title: Intradiscal Electrothermal Treatment for Chronic Discogenic Low Back Pain: Prospective Outcome Study With a Minimum 2-Year Follow-Up A prospective study of Autologous Growth Factors (AGF) in lumbar interbody fusion. Randomized Controlled Trial of Percutaneous Intradiscal Radiofrequency Thermocoagulation for Chronic Discogenic Back Pain: Lack of Effect From a 90-Second 70 C Lesion Results of the Prospective, Randomized, Multicenter Food and Drug Administration Investigational Device Exemption Study of the ProDisc®-L Total Disc Replacement Versus Circumferential Fusion for the Treatment of 1-Level Degenerative Disc Disease Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial. Four-Year Follow-up Results of Lumbar Spine Arthrodesis Using the Bagby and Kuslich Lumbar Fusion Cage Lumbar Total Disc Arthroplasty Utilizing the ProDisc Prosthesis in Smokers Versus Nonsmokers: A Prospective Study With 2-Year Minimum Follow-up A randomized placebo-controlled trial of intradiscal methylene blue injection for the treatment of chronic discogenic low back pain The Use of Intradiscal Steroid Therapy for Lumbar Spinal Discogenic Pain: A Randomized Controlled Trial Lumbar disk replacement with the ProDisc prosthesis. Intradiscal Thermal Annuloplasty for the Treatment of Lumbar Discogenic Pain in Patients with Multilevel Degenerative Disc Disease SB Charité disc replacement: report of 60 prospective randomized cases in a US center. Prospective randomized study of the Charite artificial disc: data from two investigational centers. A prospective, randomised controlled trial of femoral ring allograft versus a titanium cage in circumferential lumbar spinal fusion with minimum 2-year clinical results Efficacy of vertebral axial decompression on chronic low back pain: study of dosage regimen Minimally invasive total disc replacement: surgical technique and preliminary clinical results Evaluation of the relative contributions of various structures in chronic low back pain. Posterior Lumbar Interbody Fusion for Degenerative Disc Disease Using a Minimally Invasive B-Twin Expandable Spinal Spacer: A Multicenter Study A randomized double-blind controlled trial of intra-annular radiofrequency thermal disc therapy – A 12-month follow-up Two-year follow-up of a controlled trial of intradiscal electrothermal anuloplasty for chronic low back pain resulting from internal disc disruption. Anterior Lumbar Interbody Fusion Using rhBMP-2 With Tapered Interbody Cages Indications for full prosthetic disc arthroplasty: a correlation of clinical outcome against a variety of indications Intradiscal methylene blue injection for the treatment of chronic discogenic low back pain Estimating cost of care for patients with acute low back pain: a retrospective review of patient records. A Prospective, Randomized Controlled Clinical Trial of Anterior Lumbar Interbody Fusion Using a Titanium Cylindrical Threaded Fusion Device Management of Chronic Discogenic Low Back Pain With a Thermal Intradiscal Catheter: A Preliminary Report 2009 ISSLS Prize Winner: Does Discography Cause Accelerated Progression of Degeneration Changes in the Lumbar Disc: A Ten-Year Matched Cohort Study Intradiscal thermal annuloplasty versus intradiscal radiofrequency ablation for the treatment of discogenic pain: a prospective matched control trial. Intradiscal Electrothermal Therapy (IDET) Provides Effective Symptom Relief in Patients With Discogenic Low Back Pain Good Outcome and Restoration of Lordosis After Anterior Lumbar Interbody Fusion With Additional Posterior Fixation Pain and function after intradiscal electrothermal treatment (IDET) for symptomatic lumbar disc degeneration A Randomized Controlled Trial of Radiofrequency Denervation of the Ramus Communicans Nerve for Chronic Discogenic Low Back Pain Posterior lumbar interbody fusion using recombinant human bone morphogenetic protein type 2 with cylindrical interbody cages. 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 Nucleus Replacement With the DASCOR Disc Arthroplasty Device: Interim Two-Year Efficacy and Safety Results From Two Prospective, Non-Randomized Multicenter European Studies Treatment of 94 outpatients with chronic discogenic low back pain with the DRX9000: a retrospective chart review. A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain. Twelve-Month Follow-Up of a Controlled Trial of Intradiscal Thermal Anuloplasty for Back Pain Due to Internal Disc Disruption Preliminary results of a randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 1--Discogenic pain without disc herniation or radiculitis. Lumbar Total Disc Replacement Using ProDisc II: A Prospective Study With a 2-Year Minimum Follow-up The effect of spinal steroid injections for degenerative disc disease. Results of Surgery for Discogenic Low Back Pain: A Randomized Study Using Discography Versus Discoblock for Diagnosis Lumbar total disc arthroplasty in patients older than 60 years of age: a prospective study of the ProDisc prosthesis with 2-year minimum follow-up period. Intradiscal high-voltage, long-duration pulsed radiofrequency for discogenic pain: a preliminary report. Radiofrequency Lesioning Using Two Different Time Modalities for the Treatment of Lumbar Discogenic Pain: A Randomized Trial Clinical outcomes of lumbar degenerative disc disease treated with posterior lumbar interbody fusion allograft spacer: a prospective, multicenter trial with 2-year follow-up. A Randomized, Double-Blind, Controlled Trial: Intradiscal Electrothermal Therapy Versus Placebo for the Treatment of Chronic Discogenic Low Back Pain Outcome Analyses of Interbody Titanium Cage Fusion Used in the Anterior Discectomy for Cervical Degenerative Disc Disease Cervical disc arthroplasty: a controlled randomized prospective study with intermediate follow-up results. Invited submission from the joint section meeting on disorders of the spine and peripheral nerves, March 2005. Perioperative complications and clinical outcomes of multilevel circumferential lumbar spinal fusion in the elderly
abstract: Study Design . Prospect i ve longitudinal study with a minimum 2-year follow-up . Objective . To assess the long-term outcome of a group of patients with chronic discogenic low back pain who had failed to improve with comprehensive nonoperative care and who were subsequently treated with intradiscal electrothermal therapy ( IDET ) .  Summary of Background Data . Previous reports of patient outcomes at 1 year after IDET have demonstrated statistically significant improvement . Methods . The study group comprised 58 patients with chronic symptoms of more than 6 months who failed to improve with nonoperative care and subsequently underwent IDET .  VAS pain scores , SF-36 scores , and sitting tolerance times were collected pretreatment and at 6 , 12 , and 24 months . Results . Mean duration of pre-IDET symptoms was 60.7 months . The minimum follow-up at data collection was 24 months . The study group ( n = 58 ) demonstrated a significant improvement in pain as demonstrated by statistically significant improvement in VAS scores and bodily pain SF-36 scores . The IDET-treated group demonstrated a significant improvement in physical function as noted by statistically significant improvement in sitting tolerance times and physical function SF-36 scores . Bodily pain and physical function scores demonstrated significant improvement between the 1- and 2-year observation points . Additionally , quality of life improvement was demonstrated by a statistically significant improvement in all the SF-36 subscales . Conclusions . A cohort of patients with chronic discogenic low back pain who had failed to improve with comprehensive nonoperative care demonstrated a statistically significant improvement in pain , physical function , and quality of life at 2 years after IDET BACKGROUND Numerous pre clinical and clinical studies have reported on the use of platelet concentrates to promote tissue healing . The results in spinal fusion applications are limited and controversial . PURPOSE The purpose of the current prospect i ve clinical cohort study is to assess the effect of Autologous Growth Factors ( AGF ) on lumbar interbody fusion with specific attention paid to determination of clinical and radiographic outcomes . STUDY DESIGN / SETTING Prospect i ve clinical study PATIENT SAMPLE C and i date s for anterior-posterior lumbar fusion with diagnosis of degenerative disc disease and /or up to grade I spondylolytic spondylolisthesis based on positive provocative discography . OUTCOME MEASURES Clinical ( visual analogue pain scale/functional outcome assessment ) and radiographic outcomes ( fusion on computed tomography at 6 months and plain radiographs at 12 and 24 months ) . METHODS Thirty-seven patients were assigned to st and ard anterior-posterior interbody fusion L2-S1 ( single or two-level ) using iliac crest bone graft ( autograft group : 22 patients with 32 levels operated ) or allograft combined with autogenous growth factors ( AGF group : 15 patients with 25 levels operated ) . Radiographic outcomes were collected at 6 months postsurgery with computed tomography and at 12 and 24 months with plain radiographs . Pre- and postoperative clinical outcome measures included visual analog scores ( VAS ) for back and leg pain ( 0 - 10 ) , SF-36 scores , and Oswestry disability determination . Average clinical and radiographic follow-up for the autograft group was 24.3+/-5.6 months ( 12 - 36 months ) and AGF was 25.7+/-7.5 ( 6 - 40 months ) . RESULTS Fusion incorporation at each end plate was determined at 56 % in both autograft and AGF ( p = NS ) patients based on computed tomography at 6 months with minimal subsidence noted and no direct correlation between the incidence or degree of cage subsidence and bone graft technique . The 12- and 24-month radiographic results confirmed an 85 % arthrodesis rate for the autograft patients , whereas the AGF patients had an 89 % fusion rate ( p = NS ) . Clinical outcomes were similar for both groups and no significant differences were noted for pain or functional outcome improvements . CONCLUSIONS AGF combined with an allograft carrier is equivalent in radiographic and clinical outcomes to autograft in one- or two-level lumbar interbody fusion with supplemental posterior fixation and , thus , eliminates any morbidity from iliac crest bone graft harvesting . AGF combined with an appropriate carrier is a reasonable alternative to autograft and expensive bone induction technologies . Further research is still required to examine the optimum carriers , preparation and formulation , and platelet concentrations for this technology Study Design . A prospect i ve double-blind r and omized trial in 28 patients . Objectives . To assess the clinical effect of percutaneous intradiscal radiofrequency thermocoagulation for reducing pain , functional disability , and physical impairment in patients with chronic discogenic low back pain . Summary of Background Data . Chronic discogenic low back pain is a challenging problem in western countries . A treatment option is radiofrequency heating of the affected disc . Its clinical efficacy has never been formally tested in a controlled trial . Methods . Twenty-eight patients with a history of at least 1 year of chronic low back pain were selected on the basis of a diagnostic anesthetization of the lower intervertebral discs . Only patients with one putative painful level were selected and r and omly assigned to one of two treatment groups . Each patient in the radiofrequency treatment group ( n = 13 ) received a 90-second 70 C lesion of the intervertebral disc . Patients in the control group ( n = 15 ) underwent the same procedure , but without use of radiofrequency current . Both the treating physician and the patients were blinded to the group assignment . Before treatment , physical impairment , rating of pain , the degree of disability , and quality of life were assessed by a blinded investigator . Results . Eight weeks after treatment , there was one success in the radiofrequency group ( n = 13 ) and two in the control group ( n = 15 ) . The adjusted and unadjusted odds ratio was 0.5 and 1.1 , respectively ( not significant ) . Also , visual analog scores for pain , global perceived effect , and the Oswestry disability scale showed no differences between the two groups . Conclusions . Percutaneous intradiscal radiofrequency thermocoagulation ( 90 seconds , 70 C ) is not effective in reducing chronic discogenic low back pain Study Design . A prospect i ve , r and omized , multicenter , Food and Drug Administration-regulated Investigational Device Exemption clinical trial . Objective . To evaluate the safety and effectiveness of the ProDisc ® -L ( Synthes Spine , West Chester , PA ) lumbar total disc replacement compared to circumferential spinal fusion for the treatment of discogenic pain at 1 vertebral level between L3 and S1 . Summary of Background Data . As part of the Investigational Device Exemption clinical trial , favorable single center results of lumbar total disc replacement with the ProDisc ® -L have been reported previously . Methods . Two hundred eighty-six ( 286 ) patients were treated on protocol . Patients were evaluated before and after surgery , at 6 weeks , 3 , 6 , 12 , 18 , and 24 months . Evaluation at each visit included patient self- assessment s , physical and neurologic examinations , and radiographic evaluation . Results . Safety of ProDisc ® -L implantation was demonstrated with 0 % major complications . At 24 months , 91.8 % of investigational and 84.5 % of control patients reported improvement in the Oswestry Low Back Pain Disability Question naire ( Oswestry Disability Index [ ODI ] ) from preoperative levels , and 77.2 % of investigational and 64.8 % of control patients met the ≥15 % Oswestry Disability Index improvement criteria . Overall neurologic success in the investigational group was superior to the control group ( 91.2 % investigational and 81.4 % control ; P = 0.0341 ) . At 6 weeks and 3 months follow-up time points , the ProDisc ® -L patients recorded SF-36 Health Survey scores significantly higher than the control group ( P = 0.018 , P = 0.0036 , respectively ) . The visual analog scale pain assessment showed statistically significant improvement from preoperative levels regardless of treatment ( P < 0.0001 ) . Visual analog scale patient satisfaction at 24 months showed a statistically significant difference favoring investigational patients over the control group ( P = 0.015 ) . Radiographic range of motion was maintained within a normal functional range in 93.7 % of investigational patients and averaged 7.7 ° . Conclusions . ProDisc ® -L has been found to be safe and efficacious . In properly chosen patients , ProDisc ® -L has been shown to be superior to circumferential fusion by multiple clinical criteria OBJECT The authors report the results of a prospect i ve r and omized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion ( ACDF ) in patients treated for symptomatic single-level cervical degenerative disc disease ( DDD ) . METHODS Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and r and omly assigned to one of two treatment groups : 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System ( Medtronic Sofamor Danek ) ;  265 patients in the control group underwent decompressive ACDF . Eighty percent of the arthroplasty-treated patients ( 223 of 276 ) and 75 % of the control patients ( 198 of 265 ) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery . Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group . The arthroplasty group also had a statistically significant higher rate of neurological success ( p = 0.005 ) as well as a lower rate of secondary revision surgeries ( p = 0.0277 ) and supplemental fixation ( p = 0.0031 ) . The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months , as was relief of neck pain . The patients in the investigational group returned to work 16 days sooner than those in the control group , and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well ( p = 0.0492 , log-rank test ) . The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees . In the investigational group , there were no cases of implant failure or migration . CONCLUSIONS The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success , improved clinical outcomes , and a reduced rate of secondary surgeries compared with ACDF Study Design . This was a prospect i ve multicenter clinical trial of a lumbar interbody fusion cage with a minimum of 4 years ’ follow-up . Objectives . To determine whether the early positive clinical results in fusions with lumbar cages , such as the Bagby and Kuslich ( BAK ) cage , are maintained beyond 2 years . Summary of Background Data . Threaded cages have been used increasingly for the treatment of symptomatic degenerative intervertebral disc disease . Concerns about the long-term clinical outcomes of this procedure have been posed , particularly regarding bony fusion viability , revision rates , potential adjacent level disease , and late complications . Methods . The study cohort was a 196-patient subset from a prospect i ve investigational device exemption . In addition to early postoperative examinations , these patients were examined biannually with a minimum of 4 years ’ follow-up . Patient outcome was assessed by a 6-point scale that evaluated pain relief , and functional improvement was determined by changes in activities of daily living . Fusion rates and return to work were determined . Complications and secondary operations were reported and categorized as non – device related or device related . Results . The patient cohort with 4-year follow-up represented 25.6 % of the original study population eligible at that time . Overall , the largest percentage of pain relief and functional improvements occurred by 3 months , and these improvements were maintained at each follow-up . Overall fusion rate was 91.7 % and 95.1 % at 2 and 4 years , respectively . In this cohort , 39.5 % of patients were working or were able to work within 3 months of surgery . After 4 years , 62.7 % of patients were gainfully employed or able to work . The late-occurring complication rate in this cohort was 13.8 % ( 27/196 ) . Complications necessitating a second operation occurred in 8.7 % ( 17/196 ) , whereas reoperations that were deemed device related were performed in 3.1 % ( 6/196 ) . Conclusions . This study indicates that the early positive benefits of interbody fusion cage procedures are maintained through 4 years with acceptably low morbidity Study Design . Prospect i ve nonr and omized clinical series . Objectives . To evaluate the efficacy of ProDisc lumbar artificial disc replacement ( ADR ) in smokers versus nonsmokers . Summary of Background Data . Smoking is a negative predictor in fusion surgery . To date , a prospect i ve study of the treatment of incapacitating discogenic low back pain using ADR in smokers versus nonsmokers has not been described . Methods . A prospect i ve analysis was performed on 104 patients with disabling discogenic low back pain treated with single-level lumbar ProDisc total disc arthroplasty . Smokers and nonsmokers were assessed before surgery and after surgery using patient satisfaction , Oswestry , and Visual Analog Scores . Additionally , preoperative and postoperative neurologic , radiographic , and pain medication assessment s were performed at similar postoperative intervals . Results . Oswestry , Visual Analog Scores , and patient satisfaction scores revealed statistical improvement beginning 3 months after surgery and were maintained at minimum 2-year follow-up . Patient satisfaction scores were higher in smokers ( 94 % ) than in nonsmokers ( 87 % ) at 2-year follow-up ( P = 0.07 ) . Radiographic analysis revealed an affected disc height increase from 4 mm to 13 mm ( P < 0.05 ) and an affected disc motion from 3 ° to 7 ° ( P < 0.05 ) . No cases of loosening , dislodgment , mechanical failure , infection , or fusion of the affected segment occurred . Conclusions . The results of our study indicate that smokers do equally well compared with nonsmokers  when ProDisc ADR is used in the treatment of debilitating lumbar spondylosis . Patient outcome and radiographic scores showed significant improvement compared with preoperative levels . Although not evident in our series , additional surveillance for intraoperative and postoperative vascular spasm and occlusion may be warranted in smokers & NA ; A preliminary report of clinical study revealed that chronic discogenic low back pain could be treated by intradiscal methylene blue ( MB ) injection . We investigated the effect of intradiscal MB injection for the treatment of chronic discogenic low back pain in a r and omized placebo‐controlled trial . We recruited 136 patients who were found potentially eligible after clinical examination and 72 became eligible after discography . All the patients had discogenic low back pain lasting longer than 6 months , with no comorbidity . Thirty‐six were allocated to intradiscal MB injection and 36 to placebo treatment . The principal criteria to judge the effectiveness included alleviation of pain , assessed by a 101‐point numerical rating scale ( NRS‐101 ) , and improvement in disability , as assessed with the Oswestry Disability Index ( ODI ) for functional recovery . At the 24‐month follow‐up , both the groups differed substantially with respect to the primary outcomes . The patients in MB injection group showed a mean reduction in pain measured by NRS of 52.50 , a mean reduction in Oswestry disability scores of 35.58 , and satisfaction rates of 91.6 % , compared with 0.70 % , 1.68 % , and 14.3 % , respectively , in placebo treatment group ( p < 0.001 , p < 0.001 , and p < 0.001 , respectively ) . No adverse effects or complications were found in the group of patients treated with intradiscal MB injection . The current clinical trial indicates that the injection of methylene blue into the painful disc is a safe , effective and minimally invasive method for the treatment of intractable and incapacitating discogenic low back pain Study Design . A prospect i ve r and omized study of the therapeutic effect of intradiscal steroid injection compared to a saline placebo . Objectives . To determine whether intradiscal steroid injection influences the clinical outcome at 1 year in patients with chronic low back pain of discogenic origin . Summary of Background Data . Steroids have been used empirically in the treatment of back pain . They have been used in the epidural space and around nerve roots and have been used as an alternative to chymopapain within the disc . Previous studies have , however , shown variable results . Methods . A total of 120 patients with chronic low back pain of discogenic origin were enrolled in the study . At discography , if they had concordant pain , they were r and omized to injection of normal saline or methylprednisolone into the disc space . These patients were prospect ively followed up for 12 months , and they were asked to report pain according to a visual analogue score and their Oswestry Disability Index was recorded . The primary outcome measure was determined as a percentage change in disability , and the results were analyzed using independent sample s t test . The secondary outcome measure was a change in the pain score , and this was analyzed using the Mann-Whitney U test . Results . There was no significant difference in the primary outcome between the two groups ( P = 0.71 ) . The steroid group had a mean change of 2.28 ( SE 2.49 ) in percentage disability , while the saline group had a mean change of 3.42 ( SE 1.79 ) . With respect to the change in pain score , there was no significant difference between the two groups ( P = 0.72 ) . Those patients who had saline injection had a median change in pain score of 0 ( interquartile range −1 to 1 ) , whereas those given steroid treatment had a median change in pain score of 0 ( interquartile range −0.25 to 1 ) . Conclusions . This study demonstrates that intradiscal steroid injections do not improve the clinical outcome in patients with discogenic back pain compared with placebo Twenty-two ProDisc II prostheses ( Spine Solutions , New York , New York ) were implanted in 21 patients with degenerative disk disease at L5-S1 ( 19 disks ) and L4-L5 ( 3 disks ) . After mean follow-up of 3.1 years ( range , 17 - 49 months ) , pain intensity in all but 3 patients had improved from an average of 7.7 preoperatively to 4.6 postoperatively ( P < .001 ) on a visual analog scale . Average Oswestry Disability Index score improved from 61 to 35 ( P < .001 ) . Radiographic reconstruction of the disk space height was achieved in all cases . Previous diskectomy at the implanted level and disk degeneration adjacent to previous fusion negatively influenced the results Symptomatic degenerative disc disease ( DDD ) may lead to significant deterioration of quality of life and increased disability .  