Benefits and harms of spinal manipulative therapy for the treatment of chronic low back pain: systematic review and meta-analysis of randomised controlled trials

OBJECTIVE To assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain. DESIGN Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES Medline, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Physiotherapy Evidence Database (PEDro), Index to Chiropractic Literature, and trial registries up to 4 May 2018, including reference lists of eligible trials and related reviews. ELIGIBILITY CRITERIA FOR SELECTING STUDIES Randomised controlled trials examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded, as was grey literature. No restrictions were applied to language or setting. REVIEW METHODS Two reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence. The effect of SMT was compared with recommended therapies, non-recommended therapies, sham (placebo) SMT, and SMT as an adjuvant therapy. Main outcomes were pain and back specific functional status, examined as mean differences and standardised mean differences (SMD), respectively. Outcomes were examined at 1, 6, and 12 months. Quality of evidence was assessed using GRADE. A random effects model was used and statistical heterogeneity explored. RESULTS 47 randomised controlled trials including a total of 9211 participants were identified, who were on average middle aged (35-60 years). Most trials compared SMT with recommended therapies. Moderate quality evidence suggested that SMT has similar effects to other recommended therapies for short term pain relief (mean difference −3.17, 95% confidence interval −7.85 to 1.51) and a small, clinically better improvement in function (SMD −0.25, 95% confidence interval −0.41 to −0.09). High quality evidence suggested that compared with non-recommended therapies SMT results in small, not clinically better effects for short term pain relief (mean difference −7.48, −11.50 to −3.47) and small to moderate clinically better improvement in function (SMD −0.41, −0.67 to −0.15). In general, these results were similar for the intermediate and long term outcomes as were the effects of SMT as an adjuvant therapy. Evidence for sham SMT was low to very low quality; therefore these effects should be considered uncertain. Statistical heterogeneity coul

Effectiveness of surgery for lumbar spinal stenosis

Background: The management of spinal stenosis by surgery has increased rapidly in the past two decades, however, there is still controversy regarding the efficacy of surgery for this condition. Our aim was to investigate the efficacy and comparative effectiveness of surgery in the management of patients with lumbar spinal stenosis. Methods: Electronic searches were performed on MEDLINE, EMBASE, AMED, CINAHL, Web of Science, LILACS and Cochrane Library from inception to November 2014. Hand searches were conducted on included articles and relevant reviews. We included randomised controlled trials evaluating surgery compared to no treatment, placebo/sham, or to another surgical technique in patients with lumbar spinal stenosis. Primary outcome measures were pain, disability, recovery and quality of life. The PEDro scale was used for risk of bias assessment. Data were pooled with a random-effects model, and the GRADE approach was used to summarise conclusions. Results: Nineteen published reports (17 trials) were included. No trials were identified comparing surgery to no treatment or placebo/sham. Pooling revealed that decompression plus fusion is not superior to decompression alone for pain (mean difference -3.7, 95% confidence interval -15.6 to 8.1), disability (mean difference 9.8, 95% confidence interval -9.4 to 28.9), or walking ability (risk ratio 0.9, 95% confidence interval 0.4 to 1.9). Interspinous process spacer devices are slightly more effective than decompression plus fusion for disability (mean difference 5.7, 95% confidence interval 1.3 to 10.0), but they resulted in significantly higher reoperation rates when compared to decompression alone (28% v 7%, P < 0.001). There are no differences in the effectiveness between other surgical techniques for our main outcomes. Conclusions: The relative efficacy of various surgical options for treatment of spinal stenosis remains uncertain. Decompression plus fusion is not more effective than decompression alone. Interspinous process spacer devices result in higher reoperation rates than bony decompression

Study protocol: Cost effectiveness of two strategies to implement the NVOG guidelines on hypertension in pregnancy: An innovative strategy including a computerised decision support system compared to a common strategy of professional audit and feedback, a randomized controlled trial

Background: Hypertensive disease in pregnancy remains the leading cause of maternal mortality in the Netherlands. Seventeen percent of the clinical pregnancies are complicated by hypertension and 2% by preeclampsia. The Dutch Society of Obstetrics and Gynaecology (NVOG) has developed evidence-based guidelines on the management of hypertension in pregnancy and chronic hypertension. Previous studies showed a low adherence rate to other NVOG guidelines and a large variation in usual care in the different hospitals. An explanation is that the NVOG has no general strategy of practical implementation and evaluation of its guidelines. The development of an effective and cost effective implementation strategy to improve adherence to the guidelines on hypertension in pregnancy is needed.Methods/Design: The objective of this study is to assess the cost effectiveness of an innovative implementation strategy of the NVOG guidelines on hypertension including a computerised decision support system (BOS) compared to a common strategy of professional audit and feedback. A cluster randomised controlled trial with an economic evaluation alongside will be performed. Both pregnant women who develop severe hypertension or pre-eclampsia and professionals involved in the care for these women will participate. The main outcome measures are a combined rate of major maternal complications and process indicators extracted from the guidelines. A total of 472 patients will be included in both groups. For analysis, descriptive as well as regression techniques will be used. A cost effectiveness and cost utility analysis will be performed according to the intention-to-treat principle and from a societal perspective. Cost effectiveness ratios will be calculated using bootstrapping techniques

