Wilco C. Peul

Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial.

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.

Measuring the effect of Choosing Wisely: an integrated framework to assess campaign impact on low-value care

The Choosing Wisely campaign began in the USA in 2012 to encourage physicians and patients to discuss inappropriate and potentially harmful tests, treatments and procedures. Since its inception, the campaign has grown substantially and has been adopted by 12 countries around the world. Of great interest to countries implementing the campaign, is the effectiveness of Choosing Wisely to reduce overutilisation. This article presents an integrated measurement framework that may be used to assess the impact of a Choosing Wisely campaign on physician and provider awareness and attitudes on low-value care, provider practice behaviour and overuse of low-value services.

Total disc replacement for chronic discogenic low back pain: a Cochrane review.

Study Design. Systematic literature review. Objective. To assess the effect of total disc replacement for chronic low back pain due to lumbar degenerative disc disease compared with fusion or other treatment options. Summary of Background Data. There is an increasing use in disc replacement devices for degenerative disc disease, but their effectiveness compared with other interventions such as fusion of the motion segment or conservative treatment remains unclear. Methods. A comprehensive search in PubMedCentral, MEDLINE, EMBASE, BIOSIS, ClinicalTrials.gov, and FDA trials register was conducted. Randomized controlled trials comparing total disc replacement with any other intervention for degenerative disc disease were included. Risk of bias was assessed using the criteria of the Cochrane Back Review Group. Quality of evidence was graded according to the GRADE approach. Two review authors independently selected studies, assessed risk of bias, and extracted data. Results and upper bounds of confidence intervals were compared with predefined clinically relevant differences. Results. We included 7 randomized controlled trials with a follow-up of 24 months. There is risk of bias in the included studies due to sponsoring and absence of any kind of blinding. One study compared disc replacement with rehabilitation and found a significant advantage in favor of surgery, which, however, did not reach the predefined threshold. Six studies compared disc replacement with fusion and found that the mean improvement in visual analogue scale score of back pain was 5.2 mm higher (2 studies; 95% confidence interval 0.2–10.3) with a low quality of evidence. The improvement of Oswestry disability index score at 24 months in the disc replacement group was 4.3 points more than in the fusion group (5 studies; 95% confidence interval 1.85–6.68) with a low quality of evidence. Both upper bounds of the confidence intervals were below the predefined clinically relevant difference. Conclusion. Although statistically significant, the differences in clinical improvement were not beyond generally accepted boundaries for clinical relevance. Prevention of adjacent level disease and/or facet joint degeneration was not properly assessed. Therefore, because we think that harm and complications may occur after some years, the spine surgery community should be prudent to adopt this technology on a large scale, despite the fact that total disc replacement seems to be effective in treating low back pain in selected patients, and in the short term is at least equivalent to fusion surgery.

Clinical research: is the spine field a mine field?

