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Background Percutaneous laser disc decompression (PLDD) for patients with lumbar disc herniation is believed to be cheaper than surgery. However, cost-effectiveness has never been studied. Materials and Methods A cost utility analysis was performed alongside a randomized controlled trial comparing PLDD and conventional surgery. Patients reported their quality of life using the EuroQol five dimensions questionnaire (EQ-5D), 36-item short form health survey (SF-36 and derived SF-6D) and a visual analogue scale (VAS). Using cost diaries patients reported health care use, non-health care use and hours of absenteeism from work. The 1-year societal costs were compared with 1-year quality adjusted life years (QALYs) based on the United States (US) EQ-5D. Sensitivity analyses were carried out on the use of different utility measures (Netherland (NL) EQ-5D, SF-6D, or VAS) and on the perspective (societal or healthcare). Results On the US EQ-5D, conventional surgery provided a non-significant gain in QALYs of 0.033 (95% confidence interval (CI) -0.026 to 0.093) in the first year. PLDD resulted in significantly lower healthcare costs (difference €1771, 95% CI €303 to €3238) and non-significantly lower societal costs (difference €2379, 95% CI -€2860 to €7618). For low values of the willingness to pay for a QALY, the probability of being cost-effective is in favor of PLDD. For higher values of the willingness to pay, between €30,000 and €70,000, conventional microdiscectomy becomes favorable. Conclusions From a healthcare perspective PLDD, followed by surgery when needed, results in significantly lower 1-year costs than conventional surgery. From a societal perspective PLDD appears to be an economically neutral innovation.

Background Percutaneous laser disc decompression is a minimally invasive treatment, for lumbar disc herniation and might serve as an alternative to surgical management of sciatica. In a randomised trial with two-year follow-up we assessed the clinical effectiveness of percutaneous laser disc decompression compared to conventional surgery. Materials and methods This multicentre randomised prospective trial with a non-inferiority design, was carried out according to an intent-to-treat protocol with full institutional review board approval. One hundred and fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were randomly allocated to percutaneous laser disc decompression ( n = 55) or conventional surgery ( n = 57). The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analogue scores for back and leg pain and the patient's report of perceived recovery. Results The primary outcome measures showed no significant difference or clinically relevant difference between the two groups at two-year follow-up. The re-operation rate was 21% in the surgery group, which is relatively high, and with an even higher 52% in the percutaneous laser disc decompression group. Conclusion At two-year follow-up, a strategy of percutaneous laser disc decompression, followed by surgery if needed, resulted in non-inferior outcomes compared to a strategy of microdiscectomy. Although the rate of reoperation in the percutaneous laser disc decompression group was higher than expected, surgery could be avoided in 48% of those patients that were originally candidates for surgery. Percutaneous laser disc decompression, as a non-surgical method, could have a place in the treatment arsenal of sciatica caused by contained herniated discs.

Background Context: Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991. However, no randomized trial comparing PLDD to conventional treatment has been performed., Purpose: In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery., Study Design/setting: This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-to-treat protocol with full institutional review board approval., Patient Sample: One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included., Outcome Measures: The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient's report of perceived recovery., Methods: Patients were randomly allocated to PLDD (n=57) or conventional surgery (n=58). Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands., Results: The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 (-0.1; [95% confidence interval (CI), -2.3 to 2.1]) and 52 weeks (-1.1; 95% CI, -3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42-0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year., Conclusions: At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery., (Copyright © 2015 Elsevier Inc. All rights reserved.)

We consider a re-analysis of the wait-and-see (control) arm of a recent clinical trial on sciatica. While the original randomised trial was designed to evaluate the public policy effect of a conservative wait-and-see approach versus early surgery, we investigate the impact of surgery at the individual patient level in a re-analysis of the wait-and-see group data. Both marginal structural model re-weighted estimates as well as propensity score adjusted analyses are presented. Results indicate that patients with high propensity to receive surgery may have beneficial effects at 2 years from delayed disc surgery.

