Effect of vitamin D supplementation on pain and physical function in patients with knee osteoarthritis (OA): an OA Trial Bank protocol for a systematic review and individual patient data (IPD) meta-analysis.

INTRODUCTION: Observational data suggest that vitamin D deficiency is associated with the onset and progression of knee osteoarthritis (OA). However, randomised controlled trials (RCTs) to date investigating the efficacy of vitamin D supplementation in knee OA have reported conflicting results. Further research is needed to clarify the effects of vitamin D on patient-reported outcomes and determine whether there are patient subgroups who may benefit from the supplementation. The aim of this individual patient data (IPD) meta-analysis is to identify patient-level predictors of treatment response to vitamin D supplementation on pain and physical function. METHODS AND ANALYSIS: A systematic literature search will be conducted for RCTs of vitamin D supplementation on knee OA. Authors of original RCTs will be contacted to obtain the IPD. The primary outcomes will include long-term (≥12 months) pain and physical function. Secondary outcomes will include medium-term (≥6 months and <12 months) and short-term (<6 months) pain and physical function, as well as patient global assessment, quality of life and adverse events. Potential treatment effect modifiers to be examined in the subgroup analyses include age, gender, body mass index, baseline knee pain severity and physical function, baseline vitamin D level, radiographic stage, presence of bone marrow lesions on MRI, presence of clinical signs of local inflammation and concomitant depressive symptoms. Both one-step and two-step modelling methods will be used to determine the possible modifiable effect of each subgroup of interest. ETHICS AND DISSEMINATION: Research ethical or governance approval is exempt for this study as no new data are being collected. This study will be the first IPD meta-analysis to clarify the effect of vitamin D supplementation on clinical symptoms in different subgroups of patients with knee OA. The findings will be disseminated through peer-review publications and conference presentations. PROSPERO REGISTRATION NUMBER: CRD42018107740.

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 could not be explained. About half of the studies examined adverse and serious adverse events, but in most of these it was unclear how and whether these events were registered systematically. Most of the observed adverse events were musculoskeletal related, transient in nature, and of mild to moderate severity. One study with a low risk of selection bias and powered to examine risk (n=183) found no increased risk of an adverse event (relative risk 1.24, 95% confidence interval 0.85 to 1.81) or duration of the event (1.13, 0.59 to 2.18) compared with sham SMT. In one study, the Data Safety Monitoring Board judged one serious adverse event to be possibly related to SMT. CONCLUSION: SMT produces similar effects to recommended therapies for chronic low back pain, whereas SMT seems to be better than non-recommended interventions for improvement in function in the short term. Clinicians should inform their patients of the potential risks of adverse events associated with SMT.

2018 Consensus statement on exercise therapy and physical interventions (orthoses, taping and manual therapy) to treat patellofemoral pain: recommendations from the 5th International Patellofemoral Pain Research Retreat, Gold Coast, Australia, 2017.

Patellofemoral pain affects a large proportion of the population, from adolescents to older adults, and carries a substantial personal and societal burden. An international group of scientists and clinicians meets biennially at the International Patellofemoral Research Retreat to share research findings related to patellofemoral pain conditions and develop consensus statements using best practice methods. This consensus statement, from the 5th International Patellofemoral Research Retreat held in Australia in July 2017, focuses on exercise therapy and physical interventions (eg, orthoses, taping and manual therapy) for patellofemoral pain. Literature searches were conducted to identify new systematic reviews and randomised controlled trials (RCTs) published since the 2016 Consensus Statement. The methodological quality of included systematic reviews and RCTs was graded using AMSTAR and PEDro, respectively. Evidence-based statements were developed from included papers and presented to a panel of 41 patellofemoral pain experts for consensus discussion and voting. Recommendations from the expert panel support the use of exercise therapy (especially the combination of hip-focused and knee-focused exercises), combined interventions and foot orthoses to improve pain and/or function in people with patellofemoral pain. The use of patellofemoral, knee or lumbar mobilisations in isolation, or electrophysical agents, is not recommended. There is uncertainty regarding the use of patellar taping/bracing, acupuncture/dry needling, manual soft tissue techniques, blood flow restriction training and gait retraining in patients with patellofemoral pain. In 2017, we launched the International Patellofemoral Research Network (www.ipfrn.org) to consolidate and grow our patellofemoral research community, facilitate collaboration and disseminate patellofemoral pain knowledge to clinicians and the general public. The 6th International Patellofemoral Research Retreat will be held in Milwaukee, Wisconsin, USA, in October 2019.