Spinal surgery for infection, tumor, and major traumatic disruption may avert catastrophic outcomes such as paralysis, major deformity, or death. Recent research on decompression and fusion surgery for degenerative spinal disorders has shown the clear and relevant effectiveness of many procedures. When clinically indicated, lumbar discectomy for disc herniation, decompression for lumbar stenosis, and decompression and fusion surgery for degenerative spondylolisthesis, all offer clinical benefit in the face of serious back and radicular pain. The scientific basis for these treatments began with one of the earliest randomized trials of a surgical intervention, establishing the spine field as a leader in innovative research methods in surgery. The results of that early study have been largely confirmed in more recent randomized trials. Technical advances have made many spine operations and other interventions safer and more predictable in outcome. These advances have greatly improved critical aspects of care, including antibiotic and thromboembolic disease prophylaxis, intraoperative imaging, lighting and magnification, and analgesic strategies for pain. Critical spinal devices have improved in biocompatibility, durability, and simplicity of implantation. These advances are generally the product of cooperative research and development between the innovative clinician, clinical researcher, and the biomedical industry. The time when a clinician with a good idea could bring a new device from workbench to practice without enormous commercial and capital support is long gone. Physicians, patients, and industry share many common practical goals. However, not all new treatment strategies prove to be better or even safe. Early trials with several techniques and devices reveal a disturbing history (Table 1). Nonetheless, new and potentially helpful devices are being proffered to the spine care market at an accelerating pace. Each year, the number of new products available for consideration outstrips the ability of any individual to adequately assess their safety, effectiveness, or even reasonableness. In practice, the spine field has relied on regulatory agencies, university, and unaffiliated research programs and unbiased scientific reporting in the literature to help sort the wheat from the chaff. There are signs that this method of assessing new technology has been broken for some time and, as a consequence, clinicians concerned with spinal disorders are facing hard times ahead unless a better strategy is found. Over the past decade, the rate of some spinal procedures being performed in North America and Europe has greatly increased. For instance, a rapid increase in fusion rates followed the approval of new surgical implants, but was not associated with evidence of improved effectiveness or clarified indications. Many interventions are performed for axial back pain associated with common degenerative conditions, sometimes with weak or absent evidence of efficacy: so-called “dynamic stabilization” with various implants, distraction with interspinous devices, corticosteroid injection into the facet joints, prolotherapy, intradiscal steroid injection, botulinum toxin injection, intradiscal electrothermal therapy, radiofrequency facet denervation, radiofrequency sacroiliac denervation, and intrathecal therapy with opioids, to name a few. Though thousands of patients have been treated with these methods, there is no evidence of high-grade efficacy for even one of them. At the same time, highly publicized news stories of surgeons receiving “millions in consulting fees, royalties and research grants” have appeared, in the context of “sham consulting agreements, sham royalty agreements, and lavish trips to desirable locations.” A large device manufacturer has paid a fine to the government to settle such allegations. As a result, the spine field has been subject to ugly characterization in the press, highly skeptical governmental investigations, and frank accusations of corruption. Consumer Reports recently listed spinal surgery as number 1 on its list of overused tests and treatments. This is clearly not where this field wants to be. From the *Department of Orthopaedic Surgery, Stanford University School of Medicine, Palo Alto, CA; †Department of Family Medicine, Oregon Health and Science University, Portland, OR; ‡Research Department, Kovacs Foundation, Palma de Mallorca, Spain; §Spanish Back Pain Research Network; ¶Department of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands; Department of Medicine, Dartmouth Medical School, Hanover, NH; **Iberoamerican Cochrane Center, Servei d’Epidemiologia i Salut Pública, Hospital de la Santa Creu i Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain; ††University of Minnesota, Clinical Outcomes Research Center, Minneapolis, MN; ‡‡Corbin and Company; and §§The Back Letter, Newbury, MA. Acknowledgment date: September 25, 2008. Acceptance date: December 10, 2008. The manuscript submitted does not contain information about medical device(s)/drug(s). No funds were received in support of this work. No benefits in any form have been or will be received from a commercial party related directly or indirectly to the subject of this manuscript. Address correspondence and reprint requests to Eugene J. Carragee, MD, FACS, Department of Orthopaedic Surgery, Stanford University School of Medicine; Orthopaedic Spine Center and Spinal Surgery Service, Stanford University Hospital and Clinics, Stanford, CA; E-mail: ecarragee@mac.com

Prevention and treatment of low back pain: evidence, challenges, and promising directions

Many clinical practice guidelines recommend similar approaches for the assessment and management of low back pain. Recommendations include use of a biopsychosocial framework to guide management with initial non-pharmacological treatment, including education that supports self-management and resumption of normal activities and exercise, and psychological programmes for those with persistent symptoms. Guidelines recommend prudent use of medication, imaging, and surgery. The recommendations are based on trials almost exclusively from high-income countries, focused mainly on treatments rather than on prevention, with limited data for cost-effectiveness. However, globally, gaps between evidence and practice exist, with limited use of recommended first-line treatments and inappropriately high use of imaging, rest, opioids, spinal injections, and surgery. Doing more of the same will not reduce back-related disability or its long-term consequences. The advances with the greatest potential are arguably those that align practice with the evidence, reduce the focus on spinal abnormalities, and ensure promotion of activity and function, including work participation. We have identified effective, promising, or emerging solutions that could offer new directions, but that need greater attention and further research to determine if they are appropriate for large-scale implementation. These potential solutions include focused strategies to implement best practice, the redesign of clinical pathways, integrated health and occupational interventions to reduce work disability, changes in compensation and disability claims policies, and public health and prevention strategies.

