Clinical impact of early post-transplant red cell transfusions in kidney transplantation: a systematic review and meta-analysis

Introduction: Red blood cell transfusions (RBCT) represent a potentially modifiable risk factor for HLA sensitisation and adverse outcomes post transplantation. Evidence of the clinical impact of post-transplant RBCT has been infrequently reported. Herein, we performed a systematic review of available literature to assess the prevalence of RBCT post kidney transplant, and the effect of transfusion on transplant outcomes. Methods: We included studies from 2000 to July 2022, published on Medline, Embase and the Transplant Library. Results: Ten studies were analysed which included a total of 32,817 kidney transplant recipients, with a median transfusion prevalence of 40% (range 18-64%). There was significant heterogeneity between studies in terms of patient and allograft characteristics, immunological risk, and immunosuppression protocols. Analysis of unadjusted outcomes showed that post-transplant RBCTs are associated with inferior patient survival, allograft loss, rejection and donor specific antibodies. Adjusted outcomes were described where available, and supported the adverse associations seen in the unadjusted models in many studies. Discussion: This review demonstrates that RBCT post-transplant are common and maybe associated with inferior outcomes, highlighting the urgent need for high quality prospective evidence of the effect of RBCTs on transplant outcomes. Systematic Review Registration: https://www.crd.york.ac.uk/prospero/, identifier, CRD42022348763767

Communication style and exercise compliance in physiotherapy (CONNECT). A cluster randomized controlled trial to test a theory-based intervention to increase chronic low back pain patients’ adherence to physiotherapists’ recommendations: study rationale, design, and methods

Physical activity and exercise therapy are among the accepted clinical rehabilitation guidelines and are recommended self-management strategies for chronic low back pain. However, many back pain sufferers do not adhere to their physiotherapist’s recommendations. Poor patient adherence may decrease the effectiveness of advice and home-based rehabilitation exercises. According to self-determination theory, support from health care practitioners can promote patients’ autonomous motivation and greater long-term behavioral persistence (e.g., adherence to physiotherapists’ recommendations). The aim of this trial is to assess the effect of an intervention designed to increase physiotherapists’ autonomy-supportive communication on low back pain patients’ adherence to physical activity and exercise therapy recommendations. \ud \ud This study will be a single-blinded cluster randomized controlled trial. Outpatient physiotherapy centers (N =12) in Dublin, Ireland (population = 1.25 million) will be randomly assigned using a computer-generated algorithm to either the experimental or control arm. Physiotherapists in the experimental arm (two hospitals and four primary care clinics) will attend eight hours of communication skills training. Training will include handouts, workbooks, video examples, role-play, and discussion designed to teach physiotherapists how to communicate in a manner that promotes autonomous patient motivation. Physiotherapists in the waitlist control arm (two hospitals and four primary care clinics) will not receive this training. Participants (N = 292) with chronic low back pain will complete assessments at baseline, as well as 1 week, 4 weeks, 12 weeks, and 24 weeks after their first physiotherapy appointment. Primary outcomes will include adherence to physiotherapy recommendations, as well as low back pain, function, and well-being. Participants will be blinded to treatment allocation, as they will not be told if their physiotherapist has received the communication skills training. Outcome assessors will also be blinded. \ud \ud We will use linear mixed modeling to test between arm differences both in the mean levels and the rates of change of the outcome variables. We will employ structural equation modeling to examine the process of change, including hypothesized mediation effects. \ud \ud This trial will be the first to test the effect of a self-determination theory-based communication skills training program for physiotherapists on their low back pain patients’ adherence to rehabilitation recommendations. Current Controlled Trials ISRCTN63723433\u

Chronic non-specific low back pain - sub-groups or a single mechanism?

