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Background: A 2019 review concluded that spinal manipulative therapy (SMT) results in similar benefit compared to other interventions for chronic low back pain (LBP). Compared to traditional aggregate analyses individual participant data (IPD) meta-analyses allows for a more precise estimate of the treatment effect., Purpose: To assess the effect of SMT on pain and function for chronic LBP in a IPD meta-analysis., Data Sources: Electronic databases from 2000 until April 2016, and reference lists of eligible trials and related reviews., Study Selection: Randomized controlled trials (RCT) examining the effect of SMT in adults with chronic LBP compared to any comparator., Data Extraction and Data Synthesis: We contacted authors from eligible trials. Two review authors independently conducted the study selection and risk of bias. We used GRADE to assess the quality of the evidence. A one-stage mixed model analysis was conducted. Negative point estimates of the mean difference (MD) or standardized mean difference (SMD) favors SMT., Results: Of the 42 RCTs fulfilling the inclusion criteria, we obtained IPD from 21 (n=4223). Most trials (s=12, n=2249) compared SMT to recommended interventions. There is moderate quality evidence that SMT vs recommended interventions resulted in similar outcomes on pain (MD -3.0, 95%CI: -6.9 to 0.9, 10 trials, 1922 participants) and functional status at one month (SMD: -0.2, 95% CI -0.4 to 0.0, 10 trials, 1939 participants). Effects at other follow-up measurements were similar. Results for other comparisons (SMT vs non-recommended interventions; SMT as adjuvant therapy; mobilization vs manipulation) showed similar findings. SMT vs sham SMT analysis was not performed, because we only had data from one study. Sensitivity analyses confirmed these findings., Limitations: Only 50% of the eligible trials were included., Conclusions: Sufficient evidence suggest that SMT provides similar outcomes to recommended interventions, for pain relief and improvement of functional status. SMT would appear to be a good option for the treatment of chronic LBP. Systematic Review Registration Number PROSPERO CRD42015025714., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Background: Low-back pain, including facet joint pain, accounts for up to 20 % of all sick leaves in DenmarkA proposed treatment option is cryoneurolysis. This study aims to investigate the effect of cryoneurolysis in lumbar facet joint pain syndrome., Methods: A single-center randomized controlled trial (RCT) is performed including 120 participants with chronic facet joint pain syndrome, referred to the Department of Neurosurgery, Aarhus University Hospital. Eligible patients receive a diagnostic anesthetic block, where a reduction of pain intensity ≥ 50 % on a numerical rating scale (NRS) is required to be enrolled. Participants are randomized into three groups to undergo either one treatment of cryoneurolysis, radiofrequency ablation or placebo. Fluoroscopy and sensory stimulation is used to identify the intended target nerve prior to administrating the above-mentioned treatments. All groups receive physiotherapy for 6 weeks, starting 4 weeks after treatment. The primary outcome is the patients' impression of change in pain after intervention (Patient Global Impression of Change (PGIC)) at 4 weeks follow-up, prior to physiotherapy. Secondary outcomes are a reduction in low-back pain intensity (numeric rating scale) and quality of life (EQ-5D, SF-36) and level of function (Oswestry Disability Index), psychological perception of pain (Pain Catastrophizing Scale) and depression status (Major Depression Inventory). Data will be assessed at baseline (T0), randomization (T1), day one (T2), 4 weeks (T3), 3 (T4), 6 (T5) and 12 months (T6)., Discussion: This study will provide information on the effectiveness of cryoneurolysis vs. the effectiveness of radiofrequency ablation or placebo for patients with facet joint pain, and help to establish whether cryoneurolysis should be implemented in clinical practice for this patient population., Trial Registration: The trial is approved by the ethical committee of Central Jutland Denmark with registration number 1-10-72-27-19 and the Danish Data Protection Agency with registration number 666,852. The study is registered at Clinicaltrial.gov with the ID number NCT04786145 .

Study Design: Individual participant data (IPD) meta-analysis., Objective: The aim of this study was to identify which participant characteristics moderate the effect of spinal manipulative therapy (SMT) on pain and functioning in chronic LBP., Summary of Background: The effects of SMT are comparable to other interventions recommended in guidelines for chronic low back pain (LBP); however, it is unclear which patients are more likely to benefit from SMT compared to other therapies., Methods: IPD were requested from randomized controlled trials (RCTs) examining the effect of SMT in adults with chronic LBP for pain and function compared to various other therapies (stratified by comparison). Potential patient moderators (n = 23) were a priori based on their clinical relevance. We investigated each moderator using a one-stage approach with IPD and investigated this interaction with the intervention for each time point (1, 3, 6, and 12 months)., Results: We received IPD from 21 of 46 RCTs (n = 4223). The majority (12 RCTs, n = 2249) compared SMT to recommended interventions. The duration of LBP, baseline pain (confirmatory), smoking, and previous exposure to SMT (exploratory) had a small moderating effect across outcomes and follow-up points; these estimates did not represent minimally relevant differences in effects; for example, patients with <1 year of LBP demonstrated more positive point estimates for SMT versus recommended therapy for the outcome pain (mean differences ranged from 4.97 (95% confidence interval, CI: -3.20 to 13.13) at 3 months, 10.76 (95% CI: 1.06 to 20.47) at 6 months to 5.26 (95% CI: -2.92 to 13.44) at 12 months in patients with over a year LBP. No other moderators demonstrated a consistent pattern across time and outcomes. Few moderator analyses were conducted for the other comparisons because of too few data., Conclusion: We did not identify any moderators that enable clinicians to identify which patients are likely to benefit more from SMT compared to other treatments.Level of Evidence: 2., (Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.)