Intradiscal thermal annuloplasty ( IDTA ) is a minimally invasive treatment for painful DDD . We hypothesized that there may be an improvement in pain scores and the pain disability index ( PDI ) of patients who have multilevel DDD after IDTA . Patients 24–66 yr old , male and female with multilevel DDD ( MDDD ) and matched 1 or 2 level DDD ( 1,2-DDD ) patients were enrolled in the study . Visual analog pain scale ( VAS ) score and PDI were observed for 12 mo . The 1,2-DDD patient group had a 2.5 ± 2.4 VAS score at 12 mo after annuloplasty compared to 7.7 ± 2 before the procedure . The MDDD VAS score was 4.9 ± 2.9 at 12 mo compared to 7.4 ±1.8 before the procedure . Similar improvements in PDI were found . The pain relief and PDI were significantly better in patients with 1,2-DDD than in the MDDD group ( P = 0.0037 and P = 0.041 , respectively ) . We concluded that IDTA is an effective treatment of discogenic pain and that the number of discs affected by degeneration is an important determinant of the procedure outcome Sixty patients with one-level discogenic pain confirmed by plain radiography , magnetic resonance imaging , and provocative discography for degenerative disc disease were r and omized : one-third BAK anterior interbody fusion and two-thirds anterior SB Charité artificial disc replacement . The mean age was 40.3 years ( range 21 - 56 years ) . Nineteen cases were at L4-L5 and 41 cases were at L5-S1 . Nineteen cases had BAK anterior interbody fusion and 41 cases were r and omized as SB Charité disc replacement . The length of surgery was mean 88.4 minutes ( range 54 - 137 minutes ) for both groups . The estimated blood loss was mean 289.5 mL ( range 50 - 1800 mL ) . The length of hospital stay was a mean of 3.03 days ( range 2 - 6 days ) . Oswestry Disability Index scores for the SB Charité disc ( aggregate study group ) were 50.0 + /- 14.3 preoperatively and 25.0 + /- 20.1 at 1 - 3 years ' follow-up ( P < 0.001 ) . This is the first study that shows improvement of functional outcome measures in a prospect i ve r and omized design with disc arthroplasty treating primarily mechanical back pain and achieving comparable successful results to lumbar fusion-interbody fusion cage and BMP or interbody autograft and pedicle screw instrumentation BACKGROUND CONTEXT For decades there has been a desire to restore motion of a painful degenerated spinal segment . Artificial discs have been used in Europe for almost 20 years . In the few reports available in the literature , the results have been promising . However , there have been no prospect i ve r and omized studies comparing artificial discs with spinal fusion . PURPOSE The purpose of this study was to determine if patients with symptomatic degenerative disc disease treated with Charite artificial disc ( DePuy Spine , Raynham , MA ) arthroplasty  would show significant improvement in functional outcome measures and to compare these results to fusion . STUDY DESIGN / SETTING This was a prospect i ve r and omized clinical trial comparing total disc replacement with anterior lumbar interbody fusion using cages . The data reported were collected from two spine specialty centers participating in a Food and Drug Administration regulated trial . METHODS A consecutive series of 144 patients were r and omized using a 2:1 ratio of Charite versus BAK ( Zimmer Spine , Minneapolis , MN ) . All patients were being treated for single-level discogenic pain confirmed by plain radiography , magnetic resonance imaging and provocative discography . Data were collected at design ated follow-up periods for up to 24 months . RESULTS The mean age was 40.1 years ( range , 21 to 56 years ) . Forty-four cases had BAK anterior interbody fusion , and 100 cases were r and omized to Charite disc replacement . The mean operating time was 76.2 minutes ( range , 54 to 137 minutes ) for the Charite cases . The mean estimated blood loss was 196.2 cc ( range , 50 to 1,800 cc ) . Most patients were discharged in 1 to 2 days with a soft corset and returned to normal activities within 3 weeks if they underwent the disc replacement . The mean Oswestry Disability Index score for the BAK group was 69.6+/-12.8 preoperatively and 27.5+/-26.4 at 24-month follow-up ( p<.001 ) The corresponding mean Oswestry score for the Charite disc patients was 70.9 preoperatively and 30.0 at 24-month follow-up ( p<.001 ) . CONCLUSIONS In this prospect i ve r and omized study , both surgical groups improved significantly . Complications of total disc replacement were similar to those encountered with anterior lumbar interbody fusion . Total disc replacement appears to be a viable alternative to fusion for the treatment of single-level symptomatic disc degeneration unresponsive to nonoperative management The literature reports on the safety and efficacy of titanium cages ( TCs ) with additional posterior fixation for anterior lumbar interbody fusion . However , these papers are limited to prospect i ve cohort studies . The introduction of TCs for spinal fusion has result ed in increased costs , without evidence of superiority over the established practice . There are currently no prospect i ve controlled trials comparing TCs to femoral ring allografts ( FRAs ) for circumferential fusion in the literature . In this prospect i ve , r and omised controlled trial , our objective was to compare the clinical outcome following the use of FRA ( current practice ) to the use of TC in circumferential lumbar spinal fusion . Full ethical committee approval and institutional research and development departmental approval were obtained . Power calculations estimated a total of 80 patients ( 40 in each arm ) would be required to detect clinical ly relevant differences in functional outcome . Eighty-three patients were recruited for the study fulfilling strict entry requirements ( > 6 months chronic discogenic low back pain , failure of conservative treatment , one- or two-level discographically proven discogenic low back pain ) . The patients completed the Oswestry Disability Index ( ODI ) , Visual Analogue Score ( VAS ) for back and leg pain and the Short-Form 36 ( SF-36 ) preoperatively and also postoperatively at 6 , 12 and 24 months , respectively . The results were available for all the 83 patients with a mean follow-up of 28 months ( range 24–75 months ) . Five patients were excluded on the basis of technical infringements ( unable to insert TC in four patients and FRA in one patient due to the narrowing of the disc space ) . From the remaining 78 patients r and omised , 37 received the FRA and 41 received the TC . Posterior stabilisation was achieved with translaminar or pedicle screws . Baseline demographic data ( age , sex , smoking history , number of operated levels and preoperative outcome measures ) showed no statistical difference between groups ( p<0.05 ) other than for the vitality domain of the SF-36 . For patients who received the FRA , mean VAS ( back pain ) improved by 2.0 points ( p<0.01 ) , mean ODI improved by 15 points ( p=<0.01 ) and mean SF-36 scores improved by > 11 points in all domains ( p<0.03 ) except that of general health and emotional role . For patients who received the  TC  , mean VAS improved by 1.1 points ( p=0.004 ) , mean ODI improved by 6 points ( p=0.01 ) and SF-36 improved significantly in only two of the eight domains ( bodily pain and physical function ) . Revision procedures and complications were similar in both groups . In conclusion , this prospect i ve , r and omised controlled clinical trial shows the use of FRA in circumferential lumbar fusion to be associated with superior clinical outcomes when compared to those observed following the use of TCs . The use of TCs for circumferential lumbar spinal fusion is not justified on the basis of inferior clinical outcome and the tenfold increase in cost Abstract Vertebral axial decompression ( VAX-D ) is capable of reducing intradiscal pressure to the negative range . The purpose of this study was to compare the effects of two dosage regimens of VAX-D treatments on the level of low back pain in patients who were referred to a neurosurgical practice after failing st and ard medical therapy .  In this study , one group of patients received an average course of treatment consisting of 18 daily sessions and another group received half that number of daily treatment sessions . The treatment parameters for all patients differed only in the number of sessions . Seventy-six percent of the higher dosage group achieved remission of low back pain compared to 43 % of the lower dosage group . Chi-squared analysis revealed that the differences in response in the two dosage groups were statistically significant at p < 0.0001 Abstract . Total disc replacement has become an option for the treatment of degenerative disc disease of the lumbar spine . A new generation of implants has been developed that can be implanted through minimally invasive anterior approaches to the lumbar levels L2/3 , L3/4 , L4/5 and L5/S1 . However mid- and long-term data are still lacking . This paper describes the minimally invasive surgical approach – techniques as well as the preliminary results of our first 34 consecutive patients . The intervertebral spaces L5/S1 , L4/5 , L3/4 and L2/3 were each approached through slightly different , but st and ardized , mini-laparotomies either through a retroperitoneal or a transperitoneal route . The clinical results with a follow-up of up to 1 year show satisfactory outcomes in about 80 % of the patients . Oswestry score as well as VAS values show significant changes during the postoperative course . There have been three complications ( 8.8 % ) , two of which were specific to the implantation process , but were resolved with a good clinical outcome in both patients . The preliminary results suggest that total disc replacement may become a reasonable alternative to spinal fusion under the selection criteria used in this study An attempt was made to determine the relative contribution of various structures to chronic low back pain , including facet joint(s ) , disc(s ) , and sacroiliac joint(s ) in a prospect i ve evaluation . Precision diagnostic blocks , including disc injections , facet joint blocks , and sacroiliac joint injections , are frequently used . In contrast , selective nerve root blocks or transforaminal epidural injections are used occasionally to evaluate persistent or recurrent low back pain in patients without appropriate radiologic or neurophysiologic diagnosis . One hundred and twenty patients with a chief complaint of low back pain were evaluated with precision diagnostic injections , which included medial branch blocks , provocative discography and sacroiliac joint injections . In 40 % ( 95 % CL , 31 % , 49 % ) , of the patients , facet joint pain was diagnosed ; and in 26 % ( 95 % CL , 18 % , 34 % ) of the patients discogenic pain was diagnosed ; and 2 % of the patients were diagnosed with sacroiliac joint pain Acquired degenerative disc disease causes gradual disc space collapse , concurrent discogenic or facet-induced pain , and possible compression radiculopathy . Surgical treatment aims to re-exp and the intervertebral space and stabilize the involved segment in balanced alignment until fusion is complete . The prevailing methods make use of a twin cage device of predetermined size . Their implantation requires extensive exposure , entailing the sacrifice of posterior stabilizing structures . The procedure also results in significant traction on the dural sac and the cauda equina and is thereby a potential source of neurologic damage . The new exp and able spinal spacer ( ESS ) was design ed to mitigate all the shortcomings alluded to above . A prospect i ve multicenter clinical study was conducted of 87 patients with chronic low back pain due to degenerative disc disease , treated by posterior lumbar interbody fusion ( PLIF ) using a newly design ed ESS . The study protocol was approved by the ethics committees of all the participating institutions . The objective was to test the safety and efficacy of the device . Each participant was followed periodically for > 1 postoperative year . The ongoing record included intraoperative difficulties and complications , if any , radiologic evidence of fusion and clinical outcome as scored by pre- and postoperative question naires pertaining to pain intensity and degree of disability . No dural lacerations or neurologic deficit occurred . There were no mechanical failures of the spacer . Radiologic study demonstrated fusion in all but one patient . Disc space height that averaged 7.53 ± 2.42 mm before surgery increased to 10.03 ± 2.00 mm at the time of surgery and stabilized at 9.47 ± 2.10 mm upon final follow-up . Visual Analog Scale and Oswestry Index decreased by 60 % and 58 % , respectively . PLIF using the ESS achieves the same ultimate outcome as do other methods currently in use but does not share the h and icaps and hazards and is more user-friendly to the surgeon ABSTRACT The discTRODE ™ probe applies radiofrequency ( RF ) current , heating the annulus to treat chronic discogenic low back pain . R and omized controlled studies have not been published . We assessed the long‐term effect and safety aspects of percutaneous intradiscal radiofrequency thermocoagulation ( PIRFT ) with the discTRODE ™ probe in a prospect i ve parallel , r and omized and gender stratified , double‐blind placebo‐controlled study . Twenty selected patients with chronic low back pain and a positive one‐level pressure‐controlled provocation discography were r and omized to either intra‐annular PIRFT or intra‐annular sham treatment . A blinded interim analysis was performed when 20 patients had been followed for six months . The 6‐month analysis did not reveal any trend towards overall effect or difference between active and sham treatment for the primary endpoint : change in pain intensity ( 0–10 ) . The inclusion of patients was therefore discontinued . After 12 months the overall reduction from baseline pain had reached statistical significance , but there was no significant difference between the groups . The functional outcome measures ( Oswestry Disability Index , and SF 36 subscales and the relative change in pain ) appeared more promising , but did not reach statistical significance when compared with sham treatment . Two actively treated and two sham‐treated patients reported increased pain levels , and in both groups a higher number was unemployed after 12 months . The study did not find evidence for a benefit of PIRFT , although it can not rule out a moderate effect . Considering the high number , reporting increased pain in our study , we would not recommend intra‐annular thermal therapy with the discTRODE ™ probe BACKGROUND On the basis of observational data , intradiscal electrothermal anuloplasty ( IDETA ) has been implemented as a treatment for back pain result ing from internal disc disruption . PURPOSE To assess the efficacy of IDETA . STUDY DESIGN Prospect i ve cohort study with comparison group and 2-year follow-up . PATIENT SAMPLE Of 53 patients who satisfied the diagnostic criteria for internal disc disruption , 36 were allocated to a treatment group and 17 to a comparison group , according to whether their insurer approved treatment with IDETA . OUTCOME MEASURES Outcomes were assessed in terms of relief of pain , return to work and use of opioids to treat persisting pain . METHODS The treatment group underwent IDETA . The comparison group underwent a conventional rehabilitation program . Outcomes were assessed at 3 months , 12 months and 2 years after treatment . RESULTS As a group , the comparison patients exhibited no significant improvement in their pain at any time . One was partially relieved , but no patient was completely relieved at either 12 or 24 months . The patients treated with IDETA exhibited significant improvements in their median pain scores , which were sustained at 12 and 24 months . At 24 months , 54 % of these patients had achieved at least 50 % relief of their pain , no longer used opioids and were at work . Seven patients ( 20 % ) were totally free of pain and at work at 24 months . CONCLUSIONS The long-term results of IDETA are stable and enduring . It is not universally successful , but 54 % of patients can reduce their pain by half , and one in five patients can expect to achieve complete relief of their pain In a multicenter , prospect i ve , r and omized , nonblinded , 2-year study , 279 patients with degenerative lumbar disc disease were r and omly divided into two groups that underwent interbody fusion using two tapered threaded fusion cages . The investigational group ( 143 patients ) received rhBMP-2 on an absorbable collagen sponge , and a control group ( 136 patients ) received autogenous iliac crest bone graft . Plain radiographs and computed tomographic scans were used to evaluate fusion at 6 , 12 , and 24 months after surgery . Mean operative time ( 1.6 hours ) and blood loss ( 109.8 mL ) were less in the investigational rhBMP-2 group than in the autograft control group ( 2.0 hours and 153.1 mL ) . At 24 months the investigational group 's fusion rate ( 94.5 % ) remained higher than that of the control group ( 88.7 % ) . New bone formation occurred in all investigational patients . At all intervals , mean postoperative Oswestry , back pain , and leg pain scores and neurologic status improved in both treatment groups with similar outcomes . In the control group , eight adverse events related to the iliac crest graft harvest occurred ( 5.9 % ) , and at 24 months 32 % of patients reported graft site discomfort and 16 % were bothered by its appearance . Lumbar fusion using rhBMP-2 and a tapered titanium fusion cage can yield a solid union and eliminate the need for harvesting iliac crest bone graft Abstract . In this prospect i ve study , a total of 134 prosthetic discs were replaced in 108 patients undergoing total disc replacement surgeries for degenerative disc disease . It was the aim of this study to correlate the clinical findings and the outcome of our patients treated with Prodisc II prostheses  for various indications and to formulate indication criteria for disc replacement surgeries . The discs were implanted at L5/S1 in 61 patients , L5/L6 in 3 patients , L4/L5 in 31 patients , L3/L4 in 7 patients , and L2/L3 in 3 patients . There were 12 patients with two-level implants : from L4 to S1 in 11 of them and from L2 to L5 in the remaining one . Two patients also had three-level implants , from L3 to S1 . Follow-up evaluation included plain radiographs , physical evaluation , and subjective evaluation by the patient using the Oswestry scale , the visual analog pain scale , and the SF-36V2 well-being question naire . The evaluation exercise showed that 90.8 % of patients had excellent results , 7.4 % had good results and 1.8 % had fair results , with no poor results seen . Postoperatively , the average vertebral motion was increased in all patients at the operated level . Progression of disc degeneration at the adjacent levels was noted in ten patients . The average time to resuming activities of daily living unaided was 2.3 weeks . No implant failures or complications due to surgery were encountered in this study . Total prosthesis disc replacement for degenerative disc disease was found to be a good treatment modality , provided proper patient selection and criteria are adhered to . We were able to formulate indication criteria based on this This article was a preliminary report of prospect i ve clinical trial of a group of patients with chronic discogenic low back pain who met the criteria for lumbar interbody fusion surgery but were treated instead with an intradiscal injection of methylene blue ( MB ) for the pain relief . Twenty-four patients with chronic discogenic low back pain underwent diagnostic discography with intradiscal injection of MB . The principal criteria to judge the effectiveness included alleviation of pain , assessed by visual analog scale ( VAS ) , and improvement in disability , as assessed with the Oswestry Disability Index ( ODI ) for functional recovery . The mean follow-up period was 18.2 months ( range 12–23 months ) . Of the 24 patients , 21 ( 87 % ) reported a disappearance or marked alleviation of low back pain , and experienced a definite improvement in physical function . A statistically significant and clinical ly meaningful improvement in the changes in the ODI and the VAS scores were obtained in the patients with chronic discogenic low back pain ( P=0.0001 ) after the treatment . The study suggests that the injection of MB into the painful disc may be a very effective alternative for the surgical treatment of chronic discogenic low back pain CONTEXT Low back pain ( LBP ) has a major economic impact in the United States , with total costs related to this condition exceeding $ 100 billion per year . OBJECTIVE To estimate the cost of st and ard care compared to st and ard care plus osteopathic manipulative treatment ( OMT ) for acute LBP of less than 6 months ' duration . METHODS A retrospective review of electronic medical records from patients who visited Florida Hospital East Orl and o in Orl and o. All patients had LBP of less than 6 months ' duration and had received care between January 1 , 2002 , and December 31 , 2005 . The control group comprised patients who received st and ard care ; the study group consisted of patients who received OMT in addition to st and ard care .  Healthcare utilization ( eg , radiologic scans , prescriptions ) was determined by " episodes of care , " and costs were averaged per patient . RESULTS A total of 1556 patients and 2030 episodes of care met inclusion criteria . Compared with subjects in the control group , individuals in the OMT group had an average of 0.5 more office visits per EOC , result ing in 38 % more office visits . However , OMT patients had 18.5 % fewer prescriptions written , 74.2 % fewer radiographs , 76.9 % fewer referrals , and 90 % fewer magnetic resonance imaging scans . In the OMT group , total average costs were $ 38.26 lower ( P=.02 ) , and average prescription costs were $ 19.53 lower ( P<.001 ) . Patients in the OMT group also had $ 63.81 less average radiologic costs ( P<.0001 ) . CONCLUSION Osteopathic manipulative treatment may reduce costs for the management of acute LBP . Further research in a prospect i ve study is needed Study Design . A prospect i ve , r and omized , controlled clinical trial comparing a cylindrical threaded titanium cage to a femoral ring allograft control for anterior lumbar interbody fusion . Objective . To compare these two implants with regard to arthrodesis . Secondary outcome measures included pain relief , neurological status , and general health status . Summary of Background Data . Anterior lumbar interbody fusion is a well-accepted procedure using trapezoidal femoral ring allografts or cylindrical titanium cages . Clinical and biomechanical studies evaluating these two distinct constructs are numerous ; however , no prospect i ve , r and omized study comparing them has been done . Methods . A multicenter trial of 140 patients : 78 were r and omized to the cylindrical threaded titanium cage device treatment arm and 62 patients r and omized into the control group . All had autogenous iliac crest bone graft  packed into the device . All patients had a single-level st and -alone anterior lumbar interbody fusion at either the L4–L5 or L5–S1 interspace for symptomatic degenerative disc disease . Radiographic fusion data were collected as well as multiple types of outcome data , including pain/disability scores , neurologic status , and overall health . Results . At 12 months , 97 % of the cylindrical threaded titanium cage device group and 40 % of the control group demonstrated radiographic fusion . At 24 months , 97 % of the cylindrical threaded titanium cage group and 52 % of the control group showed radiographic fusion . These fusion rate differences are statistically significant ( P < 0.001 ) . The Oswestry and neurologic scores were not significantly different between groups . Discussion . This is the first prospect i ve , r and omized , multicenter clinical trial that compares fusion cage results to control data . Conclusion . Cylindrical threaded titanium cages have a higher fusion rate , comparable improvements in clinical outcome ( Oswestry , Low Back Pain Question naire , SF-36 ) , and fewer secondary supplemental fixation procedures compared to the femoral ring allograft control Study Design . A prospect i ve nonr and omized clinical trial . Objective . To determine the