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Mehul J Desai, Leonardo Kapural, Jeffrey D Petersohn, Ricardo Vallejo, Robert Menzies, Michael Creamer, Michael Gofeld
OBJECTIVE: This report conveys 12-month outcomes of subjects treated with intradiscal biacuplasty (IDB) and conservative medical management (CMM) for chronic low back pain of discogenic origin, and results for subjects who elected to receive IDB + CMM 6 months after CMM-alone. METHODS: Sixty-three subjects were originally randomized to the IDB + CMM group (N = 29) or CMM-alone (N = 34). Six months following continuous CMM-alone treatment, participants in this study group were permitted to "cross-over" to IDB + CMM (N = 25), and followed for an additional 6 months...
August 27, 2016: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Mehul J Desai, Leonardo Kapural, Jeffrey D Petersohn, Ricardo Vallejo, Robert Menzies, Michael Creamer, Michael Gofeld
STUDY DESIGN: This study was a prospective, randomized, crossover, multicenter trial for the evaluation of comparative effectiveness of intradiscal biacuplasty (IDB) versus conventional medical management (CMM) in the treatment of lumbar discogenic pain. OBJECTIVE: The objective was to demonstrate the superiority of IDB over CMM in the treatment of discogenic pain with respect to the primary outcome measure. SUMMARY OF BACKGROUND DATA: Current therapeutic options for the treatment of chronic low back pain of discogenic origin are limited...
July 1, 2016: Spine
Mehul J Desai, Jeremy Ollerenshaw, Robert Harrison, Laura Yu, Puneet Sayal, Tyler Crone, Alan Dine
BACKGROUND: Intradiscal biacuplasty (IDB) is a novel heating therapy using cooled radiofrequency (RF), which may offer relief for discogenic pain. Effective neuroablation may be achieved intradiscally at higher lesion temperatures. The safety of intradiscal heating at elevated temperatures using cooled RF has never been reported. OBJECTIVE: The purpose of this study is to map the intradiscal and peridiscal temperatures when IDB is performed at increased temperature using a modified lesion approach...
March 2015: Pain Physician
Leonardo Kapural, Bruce Vrooman, Sheryar Sarwar, Ljiljana Krizanac-Bengez, Richard Rauck, Christopher Gilmore, James North, Nagy Mekhail
INTRODUCTION: Discogenic low back pain (LBP) affects a considerable number of patients suffering from chronic LBP. Recently, a growing interest has emerged in minimally invasive treatment options for discogenic LBP. Intradiscal biacuplasty (IDB), which uses cooled radiofrequency technology to ablate nociceptors in the posterior aspect of the intervertebral disc, is one such option. We previously presented 6-month results of a randomized, double-blinded, sham-controlled study. Now, we present the unblinded, 12-month follow-up data for treatment patients and 6-month data for cross-over subjects from the original sham group...
March 2015: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Young Lu, Javier Z Guzman, Devina Purmessur, James C Iatridis, Andrew C Hecht, Sheeraz A Qureshi, Samuel K Cho
STUDY DESIGN: Systematic review of the literature. OBJECTIVE: A systematic evaluation of the literature was performed to investigate current nonoperative management of the treatment of discogenic low back pain. SUMMARY OF BACKGROUND DATA: Back pain is a major health care concern with up to 39% being discogenic in origin according to one study. Nonoperative therapy is likely to be the initial treatment strategy for discogenic low back pain...
July 15, 2014: Spine
Karlo Houra, Darko Perović, Drazen Kvesić, Ivan Rados, Damir Kovac, Leonardo Kapural
Low back and radicular pain recently became a major public health problem. Medical expenses in general, and surgical procedures associated with overall care for the lower back pain are high and growing. Furthermore, these two chronic pain conditions are also leading causes for missed workdays. Degenerative changes of the intervertebral disc, facet joints, sacroiliac joint or disc herniation as described during imaging diagnostics may or may not be the cause of patients' lower back pain. Diagnostic blocks often precede further interventions in order to confirm or dispute a source of the lower back pain...