Background Context: In patients with sciatica due to a lumbar disc herniation, it is generally recommended to reserve surgical treatment for those who suffer from intolerable pain or those who demonstrate persistent symptoms after conservative management. Controversy exists about the necessity of early surgical intervention for those patients that have an additional motor deficit., Purpose: The aim of this study was to compare the recovery of motor deficit among patients receiving early surgery to those receiving prolonged conservative treatment., Study Design: Subgroup analysis of a randomized controlled trial., Patient Sample: This subgroup analysis focuses on 150 (53%) of 283 patients with sciatica due to a lumbar disc herniation and whose symptoms at baseline (before randomization) were accompanied by a motor deficit., Outcome Measures: Motor deficit was assessed through manual muscle testing and graded according to the Medical Research Council (MRC) scale., Methods: In total, 150 patients with 6 to 12 weeks of sciatica due to a lumbar disc herniation and whose symptoms were accompanied by a moderate (MRC Grade 4) or severe (MRC Grade 3) motor deficit were randomly allocated to early surgery or prolonged conservative treatment. Repeated standardized neurologic examinations were performed at baseline and at 8, 26, and 52 weeks after randomization. This study was supported by a grant from the Netherlands Organization for Health Research and Development (ZonMW) and the Hoelen Foundation The Hague., Results: Sciatica recovered among seven (10%) of the 70 patients assigned to early surgery before surgery could be performed, and of the 80 patients assigned to conservative treatment, 32 patients (40%) were treated surgically because of intolerable pain. Baseline severity of motor deficit was graded moderate in 84% of patients and severe in 16% of patients. Motor deficit recovered significantly faster among patients allocated to early surgery (p=.01), but the difference was no longer significant at 26 (p=.21) or 52 weeks (p=.92). At 1 year, complete recovery of motor deficit was found in 81% of patients allocated to early surgery and in 80% of patients allocated to prolonged conservative treatment. Perceived overall recovery of sciatica was directly related to the presence of an accompanying motor deficit. Severe motor deficit at baseline (odds ratio, 5.4; confidence interval, 1.7-17.4) and a lumbar disc herniation encompassing ≥25% of the cross-sectional area of the spinal canal (odds ratio, 6.4; confidence interval, 1.3-31.8) were the most important risk factors for persistent deficit at 1 year., Conclusions: Early surgery resulted in a faster recovery of motor deficit accompanying sciatica compared with prolonged conservative treatment but the difference was no longer significant during the final follow-up examination at 1 year., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica caused by lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence of its efficacy is lacking., Objective: To determine whether a favorable cost-effectiveness for tubular diskectomy compared with conventional microdiskectomy is attained., Methods: Cost utility analysis was performed alongside a double-blind randomized controlled trial conducted among 325 patients with lumbar disk related sciatica lasting >6 to 8 weeks at 7 Dutch hospitals comparing tubular diskectomy with conventional microdiskectomy. Main outcome measures were quality-adjusted life-years at 1 year and societal costs, estimated from patient reported utilities (US and Netherlands EuroQol, Short Form Health Survey-6D, and Visual Analog Scale) and diaries on costs (health care, patient costs, and productivity)., Results: Quality-adjusted life-years during all 4 quarters and according to all utility measures were not statistically different between tubular diskectomy and conventional microdiskectomy (difference for US EuroQol, -0.012; 95% confidence interval, -0.046 to 0.021). From the healthcare perspective, tubular diskectomy resulted in nonsignificantly higher costs (difference US $460; 95% confidence interval, -243 to 1163). From the societal perspective, a nonsignificant difference of US $1491 (95% confidence interval, -1335 to 4318) in favor of conventional microdiskectomy was found. The nonsignificant differences in costs and quality-adjusted life-years in favor of conventional microdiskectomy result in a low probability that tubular diskectomy is more cost-effective than conventional microdiskectomy., Conclusion: Tubular diskectomy is unlikely to be cost-effective compared with conventional microdiskectomy.