Chronic complaints after ankle sprains: a systematic review on effectiveness of treatments.

STUDY DESIGN: Systematic review. Objective To determine the effectiveness of treatments for patients with chronic complaints after ankle sprain. BACKGROUND: Though most people recover completely after a lateral inversion ankle injury, a considerable percentage have persistent complaints. Currently, it is still unclear which treatment options are best for these patients. METHODS: Major databases, including PubMed, Embase, CINAHL, and PEDro, were searched for randomized controlled trials and controlled clinical trials conducted from 1966 to October 2012. Due to clinical heterogeneity, the data were analyzed using a best-evidence synthesis. RESULTS: A total of 20 randomized controlled trials and 1 controlled clinical trial were included in the analysis. The included studies compared different treatments (training programs, physiotherapy, chiropractic/manual therapy, surgery, postoperative training, and functional treatment). For pain and function outcomes, limited to moderate evidence was found for effectiveness of a training program compared to conservative treatment. Two studies found a decrease of recurrences after a proprioceptive training program. Four studies showed good results for different surgical methods but did not include a nonsurgical control group for comparison. Limited evidence was found for the effectiveness of an early mobilization program after surgery. CONCLUSION: In chronic ankle complaints after an ankle sprain, a training program gives better results for pain and function, and a decrease of recurrent ankle sprains, than a wait-and-see policy. There was insufficient evidence to determine the most effective surgical treatment, but limited evidence suggests that postoperative, early mobilization was more effective than a plaster cast. LEVEL OF EVIDENCE: Therapy, level 1a-.

Trends over time in the size and quality of randomised controlled trials of interventions for 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.

Effectiveness of interventions for secondary Raynaud's phenomenon: a systematic review.

OBJECTIVES: To present an evidence-based overview of the effectiveness of (non)surgical symptomatic interventions to treat secondary Raynaud's phenomenon (RP). DATA SOURCES: The Cochrane Library, PubMed, Embase, PEDro, and CINAHL were searched for relevant systematic reviews and randomized controlled trials (RCTs). STUDY SELECTION: Two reviewers independently applied the inclusion criteria to select potential studies. DATA EXTRACTION: Two reviewers independently extracted data and assessed the methodologic quality. DATA SYNTHESIS: If pooling of data was not possible, a best-evidence synthesis was used to summarize the results. Of the 5 reviews and 19 RCTs included, 1 RCT studied acupuncture and another RCT reported on percutaneous radiofrequency thoracic sympathectomy. All others concentrated on the effectiveness of drugs (oral or intravenous [IV]). It appeared that calcium channel blockers significantly reduce the frequency and severity of Raynaud attacks, and are therefore effective in the treatment of secondary RP. Iloprost (oral and IV) was also found to be effective. Limited evidence was found for atorvastatin. For other traditional and more recently discovered interventions, no clear favorable effects were found. CONCLUSIONS: This review shows that there is clear evidence in favor of calcium channel blockers and iloprost (oral and IV) to treat secondary RP. For all other interventions, only limited, conflicting, or no evidence was found. More high-quality, well-designed RCTs are needed in this field, especially for new interventions based on recent knowledge about the pathophysiology of secondary RP.

Spinal manipulative therapy for chronic low-back pain.

BACKGROUND: Many therapies exist for the treatment of low-back pain including spinal manipulative therapy (SMT), which is a worldwide, extensively practiced intervention. OBJECTIVES: To assess the effects of SMT for chronic low-back pain. SEARCH STRATEGY: An updated search was conducted by an experienced librarian to June 2009 for randomised controlled trials (RCTs) in CENTRAL (The Cochrane Library 2009, issue 2), MEDLINE, EMBASE, CINAHL, PEDro, and the Index to Chiropractic Literature.   SELECTION CRITERIA: RCTs which examined the effectiveness of spinal manipulation or mobilisation in adults with chronic low-back pain were included. No restrictions were placed on the setting or type of pain; studies which exclusively examined sciatica were excluded. The primary outcomes were pain, functional status and perceived recovery. Secondary outcomes were return-to-work and quality of life. DATA COLLECTION AND ANALYSIS: Two review authors independently conducted the study selection, risk of bias assessment and data extraction. GRADE was used to assess the quality of the evidence. Sensitivity analyses and investigation of heterogeneity were performed, where possible, for the meta-analyses. MAIN RESULTS: We included 26 RCTs (total participants = 6070), nine of which had a low risk of bias. Approximately two-thirds of the included studies (N = 18) were not evaluated in the previous review. In general, there is high quality evidence that SMT has a small, statistically significant but not clinically relevant, short-term effect on pain relief (MD: -4.16, 95% CI -6.97 to -1.36) and functional status (SMD: -0.22, 95% CI -0.36 to -0.07) compared to other interventions. Sensitivity analyses confirmed the robustness of these findings. There is varying quality of evidence (ranging from low to high) that SMT has a statistically significant short-term effect on pain relief and functional status when added to another intervention. There is very low quality evidence that SMT is not statistically significantly more effective than inert interventions or sham SMT for short-term pain relief or functional status. Data were particularly sparse for recovery, return-to-work, quality of life, and costs of care. No serious complications were observed with SMT. AUTHORS' CONCLUSIONS: High quality evidence suggests that there is no clinically relevant difference between SMT and other interventions for reducing pain and improving function in patients with chronic low-back pain. Determining cost-effectiveness of care has high priority. Further research is likely to have an important impact on our confidence in the estimate of effect in relation to inert interventions and sham SMT, and data related to recovery.