Background: This is an update of a Cochrane Review published in 2014. Chronic non-specific low back pain (LBP) has become one of the main causes of disability in the adult population around the world. Although therapeutic ultrasound is not recommended in recent clinical guidelines, it is frequently used by physiotherapists in the treatment of chronic LBP., Objectives: The objective of this review was to determine the effectiveness of therapeutic ultrasound in the management of chronic non-specific LBP. A secondary objective was to determine the most effective dosage and intensity of therapeutic ultrasound for chronic LBP., Search Methods: We performed electronic searches in CENTRAL, MEDLINE, Embase, CINAHL, PEDro, Index to Chiropractic Literature, and two trials registers to 7 January 2020. We checked the reference lists of eligible studies and relevant systematic reviews and performed forward citation searching., Selection Criteria: We included randomised controlled trials (RCTs) on therapeutic ultrasound for chronic non-specific LBP. We compared ultrasound (either alone or in combination with another treatment) with placebo or other interventions for chronic LBP., Data Collection and Analysis: Two review authors independently assessed the risk of bias of each trial and extracted the data. We performed a meta-analysis when sufficient clinical and statistical homogeneity existed. We determined the certainty of the evidence for each comparison using the GRADE approach., Main Results: We included 10 RCTs involving a total of 1025 participants with chronic LBP. The included studies were carried out in secondary care settings in Turkey, Iran, Saudi Arabia, Croatia, the UK, and the USA, and most applied therapeutic ultrasound in addition to another treatment, for six to 18 treatment sessions. The risk of bias was unclear in most studies. Eight studies (80%) had unclear or high risk of selection bias; no studies blinded care providers to the intervention; and only five studies (50%) blinded participants. There was a risk of selective reporting in eight studies (80%), and no studies adequately assessed compliance with the intervention. There was very low-certainty evidence (downgraded for imprecision, inconsistency, and limitations in design) of little to no difference between therapeutic ultrasound and placebo for short-term pain improvement (mean difference (MD) -7.12, 95% confidence interval (CI) -17.99 to 3.75; n = 121, 3 RCTs; 0-to-100-point visual analogue scale (VAS)). There was also moderate-certainty evidence (downgraded for imprecision) of little to no difference in the number of participants achieving a 30% reduction in pain in the short term (risk ratio 1.08, 95% CI 0.81 to 1.44; n = 225, 1 RCT). There was low-certainty evidence (downgraded for imprecision and limitations in design) that therapeutic ultrasound has a small effect on back-specific function compared with placebo in the short term (standardised mean difference -0.29, 95% CI -0.51 to -0.07 (MD -1.07, 95% CI -1.89 to -0.26; Roland Morris Disability Questionnaire); n = 325; 4 RCTs), but this effect does not appear to be clinically important. There was moderate-certainty evidence (downgraded for imprecision) of little to no difference between therapeutic ultrasound and placebo on well-being (MD -2.71, 95% CI -9.85 to 4.44; n = 267, 2 RCTs; general health subscale of the 36-item Short Form Health Survey (SF-36)). Two studies (n = 486) reported on overall improvement and satisfaction between groups, and both reported little to no difference between groups (low-certainty evidence, downgraded for serious imprecision). One study (n = 225) reported on adverse events and did not identify any adverse events related to the intervention (low-certainty evidence, downgraded for serious imprecision). No study reported on disability for this comparison. We do not know whether therapeutic ultrasound in addition to exercise results in better outcomes than exercise alone because the certainty of the evidence for all outcomes was very low (downgraded for imprecision and serious limitations in design). The estimate effect for pain was in favour of the ultrasound plus exercise group (MD -21.1, 95% CI -27.6 to -14.5; n = 70, 2 RCTs; 0-to-100-point VAS) at short term. Regarding back-specific function (MD - 0.41, 95% CI -3.14 to 2.32; n = 79, 2 RCTs; Oswestry Disability Questionnaire) and well-being (MD -2.50, 95% CI -9.53 to 4.53; n = 79, 2 RCTs; general health subscale of the SF-36), there was little to no difference between groups at short term. No studies reported on the number of participants achieving a 30% reduction in pain, patient satisfaction, disability, or adverse events for this comparison., Authors' Conclusions: The evidence from this systematic review is uncertain regarding the effect of therapeutic ultrasound on pain in