Copyright 2008 Wand and O'Connell; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.Background: Low back pain is a substantial health problem and has subsequently attracted a considerable amount of research. Clinical trials evaluating the efficacy of a variety of interventions for chronic non-specific low back pain indicate limited effectiveness for most commonly applied interventions and approaches. Discussion: Many clinicians challenge the results of clinical trials as they feel that this lack of effectiveness is at odds with their clinical experience of managing patients with back pain. A common explanation for this discrepancy is the perceived heterogeneity of patients with chronic non-specific low back pain. It is felt that the effects of treatment may be diluted by the application of a single intervention to a complex, heterogeneous group with diverse treatment needs. This argument presupposes that current treatment is effective when applied to the correct patient. An alternative perspective is that the clinical trials are correct and current treatments have limited efficacy. Preoccupation with sub-grouping may stifle engagement with this view and it is important that the sub-grouping paradigm is closely examined. This paper argues that there are numerous problems with the sub-grouping approach and that it may not be an important reason for the disappointing results of clinical trials. We propose instead that current treatment may be ineffective because it has been misdirected. Recent evidence that demonstrates changes within the brain in chronic low back pain sufferers raises the possibility that persistent back pain may be a problem of cortical reorganisation and degeneration. This perspective offers interesting insights into the chronic low back pain experience and suggests alternative models of intervention. Summary: The disappointing results of clinical research are commonly explained by the failure of researchers to adequately attend to sub-grouping of the chronic non-specific low back pain population. Alternatively, current approaches may be ineffective and clinicians and researchers may need to radically rethink the nature of the problem and how it should best be managed

A randomized controlled trial of tai chi for long-term low back pain (TAI CHI): Study rationale, design, and methods

<p>Abstract</p> <p>Background</p> <p>Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain.</p> <p>Methods and design</p> <p>The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes)/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452</p> <p>Discussion</p> <p>This study will be the first trial in this area and the information on its effectiveness will allow patients, clinicians and treatment funders to make informed choices regarding this treatment.</p> <p>Trial Registration</p> <p>This trial has been registered with Australian New Zealand Clinical Trials Registry. <b>ACTRN12608000270314</b></p

PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>Clinical practice guidelines recommend that the initial treatment of acute low back pain (LBP) should consist of advice to stay active and regular simple analgesics such as paracetamol 4 g daily. Despite this recommendation in all international LBP guidelines there are no placebo controlled trials assessing the efficacy of paracetamol for LBP at any dose or dose regimen. This study aims to determine whether 4 g of paracetamol daily (in divided doses) results in a more rapid recovery from acute LBP than placebo. A secondary aim is to determine if ingesting paracetamol in a time-contingent manner is more effective than paracetamol taken when required (PRN) for recovery from acute LBP.</p> <p>Methods/Design</p> <p>The study is a randomised double dummy placebo controlled trial. 1650 care seeking people with significant acute LBP will be recruited. All participants will receive advice to stay active and will be randomised to 1 of 3 treatment groups: time-contingent paracetamol dose regimen (plus placebo PRN paracetamol), PRN paracetamol (plus placebo time-contingent paracetamol) or a double placebo study arm. The primary outcome will be time (days) to recovery from pain recorded in a daily pain diary. Other outcomes will be pain intensity, disability, function, global perceived effect and sleep quality, captured at baseline and at weeks 1, 2, 4 and 12 by an assessor blind to treatment allocation. An economic analysis will be conducted to determine the cost-effectiveness of treatment from the health sector and societal perspectives.</p> <p>Discussion</p> <p>The successful completion of the trial will provide the first high quality evidence on the effectiveness of the use of paracetamol, a guideline endorsed treatment for acute LBP.</p> <p>Trail registration</p> <p>ACTRN12609000966291.</p

The relationship between low back pain and leisure time physical activity in a working population of cleaners - a study with weekly follow-ups for 1 year

