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 .. The 11 RCTs investigated traction therapy, injections and ablative techniques. 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. A total of 22 patients underwent intradiscal PRP; 9 patients underwent a single-level injection, 10 at 2 levels, 2 at 3 levels, and 1 at 5 levels. Lu and colleagues (2014) carried out a systematic evaluation of the literature to examine current non-operative management for the treatment of discogenic LBP. There was a statistically significant decrease in VAS and ODI scores before and after treatment. 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. Moreover, they stated that future prospective, double-blinded, randomized, and placebo-controlled studies are needed to determine the efficacy of this treatment. For pain assessment evaluation, the VAS was used. 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. The medical notes of 33 patients, admitted for nucleoplasty between June 2006 and September 2007, were reviewed retrospectively. 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). Pettine and colleagues (2017) evaluated the safety and feasibility of intradiscal bone marrow concentrate (BMC) injections for the treatment of low back discogenic pain as an alternative to surgery with 3 years minimum follow-up. Washington State Department of Labor & Industries; July 20, 2000. The authors concluded that both techniques were equivalent in pain reduction, however, DiscoGel had a greater effect on decreasing disability after 12 months, although the rate of progression to secondary treatments and/or surgery was almost equal in the 2 groups. B. Sunnyvale, CA: ArthroCare; 2001. The authors concluded that limited observational data supported the use of intradiscal biologic agents for the treatment of discogenic LBP. 2019;44(3):389-397. Mean post-treatment pain scores at months 1 and 6 were significantly lower (p < 0.01) in both groups, and between-group differences were not significant. Available at: http://www.nucleoplasty.com/dph/information/vijay_sing_poster_for_IITS.pdf. Patients with greater concentrations of CFU-F (greater than 2,000/ml) and CD34+ cells (greater than 2 million/ml) in BMC tended to have significantly better clinical improvement. Interventional Procedures Consultation Document. When the spine is moved abnormally through heavy lifting or injury, the discs can rupture, limiting their ability to absorb the compressive forces theyre continuously exposed to. How Is Nonsurgical Spinal Decompression Done? AETMIS 05-02 RE. 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. Sunnyvale, CA: ArthroCare; 2001. 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. 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. Results from 2 randomized controlled trials showed no differences between PIRFT and placebo, and between different PIRFT techniques. 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. text-decoration: line-through; Long-term clinical effects of DiscoGel for cervical disc herniation. margin-top: 38px; Centre for Reviews and Dissemination (CRD). Moderate and severe physical disability prior to treatment (96.6 %) was reduced to less than 30 % after 12 months. With locations in Michigan, Minnesota, Pennsylvania, and North Carolina, The Disc Institute has one primary goal: to help you avoid #backsurgery 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. "I warn them, 'If we do try this and you experience pain, we'll stop. 2019;44:499506. Foot Pain: Are You Putting Your Best Foot Forward? lack of a formal assessment of blinding effectiveness. Analysis by conservative worst-case scenario definitions (treating all subjects lost to follow-up as treatment failures) would adjust the treatment success rate to 50 % (95 % CI: 29 % to 71 %) and 59 % (95 % CI: 9 % to 80 %) for pain reduction and functional improvement, respectively, in the C-RFA group. The above policy is based on the following references: Last Review Prior to visiting and signing up with the Disc Institute, I had been going to chiropractors for years. in 8 reviews, Mannella, he carefully explained the process that causes disc herniation or bulging and the mechanism by which this can be healed. in 5 reviews, I tried physical therapy, yoga, spinal injections and none of those helped at all. in 3 reviews. However, these results need to be confirmed in prospective, randomized trials. FTC 16 CFR Part 255 Compliance Statement: Results not typical. Clinical outcomes following intradiscal injections of higher-concentration platelet-rich plasma in patients with chronic lumbar discogenic pain. 2017;8(1):262. 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. This thermal therapy is postulated to alleviate discogenic pain by shrinking collagen and denervating nerve endings in the disc annulus. Still interested in VAX-D? 2000;25(20):2601-2607. Furthermore, an UpToDate review on "Subacute and chronic low back pain: Nonsurgical interventional treatment" (Chou, 2020) does not mention bone marrow aspirate as a management option. 20 reviews of Nerve & Disc Institute: Clinton Township "Dr Mannella helped me so much, that I was able to cancel my back surgery. Pain Physician. } For this systematic review, a total of 37 studies were considered for inclusion. .newText { Calisaneller T, Ozdemir O, Karadeli E, Altinors N. Six months post-operative clinical and 24 hour post-operative MRI examinations after nucleoplasty with radiofrequency energy. Bloomington, MN: HTAC; March 2001. 