individuals with chronic non-specific LBP. Whilst there is some evidence that therapeutic ultrasound may have a small effect on improving low back function in the short term compared to placebo, the certainty of evidence is very low. The true effect is likely to be substantially different. There are few high-quality randomised trials, and the available trials were very small. The current evidence does not support the use of therapeutic ultrasound in the management of chronic LBP., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Objectives: To evaluate the cost-effectiveness of radiofrequency denervation when added to a standardized exercise program for patients with chronic low back pain., Methods: An economic evaluation was conducted alongside 3 pragmatic multicenter, nonblinded randomized clinical trials (RCTs) in The Netherlands with a follow up of 52 weeks. Eligible participants were included between January 1, 2013, and October 24, 2014, and had chronic low back pain; a positive diagnostic block at the facet joints (n = 251), sacroiliac (SI) joints (n = 228), or a combination of facet joints, SI joints, and intervertebral discs (n = 202); and were unresponsive to initial conservative care. Quality-adjusted life-years (QALYs) and societal costs were measured using self-reported questionnaires. Missing data were imputed using multiple imputation. Bootstrapping was used to estimate statistical uncertainty., Results: After 52 weeks, no difference in costs between groups was found in the facet joint or combination RCT. The total costs were significantly higher for the intervention group in the SI joint RCT. The maximum probability of radiofrequency denervation being cost-effective when added to a standardized exercise program ranged from 0.10 in the facet joint RCT to 0.17 in the SI joint RCT irrespective of the ceiling ratio, and 0.65 at a ceiling ratio of €30 000 per QALY in the combination RCT., Conclusions: Although equivocal among patients with symptoms in a combination of the facet joints, SI joints, and intervertebral discs, evidence suggests that radiofrequency denervation combined with a standardized exercise program cannot be considered cost-effective from a societal perspective for patients with chronic low back pain originating from either facet or SI joints in a Dutch healthcare setting., (Copyright © 2020 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

Objective: To investigate whether 2 previously published classification approaches, the updated treatment-based classification system and a Pilates subgroup defined by a preliminary clinical prediction rule, could identify patients with chronic low back pain who would benefit more from Pilates exercises compared to an educational booklet., Design: Secondary analysis of a randomized controlled trial., Methods: Two hundred twenty-two patients received advice and were randomly allocated to a group that received an educational booklet with no additional treatment (n = 74) or a group that received Pilates-based exercise treatment (n = 148) 2 or 3 times a week. At baseline, using a treatment-based classification system, patients were classified as having a good prognosis (positive movement control) or a poor prognosis. Similarly, using the Pilates clinical prediction rule, patients were classified as having a good prognosis (positive) or a poor prognosis (negative). The analysis was conducted using linear regression models to analyze the interaction between subgroup characteristics and treatment effect size, with changes in pain and disability from baseline to 6 weeks after randomization as dependent variables., Results: None of the interaction terms for pain and disability were statistically significant. The treatment effect of Pilates versus an educational booklet was similar in all subgroups., Conclusion: The treatment-based classification system and the Pilates clinical prediction rule did not differentiate subgroups of patients with chronic low back pain who were more or less likely to benefit more from Pilates compared to an educational booklet. J Orthop Sports Phys Ther 2020;50(4):189-197. Epub 23 Aug 2019. doi:10.2519/jospt.2019.8839 .

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 X 2 , Nagelkerke's R 2 ) 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 interpreted as moderate (≥0.71)., Conclusion: Future studies should focus on understanding the mechanisms associated with the identified predictors for high societal costs in order to design effective cost reduction initiatives., Significance: Identifying low back pain patients who are at risk (risk stratification) of becoming high-cost users and making appropriate initiatives could help in reducing high costs., (© 2019 The Authors. European Journal of Pain published by John Wiley & Sons Ltd on behalf of European Pain Federation - EFIC ®.)