outcome in a group of patients with chronic , function-limiting low back pain who met the criteria for interbody fusion surgery , but were instead treated with an intradiscal thermal catheter ( SpineCath , Oratec Interventions , Inc. , Menlo Park , CA ) . Summary of Background Data . This study represents the first reported trial of treatment for chronic discogenic low back pain with a novel thermal intradiscal catheter . Methods . The authors evaluated 25 consecutive patients . The minimum duration of nonoperative care with the authors was 6 months . The visual analog pain scores , sitting tolerance times , and SF-36 summary scores were tabulated . Results . The mean follow-up period was 7 months , and the mean duration of symptoms 58.5 months . Of the 25 patients , 20 ( 80 % ) reported a reduction of at least 2 points in visual analog pain scores , and 18 ( 72 % ) reported an improvement in sitting tolerance as well as reduction or discontinuance of analgesic medication . Visual analog pain scores improved by a mean reduction of 3.74 , a 51 % change ( P = 0.0001 ) . On the SF-36 physical function subscale , 72 % of the patients improved by a mean increase of 15 points ( P = 0.001 ) , a mean change of 38 % , and by a mean increase of 14 points on the bodily pain subscale ( P = 0.004 ) , a mean change of 48 % . Conclusions . A statistically significant improvement in functional outcome was obtained in patients with chronic discogenic low back pain treated thermally by the SpineCath Study Design . Prospect i ve , match-cohort study of disc degeneration progression over 10 years with and without baseline discography . Objectives . To compare progression of common degenerative findings between lumbar discs injected 10 years earlier with those same disc levels in matched subjects not exposed to discography . Summary of Background Data . Experimental disc puncture in animal and in vivo studies have demonstrated accelerated disc degeneration . Whether intradiscal diagnostic or treatment procedures used in clinical practice causes any damage to the punctured discs over time is currently unknown . Methods . Seventy-five subjects without serious low back pain illness underwent a protocol MRI and  an L3/4 , L4/5 , and L5/S1 discography examination in 1997 . A matched group was enrolled at the same time and underwent the same protocol MRI examination . Subjects were followed for 10 years . At 7 to 10 years after baseline assessment , eligible discography and controlled subjects underwent another protocol MRI examination . MRI grade rs , blind to group design ation , scored both groups for qualitative findings ( Pfirrmann grade , herniations , endplate changes , and high intensity zone ) . Loss of disc height and loss of disc signal were measured by quantitative methods . Results . Well matched cohorts , including 50 discography subjects and 52 control subjects , were contacted and met eligibility criteria for follow-up evaluation . In all grade d or measured parameters , discs that had been exposed to puncture and injection had greater progression of degenerative findings compared to control ( noninjected ) discs : progression of disc degeneration , 54 discs ( 35 % ) in the discography group compared to 21 ( 14 % ) in the control group ( P = 0.03 ) ; 55 new disc herniations in the discography group compared to 22 in the control group ( P = 0.0003 ) . New disc herniations were disproportionately found on the side of the anular puncture ( P = 0.0006 ) . The quantitative measures of disc height and disc signal also showed significantly greater loss of disc height ( P = 0.05 ) and signal intensity ( P = 0.001 ) in the discography disc compared to the control disc . Conclusion . Modern discography techniques using small gauge needle and limited pressurization result ed in accelerated disc degeneration , disc herniation , loss of disc height and signal and the development of reactive endplate changes compared to match-controls . Careful consideration of risk and benefit should be used in recommending procedures involving disc injection OBJECTIVE Two minimally invasive techniques have been used more recently as a possible treatment for  painful internal disk disruption ( IDD ) .  Intradiscal thermal annuloplasty ( IDTA ) , known as IDET , has already shown promising results in pain reduction and functional restoration . The second technique , radiofrequency posterior annuloplasty ( RFA ) , is used in many interventional pain practice s , although studies on the technique 's efficacy are lacking . This study compares the effectiveness of those two methods . DESIGN AND PATIENTS We matched 42 patients ( 21 had IDTA and 21 radiofrequency annuloplasty ) for age , sex , weight , smoking history , manual labor , and number of intervertebral disks treated . Enrolled patients completed pain disability index ( PDI ) question naires before receiving either IDTA or RFA ; at 2 weeks ; and 2 , 3 , 6 , 9 , and 12 months following either treatment . RESULTS From the third to the twelfth month after the procedure , the IDTA group had significantly lower mean pain scores than the RFA group . Visual analog scale ( VAS ) pain scores decreased from 6.6 + /- 2.0 before to 4.4 + /- 2.4 at 1 year after radiofrequency annuloplasty ( P = 0.001 ) , while in the IDTA group the average VAS pain score decreased from 7.4 + /- 1.9 before IDTA to 1.4 + /- 1.9 at 1 year follow-up . Similarly , PDI scores in the IDTA group had a significantly larger improvement than those for patients who received radiofrequency annuloplasty . CONCLUSIONS This study shows significant improvement in pain scores and patients ' PDI following IDTA but not after RFA of the intervertebral disks . IDTA appears to be more efficacious than RFA based on PDI and VAS scores measured at 1 year following procedure Study Design Single-arm , prospect i ve clinical trial . Objective To evaluate back pain severity , physical function , and quality of life outcomes in highly selected patients with lumbar discogenic pain treated with intradiscal electrothermal therapy ( IDET ) .  Summary of Background Data Degeneration and disruption of the intervertebral disc can be the source of severe low back pain and the associated physical dysfunction . IDET is a minimally invasive treatment option in the continuum of care between conservative nonoperative management and spinal surgery . Methods Using magnetic resonance imaging , pressure-controlled discography , and postdiscogram computed tomography findings , 56 patients with lumbar discogenic pain were identified , underwent IDET treatment and followed for 20.5±4.4 months , on average . Outcomes included assessment s of back pain severity by visual analog scale , sitting , st and ing , and walking tolerances , and health-related quality of life using the SF-36 . Results Mean pain severity scores ( visual analog scale ) improved from 6.1±1.8 pretreatment to 2.4±2.6 at final follow-up ( P=0.0001 ) . Mean tolerance times ( minutes ) improved from 40.9±40.6 to 84.5±54.4 , 46.8±42.9 to 84.4±54.2 , and 39.2±39.6 to 77.9±50.8 between baseline and final follow-up for sitting , st and ing , and walking , respectively ( P=0.0001 for all comparisons ) . Seven of 8 quality of life domains showed significant ( P=0.0001 for all comparisons ) improvement over baseline . Forty-two patients ( 75 % ) were classified as a treatment success by virtue of a ≥2-point improvement in pain severity or a ≥10-point improvement in either the physical functioning or bodily pain domain of the SF-36 . Conclusions The findings of this study suggest that durable clinical improvements can be realized after IDET in highly selected patients with mild disc degeneration , confirmatory imaging evidence of annular disruption , and concordant pain provocation by low pressure discography Study Design . Fifty-two patients with degenerative disc disease underwent  single- or double-level anterior lumbar interbody fusion with SynCage and additional posterior fixation  as treatment for degenerative disc disease and were prospect ively followed for 4 years . Objectives . To test the clinical performance of anterior lumbar interbody fusion with SynCage , with emphasis on the safety and efficacy of the surgical procedure and the ability to restore anatomy and fuse the motion segment . Summary of Background Data . Anterior lumbar interbody fusion using femoral allograft and /or autologous bone has a high complication rate . With cage technology , some of these complications can be avoided . The design characteristics of the SynCage offer advantages in restoring and maintaining intervertebral height and restoration of lumbar lordosis . Methods . Thirty-three patients underwent single-level and 19 patients double-level anterior lumbar interbody fusion with SynCage and additional posterior fixation ( translaminar screws , n = 32 or pedicle screws , n = 10 ) . Radiologic and functional results ( VAS and Oswestry score ) were evaluated . Results . Intervertebral height was corrected from an average of 8.7 to 17.6 mm . Lordosis of the fused segment was significantly increased ( average 10.6 ° for the fused segment and 8 ° for lumbosacral lordosis ) . After 2 years , there was radiologic evidence for fusion in 70 of 71 ( 98.6 % ) levels . Functional scores showed a significant improvement in pain and function up to the 2-year follow-up observation . At the 4-year follow-up observation , there was some loss of the initial improvement in VAS and Oswestry scores . Despite this loss , they remained significantly better than the preoperative scores . Conclusions . Anterior lumbar interbody fusion with SynCage and additional posterior fixation is a safe and effective procedure . Intervertebral height is corrected , and lumbosacral lordosis is restored . An initial improvement in VAS and Oswestry scores is partly lost at the 4-year follow-up observation , but 4-year results are still significantly better than the preoperative scores Abstract . The goal of this study was to evaluate the short-term effects of intradiscal electrothermal treatment ( IDET ) for chronic discogenic low back pain . Twenty consecutive patients with symptomatic degenerative discs were treated with IDET and evaluated preoperatively , and 3 and 6 months postoperatively . Pain was measured with a 100-mm visual analog scale ( VAS ) and function was evaluated with the Oswestry score and SF-36 question naire . The VAS scores improved by 14 mm on average ( P=0.046 ) , but the individual scores show great variation . The Oswestry scores did not improve significantly . The SF-36 showed improvement , but only for the subscales vitality ( P=0.023 ) and bodily pain ( P=0.047 ) . Based on these results , we conclude that IDET is not effective in reducing pain and improving functional performance in a sample of 20 patients treated for chronic discogenic low back pain after 6 months follow-up Objective The objective of this study was to determine the efficacy of percutaneous radiofrequency ( RF ) thermocoagulation of the ramus communicans nerve in patients suffering from chronic discogenic low back pain . Methods Forty-nine patients who suffered chronic discogenic low back pain at only 1 painful vertebral level , and whose pain continued after undergoing intradiscal electrothermal annuloplasty ( IDET )  , were r and omly assigned to 1 of 2 treatment groups . The lesion group ( n = 26 ) received RF thermocoagulation of the ramus communicans nerve . Patients in the control group ( n = 23 ) received an injection of lidocaine without radiofrequency .  