Background: Tubular discectomy compared with conventional microdiscectomy has been introduced to speed up the rate of recovery in patients with lumbar disc related sciatica, although similar results have been shown. The authors performed a subgroup analysis to investigate whether certain patients might benefit more from either two surgical treatments., Methods: A double-blinded randomised trial was performed to compare the rate of recovery and outcome at 1 year between tubular discectomy and conventional microdiscectomy. Complete and nearly complete recovery, documented on the patient's global perceived recovery, were defined as a good outcome. The effect modification of the allocated treatment strategy by predefined variables on the rate of recovery and outcome at 1 year was analysed by Cox proportional hazard analyses and logistic regression analyses, respectively., Results: With respect to the outcome rate of recovery, interaction with treatment effect was present for the variable gender and type of disc herniation. Patients with a contained disc herniation (HR 0.73; 95% CI 0.49 to 1.09) and women (HR 0.75; 95% CI 0.54 to 1.06) had slower rates of recovery when treated with tubular discectomy. Variables correlated with good outcome at 1 year were the level of education and Slump test. Higher educated patients (OR 0.18; 95% CI 0.06 to 0.59) and patients with a negative Slump (OR 0.24; 95% CI 0.06 to 0.92) fared worse at 1 year when they underwent tubular discectomy., Conclusions: Superiority of tubular discectomy compared with conventional microdiscectomy was not demonstrated. Subgroup analyses identified only a few variables that were associated with more or less benefit from one of the allocated treatments. Trial registration isrct.org Identifier: ISRCTN51857546.

Context: Conventional microdiskectomy is the most frequently performed surgery for patients with sciatica due to lumbar disk herniation. Transmuscular tubular diskectomy has been introduced to increase the rate of recovery, although evidence is lacking of its efficacy., Objective: To determine outcomes and time to recovery in patients treated with tubular diskectomy compared with conventional microdiskectomy., Design, Setting, and Patients: The Sciatica Micro-Endoscopic Diskectomy randomized controlled trial was conducted among 328 patients aged 18 to 70 years who had persistent leg pain (>8 weeks) due to lumbar disk herniations at 7 general hospitals in The Netherlands from January 2005 to October 2006. Patients and observers were blinded during the follow-up, which ended 1 year after final enrollment., Interventions: Tubular diskectomy (n = 167) vs conventional microdiskectomy (n = 161)., Main Outcome Measures: The primary outcome was functional assessment on the Roland-Morris Disability Questionnaire (RDQ) for sciatica (score range: 0-23, with higher scores indicating worse functional status) at 8 weeks and 1 year after randomization. Secondary outcomes were scores on the visual analog scale for leg pain and back pain (score range: 0-100 mm) and patient's self-report of recovery (measured on a Likert 7-point scale)., Results: Based on intention-to-treat analysis, the mean RDQ score during the first year after surgery was 6.2 (95% confidence interval [CI], 5.6 to 6.8) for tubular diskectomy and 5.4 (95% CI, 4.6 to 6.2) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, -0.2 to 1.7). At 8 weeks after surgery, the RDQ mean (SE) score was 5.8 (0.4) for tubular diskectomy and 4.9 (0.5) for conventional microdiskectomy (between-group mean difference, 0.8; 95% CI, -0.4 to 2.1). At 1 year, the RDQ mean (SE) score was 4.7 (0.5) for tubular diskectomy and 3.4 (0.5) for conventional microdiskectomy (between-group mean difference, 1.3; 95% CI, 0.03 to 2.6) in favor of conventional microdiskectomy. On the visual analog scale, the 1-year between-group mean difference in improvement was 4.2 mm (95% CI, 0.9 to 7.5 mm) for leg pain and 3.5 mm (95% CI, 0.1 to 6.9 mm) for back pain in favor of conventional microdiskectomy. At 1 year, 107 of 156 patients (69%) assigned to tubular diskectomy reported a good recovery vs 120 of 151 patients (79%) assigned to conventional microdiskectomy (odds ratio, 0.59 [95% CI, 0.35 to 0.99]; P = .05)., Conclusions: Use of tubular diskectomy compared with conventional microdiskectomy did not result in a statistically significant improvement in the Roland-Morris Disability Questionnaire score. Tubular diskectomy resulted in less favorable results for patient self-reported leg pain, back pain, and recovery., Trial Registration: isrctn.org Identifier: ISRCTN51857546.

Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while "sciatica provoked by sitting" showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7-3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8-2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.

Background: Nerve root decompression with instrumented spondylodesis is the most frequently performed surgical procedure in the treatment of patients with symptomatic low-grade spondylolytic spondylolisthesis. Nerve root decompression without instrumented fusion, i.e. Gill's procedure, is an alternative and less invasive approach. A comparative cost-effectiveness study has not been performed yet. We present the design of a randomised controlled trial on cost-effectiveness of decompression according to Gill versus instrumented spondylodesis., Methods/design: All patients (age between 18 and 70 years) with sciatica or neurogenic claudication lasting more than 3 months due to spondylolytic spondylolisthesis grade I or II, are eligible for inclusion. Patients will be randomly allocated to nerve root decompression according to Gill, either unilateral or bilateral, or pedicle screw fixation with interbody fusion. The main primary outcome measure is the functional assessment of the patient measured with the Roland Disability Questionnaire for Sciatica at 12 weeks and 2 years. Other primary outcome measures are perceived recovery and intensity of leg pain and low back pain. The secondary outcome measures include, incidence of re-operations, complications, serum creatine phosphokinase, quality of life, medical consumption, costs, absenteeism, work perception, depression and anxiety, and treatment preference. The study is a randomised prospective multicenter trial in which two surgical techniques are compared in a parallel group design. Patients and research nurse will not be blinded during the follow-up period of 2 years., Discussion: Currently, nerve root decompression with instrumented fusion is the golden standard in the surgical treatment of low-grade spondylolytic spondylolisthesis, although scientific proof justifying instrumented spondylodesis over simple decompression is lacking. This trial is designed to elucidate the controversy in best surgical treatment of symptomatic patients with low-grade spondylolytic spondylolisthesis.

A randomized trial showed that surgery speeds up recovery of patients suffering sciatica for 6 weeks but prolonged conservative care yields similar results at one year. However 39% of this conservative care group ultimately underwent surgery after a mean period of 18.7 weeks. We evaluated variables to improve prediction of surgery in the conservatively treated cohort. Baseline data on 142 patients enroled in the conservative treatment arm of a randomized trial were analyzed to select those that could contribute to the prediction of surgery. The actual occurrence of surgery was used as dependent outcome of interest. Variables measured at baseline included neurological examination results, the visual analogue scale for pain (VAS) and the Roland disability questionnaire (RDQ). Higher pain intensity and functional limitations at baseline were associated with an increased likelihood of surgery during follow-up. Mutually adjusted Odds Ratios of 1.7 (95% CI; 1.1-2.7) per 20mm incremental intensification of pain on the VAS score and 1.8 (95% CI; 1.2-2.9) per 3 points of deterioration of the RDQ score quantify the increasing chance of undergoing delayed surgery. Despite maximal efforts to the contrary, surgery could not be prevented for a considerable proportion of patients in a conservatively treated cohort. Compared to those with lower scores initially, patients with more intense leg pain or higher disability scores were at higher risk to undergo delayed surgery. The individual surgical decision process is facilitated by the use of pain and disability scales complemented by patient preferences.