<p>Abstract</p> <p>Background</p> <p>Low back pain (LBP) and leisure time physical activity (LTPA) are considered to be closely related, and clinical guidelines for the treatment of acute LBP recommend patients stay physically active. However, the documentation for this recommendation is sparse and based on studies involving patient populations. The purpose of the study was (1) to investigate the correlation between LBP and LTPA on a weekly basis over the course of a year in a high-risk group of cleaners; and (2) to investigate if maintaining LTPA during an episode of acute LBP has a positive effect on LBP intensity in the subsequent 4 weeks.</p> <p>Methods</p> <p>188 cleaners consented to participate in a 52-week text message survey about hours of LTPA and intensity of LBP (from 0 to 9) over the previous 7 days. The correlation between LBP and LTPA was calculated by Pearson correlation coefficient. During an episode of acute LBP, a mixed effect logistic regression model was used to investigate whether cleaners who maintain LTPA have a lower pain intensity and higher probability of returning to initial pain intensity within the following four weeks compared with cleaners who decrease LTPA during acute LBP.</p> <p>Results</p> <p>The correlation between weekly LTPA and LBP data was negative, but numerically low (r = -0.069) and statistically insignificant (<it>p </it>= 0.08). Among the 82 cleaners experiencing at least one episode of acute LBP, those maintaining LTPA during an episode of acute LBP did not have a lower pain intensity (average LBP intensity difference between groups of 0.06; 95% confidence interval (95% CI) of -0.417 to 0.539) or higher probability of returning to initial pain level (Odds ratio 1,02; 95% CI of 0.50 to 2.09) in the following four weeks compared with cleaners decreasing LTPA during acute LBP.</p> <p>Conclusions</p> <p>Hours of LTPA and intensity of LBP measured on a weekly basis throughout a year showed no close correlation. Maintaining LTPA during an episode of acute LBP did not result in a positive effect on LBP in the following 4 weeks. Documentation of LTPA recommendations for acute LBP in working populations is still needed.</p

The COPE LBP trial: Cognitive Patient Education for Low Back Pain - a cluster randomized controlled trial in primary care

<p>Abstract</p> <p>Background</p> <p>Non-specific low back pain (LBP) is usually self-limiting within 4-6 weeks. Longstanding pain and disability are not predictable from clinical signs or pathoanatomical findings. Pain cognition and physical performance have been shown to improve patients with chronic LBP following neurophysiological education. The primary aim of this study is to evaluate whether a specific cognitive based education programme for patients with LBP in primary care is more effective than normal care in terms of increased function. The secondary aims of the study are to evaluate whether this intervention also results in earlier return to work, decreased pain, increased patient satisfaction, increased quality-of-life, and cost utility.</p> <p>Methods/Design</p> <p>Cluster randomised controlled trial with 20 general practitioners and 20 physiotherapists in primary care as the unit of randomisation. Each practitioner will recruit up to 10 patients, aged 20 to 55 years, with non-specific sub-acute/chronic LBP of more than four weeks but less than 1 year's duration. Practitioners in the intervention arm will provide cognitive patient education intervention in up to four weekly sessions, each lasting 30 minutes. Practitioners in the control arm will provide normal treatment, but have to make four appointments for the patients. Patients, outcome assessors, and study statistician will be blinded to group allocation.</p> <p>Discussion</p> <p>We present the rationale and design of an ongoing RCT study that potentially offers an easily implemented treatment strategy for LBP patients in primary care. The results will be available in 2012.</p> <p>Trial registration</p> <p>ISRCTN04323845</p

Specific treatment of problems of the spine (STOPS): design of a randomised controlled trial comparing specific physiotherapy versus advice for people with subacute low back disorders

<p>Abstract</p> <p>Background</p> <p>Low back disorders are a common and costly cause of pain and activity limitation in adults. Few treatment options have demonstrated clinically meaningful benefits apart from advice which is recommended in all international guidelines. Clinical heterogeneity of participants in clinical trials is hypothesised as reducing the likelihood of demonstrating treatment effects, and sampling of more homogenous subgroups is recommended. We propose five subgroups that allow the delivery of specific physiotherapy treatment targeting the pathoanatomical, neurophysiological and psychosocial components of low back disorders. The aim of this article is to describe the methodology of a randomised controlled trial comparing specific physiotherapy treatment to advice for people classified into five subacute low back disorder subgroups.</p> <p>Methods/Design</p> <p>A multi-centre parallel group randomised controlled trial is proposed. A minimum of 250 participants with subacute (6 weeks to 6 months) low back pain and/or referred leg pain will be classified into one of five subgroups and then randomly allocated to receive either physiotherapy advice (2 sessions over 10 weeks) or specific physiotherapy treatment (10 sessions over 10 weeks) tailored according to the subgroup of the participant. Outcomes will be assessed at 5 weeks, 10 weeks, 6 months and 12 months following randomisation. Primary outcomes will be activity limitation measured with a modified Oswestry Disability Index as well as leg and back pain intensity measured on separate 0-10 Numerical Rating Scales. Secondary outcomes will include a 7-point global rating of change scale, satisfaction with physiotherapy treatment, satisfaction with treatment results, the Sciatica Frequency and Bothersomeness Scale, quality of life (EuroQol-5D), interference with work, and psychosocial risk factors (Orebro Musculoskeletal Pain Questionnaire). Adverse events and co-interventions will also be measured. Data will be analysed according to intention to treat principles, using linear mixed models for continuous outcomes, Mann Whitney U tests for ordinal outcomes, and Chi-square, risk ratios and risk differences for dichotomous outcomes.</p> <p>Discussion</p> <p>This trial will determine the difference in outcomes between specific physiotherapy treatment tailored to each of the five subgroups versus advice which is recommended in guidelines as a suitable treatment for most people with a low back disorder.</p> <p>Trial registration</p> <p>Australia and New Zealand Clinical Trials Register (ANZCTR): <a href="http://www.anzctr.org.au/ACTRN12609000834257.aspx">ACTRN12609000834257</a>.</p