Background: Many people with low back pain (LBP) become frequent users of healthcare services in their attempt to find treatments that minimise the severity of their symptoms. Back School consists of a therapeutic programme given to groups of people that includes both education and exercise. However, the content of Back School has changed over time and appears to vary widely today. This review is an update of a Cochrane review of randomised controlled trials (RCTs) evaluating the effectiveness of Back School. We split the Cochrane review into two reviews, one focusing on acute and subacute LBP, and one on chronic LBP., Objectives: The objective of this systematic review was to determine the effect of Back School on pain and disability for adults with chronic non-specific LBP; we included adverse events as a secondary outcome. In trials that solely recruited workers, we also examined the effect on work status., Search Methods: We searched for trials in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, CINAHL, two other databases and two trials registers to 15 November 2016. We also searched the reference lists of eligible papers and consulted experts in the field of LBP management to identify any potentially relevant studies we may have missed. We placed no limitations on language or date of publication., Selection Criteria: We included only RCTs and quasi-RCTs evaluating pain, disability, and/or work status as outcomes. The primary outcomes for this update were pain and disability, and the secondary outcomes were work status and adverse events., Data Collection and Analysis: Two review authors independently performed the 'Risk of bias' assessment of the included studies using the 'Risk of bias' assessment tool recommended by The Cochrane Collaboration. We summarised the results for the short-, intermediate-, and long-term follow-ups. We evaluated the overall quality of evidence using the GRADE approach., Main Results: For the outcome pain, at short-term follow-up, we found very low-quality evidence that Back School is more effective than no treatment (mean difference (MD) -6.10, 95% confidence interval (CI) -10.18 to -2.01). However, we found very low-quality evidence that there is no significant difference between Back School and no treatment at intermediate-term (MD -4.34, 95% CI -14.37 to 5.68) or long-term follow-up (MD -12.16, 95% CI -29.14 to 4.83). There was very low-quality evidence that Back School reduces pain at short-term follow-up compared to medical care (MD -10.16, 95% CI -19.11 to -1.22). Very low-quality evidence showed there to be no significant difference between Back School and medical care at intermediate-term (MD -9.65, 95% CI -22.46 to 3.15) or long-term follow-up (MD -5.71, 95% CI -20.27 to 8.84). We found very low-quality evidence that Back School is no more effective than passive physiotherapy at short-term (MD 1.96, 95% CI -9.51 to 13.43), intermediate-term (MD -16.89, 95% CI -66.56 to 32.79), or long-term follow-up (MD -12.86, 95% CI -61.22 to 35.50). There was very low-quality evidence that Back School is no better than exercise at short- term follow-up (MD -2.06, 95% CI -14.58 to 10.45). There was low-quality evidence that Back School is no better than exercise at intermediate-term (MD -4.46, 95% CI -19.44 to 10.52) and long-term follow-up (MD 4.58, 95% CI -0.20 to 9.36).For the outcome disability, we found very low-quality evidence that Back School is no more effective than no treatment at intermediate-term (MD -5.92, 95% CI -12.08 to 0.23) and long-term follow-up (MD -7.36, 95% CI -22.05 to 7.34); medical care at short-term (MD -1.19, 95% CI -7.02 to 4.64) and long-term follow-up (MD -0.40, 95% CI -7.33 to 6.53); passive physiotherapy at short-term (MD 2.57, 95% CI -15.88 to 21.01) and intermediate-term follow-up (MD 6.88, 95% CI -4.86 to 18.63); and exercise at short-term (MD -1.65, 95% CI -8.66 to 5.37), intermediate-term (MD 1.57, 95% CI -3.86 to 7.00), and long-term follow-up (MD 4.54, 95% CI -4.44 to 13.52). We found very low-quality evidence of a small difference between Back School and no treatment at short-term follow-up (MD -3.38, 95% CI -6.70 to -0.05) and medical care at intermediate-term follow-up (MD -6.34, 95% CI -10.89 to -1.79). Still, at long-term follow-up there was very low-quality evidence that passive physiotherapy is better than Back School (MD 9.60, 95% CI 3.65 to 15.54).Few studies measured adverse effects. The results were reported as means without standard deviations or group size was not reported. Due to this lack of information, we were unable to statistically pool the adverse events data. Work status was not reported., Authors' Conclusions: Due to the low- to very low-quality of the evidence for all treatment comparisons, outcomes, and follow-up periods investigated, it is uncertain if Back School is effective for chronic low back pain. Although the quality of the evidence was mostly very low, the results showed no difference or a trivial effect in favour of Back School. There are myriad potential variants on the Back School approach regarding the employment of different exercises and educational methods. While current evidence does not warrant their use, future variants on Back School may have different effects and will need to be studied in future RCTs and reviews.

Purpose: To evaluate the cost-effectiveness of manual therapy according to the Utrecht School (MTU) in comparison with physiotherapy (PT) in sub-acute and chronic non-specific neck pain patients from a societal perspective., Methods: An economic evaluation was conducted alongside a 52-week randomized controlled trial, in which 90 patients were randomized to the MTU group and 91 to the PT group. Clinical outcomes included perceived recovery (yes/no), functional status (continuous and yes/no), and quality-adjusted life-years (QALYs). Costs were measured from a societal perspective using self-reported questionnaires. Missing data were imputed using multiple imputation. To estimate statistical uncertainty, bootstrapping techniques were used., Results: After 52 weeks, there were no significant between-group differences in clinical outcomes. During follow-up, intervention costs (β:€-32; 95 %CI: -54 to -10) and healthcare costs (β:€-126; 95 %CI: -235 to -32) were significantly lower in the MTU group than in the PT group, whereas unpaid productivity costs were significantly higher (β:€186; 95 %CI:19-557). Societal costs did not significantly differ between groups (β:€-96; 95 %CI:-1975-2022). For QALYs and functional status (yes/no), the maximum probability of MTU being cost-effective in comparison with PT was low (≤0.54). For perceived recovery (yes/no) and functional status (continuous), a large amount of money must be paid per additional unit of effect to reach a reasonable probability of cost-effectiveness., Conclusions: From a societal perspective, MTU was not cost-effective in comparison with PT in patients with sub-acute and chronic non-specific neck pain for perceived recovery, functional status, and QALYs. As no clear total societal cost and effect differences were found between MTU and PT, the decision about what intervention to administer, reimburse, and/or implement can be based on the preferences of the patient and the decision-maker at hand., Trial Registration: ClinicalTrials.gov Identifier: NCT00713843.