July 2013: Lijec̆nic̆ki Vjesnik
Puneet K Sayal, Mehul J Desai
INTRODUCTION: Transdiscal biacuplasty (TDB) is a minimally invasive procedure for the treatment of lumbar discogenic pain. Theoretically, TDB ablates the aberrant ingrowth of nerve fibers beyond the outer third of the annulus fibrosis of the lumbar intervertebral disk and treats annular tears via collagen reformation. Typically, recovery involves a robust rehabilitation protocol that emphasizes lumbar stabilization exercises, focusing on extension maneuvers while also strengthening the multifidi and transverse abdominus...
February 2014: Pain Practice: the Official Journal of World Institute of Pain
Leonardo Kapural, Bruce Vrooman, Sheryar Sarwar, Ljiljana Krizanac-Bengez, Richard Rauck, Christopher Gilmore, James North, Girgis Girgis, Nagy Mekhail
OBJECTIVE: The aim was to compare the efficacy of intradiscal biacuplasty (IDB) with that of placebo treatment for discogenic low back pain. DESIGN: This is a randomized, placebo-controlled trial. Subjects were randomized on a 1:1 basis to IDB and sham groups. Follow-ups were conducted at 1, 3, and 6 months. Subjects and coordinators were blinded to randomization until 6 months. Of the 1,894 subjects screened, 64 subjects were enrolled, and 59 were treated: 29 randomized to IDB and 30 to sham...
March 2013: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Standiford Helm Ii, Timothy R Deer, Laxmaiah Manchikanti, Sukdeb Datta, Pradeep Chopra, Vijay Singh, Joshua A Hirsch
BACKGROUND: Persistent low back pain refractory to conservative treatment is a common problem that leads to widespread impairment, resulting in significant costs to society. The intervertebral disc is a major source of persistent low back pain. Technologies developed to treat this problem, including various surgical instrumentation and fusion techniques, have not reliably provided satisfactory results in terms of either pain relief or increased function. Thermal annular procedures (TAPs) were first developed in the late 1990s in an attempt to treat discogenic pain...
May 2012: Pain Physician
Haktan Karaman, Adnan Tüfek, Gönül Ölmez Kavak, Sedat Kaya, Zeynep Baysal Yildirim, Ersin Uysal, Feyzi Celik
STUDY DESIGN: Prospective observational study. OBJECTIVE: Our aim is to investigate the efficacy and safety of TransDiscal Biacuplasty. SUMMARY OF BACKGROUND DATA: Chronic discogenic pain is one of the leading causes of low back pain; however, the condition is not helped by most non-invasive methods. The results of major surgical operations for these patients are unsatisfactory. Recently, attention has shifted to disk heating methods for treatment...
2010: International Journal of Medical Sciences
Jan Willem Kallewaard, Michel A M B Terheggen, Gerbrand J Groen, Menno E Sluijter, Richard Derby, Leonardo Kapural, Nagy Mekhail, Maarten van Kleef
An estimated 40% of chronic lumbosacral spinal pain is attributed to the discus intervertebralis. Degenerative changes following loss of hydration of the nucleus pulposus lead to circumferential or radial tears within the annulus fibrosus. Annular tears within the outer annulus stimulate the ingrowth of blood vessels and accompanying nociceptors into the outer and occasionally inner annulus. Sensitization of these nociceptors by various inflammatory repair mechanisms may lead to chronic discogenic pain. The current criterion standard for diagnosing discogenic pain is pressure-controlled provocative discography using strict criteria and at least one negative control level...
November 2010: Pain Practice: the Official Journal of World Institute of Pain
Leonardo Kapural, Katarina Sakic, Kaylea Boutwell
OBJECTIVES: Discogenic pain in the thoracic region is a challenging condition characterized by refractoriness to conservative treatments. Unlike lumbar discogenic pain there is a lack of effective surgical options. Reported here is the treatment of thoracic discogenic pain in 3 patients using a new minimally invasive procedure named intradiscal biacuplasty. METHODS: Clinical case series in outpatient clinical setting. The procedure is detailed and step-by-step fluoroscopic imaging is presented...
May 2010: Clinical Journal of Pain
Leonardo Kapural, Juan P Cata, Samer Narouze
Discogenic back pain is frequently present in patients after discectomy. Here, we describe a case of young woman, previously discectomized, who was treated by a novel annuloplasty procedure, intradiscal biacuplasty (IDB). The improvement in functional capacity and pain scores were profound 12 months after the IDB. Visual analog pain scores (0-10) changed from 5 to 3. Oswestry scale showed functional improvement from 52%, or severe disability, to 14%, or minimal disability, and the SF-36 physical function scale score changed from 55 to 95...