Clinical practice guidelines for the management of non-specific low back pain in primary care: an updated overview

Objective: The aim of this study was to provide an overview of the recommendations regarding the diagnosis and treatment contained in current clinical practice guidelines for patients with non-specific low back pai

Predictive factors of high societal costs among chronic low back pain patients

Background: Societal costs of low back pain (LBP) are high, yet few studies have been performed to identify the predictive factors of high societal costs among chronic LBP patients. This study aimed to determine which factors predict high societal costs in patients with chronic LBP. Methods: Data of 6,316 chronic LBP patients were used. In the main analysis, high societal costs were defined as patients in the top 10% of cost outcomes. Sensitivity analyses were conducted using patients in the top 5% and top 20% of societal costs. Potential predictive factors included patient expectations, demographic factors (e.g. age, gender, nationality), socio-economic factors (e.g. employment, education level) and health-related factors (e.g. body mass index [BMI], general health, mental health). The final prediction models were obtained using backward selection. The model's prognostic accuracy (Hosmer–Lemeshow X2, Nagelkerke's R2) and discriminative ability (area under the receiver operating curve [AUC]) were assessed, and the models were internally validated using bootstrapping. Results: Poor physical health, high functional disability, low health-related quality of life, high impact of pain experience, non-Dutch nationality and decreasing pain were found to be predictive of high societal costs in all models, and were therefore considered robust. After internal validation, the models' fit was good, their explained variance was relatively low (≤14.1%) and their AUCs could be interpre

Lumbale herniaoperatie: Endoscopisch of open?

_Achtergrond en het waarom van de studie_ In Nederland vinden jaarlijks veel operaties voor een lumbale discushernia plaats. Patiënten krijgen meestal een open microdiscectomie, waarbij de hernia wordt opgeheven via een klein sneetje in de rug en de zenuwwortel wordt vrijgelegd (figuur a). Een andere techniek is percutane transforaminale endoscopische discectomie (PTED) (figuur b). Hierbij wordt de hernia onder indirect zicht opgeheven door een kleinere snee van 8 mm via het wortelkanaal, dus meer vanaf de zijkant. PTED vindt plaats in dagbehandeling onder lichte sedatie, waardoor de patiënt gedurende de ingreep aanspreekbaar is. Mogelijke voordelen van deze techniek zijn minder risico op littekenvorming en een snellere revalidatie. Een mogelijk nadeel is een groter risico op recidieven omdat er minder discusmateriaal kan worden uitgeruimd. PTED behoort nog niet tot het basispakket, omdat Zorginstituut Nederland meent dat PTED niet voldoet aan de stand van de wetenschap en praktijk. Met de PTED-studie willen wij de hypothese toetsen dat PTED bij patiënten met een lumbale hernia niet minder effectief is dan open microdiscectomie. Daarnaast zullen wij ook de kosteneffectiviteit analyseren. _Vraagstelling:_ Is PTED niet minder effectief en niet minder kosteneffectief dan microdiscectomie bij patiënten met lumbosacraal radiculair syndroom door een discushernia

BAck complaints in the elders - Chiropractic (BACE-C): Protocol of an international cohort study of older adults with low back pain seeking chiropractic care

Background: Low back pain is a common condition among older adults that significantly influences physical function and participation. Compared to their younger counterparts, there is limited information available about the clinical course of low back pain in older people, in particularly those presenting for chiropractic care. Improving our understanding of this patient population and the course of their low back pain may provide input for studies researching safer and more effective care than is currently provided. Objectives: The primary objectives are to examine the clinical course over one year of pain intensity, healthcare costs and pain, functional status and recovery rates of low back pain in people 55 years and older who visit a chiropractor for a new episode of low back pain. Methods: An international prospective, multi-center cohort study with one-year follow-up. Chiropractic practices are to be recruited in the Netherlands, Sweden, United Kingdom and Australia. Treatment will be left to the discretion of the chiropractor. Inclusion/Exclusion criteria: Patients aged 55 and older who consult a chiropractor for a new episode of low back pain, meaning low back pain for the first time or those patients who have not been to a chiropractor in the previous six months. This is independent of whether they have seen another type of health care provider for the current episode. Patients who are unable to complete the web-based questionnaires because of language restrictions or those with computer literacy restrictions will be excluded as well as those with cognitive disorders. In addition, those with a suspected tumor, fracture, infection or any other potential red flag or condition considered to be a contraindication for chiropractic care will be excluded. Data will be collected using online questionnaires at baseline, and at 2 and 6 weeks and at 3, 6, 9 and 12 months. Discussion: This study, to our knowledge, is the first large-scale, prospective, multicenter, international cohort study to be conducted in a chiropractic setting to focus on older adults with low back pain consulting a chiropractor. By understanding the clinical course, satisfaction and safety of chiropractic treatment of this common debilitating condition in the aged population, this study will provide input for informing future clinical trials. Trial registration: Nederlandse Trial Registrar NL7507