Diagnosis of Lumbar Spinal Stenosis An Updated Systematic Review of the Accuracy of Diagnostic Tests

Study Design. Systematic review of diagnostic studies. Objective. To update our previous systematic review on the diagnostic accuracy of tests used to diagnose lumbar spinal stenosis. Summary of Background Data. A wide range of clinical, radiological, and electrodiagnostic tests are used to diagnose lumbar spinal stenosis. An accurate diagnosis is vital, because lumbar spinal stenosis may require specific medical advice and treatment. Therefore, it is important to know the accuracy of these diagnostic tests currently available. Methods. A comprehensive literature search was conducted for original diagnostic studies on lumbar spinal stenosis, in which one or more diagnostic tests were evaluated with a reference standard, and diagnostic accuracy was reported or could be calculated. Our previous systematic review included studies up to March 2004; this review is current up to March 2011. Included studies were assessed for their methodological quality using the QUADAS tool. Study characteristics and reported diagnostic accuracy were extracted. Results. Twenty-two additional articles in addition to the 24 included in the previous review met the inclusion criteria. Combined, this resulted in 20 articles concerning imaging tests, 11 articles evaluating electrodiagnostic tests, and 15 articles evaluating clinical tests. Estimates of the diagnostic accuracy of the tests differed considerably. Conclusion. There is a need for a consensus on criteria to define and classify lumbar spinal stenosis. At present, the most promising imaging test for lumbar spinal stenosis is magnetic resonance imaging, avoiding myelography because of its invasiveness and lack of superior accuracy. Electrodiagnostic studies showed no superior accuracy for conventional electrodiagnostic testing compared with magnetic resonance imaging. These tests should be considered in the context of those presenting symptoms with the highest diagnostic value, including radiating leg pain that is exacerbated while standing up, the absence of pain when seated, the improvement of symptoms when bending forward, and a wide-based gait. Level of Evidence: 1

Prediction of Quality of Life and Survival After Surgery for Symptomatic Spinal Metastases: A Multicenter Cohort Study to Determine Suitability for Surgical Treatment.

BACKGROUND Surgery for symptomatic spinal metastases aims to improve quality of life, pain, function, and stability. Complications in the postoperative period are not uncommon; therefore, it is important to select appropriate patients who are likely to benefit the greatest from surgery. Previous studies have focused on predicting survival rather than quality of life after surgery. OBJECTIVE To determine preoperative patient characteristics that predict postoperative quality of life and survival in patients who undergo surgery for spinal metastases. METHODS In a prospective cohort study of 922 patients with spinal metastases who underwent surgery, we performed preoperative and postoperative assessment of EuroQol EQ-5D quality of life, visual analog score for pain, Karnofsky physical functioning score, complication rates, and survival. RESULTS The primary tumor type, number of spinal metastases, and presence of visceral metastases were independent predictors of survival. Predictors of quality of life after surgery included preoperative EQ-5D (P = .002), Frankel score (P < .001), and Karnofsky Performance Status (P < .001). CONCLUSION Data from the largest prospective surgical series of patients with symptomatic spinal metastases revealed that tumor type, the number of spinal metastases, and the presence of visceral metastases are the most useful predictors of survival and that quality of life is best predicted by preoperative Karnofsky, Frankel, and EQ-5D scores. The Karnofsky score predicts quality of life and survival and is easy to determine at the bedside, unlike the EQ-5D index. Karnofsky score, tumor type, and spinal and visceral metastases should be considered the 4 most important prognostic variables that influence patient management.

Course and prognosis of older back pain patients in general practice: A prospective cohort study

&NA; At 3 months’ follow‐up, 61% of older back pain patients reported non‐recovery. Baseline characteristics that were associated with non‐recovery at 3 months’ follow‐up were identified. &NA; The aim of the current study was to determine the course of back pain in older patients and identify prognostic factors for non‐recovery at 3 months’ follow‐up. We conducted a prospective cohort study (the BACE study) of patients aged >55 years visiting a general practitioner (GP) with a new episode of back pain in the Netherlands. The course of back pain was described in terms of self‐perceived recovery, pain severity, disability, pain medication, and GP visits at 6 weeks’ and 3 months’ follow‐up. Prognostic factors for non‐recovery at 3 months’ follow‐up were derived from the baseline questionnaire and physical examination. Variables with a prognostic value were identified with multivariable logistic regression analysis (method backward), and an area under the receiver operating curve (AUC) was calculated for the prognostic model. A total of 675 back pain patients (mean age 66.4 (SD 7.6) years) participated in the BACE cohort study. At 6 weeks’ follow‐up 64% of the patients reported non‐recovery from back pain. At 3 months’ follow‐up 61% still reported non‐recovery, but only 26% of these patients had revisited the GP. Longer duration of the back pain, severity of back pain, history of back pain, absence of radiating pain in the leg below the knee, number of comorbidities, patients’ expectation of non‐recovery, and a longer duration of the timed ‘Up and Go’ test were significantly associated with non‐recovery in a multiple regression model (AUC 0.79). This information can help GPs identify older back pain patients at risk for non‐recovery.