Sciatica caused by a lumbar disk herniation is a frequently diagnosed disorder with a favorable natural course. While most prognostic studies focus on good outcome, patients might experience unsatisfactory results. Female gender has been found to be associated with chronic pain in other musculoskeletal disorders. Our aim is to quantify the relationship between gender and (1) rate of recovery and (2) outcome at one year. Recovery was registered on a 7-point Likert scale for 283 patients with 6-12 weeks of persistent sciatica who participated in a randomized trial to investigate timing of surgery. Complete and near complete recovery were considered good outcomes. Function and pain were registered by the Roland Disability Questionnaire (RDQ) and a visual analogue scale (VAS). A univariate Cox model was used to study the influence of variables on rate of recovery while a univariate and multivariate logistic regression analysis evaluated variables predicting unsatisfactory outcome at 12 months. At one year unsatisfactory outcome was registered for 17% of patients, 11% of all males and 28% of all females (p<0.001). Patients with an unsatisfactory outcome had worse RDQ and VAS scores compared to those who recovered satisfactorily (p<0.001). Women had a slower rate of recovery: HR 0.76 (95% CI 0.59-0.99) and xbfnkbsdkvbated with an unsatisfactory outcome represented by an unadjusted odds ratio of 3.3 (95% CI 1.7-6.3) compared to males. Besides a slower recovery rate, female gender was a strong predictor of unsatisfactory outcome at one year for patients with sciatica.

Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up., Design: Randomised controlled trial., Setting: Nine Dutch hospitals., Participants: 283 patients with 6-12 weeks of sciatica., Interventions: Early surgery or an intended six months of continued conservative treatment, with delayed surgery if needed., Main Outcome Measures: Scores from Roland disability questionnaire for sciatica, visual analogue scale for leg pain, and Likert self rating scale of global perceived recovery., Results: Of the 141 patients assigned to undergo early surgery, 125 (89%) underwent microdiscectomy. Of the 142 patients assigned to conservative treatment, 62 (44%) eventually required surgery, seven doing so in the second year of follow-up. There was no significant overall difference between treatment arms in disability scores during the first two years (P=0.25). Improvement in leg pain was faster for patients randomised to early surgery, with a significant difference between "areas under the curves" over two years (P=0.05). This short term benefit of early surgery was no longer significant by six months and continued to narrow between six months and 24 months. Patient satisfaction decreased slightly between one and two years for both groups. At two years 20% of all patients reported an unsatisfactory outcome., Conclusions: Early surgery achieved more rapid relief of sciatica than conservative care, but outcomes were similar by one year and these did not change during the second year., Trial Registry: ISRCT No 26872154.

Objective: To determine whether the faster recovery after early surgery for sciatica compared with prolonged conservative care is attained at reasonable costs., Design: Cost utility analysis alongside a randomised controlled trial., Setting: Nine Dutch hospitals., Participants: 283 patients with sciatica for 6-12 weeks, caused by lumbar disc herniation., Interventions: Six months of prolonged conservative care compared with early surgery., Main Outcome Measures: Quality adjusted life years (QALYs) at one year and societal costs, estimated from patient reported utilities (UK and US EuroQol, SF-6D, and visual analogue scale) and diaries on costs (healthcare, patient's costs, and productivity)., Results: Compared with prolonged conservative care, early surgery provided faster recovery, with a gain in QALYs according to the UK EuroQol of 0.044 (95% confidence interval 0.005 to 0.083), the US EuroQol of 0.032 (0.005 to 0.059), the SF-6D of 0.024 (0.003 to 0.046), and the visual analogue scale of 0.032 (-0.003 to 0.066). From the healthcare perspective, early surgery resulted in higher costs (difference euro1819 (pound1449; $2832), 95% confidence interval euro842 to euro2790), with a cost utility ratio per QALY of euro41 000 (euro14,000 to euro430 000). From the societal perspective, savings on productivity costs led to a negligible total difference in cost (euro-12, euro-4029 to euro4006)., Conclusions: Faster recovery from sciatica makes early surgery likely to be cost effective compared with prolonged conservative care. The estimated difference in healthcare costs was acceptable and was compensated for by the difference in absenteeism from work. For a willingness to pay of euro40,000 or more per QALY, early surgery need not be withheld for economic reasons. Trial registration Current Controlled Trials ISRCTN 26872154.