Carpal tunnel syndrome. Part I: effectiveness of nonsurgical treatments--a systematic review.

OBJECTIVE: To review literature systematically concerning effectiveness of nonsurgical interventions for treating carpal tunnel syndrome (CTS). DATA SOURCES: The Cochrane Library, PubMed, EMBASE, CINAHL, and PEDro were searched for relevant systematic reviews and randomized controlled trials (RCTs). STUDY SELECTION: Two reviewers independently applied the inclusion criteria to select potential studies. DATA EXTRACTION: Two reviewers independently extracted the data and assessed the methodologic quality. DATA SYNTHESIS: A best-evidence synthesis was performed to summarize the results of the included studies. Two reviews and 20 RCTs were included. Strong and moderate evidence was found for the effectiveness of oral steroids, steroid injections, ultrasound, electromagnetic field therapy, nocturnal splinting, and the use of ergonomic keyboards compared with a standard keyboard, and traditional cupping versus heat pads in the short term. Also, moderate evidence was found for ultrasound in the midterm. With the exception of oral and steroid injections, no long-term results were reported for any of these treatments. No evidence was found for the effectiveness of oral steroids in long term. Moreover, although higher doses of steroid injections seem to be more effective in the midterm, the benefits of steroids injections were not maintained in the long term. For all other nonsurgical interventions studied, only limited or no evidence was found. CONCLUSIONS: The reviewed evidence supports that a number of nonsurgical interventions benefit CTS in the short term, but there is sparse evidence on the midterm and long-term effectiveness of these interventions. Therefore, future studies should concentrate not only on short-term but also on midterm and long-term results.

A systematic review on the effectiveness of complementary and alternative medicine for chronic non-specific low-back pain.

The purpose of this systematic review was to assess the effects of spinal manipulative therapy (SMT), acupuncture and herbal medicine for chronic non-specific LBP. A comprehensive search was conducted by an experienced librarian from the Cochrane Back Review Group (CBRG) in multiple databases up to December 22, 2008. Randomised controlled trials (RCTs) of adults with chronic non-specific LBP, which evaluated at least one clinically relevant, patient-centred outcome measure were included. Two authors working independently from one another assessed the risk of bias using the criteria recommended by the CBRG and extracted the data. The data were pooled when clinically homogeneous and statistically possible or were otherwise qualitatively described. GRADE was used to determine the quality of the evidence. In total, 35 RCTs (8 SMT, 20 acupuncture, 7 herbal medicine), which examined 8,298 patients, fulfilled the inclusion criteria. Approximately half of these (2 SMT, 8 acupuncture, 7 herbal medicine) were thought to have a low risk of bias. In general, the pooled effects for the studied interventions demonstrated short-term relief or improvement only. The lack of studies with a low-risk of bias, especially in regard to SMT precludes any strong conclusions; however, the principal findings, which are based upon low- to very-low-quality evidence, suggest that SMT does not provide a more clinically beneficial effect compared with sham, passive modalities or any other intervention for treatment of chronic low-back pain. There is evidence, however, that acupuncture provides a short-term clinically relevant effect when compared with a waiting list control or when acupuncture is added to another intervention. Although there are some good results for individual herbal medicines in short-term individual trials, the lack of homogeneity across studies did not allow for a pooled estimate of the effect. In general, these results are in agreement with other recent systematic reviews on SMT, but in contrast with others. These results are also in agreement with recent reviews on acupuncture and herbal medicine. Randomized trials with a low risk of bias and adequate sample sizes are directly needed.