RESULTS The results of this review confirm and help quantify the significant differences that existed in the terminology and all the areas of diagnosis and treatment of presumed discogenic pain .
Our findings show that suspected discogenic pain , despite its extensive affirmation in the literature and enormous re sources regularly devoted to it , currently lacks clear diagnostic criteria and uniform treatment or terminology
BACKGROUND CONTEXT Pain innate to intervertebral disc , often referred to as discogenic pain , is suspected by some authors to be the major source of chronic low back and neck pain .
Current management of suspected discogenic pain lacks st and ardized diagnosis , treatment , and terminology .
PURPOSE In an attempt to determine whether patterns existed that may facilitate st and ardization of care , we sought to analyze the terminologies used and the various modes of diagnosis and treatment of suspected discogenic pain .
A Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemptions Study of Lumbar Total Disc Replacement With the CHARITÉ™ Artificial Disc Versus Lumbar Fusion: Part I: Evaluation of Clinical Outcomes
Study Design . A prospect i ve , r and omized , multicenter , Food and Drug Administration-regulated Investigational Device Exemption clinical trial . Objectives . The purpose of this study was to compare the safety and effectiveness of lumbar total disc replacement , using the CHARITÉ ™ artificial disc ( DePuy Spine , Raynham , MA ) , with anterior lumbar interbody fusion , for the treatment of single-level degenerative disc disease from L4-S1 unresponsive to nonoperative treatment . Summary of Background Data . Reported results of lumbar total disc replacement have been favorable , but studies have been limited to retrospective case series and /or small sample sizes . Methods . Three hundred four ( 304 ) patients were enrolled in the study at 14 centers across the United States and r and omized in a 2:1 ratio to treatment with the CHARITÉ ™ artificial disc or the control group , instrumented anterior lumbar interbody fusion .  Data were collected pre- and perioperatively at 6 weeks and at 3 , 6 , 12 , and 24 months following surgery . The key clinical outcome measures were a Visual Analog Scale assessing back pain , the Oswestry Disability Index question naire , and the SF-36 Health Survey . Results . Patients in both groups improved significantly following surgery . Patients in the CHARITÉ ™ artificial disc group recovered faster than patients in the control group . Patients in the CHARITÉ ™ artificial discgroup had lower levels of disability at every time interval from 6 weeks to 24 months , compared with the control group , with statistically lower pain and disability scores at all but the 24 month follow-up ( P < 0.05 ) . At the 24-month follow-up period , a significantly greater percentage of patients in the CHARITÉ ™ artificial disc group expressed satisfaction with their treatment and would have the same treatment again , compared with the fusion group ( P < 0.05 ) . The hospital stay was significantly shorter in the CHARITÉ ™ artificial disc group ( P < 0.05 ) . The complication rate was similar between both groups . Conclusions . This prospect i ve , r and omized , multicenter study demonstrated that quantitative clinical outcome measures following lumbar total disc replacement with the CHARITÉ ™ artificial disc are at least equivalent to clinical outcomes with anterior lumbar interbody fusion . These results support earlier reports in the literature that total disc replacement with the CHARITÉ ™ artificial disc is a safe and effective alternative to fusion for the surgical treatment of symptomatic disc degeneration in properly indicated patients . The CHARITÉ ™ artificial disc group demonstrated statistically significant superiority in two major economic areas , a 1-day shorter hospitalization , and a lower rate of reoperations ( 5.4 % compared with 9.1 % ) . At 24 months , the investigational group had a significantly higher rate of satisfaction ( 73.7 % ) than the 53.1 % rate of satisfaction in the control group ( P = 0.0011 ) . This prospect i ve r and omized multicenter study also demonstrated an increase in employment of 9.1 % in the investigational group and 7.2 % in the control group
RESULTS The results of this review confirm and help quantify the significant differences that existed in the terminology and all the areas of diagnosis and treatment of presumed discogenic pain .
Our findings show that suspected discogenic pain , despite its extensive affirmation in the literature and enormous re sources regularly devoted to it , currently lacks clear diagnostic criteria and uniform treatment or terminology
BACKGROUND CONTEXT Pain innate to intervertebral disc , often referred to as discogenic pain , is suspected by some authors to be the major source of chronic low back and neck pain .
Current management of suspected discogenic pain lacks st and ardized diagnosis , treatment , and terminology .
PURPOSE In an attempt to determine whether patterns existed that may facilitate st and ardization of care , we sought to analyze the terminologies used and the various modes of diagnosis and treatment of suspected discogenic pain .