Visual analog scale ( VAS ) pain scores , analgesic requirements , SF-36 subscales , and the overall patient satisfaction with the procedure were tabulated . Results The average follow-up period was 4 months . The patient-reported VAS pain scores were significantly lower ( P < 0.05 ) in the lesion group . The scores of the RF lesion group improved by a mean increase of 11.3 points ( P < 0.05 ) on the SF-36 bodily pain subscale , and by a mean increase of 12.4 points on the physical function subscale ( P < 0.05 ) . In a follow-up analysis within the RF lesion group , VAS pain scores improved by a mean reduction of 3.32 ( P = 0.001 ) . The scores improved by a mean increase of 14.5 points ( P = 0.005 ) on the SF-36 bodily pain subscale and 15.2 points(P = 0.002 ) on the physical function subscale within the RF lesion group . One patient in the lesion group complained of mild lower limb weakness , but he completely recovered at postoperative 15 days without any serious problems . Discussion In patients with chronic discogenic low back pain , percutaneous RF denervation of the ramus communicans nerve should be considered as a treatment option BACKGROUND CONTEXT In a large series of human patients undergoing open anterior lumbar interbody fusion with a tapered titanium fusion cage , recombinant human bone morphogenetic protein type 2 ( rhBMP-2 ) on an absorbable collagen sponge carrier has been shown to decrease operative time and blood loss , to promote osteoinduction and fusion and to be a safe and effective substitute for iliac crest harvesting . PURPOSE The purpose of the study was to determine the clinical and radiographic outcomes in patients treated for single-level degenerative lumbar disc disease with a posterior interbody fusion , using st and -alone cylindrical threaded titanium fusion cages with either autogenous bone graft or rhBMP-2 and an absorbable collagen sponge carrier . STUDY DESIGN / SETTING A prospect i ve , r and omized , nonblinded , 2-year pilot study at 14 investigational sites . PATIENT SAMPLE Between March 1999 and December 1999 , 67 patients with symptomatic , single-level degenerative lumbar disc disease of at least 6 months ' duration underwent a single-level posterior lumbar interbody fusion using two paired cylindrical threaded titanium fusion devices . Patients were r and omly assigned to one of two groups : one ( n=34 patients ) received rhBMP-2 on a collagen sponge carrier ; the other ( n=33 patients ) autogenous iliac crest bone graft . OUTCOME MEASURES Clinical outcomes were measured using low back and leg pain numerical rating scales , the Short Form (SF)-36 , Oswestry Low Back Pain Disability Question naire and work status . Plain radiographs and computed tomographic scans were used to evaluate fusion at 6 , 12 and 24 months after surgery . METHODS In this prospect i ve nonblinded study , 67 patients were r and omly assigned to one of two groups who underwent interbody fusion using two cylindrical threaded fusion cages : the investigational group ( 34 patients ) , who received rhBMP-2 on an absorbable collagen sponge , and a control group ( 33 patients ) , who received autogenous iliac crest bone graft . Clinical data were collected and analyzed by a commercial entity . RESULTS The mean operative time and blood loss for the investigational rhBMP-2 group was 2.6 hours and 322.8 ml , respectively . For the autograft control group , these values were 3.0 hours and 372.7 ml . The differences were not significant . Although not statistically different , at 24 months , the investigational group 's fusion rate of 92.3 % was higher than the control 's at 77.8 % . At all postoperative intervals , the mean Oswestry , back and leg pain scores and physical components of the SF-36 improved in both treatment groups compared with preoperative scores , but no significant differences were found between groups . A statistically significant difference in the change in back pain was found at 24 months for the investigational group . In the control group , two adverse events related to harvesting of the iliac crest graft occurred in two patients ( 6.1 % ) . CONCLUSIONS This small multicenter , r and omized , nonblinded trial showed few statistically significant differences between the study groups . Both groups showed comparable improvements on outcome scores . Overall results show that the use of rhBMP-2 can eliminate the need for harvesting iliac crest graft and may be an equivalent replacement for autograft for use in successful posterior lumbar interbody fusions . Further studies of the use of rhBMP-2 in posterior lumbar interbody fusion cage procedures are needed 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 Study Design . A prospect i ve , nonr and omized multicenter study of lumbar disc nucleus replacement using the DASCOR Disc Arthroplasty Device . An interim analysis of clinical results is presented , obtained from European patients enrolled in 2 studies . Objective . To determine the safety and efficacy of the DASCOR Device for the treatment of symptomatic single-level degenerative disc disease ( DDD ) . Summary of Background Data . Patients suffering from DDD have been limited to a choice between nonoperative therapies or invasive surgical treatments such as total disc replacement or spinal fusion . The DASCOR Device was developed to provide an alternative treatment with a less invasive surgical intervention . Methods . A total of 85 patients from 11 European centers were enrolled in 1 of 2 studies between February 2003 and July 31 , 2007 . Data were collected before surgery and after surgery at 6 weeks and at 3 , 6 , 12 , and 24 months . The clinical outcome measures were obtained from the Visual Analog Scale ( VAS ) for back pain , the Oswestry Disability Index ( ODI ) , radiographic assessment s , and records of analgesic medication use . Results . Mean VAS and ODI scores improved significantly after 6 weeks and throughout the 2 years . Radiographic results demonstrated , at a minimum , maintenance of disc height with no device expulsion and , despite Modic-Type 1 changes , no subsidence .  Fourteen patients had serious adverse events including device explants in 7 patients ( 7 of 85 ) , in which the main complication was resumed back pain after time . Patients ’ rate of analgesic medication decreased dramatically over time , with all patients experiencing significant improvements after 3 months and nearly no analgesic medication or narcotic drug use at 2 years . Conclusion . The interim outcomes showed significant improvements in mean ODI and VAS scores . The results of these European studies suggest that the DASCOR Device may be a safe and effective less-invasive surgical option for patients with DDD BACKGROUND This study 's goal was a retrospective chart audit of 100 out patients with discogenic low back pain ( LBP ) lasting more than 12 weeks treated with a 2-month course of motorized spinal decompression via the DRX9000 ( Axiom Worldwide , Tampa , FL , U.S.A. ) . METHODS Patients at a convenience sample of four clinics received 30-minute DRX9000 sessions daily for the first 2 weeks tapering to 1 session/week . Treatment protocol included lumbar stretching , myofascial release , or heat prior to treatment , with ice and /or muscle stimulation afterwards . Primary outcome was verbal numerical pain intensity rating ( NRS ) 0 to 10 before and after the 8-week treatment . RESULTS Of the 100 initial subjects , three withdrew their protected health information , and three were excluded because their LBP duration was less than 12 weeks . The remaining 94 subjects ( 63 % female , 95 % white , age = 55 ( SD 16 ) year , 52 % employed , 41 % retired , LBP median duration of 260 weeks ) had diagnoses of herniated disc ( 73 % of patients ) , degenerative disc disease ( 68 % ) , or both ( 27 % ) . Mean NRS equaled 6.05 ( SD 2.3 ) at presentation and decreased significantly to 0.89 ( SD 1.15 ) at end of 8-week treatment ( P < 0.0001 ) . Analgesic use also appeared to decrease ( charts with data = 20 ) and Activities of Daily Living improved ( charts with data = 38 ) . Follow-up ( mean 31 weeks ) on 29/94 patients reported mean 83 % LBP improvement , NRS of 1.7 ( SD 1.15 ) , and satisfaction of 8.55/10 ( median 9 ) . CONCLUSIONS This retrospective chart audit provides preliminary data that chronic LBP may improve with DRX9000 spinal decompression . R and omized double-blind trials are needed to measure the efficacy of such systems BACKGROUND Intradiscal electrothermal therapy ( IDET ) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested . PURPOSE To compare the efficacy of IDET with that of a placebo treatment . STUDY DESIGN / SETTING R and omized , placebo-controlled , prospect i ve trial . PATIENT SAMPLE Patients were recruited by referral and the media . No inducements were provided to any patient in order to have them participate . Of 1,360 individuals who were prepared to su bmi t to r and omization , 260 were found potentially eligible after clinical examination and 64 became eligible after discography . All had discogenic low back pain lasting longer than 6 months , with no comorbidity . Thirty-seven were allocated to IDET and 27 to sham treatment . Both groups were satisfactorily matched for demographic and clinical features . METHODS IDET was performed using a st and ard protocol , in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure . Thirty-two ( 85 % ) of the patients r and omized to the  IDET  group and 24 ( 89 % ) of those assigned to the sham group complied fully with the protocol of the study , and complete follow-up data are available for all of these patients . OUTCOME MEASURES The principal outcome measures were pain and disability , assessed using a visual analog scale for pain , the Short Form (SF)-36 , and the Oswestry disability scale . RESULTS Patients in both groups exhibited improvements , but mean improvements in pain , disability and depression were significantly greater in the group treated with IDET . More patients deteriorated when subjected to sham treatment , whereas a greater proportion showed improvements in pain when treated with IDET . The number needed to treat , to achieve 75 % relief of pain , was five . Whereas approximately 40 % of the patients achieved greater than 50 % relief of their pain , approximately 50 % of the patients experienced no appreciable benefit . CONCLUSIONS Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET , but its efficacy can not be attributed wholly to a placebo effect . The results of this trial can not be generalized to patients who do not fit the strict inclusion criteria of this study , but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain Study Design . Case-control study . Objectives . To determine the prima facie efficacy of intradiscal electrothermal anuloplasty ( IDTA ) . Summary of Background Data . Although it is being used increasingly as a putative treatment for internal disc disruption , no studies have been published on the efficacy of IDTA . Methods . Fifty-three patients with back pain determined by computed tomographic (CT)-discography to be due to internal disc disruption were offered treatment . The outcomes of 35 patients treated with IDTA were compared with those of a convenience sample of 17 patients treated with a physical rehabilitation program , by using a visual analog pain scale , use of analgesics , and return to work as measures . Results . At 3 months , only one control patient obtained any significant degree of relief of pain , compared with 23 in the index group . Relief of pain was sustained at 6 and 12 months and was associated with improvement in disability , reduced drug use , and a return to work rate of 53 % . Depending on the stringency of criteria used , the success rate of IDTA may be as low as 23 % or as high as 60 % with confidence intervals of ±16 % . Conclusions . In carefully selected cases , IDTA can eliminate or dramatically reduce the pain of internal disc disruption in a substantial proportion of patients and appears to be superior to conventional conservative care for internal disc disruption BACKGROUND Intervertebral discs , facet joints , ligaments , fascia , muscles , and nerve root dura have been described as tissues capable of transmitting pain in the low back . The pathophysiology of spinal radicular pain is the subject of ongoing research and controversy with discogenic pain assuming a major role as a cause of non-specific low back pain . Even though epidural injections are frequently administered in managing axial low back pain , the evidence is lacking . STUDY DESIGN A r and omized , double-blind , equivalence trial . SETTING An interventional pain management practice , a specialty referral center , a private practice setting in the United States . OBJECTIVES To evaluate the effectiveness of caudal epidural injections with or without steroids in managing chronic low back pain without disc herniation or radiculitis in providing effective and long-lasting pain relief and to evaluate the differences between local anesthetic with or without steroids . METHODS Patients were r and omly assigned to one of 2 groups , Group I patients received caudal epidural injections with local anesthetic ( lidocaine 0.5 % ) , whereas Group