Clinical outcomes after percutaneous transforaminal endoscopic discectomy for lumbar disc herniation: a prospective case series.

OBJECTIVE Throughout the last decades, full-endoscopic techniques to treat lumbar disc herniation (LDH) have gained popularity in clinical practice. To date, however, no Class I evidence on the efficacy of percutaneous transforaminal endoscopic discectomy (PTED) has been published, and studies describing its safety and short- and long-term efficacy are scarce. In this study the authors aimed to evaluate the clinical outcomes and safety in patients undergoing PTED for LDH. METHODS Patients who underwent PTED for LDH between January 2009 and December 2012 were prospectively followed. The primary outcomes were the visual analog scale (VAS) score for leg pain and the score on the Quebec Back Pain Disability Scale (QBPDS). Secondary outcomes were the perceived experience with the local anesthesia used and satisfaction with the results after 1 year using Likert-type scales. The pretreatment means were compared with the means obtained 6 and 52 weeks after surgery using paired t-tests. RESULTS A total of 166 patients underwent surgery for a total of 167 LDHs. The mean duration of surgery (± SD) was 51.0 ± 9.0 minutes. The 1-year follow-up rate was 95.2%. The mean reported scores on the VAS and QBPDS were 82.5 ± 17.3 mm and 60.0 ± 18.4 at baseline, respectively. Six weeks after surgery, the scores on the VAS and QBPDS were significantly reduced to 28.8 ± 24.5 mm and 26.7 ± 20.6, respectively (p < 0.001). After 52 weeks of follow-up, the scores were further reduced compared with baseline scores (p < 0.001) to 19.6 ± 23.5 mm on the VAS and 20.2 ± 18.1 on the QBPDS. A total of 4 complications were observed, namely 1 dural tear, 1 deficit of ankle dorsiflexion, and 2 cases of transient paresis in the foot due to the use of local anesthetics. CONCLUSIONS PTED appears to be a safe and effective intervention for LDH and has similar clinical outcomes compared to conventional open microdiscectomy. High-quality randomized controlled trials are required to study the efficacy and cost-effectiveness of PTED.

Rapid improvements in pain and quality of life are sustained after surgery for spinal metastases in a large prospective cohort.

Abstract Introduction Metastatic spinal cancer is a common condition that may lead to spinal instability, pain and paralysis. In the 1980s, surgery was discouraged because results showed worse neurological outcomes and pain compared with radiotherapy alone. However, with the advent of modern imaging and spinal stabilisation techniques, the role of surgery has regained centre stage, though few studies have assessed quality of life and functional outcomes after surgery. Objective We investigated whether surgery provides sustained improvement in quality of life and pain relief for patients with symptomatic spinal metastases by analysing the largest reported surgical series of patients with epidural spinal metastases. Methods A prospective cohort study of 922 consecutive patients with spinal metastases who underwent surgery, from the Global Spine Tumour Study Group database. Pre- and post-operative EQ-5D quality of life, visual analogue pain score, Karnofsky physical functioning score, complication rates and survival were recorded. Results Quality of life (EQ-5D), VAS pain score and Karnofsky physical functioning score improved rapidly after surgery and these improvements were sustained in those patients who survived up to 2 years after surgery. In specialised spine centres, the technical intra-operative complication rate of surgery was low, however almost a quarter of patients experienced post-operative systemic adverse events. Conclusion Surgical treatment for spinal metastases produces rapid pain relief, maintains ambulation and improves good quality of life. However, as a group, patients with cancer are vulnerable to post-operative systemic complications, hence the importance of appropriate patient selection.