March 2009: Pain Practice: the Official Journal of World Institute of Pain
Standiford Helm, Salim M Hayek, Ramsin M Benyamin, Laxmaiah Manchikanti
BACKGROUND: Chronic discogenic low back pain is a common problem with significant personal and societal costs. Thermal annular procedures (TAPs) have been developed in an effort to provide a minimally invasive treatment for this disorder. Multiple techniques utilized are intradiscal electrothermal therapy (IDET), radiofrequency annuloplasty, and intradiscal biacuplasty (IDB). However, these treatments continue to be controversial, coupled with a paucity of evidence. STUDY DESIGN: A systematic review of the literature evaluating the efficacy or effectiveness of TAPs...
January 2009: Pain Physician
Kevin Pauza
BACKGROUND: Disc Biacuplasty is a procedure for treating discogenic pain through neuron ablation by heating intervertebral disc tissue using cooled, bipolar radiofrequency (RF) technology. This study demonstrates temperature profiles created by disc biacuplasty in human cadavers. OBJECTIVE: To assess temperature profiles created by disc biacuplasty in human cadaver discs. DESIGN: The design of the experiment is a cadaver study with temperature monitoring in the intervertebral disc during disc biacuplasty...
September 2008: Pain Physician
Leonardo Kapural, Nagy Mekhail, David Hicks, Miranda Kapural, Steven Sloan, Nadeem Moghal, Jeffrey Ross, Dejan Petrinec
OBJECTIVE AND STUDY DESIGN: The purpose of this experimentation was to investigate the safety of a novel cooled bipolar radiofrequency system by examining histology and monitoring temperature distribution in the disc, epidural space, and adjacent to the nerve roots. In our study we used two human cadaver lumbar spines, one moderately to severely degenerated and the other mildly degenerated. SETTING AND INTERVENTIONS: Radiofrequency ablation of the disc posterior annulus is a theoretically plausible technique to ablate the nociceptors and to modify collagen of the annulus fibrosus...
January 2008: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Leonardo Kapural, Alan Ng, Jarrod Dalton, Edward Mascha, Miranda Kapural, Miguel de la Garza, Nagy Mekhail
OBJECTIVE: Intradiscal biacuplasty (IDB) is a novel bipolar cooled radiofrequency system for the treatment of degenerative disk disease. We present the results of a pilot trial with 6-month follow-up. DESIGN, SETTING, PATIENTS, AND INTERVENTIONS: Fifteen patients, 22-55 years old, underwent one- or two-level IDB treatment of their painful lumbar discs. All had chronic low back pain >6 months, back pain exceeding leg pain, concordant pain on provocative discography, disc height >50% of control, and evidence of single- or two-level degenerative disc disease without evidence of additional changes on magnetic resonance imaging...
January 2008: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Jeffrey D Petersohn, Laura R Conquergood, Mark Leung
BACKGROUND: Thermal treatment of the lumbar intervertebral disc has been suggested for the treatment of chronic discogenic pain. Disc biacuplasty (D-BAC) is a novel procedure that uses two water-cooled radiofrequency electrodes in a bipolar configuration to heat a large volume of the posterior annulus fibrosus. METHODS: Seven porcine lumbar discs were treated with D-BAC to assess acute effects on the treated tissue in a "worst-case"in vivo model. Intradiscal and peridiscal temperatures were measured during treatment and histologic analysis was used to assess for evidence of acute thermal injury...
January 2008: Pain Medicine: the Official Journal of the American Academy of Pain Medicine
Leonardo Kapural, Nagy Mekhail
Reported here is the treatment of severe axial discogenic pain in a young man utilizing the new minimally invasive transdiscal radiofrequency technique called intradiscal biacuplasty (Baylis Medical Inc., Montreal, Canada). The new procedure is detailed and step-by-step fluoroscopic imaging presented. There were no intra- and postoperative complications, and significant improvements in patient functional capacity, and pain scores were noted. Visual analog scale pain score decreased from 5 to 1 cm at 6-month follow-up, Oswestry disability scores improved from 14 (28% or moderate disability) to 6 points (12% or minimal disability) and SF-36-PF (physical function) score changed from 67 to 82...
June 2007: Pain Practice: the Official Journal of World Institute of Pain
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