II patients received caudal epidural injections with 0.5 % lidocaine 9 mL mixed with 1 mL of steroid . R and omization was performed by computer-generated r and om allocation sequence by simple r and omization . OUTCOMES ASSESSMENT Multiple outcome measures were utilized which included the Numeric Rating Scale ( NRS ) , the Oswestry Disability Index 2.0 ( ODI ) , employment status , and opioid intake with assessment at 3 months , 6 months , and 12 months post-treatment . Significant pain relief was defined as 50 % or more , whereas significant improvement in disability score was defined as reduction of 40 % or more . RESULTS Significant pain relief ( > or = 50 % ) was demonstrated in 72 % to 81 % of patients and functional status improvement was demonstrated by a reduction of 40 % in the ODI scores in 81 % of the patients . The overall average procedures per year were 3.6 + /- 1.05 in Group I and 3.9 + /- 1.33 in Group II with an average total relief per year of 32.3 + /- 16.93 weeks in Group I and 30.7 + /- 17.94 weeks in Group II over a period of 52 weeks . LIMITATIONS The results of this study are limited by lack of a placebo group and a preliminary report of 36 patients in each group . CONCLUSION Caudal epidural injections with or without steroids may be effective in patients with chronic function-limiting low back pain without facet joint pain , disc herniation , and /or radiculitis in over 70 % of the patients A lumbar total disc replacement ( TDR ) is believed to be a promising substitute in the surgical treatment for lumbar degenerative disc disease . The purpose of this study is to report the clinical and radiographic outcomes of 36 consecutive patients who underwent lumbar TDR using ProDisc II  , and the factors associated with a better clinical outcome after a 2-year minimum follow-up . At the time of the latest follow-up , the success rate was 94 % of 36 patients according to the criteria of the US Food and Drug Administration . Of the 10 patients unable to work preoperatively , 7 patients returned to work . Moreover , mean score on the visual analog scale for low back and leg pain improved significantly from 7.5 and 4.7 to 3.0 and 1.2 , respectively ( P<0.001 ) . In addition , mean Oswestry disability index scores improved significantly from 69.2 to 21.0 ( P<0.001 ) . Mean disc height at the operative level increased significantly from 9.0 to 17.6 mm , and mean range of motion increased significantly from 9.7 to 12.7 degrees ( P<0.01 ) . Statistical analysis showed that the factors associated with a better clinical outcome were single level , and a higher postoperative segmental ROM at the operative level . At a minimum follow-up of 2 years , the lumbar TDR using ProDisc II showed excellent clinical and radiographic outcomes without any significant complication . However , future efforts need to be directed toward the evaluation of a larger number of patients with longer follow-up BACKGROUND No conclusive evidence exists to determine that spinal steroid injections give lasting improvement in patients with predominantly axial low back pain result ing from lumbar degenerative disc disease ( DDD ) . PURPOSE The objectives of the study were to determine the effect of epidural steroid injections ( ESIs ) and intradiscal steroid injections ( ISIs ) in patients who exhibit DDD symptoms for more than 1 year and to determine whether patients with inflammatory end-plate changes are a unique subgroup of DDD patients in terms of treatment response . STUDY DESIGN Pain and function in patients with DDD were prospect ively assessed by an outcomes question naire before and after various spinal injections . Further correlation was made with end-plate inflammatory ( Modic Type 1 ) changes identified on magnetic resonance imaging ( MRI ) . PATIENT SAMPLE ESI  was performed in 232 patients who were referred for treatment of DDD , and discography with or without intradiscal steroid was performed in 171 patients who were possible spinal arthrodesis c and i date s. OUTCOME MEASURES Pain and function were determined by a self-administered outcomes question naire that consisted of a visual analog pain scale , pain drawing , Oswestry Disability Index , use of pain medication and opinion of treatment success . METHODS ESI was performed in 93 patients with DDD and inflammatory end-plate changes and in 139 patients without inflammatory end-plate changes . Patients with inflammatory end-plate changes ( n=78 ) or without inflammatory end-plate changes ( n=93 ) , all of whom were considered fusion c and i date s , underwent discography with or without intradiscal steroid in a r and omized fashion . Pain and function were prospect ively determined by a self-administered outcomes survey ( VAS pain , Oswestry Disability index [ ODI ] , pain diagram [ PD ] and opinion of success ) before and after the patients ' injection for a 2-year follow-up period . MRI and discography results were correlated with patient outcomes scores . RESULTS ESI was effective in improving pain and function , as assessed by outcomes scores at short-term follow-up . However , at 2 years , less than one-third had not had additional invasive treatment . Patients with inflammatory end-plate changes had greater improvement in ODI and PD scores in the first 6 months than did those patients without the end-plate changes . Intradiscal steroid injections into discs with concordant pain at the time of discography led to significant improvement in patients with inflammatory end-plate changes in all outcomes scales , but only minimal temporary improvement in patients without the end-plate changes . Disc pressure manometry at the time of discography found that discs with adjacent inflammatory end-plate changes reproduced symptoms at pressures significantly lower than those in other types of discs . CONCLUSIONS Spinal steroid injections , both ESI and ISI , are beneficial for a small number of patients with advanced DDD and chronic low back pain . For those patients in whom a beneficial effect is found , spinal steroid injection is a low-risk and rapid treatment option . Spinal steroid injections are more effective in patients with MRI findings of discogenic inflammation , specifically adjacent inflammatory end-plate changes Study Design . R and omized , controlled study . Objective . To evaluate the diagnosis of discogenic low back pain ( LBP ) with discography and discoblock . Summary of Background Data . Discogenic LBP is usually diagnosed by magnetic resonance imaging and discography . However , the reliability of discography is controversial . Previously , we reported the usefulness of discoblock with bupivacaine for diagnosis , and discoblock improved the results of anterior interbody fusion surgery . However , that study was not a r and omized , controlled study . Therefore , the purpose of the current study was to compare the results of surgery after diagnosis of LBP by discography and discoblock . Methods . Patients ( n = 42 ) with severe LBP showing L4–L5 or L5–S1 disc degeneration on magnetic resonance imaging were evaluated by discography ( 1.5 mL of contrast medium ) or discoblock ( intradisc injection of 0.75 mL of 0.5 % bupivacaine ) . We r and omized the patients in turn . Anterior discectomy and interbody fusion were performed in patients who responded to the diagnostic procedures . The visual analogue scale score ( 0 , no pain ; 100 , worst pain ) , Japanese Orthopedic Association Score ( 0 , worst pain ; 3 , no pain ) , Oswestry Disability Index , and patient satisfaction before and 3 years after surgery were recorded and compared between groups . Results . Twelve patients did not show pain provocation by discography or pain relief by discoblock and were excluded . Fifteen patients who showed pain provocation by  discography and 15 patients who experienced pain relief with discoblock were evaluated . Rates of improvement in the visual analogue scale score , Japanese Orthopedic Association Score , and Oswestry Disability Index score in the discoblock group were significantly higher than those in the discography group ( P < 0.05 ) from baseline to 3 years after surgery . Three patients were dissatisfied with surgery after discography compared with one patient after discoblock . Conclusion . Pain relief after injection of a small amount of bupivacaine into the painful disc was a useful tool for the diagnosis of discogenic LBP compared with discography OBJECT The authors conducted a prospect i ve longitudinal study to obtain outcome ( minimum follow-up period 2 years ) regarding the safety and efficacy of single-level lumbar disc ( ProDisc prosthesis ) replacement in patients 60 years of age or older . METHODS This prospect i ve analysis involved 22 patients treated in whom the lumbar ProDisc prosthesis was used for total disc arthroplasty .  All patients presented with disabling discogenic low-back pain ( LBP ) with or without radicular pain . The involved segments ranged from L-2 to S-1 . Patients in whom there was no evidence of radiographic circumferential spinal stenosis and with minimal or no facet joint degeneration were included . Patients were assessed preoperatively and outcome was evaluated postoperatively at 3 , 6 , 12 , and 24 months by administration of st and ardized tests ( the visual analog scale [ VAS ] , Oswestry Disability Index [ ODI ] , and patient satisfaction ) . Secondary parameters included analysis of pre- and postoperative radiographic results of disc height at the affected level , adjacent-level disc height and motion , and complications . Twenty-two ( 100 % ) fulfilled all follow-up criteria . The median age of all patients was 63 years ( range 61 - 71 years ) . There were 17 single-level cases , four two-level cases , and one three-level case . Statistical improvements in VAS , ODI , and patient satisfaction scores were observed at 3 months postoperatively . These improvements were maintained at 24-month follow-up examination . Patient satisfaction rates were 94 % at 24 months ( compared with 95 % reported in a previously reported ProDisc study ) . Radicular pain also decreased significantly . Patients in whom bone mineral density was decreased underwent same-session vertebroplasty following implantation of the ProDisc device(s ) . There were two cases involving neurological deterioration : unilateral foot drop and loss of proprioception and vibration in one patient and unilateral foot drop in another patient . Both deficits occurred in patients in whom there was evidence preoperatively of circumferential spinal stenosis . There were two cases of implant subsidence and no thromboembolic phenomena . CONCLUSIONS Significant improvements in patient satisfaction and ODI scores were observed by 3 months postoperatively and these improvements were maintained at the 2-year follow-up examination . Although the authors ' early results indicate that the use of ProDisc lumbar total disc arthroplasty in patients older than 60 years of age reduces chronic LBP and improves clinical functional outcomes , they recommend the judicious use of artificial disc replacement in this age group . Until further findings are reported , the authors cautiously recommend the use of artificial disc replacement in the treatment of chronic discogenic LBP in patients older than age 60 years in whom bone quality is adequate in the absence of circumferential spinal stenosis BACKGROUND Intradiscal radiofrequency , with the electrode placed in the center of the nucleus pulposus , has been a controversial procedure in patients with discogenic pain . Possibly the effect has not been due to the production of heat , but to exposure to electric fields . DESIGN We have investigated the effect of high-voltage , long- duration intradiscal pulsed radiofrequency in patients with one-level discogenic low back pain , as confirmed by discography . OUTCOME MEASURE The pain intensity score on a 0 - 10 numeric rating scale ( NRS ) was taken as outcome measure . PATIENTS Eight patients were reported . The  mean duration of pain was 6.3 years ( range 0.5 - 16 , median 4 ) . The mean NRS score was 7.75 ( range 5 - 9 ) . Disc height was reduced 60 % in one patient and up to 30 % in the others . INTERVENTION A 15-cm , 20-gauge needle with a 15-mm active tip was placed central ly in the disc . Pulsed radiofrequency was applied for 20 min at a setting of 2 x 20 ms/s and 60 V. RESULTS There was a very significant fall