Background: Lumbar-disk surgery often is performed in patients who have sciatica that does not resolve within 6 weeks, but the optimal timing of surgery is not known., Methods: We randomly assigned 283 patients who had had severe sciatica for 6 to 12 weeks to early surgery or to prolonged conservative treatment with surgery if needed. The primary outcomes were the score on the Roland Disability Questionnaire, the score on the visual-analogue scale for leg pain, and the patient's report of perceived recovery during the first year after randomization. Repeated-measures analysis according to the intention-to-treat principle was used to estimate the outcome curves for both groups., Results: Of 141 patients assigned to undergo early surgery, 125 (89%) underwent microdiskectomy after a mean of 2.2 weeks. Of 142 patients designated for conservative treatment, 55 (39%) were treated surgically after a mean of 18.7 weeks. There was no significant overall difference in disability scores during the first year (P=0.13). Relief of leg pain was faster for patients assigned to early surgery (P<0.001). Patients assigned to early surgery also reported a faster rate of perceived recovery (hazard ratio, 1.97; 95% confidence interval, 1.72 to 2.22; P<0.001). In both groups, however, the probability of perceived recovery after 1 year of follow-up was 95%., Conclusions: The 1-year outcomes were similar for patients assigned to early surgery and those assigned to conservative treatment with eventual surgery if needed, but the rates of pain relief and of perceived recovery were faster for those assigned to early surgery. (Current Controlled Trials number, ISRCTN26872154 [controlled-trials.com].)., (Copyright 2007 Massachusetts Medical Society.)

Background: The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome)., Methods/design: Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years., Discussion: Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery.

Background: The reference surgical procedure for the treatment of lumbar disc herniation is open microdiscectomy. Minimal invasive discectomy with tubular retractors is hypothesised to cause less tissue damage and result in lower blood loss, less postoperative pain and faster recovery. We previously reported our 1 and 2-year results, and found no better outcomes of tubular discectomy compared with open microdiscectomy. Until now, no studies on tubular discectomy have reported results with more than 2 years of follow-up. Studies with long-term follow-up are required to determine if clinical outcomes are sustained and to assess specific long-term outcomes such as reoperation rate and iatrogenic low back pain due to impaired spinal integrity. The aim of this study is to evaluate the 5-year results of tubular discectomy compared with conventional microdiscectomy.Methods: The study was designed as a double-blind randomised controlled trial. 325 patients with a symptomatic lumbar disc herniation were randomly allocated to tubular discectomy (166 patients) or conventional microdiscectomy (159 patients). Repeated standardised follow-up measurements were performed at 2, 4, 6, 8, 12, 26, 38, 52, 78, 104, 156, 208 and 260 weeks after randomisation. Main outcomes are the Roland-Morris Disability Questionnaire for Sciatica (RDQ), Visual Analogue Scale for leg pain and low back pain, self-perceived recovery and reoperation incidence.Results: There was no clinically significant difference between tubular discectomy and conventional microdiscectomy regarding the main clinical outcomes at any time point during the 5 years of follow-up. RDQ scores at 5 years were 4.3 (95% CI 3.3 to 5.2) in the tubular discectomy group and 3.4 (95% CI 2.4 to 4.5) in the conventional microdiscectomy group. The mean difference of 0.9 (95% CI -0.6 to 2.2) was not significant. Mean differences for leg pain and back pain were 0.2 (95% CI -5.5 to 6.0) and 0.4 (95% CI -5.9 to 6.7), respectively. 77% of patients allocated to conventional discectomy reported complete or near-complete recovery of symptoms compared with 74% of patients allocated to tubular discectomy (p=0.79). The reoperation rate was 18% in the tubular discectomy group and 13% in the conventional discectomy group (p=0.29).Conclusions: Long-term functional and clinical outcome did not differ between patients allocated to tubular discectomy and conventional microdiscectomy. Primary and secondary outcome measures did not support the hypothesised advantages of tubular discectomy over conventional microdiscectomy.Trial Registration Number: ISRCTN51857546. [ABSTRACT FROM AUTHOR]