Background: Chronic back pain is an important health problem. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used to treat people with low back pain, especially people with acute back pain. Short term NSAID use is also recommended for pain relief in people with chronic back pain. Two types of NSAIDs are available and used to treat back pain: non-selective NSAIDs and selective COX-2 NSAIDs. In 2008, a Cochrane review identified a small but significant effect from NSAIDs compared to placebo in people with chronic back pain. This is an update of the Cochrane review published in 2008 and focuses on people with chronic low back pain., Objectives: To determine if NSAIDs are more efficacious than various comparison treatments for non-specific chronic low back pain and if so, which type of NSAID is most efficacious., Search Methods: We searched CENTRAL, MEDLINE, EMBASE, PubMed and two clinical trials registry databases up to 24 June 2015 for randomized controlled trials (RCTs) published in English, German or Dutch. We also screened references cited in relevant reviews., Selection Criteria: We included RCTs (double-blind and single-blind) of NSAIDs used to treat people with chronic low back pain., Data Collection and Analysis: Two review authors independently screened trials for inclusion in this Cochrane review according to the inclusion criteria. One review author extracted the data, and a second review author checked the data. Two review authors independently evaluated the risk of bias of all included trials. If data were clinically homogeneous, we performed a meta-analysis and assessed the quality of evidence using the GRADE approach., Main Results: We included 13 trials in this Cochrane review. Ten studies were at 'low' risk of bias. Six studies compared NSAIDs with placebo, and included 1354 participants in total. There is low quality evidence that NSAIDs are more effective than placebo, with a mean difference in pain intensity score from baseline of -3.30 (95% CI -5.33 to -1.27) on a 0 to 100 visual analogue scale (VAS) with a median follow-up of 56 days (interquartile range (IQR) 13 to 91 days). Four studies measured disability using the Roland Morris Disability Questionnaire. There is low quality evidence that NSAIDs are more effective than placebo on disability, with a mean difference from baseline of -0.85 (95% CI -1.30 to -0.40) on a scale from 0 to 24 with a median follow-up of 84 days (IQR 42 to 105 days). All six placebo controlled studies also reported adverse events, and suggested that adverse events are not statistically significant more frequent in participants using NSAIDs compared to placebo (RR 1.04, 95% CI 0.92 to 1.17). Due to the relatively small sample size and relatively short follow-up in most included trials, it is likely that the proportion of patients experiencing an adverse event is underestimated.Two studies compared different types of non-selective NSAIDs, namely ibuprofen versus diclofenac and piroxicam versus indomethacin. The trials did not find any differences between these NSAID types, but both trials had small sample sizes. One trial reported no differences in pain intensity between treatment groups that used selective or non-selective NSAIDs. One other trial compared diflunisal with paracetamol and showed no difference in improvement from baseline on pain intensity score. One trial showed a better global improvement in favour of celecoxib versus tramadol.One included trial compared NSAIDs with 'home-based exercise'. Disability improved more in participants who did exercises versus participants receiving NSAIDs, but pain scores were similar., Authors' Conclusions: Six of the 13 included RCTs showed that NSAIDs are more effective than placebo regarding pain intensity. NSAIDs are slightly more effective than placebo regarding disability. However, the magnitude of the effects is small, and the level of evidence was low. When we only included RCTs at low risk of bias, differences in effect between NSAIDs and placebo were reduced. We identified no difference in efficacy between different NSAID types, including selective versus non-selective NSAIDs. Due to inclusion of RCTs only, the relatively small sample sizes and relatively short follow-up in most included trials, we cannot make firm statements about the occurrence of adverse events or whether NSAIDs are safe for long-term use.