in the NRS scores over the first 3 months ( P < 0.0001 ) . On an individual basis , all patients had a fall of the NRS score of at least 4 points at the 3-month follow-up . A follow-up of 12.8 months ( range 6 - 25 , median 9 ) was available for five patients . All these patients are now pain free , except for one patient with an NRS score of 2 . Conclusion . It is concluded that this method merits a controlled , prospect i ve study Study Design . A prospect i ve r and omized trial . Objective . To evaluate the efficacy of percutaneous intradiscal radiofrequency thermocoagulation by modifying the duration of heating , using two different time methods , for relieving pain and improving functional disability . Summary of Background Data . Lumbar discogenic pain is the major problem in lumbar degenerative disc disease that percutaneous intradiscal radiofrequency thermocoagulation has been suggested for as a nonsurgical invasive treatment technique for lumbar discogenic pain . In a previous controlled study , this method was found to be ineffective with 8 weeks of follow-up . Material s and Methods . Sixty patients with chronic low back pain were selected for provocative discography to diagnose the discogenic pain and to locate the discs to be treated . From this group , 39 patients were r and omly selected and divided into two groups . In the first group , treatment was performed for 120 seconds , and in the second group for 360 seconds , both at 80C . Patients were assessed with a visual analogue scale for pain relief and functional improvement . Evaluations were performed before , immediately after treatment , at 1 and 2 weeks , and at 1 , 3 , and 6 months after the procedure . Results . A total of 39 patients with positive provocative discographies were found to eligible for the study . There were no statistical differences in pain relief and functional improvement between two groups ( P > 0.05 ) . The immediate , 1-week and 2-week , and 1-month visual analogue scale ( VAS ) scores were decreased significantly in both groups when comparing them with the pretreatment scores ( P < 0.05 ) . However , the final values after 6 months were similar to those measured at the beginning of the study ( P > 0.05 ) . Conclusion . Percutaneous intradiscal radiofrequency thermocoagulation has been suggested and performed to relieve discogenic pain . In the previous controlled study , no effective pain relief has been obtained . In this study , the authors increased the duration of radiofrequency thermocoagulation to improve the effectiveness of this method . Yet , the authors have not found any significant differences between the application of lesioning at two different times in percutaneous intradiscal radiofrequency thermocoagulation The clinical benefits and complications of posterior lumbar interbody fusion ( PLIF ) have been studied over the past 60 years . In recent years , spine surgeons have had the option of treating low back pain caused by degenerative disc disease using PLIF with machined allograft spacers and posterior pedicle fixation . The purpose of this clinical series was to assess the clinical benefits of using a machined PLIF allograft spacer and posterior pedicle fixation to treat degenerative disc disease , both in terms of fusion rates and patient outcomes , and to compare these results with those in previous studies using autograft and metal interbody fusion devices . Results were also compared with results from studies using transverse process fusion . This prospect i ve , nonr and omized clinical series was conducted at 10 US medical centers . Eighty-nine ( 55 male , 34 female ) patients underwent PLIF with a presized , machined allograft spacer and posterior pedicle fixation between January 2000 and April 2003 . Their outcomes were compared with outcomes in previous series described in the literature . All patients had experienced at least 6 months of low back pain that had been unresponsive to nonsurgical treatment . Physical examinations were performed before surgery , after surgery , and at 4 follow-up visits ( 6 weeks , 6 months , 12 months , 24 months ) . At each interval , we obtained radiographs and patient outcome measures , including SF-36 Bodily Pain Score , visual analog scale pain rating , and Oswestry Disability Index . The primary outcome was fusion results at 12 and 24 months ; the secondary outcomes were pain , disability , function/ quality of life , and satisfaction . One-level PLIFs were performed in 65 patients , and 2-level PLIFs in 24 patients . Flexion-extension radiographs at 12 and 24 months revealed a 98 % fusion rate . Of the 72 patients who reached the 12-month follow-up , 86 % reported decreased pain and disability as measured with the Oswestry Disability Index . Decreased pain as measured with the SF-36 Bodily Pain Score was reported by 74 % of patients who reached the 12-month follow-up . The graft-related complication rate among all patients who underwent PLIF was 1.61 % . When performed with machined allograft spacers and posterior pedicle fixation , PLIF is a safe and effective surgical treatment for low back pain caused by degenerative disc disease . The patients in this clinical series had outcomes equal or superior to the outcomes in previous series Study Design . A prospect i ve , r and omized , double-blind , placebo-controlled trial of intradiscal electrothermal therapy ( IDET ) for the treatment of chronic discogenic low back pain ( CDLBP ) . Objectives . To test the safety and efficacy of IDET compared with a sham treatment ( placebo ) . Summary of Background Data . In North America alone , more than 40,000 intradiscal catheters have been used to treat CDLBP . The evidence for efficacy of IDET is weak coming from retrospective and prospect i ve cohort studies providing only Class II and Class III evidence . There is one study published with Class I evidence . This demonstrates statistically significant improvements following IDET ; however , the clinical significance of these improvements is question able . Methods . Patients with CDLBP who failed to improve following conservative therapy were considered for this study . Inclusion criteria included the presence of one- or two-level symptomatic disc degeneration with posterior or posterolateral anular tears as determined by provocative computed tomography ( CT ) discography . Patients were excluded if there was greater than 50 % loss of disc height or previous spinal surgery . Fifty-seven patients were r and omized with a 2:1 ratio : 38 to IDET and 19 to sham procedure ( placebo ) . In all cases , the IDET catheter was positioned to cover at least 75 % of the annular tear as defined by the CT discography . An independent technician connected the catheter to the generator and then either delivered electrothermal energy ( active group ) or did not ( sham group ) . Surgeon , patient , and independent outcome assessor were all blinded to the treatment . All patients followed a st and ard postprocedural rehabilitation program . Independent statistical analysis was performed . Outcome Measures . Low Back Outcome Score ( LBOS ) , Oswestry Disability Index ( ODI ) , Short Form 36 question naire ( SF-36 ) , Zung Depression Index ( ZDI ) , and Modified Somatic Perceptions Question naire ( MSPQ ) were measured at baseline and 6 months . Successful outcome was defined as : no neurologic deficit , improvement in LBOS of greater then 7 points , and improvement in SF-36 subsets ( physical function and bodily pain ) of greater than 1 st and ard deviation . Results . Baseline demographic data , initial LBOS , ODI , SF-36 , ZDI , and MSPQ were similar for both groups . No neurologic deficits occurred . No subject in either arm showed improvement of greater than 7 points in LBOS or greater than 1 st and ard deviation in the specified domains of the SF-36 . Mean ODI was 41.42 at baseline and 39.77 at 6 months for the IDET group , compared with 40.74 at baseline and 41.58 at 6 months for the placebo group . There was no significant change in ZDI or MSPQ scores for either group . Conclusions . The IDET procedure appeared safe with no permanent complications . No subject in either arm met criteria for successful outcome . Further detailed analyses showed no significant change in outcome measures in either group at 6 months . This study demonstrates no significant benefit from IDET over placebo Anterior discectomy and fusion to treat cervical degenerative disc disease is the preferred procedure for many spine surgeons . The ideal device for structural reconstruction of the anterior cervical spine remains controversial . The purpose of this prospect i ve study was to investigate the effectiveness of a non-threaded titanium cage in performing anterior spinal fusion for cervical degenerative disc disease . The clinical and radiologic data of 78 consecutive patients were review ed . Neurologic outcome was assessed using Odom 's criteria . Neck pain was grade d using a 10-point visual analog scale . The cervical spinal curvature , the height of foramina , and fusion status were evaluated on preoperative and postoperative radiographs . Mean follow-up was 24.9 ( range 18 - 35 ) months . An excellent or good result was found in 92 % of the patients with radiculopathy , 69 % of those with myelopathy , and 73 % of those with myeloradiculopathy . Statistical analyses also showed improvement of cervical pain after surgery ( P < 0.001 ) and a significant increase in foraminal height ( P = 0.035 ) . Cervical kyphosis was present in 27 ( 34 % ) patients before surgery ; it was corrected to lordosis in 9 . The fusion rate at 12 months and 24 months was 91 % and 95 % , respectively . No surgery or cage-related complication occurred in these patients . Non-threaded interbody cage fusion in this study achieved a high fusion rate and had a good neurologic outcome . These results suggest that non-threaded cage fusion is a safe and effective method for anterior cervical discectomy OBJECT The authors of studies of anterior cervical fusion for disc-related disease have documented satisfying clinical results and infrequent complications . Recently , cervical disc arthroplasty has entered clinical trials as an alternative to fusion . Although the results of anecdotal reports and prospect i ve studies support this procedure , these studies have not conferred the validity of a controlled r and omized study . In the present study , the author presents data obtained in such a study . METHODS After symptoms failed to respond to conservative therapy , 46 patients with one-level discogenic cervical radiculopathy and /or myelopathy were r and omized to undergo arthroplasty or fusion as part of a US Food and Drug Administration medical device study . In all patients there was a minimum follow-up duration of 1 year . Equivalent results for the relief of arm pain and neck pain were noted in both treatment groups . Treatment parameters other than operative time were similar . No neurological or serious systemic complications occurred . CONCLUSIONS Although extended follow-up data and larger patient population s are needed , the results of this study indicate that arthroplasty is a viable alternative to cervical fusion Combined anterior-posterior lumbar fusion across multiple levels is thought to be associated with increased perioperative morbidity and worse clinical outcomes when performed in elderly patients . We conducted a retrospective review of the medical , surgical , and radiological records of 73 patients who underwent multilevel anterior lumbar interbody fusion ( ALIF ) with posterolateral lumbar fusion with instrumentation for symptomatic lumbar degenerative disc disease . Mean follow-up was 19 months . Thirty patients were at least 65 years old and 43 patients were younger . There were no significant differences in the number of levels fused , operative time , mean length of hospital stay or perioperative complication rates in either group . Similarly , there were no statistically significant differences in the improvement in back pain or in the rates of fusion between the groups at last follow-up . Perioperative events , intermediate-term clinical outcomes , and fusion rates after multilevel 360-degree lumbar fusion in the elderly are comparable to those of younger patients
target: 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: 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 .