Total disc replacement surgery for symptomatic degenerative lumbar disc disease: a systematic review of the literature

The objective of this study is to evaluate the effectiveness and safety of total disc replacement surgery compared with spinal fusion in patients with symptomatic lumbar disc degeneration. Low back pain (LBP), a major health problem in Western countries, can be caused by a variety of pathologies, one of which is degenerative disc disease (DDD). When conservative treatment fails, surgery might be considered. For a long time, lumbar fusion has been the “gold standard” of surgical treatment for DDD. Total disc replacement (TDR) has increased in popularity as an alternative for lumbar fusion. A comprehensive systematic literature search was performed up to October 2008. Two reviewers independently checked all retrieved titles and abstracts, and relevant full text articles for inclusion. Two reviewers independently assessed the risk of bias of included studies and extracted relevant data and outcomes. Three randomized controlled trials and 16 prospective cohort studies were identified. In all three trials, the total disc replacement was compared with lumbar fusion techniques. The Charité trial (designed as a non-inferiority trail) was considered to have a low risk of bias for the 2-year follow up, but a high risk of bias for the 5-year follow up. The Charité artificial disc was non-inferior to the BAK® Interbody Fusion System on a composite outcome of “clinical success” (57.1 vs. 46.5%, for the 2-year follow up; 57.8 vs. 51.2% for the 5-year follow up). There were no statistically significant differences in mean pain and physical function scores. The Prodisc artificial disc (also designed as a non-inferiority trail) was found to be statistically significant more effective when compared with the lumbar circumferential fusion on the composite outcome of “clinical success” (53.4 vs. 40.8%), but the risk of bias of this study was high. Moreover, there were no statistically significant differences in mean pain and physical function scores. The Flexicore trial, with a high risk of bias, found no clinical relevant differences on pain and physical function when compared with circumferential spinal fusion at 2-year follow up. Because these are preliminary results, in addition to the high risk of bias, no conclusions can be drawn based on this study. In general, these results suggest that no clinical relevant differences between the total disc replacement and fusion techniques. The overall success rates in both treatment groups were small. Complications related to the surgical approach ranged from 2.1 to 18.7%, prosthesis related complications from 2.0 to 39.3%, treatment related complications from 1.9 to 62.0% and general complications from 1.0 to 14.0%. Reoperation at the index level was reported in 1.0 to 28.6% of the patients. In the three trials published, overall complication rates ranged from 7.3 to 29.1% in the TDR group and from 6.3 to 50.2% in the fusion group. The overall reoperation rate at index-level ranged from 3.7 to 11.4% in the TDR group and from 5.4 to 26.1% in the fusion group. In conclusion, there is low quality evidence that the Charité is non-inferior to the BAK cage at the 2-year follow up on the primary outcome measures. For the 5-year follow up, the same conclusion is supported only by very low quality evidence. For the ProDisc, there is very low quality evidence for contradictory results on the primary outcome measures when compared with anterior lumbar circumferential fusion. High quality randomized controlled trials with relevant control group and long-term follow-up is needed to evaluate the effectiveness and safety of TDR