Background: Radiofrequency (RF) denervation, an invasive treatment for chronic low back pain (CLBP), is used most often for pain suspected to arise from facet joints, sacroiliac (SI) joints or discs. Many (uncontrolled) studies have shown substantial variation in its use between countries and continued uncertainty regarding its effectiveness., Objectives: The objective of this review is to assess the effectiveness of RF denervation procedures for the treatment of patients with CLBP. The current review is an update of the review conducted in 2003., Search Methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, three other databases, two clinical trials registries and the reference lists of included studies from inception to May 2014 for randomised controlled trials (RCTs) fulfilling the inclusion criteria. We updated this search in June 2015, but we have not yet incorporated these results., Selection Criteria: We included RCTs of RF denervation for patients with CLBP who had a positive response to a diagnostic block or discography. We applied no language or date restrictions., Data Collection and Analysis: Pairs of review authors independently selected RCTs, extracted data and assessed risk of bias (RoB) and clinical relevance using standardised forms. We performed meta-analyses with clinically homogeneous studies and assessed the quality of evidence for each outcome using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach., Main Results: In total, we included 23 RCTs (N = 1309), 13 of which (56%) had low RoB. We included both men and women with a mean age of 50.6 years. We assessed the overall quality of the evidence as very low to moderate. Twelve studies examined suspected facet joint pain, five studies disc pain, two studies SI joint pain, two studies radicular CLBP, one study suspected radiating low back pain and one study CLBP with or without suspected radiation. Overall, moderate evidence suggests that facet joint RF denervation has a greater effect on pain compared with placebo over the short term (mean difference (MD) -1.47, 95% confidence interval (CI) -2.28 to -0.67). Low-quality evidence indicates that facet joint RF denervation is more effective than placebo for function over the short term (MD -5.53, 95% CI -8.66 to -2.40) and over the long term (MD -3.70, 95% CI -6.94 to -0.47). Evidence of very low to low quality shows that facet joint RF denervation is more effective for pain than steroid injections over the short (MD -2.23, 95% CI -2.38 to -2.08), intermediate (MD -2.13, 95% CI -3.45 to -0.81), and long term (MD -2.65, 95% CI -3.43 to -1.88). RF denervation used for disc pain produces conflicting results, with no effects for RF denervation compared with placebo over the short and intermediate term, and small effects for RF denervation over the long term for pain relief (MD -1.63, 95% CI -2.58 to -0.68) and improved function (MD -6.75, 95% CI -13.42 to -0.09). Lack of evidence of short-term effectiveness undermines the clinical plausibility of intermediate-term or long-term effectiveness. When RF denervation is used for SI joint pain, low-quality evidence reveals no differences from placebo in effects on pain (MD -2.12, 95% CI -5.45 to 1.21) and function (MD -14.06, 95% CI -30.42 to 2.30) over the short term, and one study shows a small effect on both pain and function over the intermediate term. RF denervation is an invasive procedure that can cause a variety of complications. The quality and size of original studies were inadequate to permit assessment of how often complications occur., Authors' Conclusions: The review authors found no high-quality evidence suggesting that RF denervation provides pain relief for patients with CLBP. Similarly, we identified no convincing evidence to show that this treatment improves function. Overall, the current evidence for RF denervation for CLBP is very low to moderate in quality; high-quality evidence is lacking. High-quality RCTs with larger patient samples are needed, as are data on long-term effects.

Background: Low back pain (LBP) is responsible for considerable personal suffering worldwide. Those with persistent disabling symptoms also contribute to substantial costs to society via healthcare expenditure and reduced work productivity. While there are many treatment options, none are universally endorsed. The idea that chronic LBP is a condition best understood with reference to an interaction of physical, psychological and social influences, the 'biopsychosocial model', has received increasing acceptance. This has led to the development of multidisciplinary biopsychosocial rehabilitation (MBR) programs that target factors from the different domains, administered by healthcare professionals from different backgrounds., Objectives: To review the evidence on the effectiveness of MBR for patients with chronic LBP. The focus was on comparisons with usual care and with physical treatments measuring outcomes of pain, disability and work status, particularly in the long term., Search Methods: We searched the CENTRAL, MEDLINE, EMBASE, PsycINFO and CINAHL databases in January and March 2014 together with carrying out handsearches of the reference lists of included and related studies, forward citation tracking of included studies and screening of studies excluded in the previous version of this review., Selection Criteria: All studies identified in the searches were screened independently by two review authors; disagreements regarding inclusion were resolved by consensus. The inclusion criteria were published randomised controlled trials (RCTs) that included adults with non-specific LBP of longer than 12 weeks duration; the index intervention targeted at least two of physical, psychological and social or work-related factors; and the index intervention was delivered by clinicians from at least two different professional backgrounds., Data Collection and Analysis: Two review authors extracted and checked information to describe the included studies, assessed risk of bias and performed the analyses. We used the Cochrane risk of bias tool to describe the methodological quality. The primary outcomes were pain, disability and work status, divided into the short, medium and long term. Secondary outcomes were psychological functioning (for example depression, anxiety, catastrophising), healthcare service utilisation, quality of life and adverse events. We categorised the control interventions as usual care, physical treatment, surgery, or wait list for surgery