Background: Percutaneous laser disc decompression (PLDD) for patients with lumbar disc herniation is believed to be cheaper than surgery. However, cost-effectiveness has never been studied. Materials and Methods: A cost utility analysis was performed alongside a randomized controlled trial comparing PLDD and conventional surgery. Patients reported their quality of life using the EuroQol five dimensions questionnaire (EQ-5D), 36-item short form health survey (SF-36 and derived SF-6D) and a visual analogue scale (VAS). Using cost diaries patients reported health care use, non-health care use and hours of absenteeism from work. The 1-year societal costs were compared with 1-year quality adjusted life years (QALYs) based on the United States (US) EQ-5D. Sensitivity analyses were carried out on the use of different utility measures (Netherland (NL) EQ-5D, SF-6D, or VAS) and on the perspective (societal or healthcare). Results: On the US EQ-5D, conventional surgery provided a non-significant gain in QALYs of 0.033 (95% confidence interval (CI) €0.026 to 0.093) in the first year. PLDD resulted in significantly lower healthcare costs (difference E1771, 95% CI E303 to E3238) and non-significantly lower societal costs (difference E2379, 95% CI €E2860 to E7618). For low values of the willingness to pay for a QALY, the probability of being cost-effective is in favor of PLDD. For higher values of the willingness to pay, between E30,000 and E70,000, conventional microdiscectomy becomes favorable. Conclusions: From a healthcare perspective PLDD, followed by surgery when needed, results in significantly lower 1-year costs than conventional surgery. From a societal perspective PLDD appears to be an economically neutral innovation. [ABSTRACT FROM AUTHOR]

The concept of minimally invasive lumbar disc surgery comprises reduced muscle injury. The aim of this study was to evaluate creatine phosphokinase (CPK) in serum and the cross-sectional area (CSA) of the multifidus muscle on magnetic resonance imaging as indicators of muscle injury. We present the results of a double-blind randomized trial on patients with lumbar disc herniation, in which tubular discectomy and conventional microdiscectomy were compared. In 216 patients, CPK was measured before surgery and at day 1 after surgery. In 140 patients, the CSA of the multifidus muscle was measured at the affected disc level before surgery and at 1 year after surgery. The ratios (i.e. post surgery/pre surgery) of CPK and CSA were used as outcome measures. The multifidus atrophy was classified into three grades ranging from 0 (normal) to 3 (severe atrophy), and the difference between post and pre surgery was used as an outcome. Patients' low-back pain scores on the visual analogue scale (VAS) were documented before surgery and at various moments during follow-up. Tubular discectomy compared with conventional microdiscectomy resulted in a nonsignificant difference in CPK ratio, although the CSA ratio was significantly lower in tubular discectomy. At 1 year, there was no difference in atrophy grade between both groups nor in the percentage of patients showing an increased atrophy grade (14% tubular vs. 18% conventional). The postoperative low-back pain scores on the VAS improved in both groups, although the 1-year between-group mean difference of improvement was 3.5 mm (95% CI; 1.4-5.7 mm) in favour of conventional microdiscectomy. In conclusion, tubular discectomy compared with conventional microdiscectomy did not result in reduced muscle injury. Postoperative evaluation of CPK and the multifidus muscle showed similar results in both groups, although patients who underwent tubular discectomy reported more low-back pain during the first year after surgery. [ABSTRACT FROM AUTHOR]

Background: The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design: The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18-70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion: Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the standard surgical procedure, and is more cost-effective, will be determined by this trial. Trial registration: Current Controlled Trials ISRCTN25884790. [ABSTRACT FROM AUTHOR]