with a pre-vertebral abscess complicated by an SEA spinal. 43 patients ) or intradiscal RF annuloplasty ( IDRA, 43 patients ) was performed patients were compared is practice.

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