Cost-effectiveness of combination therapy (Mechanical Diagnosis and Treatment and Transforaminal Epidural Steroid Injections) among patients with an indication for a Lumbar Herniated Disc surgery: Protocol of a randomized controlled trial

Objectives: The general consensus is that surgical treatment is advised when conservative methods fail in patients with lumbosacral radicular syndrome (LRS). Preliminary evidence from our pilot study indicates that combination therapy (mechanical diagnosis therapy and transforaminal epidural injections) can prevent surgical treatment in patients on the waiting list for surgery. The pilot study lacked a control group, and therefore, firm conclusions pertaining to effects could not be made. This study aims to determine if combination therapy, performed while being on the waiting list for lumbar herniated disc surgery, is effective and cost-effective compared with usual care (i.e., no intervention while being on the waiting list) among patients with a magnetic resonance imaging (MRI)-confirmed indication for a lumbar herniated disc surgery. Methods: A randomized controlled trial will be conducted with an economic evaluation. Patients aged 18 and above with incapacitating LRS, with leg pain and an MRI confirmed indication for lumbar disc hernia surgery, will be recruited from seven Dutch hospitals. While being on the waiting list for lumbar herniated disc surgery, patients will be randomized to either the combination therapy or usual care group. The primary outcome measure is the number of patients undergoing lumbar disc surgery during 12-month follow-up. Secondary outcomes include back and leg pain intensity (numeric pain rating scale), physical functioning (Roland Morris Disability Questionnaires-23), self-perceived recovery (global perceived effect), and health-related quality of life (EuroQol Five Dimensions Health Questionnaire (EQ-5D-5L) and 12-Item Short Form Health Survey (SF-12)). For the economic evaluation, societal and health care costs will be measured. Measurements moments are baseline, 1, 2, 4, 6, 9, and 12 months. Data will be analysed according to the intention-to-treat principle. Conclusion: No randomized controlled trials have evaluated the effectiveness and cost-effectiveness of combination therapy compared with usual care in patients with an indication for lumbar herniated disc surgery, which emphasizes the importance of this study

Influence of corresponding parameters on the pressure and derivative. (A) preferential flow path length <i>L_D</i>, (B) equivalent radius <i>r_pD</i>, (C) conductivity <i>C_dD</i>, (D) vertical elevation <i>z_pD</i>,, (E) flow rate constant <i>q_DND</i> and (F) storage effect <i>C_D</i>.

<p>Influence of corresponding parameters on the pressure and derivative. (A) preferential flow path length <i>L_D</i>, (B) equivalent radius <i>r_pD</i>, (C) conductivity <i>C_dD</i>, (D) vertical elevation <i>z_pD</i>,, (E) flow rate constant <i>q_DND</i> and (F) storage effect <i>C_D</i>.</p

Effect of medication reconciliation on medication costs after hospital discharge in relation to hospital pharmacy labor costs

BACKGROUND: Medication reconciliation aims to correct discrepancies in medication use between health care settings and to check the quality of pharmacotherapy to improve effectiveness and safety. In addition, medication reconciliation might also reduce costs. OBJECTIVE: To evaluate the effect of medication reconciliation on medication costs after hospital discharge in relation to hospital pharmacy labor costs. METHODS: A prospective observational study was performed. Patients discharged from the pulmonology department were included. A pharmacy team assessed medication errors prevented by medication reconciliation. Interventions were classified into 3 categories: correcting hospital formulary-induced medication changes (eg, reinstating less costly generic drugs used before admission), optimizing pharmacotherapy (eg, discontinuing unnecessary laxative), and eliminating discrepancies (eg, restarting omitted preadmission medication). Because eliminating discrepancies does not represent real costs to society (before hospitalization, the patient was also using the medication), these medication costs were not included in the cost calculation. Medication costs at 1 month and 6 months after hospital discharge and the associated labor costs were assessed using descriptive statistics and scenario analyses. For the 6-month extrapolation, only medication intended for chronic use was included. RESULTS: Two hundred sixty-two patients were included. Correcting hospital formulary changes saved?1 €63/patient (exchange rate: EUR 1 = USD 1.3443) in medication costs at 1 month after discharge and?9 €79 at 6 months. Optimizing pharmacotherapy saved?20 euro;13/patient in medication costs at 1 month and? €86.86 at 6 months. The associated labor costs for performing medication reconciliation were? €41.04/patient. Medication cost savings from correcting hospital formularyinduced changes and optimizing of pharmacotherapy?(€96.65/patient) outweighed the labor costs at 6 months extrapolation by? €55.62/patient (sensitivity analysis?€ 37.25-71.10). CONCLUSIONS: Preventing medication errors through medication reconciliation results in higher benefits than the costs related to the net time investment