2008;9(8):1016-1021. Pettine KA, Suzuki RK, Sand TT, Murphy MB. Secondary outcomes included greater than or equal to 2-point pain score reduction on NRS; patient satisfaction; functional improvement; decreased use of other health care, including analgesics and surgery; and structural disc changes on MRI. Desai MJ, Kapural L, Petersohn JD, et al. Daily opioid use did not change significantly from baseline: from 40 (95 % CI: 40 to 120) before IDB to 5 (0 to 40) mg of morphine sulfate equivalent 6 months after IDB. The authors concluded that superior performance of IDB with respect to all study outcomes suggested that it is a more effective treatment for discogenic pain than CMM-alone. At 12 months, 65 % of the original C-RFA group had pain reduction greater than or equal to 50 %, and the mean overall drop was 4.3 points (p < 0.0001) on the NRS; 75 % reported improved effects. Then you may want to follow this advice from seasoned VAX-D practitioners. Buenos Aires, Argentina: Institute for Clinical Effectiveness and Health Policy (IECS); 2005. There was no supporting evidence for provocative discography in patients with lumbar radicular pain. At 2 weeks, no patient had soreness at the needle insertion site or new areas of back pain; however, new numbness and tingling was present in 15 % of patients. list-style-type: upper-roman; Most patients who experience pain with VAX-D have spinal stenosis along with herniated discs, Chemaly says. Subjects and coordinators were blinded to randomization until 6 months. Pain Med. Washington State Department of Labor & Industries, Office of the Medical Director. These preliminary findings need to be validated by well-designed studies. A 25-year-old man with a history of LDH in L4/L5, who underwent transforaminal full endoscopic lumbar discectomy (FELD) when he was 17 years old, complained of severe pain radiating to his left leg for 1 month. border-radius: 4px; 2020;33(1):66-72. In patient 1 VAS went from 7 to 8 cm claiming no improvements after the procedure. In particular, single-needle radiofrequency thermocoagulation of the discus is not recommended for patients with discogenic pain. color: #FFF; 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. AccessedJanuary 15, 2002. Nezer D, Hermoni D. Percutaneous discectomy and intradiscal radiofrequency thermocoagulation for low back pain: Evaluation according to the best available evidence. Outcomes were compared to a historical cohort of 29 patients who received intradiscal injections of less than 5X PRP. These 2 measures, 5-point Likert scale patient satisfaction, and surgical rate data were collected at 8 years. 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. The authors concluded that these preliminary findings suggested that O2-O3 chemonucleolysis may be an additional therapeutic option in this category of patients; however, these promising results await confirmation in future studies on larger patient cohorts. "What do they do when it's done? The studies utilized sophisticated random . Nucleoplasty with or without intradiscal electrothermal therapy (IDET) as a treatment for lumbar herniated disc. Technology Assessment Report. In 2002 Oratec was acquired by Smith & Nephew. 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. IDET was introduced in 1997 and case series without controls have reported encouraging results. Kapural and colleagues (2008) stated that IDB is a novel bipolar cooled radiofrequency system for the treatment of degenerative disk disease. McCormick ZL, Choi H, Reddy R, et al. At 6-months patients in the CMM-alone group were eligible for cross-over if desired. Moreover, there is currently insufficient evidence to recommend intra-discal electrothermal therapy and intradiscal biacuplasty. The device is activated for 90 seconds at a temperature of 70 degrees Celsius. Lutz C, Cheng J, Prysak M, et al. 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). The authors concluded that in patients who had radicular pain associated with a contained lumbar disc herniation, PDDresulted insignificantly reduced pain and better quality of life scores than repeated TFESI. 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. Typically they're less obese, have less [spinal] degeneration going on, more abdominal strength and better flexibility," he says. The authors stated that this study had several drawbacks. 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. In recent years, due to improved extraction techniques, remarkable biocompatibility, excellent mechanical properties, well-controlled biodegradation rate, and the potential of multitudinous functional modifications, silk has become one of the most prevalent polymeric biomaterials in the regenerative medicine field to-date. Lu Y, Guzman JZ, Purmessur D, et al. Management of chronic discogenic low back pain with a thermal intradiscal catheter. Percutaneous intradiscal radiofrequency thermocoagulation for lower back pain (second consultation). 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. /* aetna.com standards styles for templates */ 2013;14(3):362-373. Clinical effects of DiscoGel for cervical disc herniation lutz C, Cheng J, Prysak M et. Encouraging results disc herniation double-blinded, randomized, and between different PIRFT techniques available evidence with lumbar... Lumbar radicular pain and after treatment and Dissemination ( CRD ) by well-designed studies of discogenic.... Studies are needed to determine the efficacy of this treatment nerve endings in the disc annulus discogenic... Following intradiscal injections of higher-concentration platelet-rich plasma in patients with lumbar radicular pain needed to determine the efficacy this! Several drawbacks however, these results need to be confirmed in prospective,,! 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