in separate meta-analyses. The first two comparisons formed our primary focus. We performed meta-analyses using random-effects models and assessed the quality of evidence using the GRADE method. We performed sensitivity analyses to assess the influence of the methodological quality, and subgroup analyses to investigate the influence of baseline symptom severity and intervention intensity., Main Results: From 6168 studies identified in the searches, 41 RCTs with a total of 6858 participants were included. Methodological quality ratings ranged from 1 to 9 out 12, and 13 of the 41 included studies were assessed as low risk of bias. Pooled estimates from 16 RCTs provided moderate to low quality evidence that MBR is more effective than usual care in reducing pain and disability, with standardised mean differences (SMDs) in the long term of 0.21 (95% CI 0.04 to 0.37) and 0.23 (95% CI 0.06 to 0.4) respectively. The range across all time points equated to approximately 0.5 to 1.4 units on a 0 to 10 numerical rating scale for pain and 1.4 to 2.5 points on the Roland Morris disability scale (0 to 24). There was moderate to low quality evidence of no difference on work outcomes (odds ratio (OR) at long term 1.04, 95% CI 0.73 to 1.47). Pooled estimates from 19 RCTs provided moderate to low quality evidence that MBR was more effective than physical treatment for pain and disability with SMDs in the long term of 0.51 (95% CI -0.01 to 1.04) and 0.68 (95% CI 0.16 to 1.19) respectively. Across all time points this translated to approximately 0.6 to 1.2 units on the pain scale and 1.2 to 4.0 points on the Roland Morris scale. There was moderate to low quality evidence of an effect on work outcomes (OR at long term 1.87, 95% CI 1.39 to 2.53). There was insufficient evidence to assess whether MBR interventions were associated with more adverse events than usual care or physical interventions.Sensitivity analyses did not suggest that the pooled estimates were unduly influenced by the results from low quality studies. Subgroup analyses were inconclusive regarding the influence of baseline symptom severity and intervention intensity., Authors' Conclusions: Patients with chronic LBP receiving MBR are likely to experience less pain and disability than those receiving usual care or a physical treatment. MBR also has a positive influence on work status compared to physical treatment. Effects are of a modest magnitude and should be balanced against the time and resource requirements of MBR programs. More intensive interventions were not responsible for effects that were substantially different to those of less intensive interventions. While we were not able to determine if symptom intensity at presentation influenced the likelihood of success, it seems appropriate that only those people with indicators of significant psychosocial impact are referred to MBR.

Background: Chronic non-specific low-back pain (LBP) has become one of the main causes of disability in the adult population around the world. Therapeutic ultrasound is frequently used by physiotherapists in the treatment of LBP and is one of the most widely used electro-physical agents in clinical practice., Objectives: The objective of this review is to determine the effectiveness of therapeutic ultrasound in the management of chronic non-specific LBP., Search Methods: Electronic searches were performed using CENTRAL, MEDLINE, EMBASE, PEDro, and PsycLIT databases in October 2013. Reference lists of eligible studies and relevant systematic reviews were checked and forward citation searching was also performed., Selection Criteria: Randomised controlled trials on therapeutic ultrasound for non-specific chronic LBP were included., Data Collection and Analysis: Two review authors independently assessed the risk of bias of each trial and extracted the data. When sufficient clinical and statistical homogeneity existed, a meta-analysis was performed. The quality of the evidence for each comparison was determined using the GRADE approach., Main Results: Seven small randomised controlled trials involving a total of 362 participants with chronic LBP were included. Two of the studies had a low risk of bias, meeting six or more of the 12 criteria used for assessing risk of bias. All studies were carried out in secondary care settings and most applied therapeutic ultrasound in addition to exercise therapy, at various intensities for six to 18 treatment sessions. There was moderate quality evidence that therapeutic ultrasound improves back-specific function (standardised mean difference (SMD) [95%CI] -0.45 [-0.84 to -0.05]) compared with placebo in the short term. There was low quality evidence that therapeutic ultrasound is no better than placebo for short-term pain improvement (mean difference (MD) [95%CI] -7.12 [-17.99 to 3.75]; zero to100-point scale). There was low quality evidence that therapeutic ultrasound plus exercise is no better than exercise alone for short-term pain improvement (MD [95%CI] -2.16 [-4.66 to 0.34]; zero to 50-point scale), or functional disability (MD [95%CI] -0.41 [-3.14 to 2.32]; per cent). The studies comparing therapeutic ultrasound versus placebo or versus exercise alone did not report on overall satisfaction with treatment, or quality of life. There was low quality evidence that spinal manipulation reduces pain and functional disability more than ultrasound over the short to medium term. There is also very low quality evidence that there is no clear benefit on any outcome measure between electrical stimulation and therapeutic ultrasound; and that phonophoresis results in improved SF-36 scores compared to therapeutic ultrasound. None of the included studies reported on adverse events related to the application of therapeutic ultrasound., Authors' Conclusions: No high quality evidence was found to support the use of ultrasound for improving pain or quality of life in patients with non-specific chronic LBP. There is some evidence that therapeutic ultrasound has a small effect on improving low-back function in the short term, but this benefit is unlikely to be clinically important. Evidence from comparisons between other treatments and therapeutic ultrasound for chronic LBP were indeterminate and generally of low quality. Since there are few high quality randomised trials and the available trials are very small, future large trials with valid methodology are likely to have an important impact on our confidence in the estimate of effect and may change the estimate.

Background: Minimal interventional procedures are frequently applied in patients with mechanical low back pain which is defined as pain presumably resulting from single sources: facet, disc, sacroiliac joint or a combination of these. Usually, these minimal interventional procedures are an integral part of a multidisciplinary pain programme. A recent systematic review issued by the Dutch Health Insurance Council showed that the effectiveness of these procedures for the total group of patients with chronic low back pain is yet unclear and cost-effectiveness unknown. The aim of the study is to evaluate whether a multidisciplinary pain programme with minimal interventional procedures is cost-effective compared to the multidisciplinary pain programme alone for patients with chronic mechanical low back pain who did not respond to conservative primary care and were referred to a pain clinic., Methods: All patients with chronic low back pain who are referred to one of the 13 participating pain clinics will be asked to participate in an observational study. Patients with a suspected diagnosis of facet, disc or sacroiliac joint problems will receive a diagnostic block to confirm this diagnosis. If confirmed, they will be asked to participate in a randomized controlled trial (RCT). For each single source a separate RCT will be conducted. Patients with a combination of facet, disc or sacroiliac joint problems will be invited for participation in a RCT as well. An economic evaluation from a societal perspective will be performed alongside these four RCTs. Patients will complete questionnaires at baseline, 3 and 6 weeks, 3, 6, 9 and 12 months after start of the treatment. Costs will be collected using self-completed cost questionnaires., Discussion: No trials are yet available which have evaluated the cost-effectiveness of minimal interventional procedures in patients with chronic mechanical low back pain, which emphasizes the importance of this study., Trial Registration Number: National Trial Register: NTR3531.

Study Design: A randomized controlled trial., Objective: To assess the effectiveness of Delitto's classification-based treatment approach compared with usual physical therapy care in patients with subacute or chronic low back pain., Summary of Background Data: No trial has evaluated this approach in patients with subacute and chronic low back pain., Methods: Before randomization, all patients were classified by research physical therapists according to a modified version of Delitto's classification-based system. Randomization was computer-generated, with centralized allocation concealment. The statistician and the physical therapists were unblinded. Patients and assistants who collected follow-up questionnaires were blinded. Follow-up assessments were completed at 8, 26, and 52 weeks. The primary analysis was performed according to the intention-to-treat principle, using multilevel analysis. The main outcomes were global perceived effect, disability (Oswestry Disability Index, 0-100), and pain intensity (Numerical Rating Scale, 0-10). Secondary outcomes were quality of life, fear-avoidance beliefs, and psychosocial status. RESULTS.: A total of 156 patients were included (classification-based group, n = 74; usual physical therapy group, n = 82). There were no statistically significant differences between the treatment groups for any of the outcomes at any of the follow-up time points. After 8 weeks, patients in the classification-based group had greater global perceived effect scores; adjusted odds ratio of 1.01 (95% confidence interval [CI], 0.31 to 3.28), and higher adjusted Oswestry Disability Index and Numerical Rating Scale scores; mean adjusted differences of 0.48 points (95% CI, -4.59 to 3.63) and 0.49 points (95% CI, -1.34 to 0.37) respectively, but all differences were statistically nonsignificant., Conclusion: The classification-based system used in this study was not effective for improving physical therapy care outcomes in a population of patients with subacute and chronic low back pain.

Purpose: Previous reviews of randomised controlled trials (RCTs) for low-back pain (LBP) have failed to identify any positive trend in study quality with more recent years of publication. This study aimed to identify and describe trends over time in the study design characteristics and risk of bias in chronic LBP trials performed over the past 30 years., Methods: One fifty-seven randomised trials of interventions for chronic LBP were extracted from recently published systematic reviews. The reviews included RCTs on physical and rehabilitation interventions, injection therapy and denervation procedures, complementary and alternative therapies and pharmacological interventions for chronic LBP. Study level data were extracted and analysed for trends associated with year of publication., Results: Overall, the mean sample size in the RCTs was 141 (median 70; range 17-3093). There was a slight increase in the median number of risk of bias criteria fulfilled from trials published prior to 1995 to those published after 1996. The analysis showed that in more recent years RCTs of medical interventions were more likely to be successfully blinded than RCTs of non-medical interventions., Conclusions: The continuing uncertainty regarding the efficacy of many interventions for chronic LBP again stresses the need for large RCTs with low risk of bias. Further research is needed into specific risks of bias within the RCTs for chronic LBP and the effect they have on the plausibility of the results.