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1.  Match injuries in amateur Rugby Union: a prospective cohort study - FICS Biennial Symposium Second Prize Research Award 
Background
The majority of Rugby Union (rugby) players participate at the amateur level. Knowledge of player characteristics and injury risks is predominantly ascertained from studies on professional or junior athletes in rugby. The objectives of the current study are to: (1) describe the health-related quality of life (HRQoL) and physical characteristics of a cohort of amateur rugby players; (2) describe the incidence, severity and mechanism of match injuries in amateur rugby, and; (3) explore factors associated with rates of match injury in this population.
Methods
Participants (n = 125) from one amateur men’s rugby club were followed in a one-season (2012) prospective cohort study. Match injury and match time exposure data were collected. A participant match exposure log was maintained. Baseline variables collected include: participant’s age, playing experience, position of play, the SF-36v2 health survey, height and weight. Injury incidence rates (IIRs) per 1000 match-hours exposure were calculated. Injury sub-groups were compared by calculating rate ratios of two IIRs. Poisson mixed-effects generalised linear modelling was used to explore relationships between IIRs and baseline predictors.
Results
A total of 129 injuries occurred during a combined period of 2465 match-hours of exposure. The overall IIR was 52.3 (43.7–62.2) /1000 match-hours exposure. Moderate-severe injuries (>1 week time-loss from play) comprised 36 % of all injuries. Tackling was the most common mechanism of injury, the head/face was the most common body region of injury and sprain/ligament injuries were the most common injury type. Fewer years of rugby participation, lower BMI and lower SF-36v2 mental component summary score were associated with higher IIR in amateur rugby. Age, player position i.e., backs versus forwards and SF-36v2 physical component summary score were not associated with injury incidence.
Conclusion
Amateur rugby players report similar HRQoL as the general population. We found amateur players had a higher rate of injury and lower injury severity than previous amateur studies, but location, type, and mechanism were similar. In this study pre-season HRQoL and BMI were weakly associated with higher injury rate when controlling for other factors; a finding that should be interpreted with caution and clarified with future research.
Electronic supplementary material
The online version of this article (doi:10.1186/s12998-016-0098-7) contains supplementary material, which is available to authorized users.
doi:10.1186/s12998-016-0098-7
PMCID: PMC4888508  PMID: 27252828
Sports; Football; Rugby Union; Athletic injuries; Epidemiology
2.  Estimating the Risk of Chronic Pain: Development and Validation of a Prognostic Model (PICKUP) for Patients with Acute Low Back Pain 
PLoS Medicine  2016;13(5):e1002019.
Background
Low back pain (LBP) is a major health problem. Globally it is responsible for the most years lived with disability. The most problematic type of LBP is chronic LBP (pain lasting longer than 3 mo); it has a poor prognosis and is costly, and interventions are only moderately effective. Targeting interventions according to risk profile is a promising approach to prevent the onset of chronic LBP. Developing accurate prognostic models is the first step. No validated prognostic models are available to accurately predict the onset of chronic LBP. The primary aim of this study was to develop and validate a prognostic model to estimate the risk of chronic LBP.
Methods and Findings
We used the PROGRESS framework to specify a priori methods, which we published in a study protocol. Data from 2,758 patients with acute LBP attending primary care in Australia between 5 November 2003 and 15 July 2005 (development sample, n = 1,230) and between 10 November 2009 and 5 February 2013 (external validation sample, n = 1,528) were used to develop and externally validate the model. The primary outcome was chronic LBP (ongoing pain at 3 mo). In all, 30% of the development sample and 19% of the external validation sample developed chronic LBP. In the external validation sample, the primary model (PICKUP) discriminated between those who did and did not develop chronic LBP with acceptable performance (area under the receiver operating characteristic curve 0.66 [95% CI 0.63 to 0.69]). Although model calibration was also acceptable in the external validation sample (intercept = −0.55, slope = 0.89), some miscalibration was observed for high-risk groups. The decision curve analysis estimated that, if decisions to recommend further intervention were based on risk scores, screening could lead to a net reduction of 40 unnecessary interventions for every 100 patients presenting to primary care compared to a “treat all” approach. Limitations of the method include the model being restricted to using prognostic factors measured in existing studies and using stepwise methods to specify the model. Limitations of the model include modest discrimination performance. The model also requires recalibration for local settings.
Conclusions
Based on its performance in these cohorts, this five-item prognostic model for patients with acute LBP may be a useful tool for estimating risk of chronic LBP. Further validation is required to determine whether screening with this model leads to a net reduction in unnecessary interventions provided to low-risk patients.
Adrian Traeger and colleagues report the development and validation of a prognostiv model (PICKUP) for estimating risk of developing chronic low back pain.
Author Summary
Why Was This Study Done?
A minority of patients who experience an episode of low back pain develop persistent (chronic) pain.
Offering tests and treatments to all these patients exposes high numbers of low-risk patients to unnecessary intervention, which is very costly and potentially harmful.
A tool to help healthcare practitioners accurately predict whether a patient with a recent episode of low back pain will develop persistent pain stands to greatly reduce the burden of low back pain on the health system and on patients.
What Did the Researchers Do and Find?
We developed a five-item screening questionnaire using study data from 1,230 patients with a recent episode of low back pain.
We tested how well this screening questionnaire could predict the onset of persistent pain in a separate sample of 1,528 patients.
We found that the screening questionnaire could predict the onset of persistent pain with acceptable levels accuracy (area under the receiver operating characteristic curve = 0.66 [95% CI 0.63 to 0.69]; intercept = 0.55, slope = 0.89).
What Do These Findings Mean?
This brief, easy-to-use screening questionnaire could help healthcare practitioners and researchers make an early estimate of a patient’s risk of persistent low back pain.
The screening questionnaire predicted outcome more accurately in patients with low risk scores than in those with high risk scores.
Screening patients with a recent episode of low back pain could reduce the number of unnecessary interventions provided to low-risk patients.
doi:10.1371/journal.pmed.1002019
PMCID: PMC4871494  PMID: 27187782
3.  Musculoskeletal pain in children and adolescents 
ABSTRACT
Introduction
Musculoskeletal (MSK) pain in children and adolescents is responsible for substantial personal impacts and societal costs, but it has not been intensively or systematically researched. This means our understanding of these conditions is limited, and healthcare professionals have little empirical evidence to underpin their clinical practice. In this article we summarise the state of the evidence concerning MSK pain in children and adolescents, and offer suggestions for future research.
Results
Rates of self-reported MSK pain in adolescents are similar to those in adult populations and they are typically higher in teenage girls than boys. Epidemiological research has identified conditions such as back and neck pain as major causes of disability in adolescents, and in up to a quarter of cases there are impacts on school or physical activities. A range of physical, psychological and social factors have been shown to be associated with MSK pain report, but the strength and direction of these relationships are unclear. There are few validated instruments available to quantify the nature and severity of MSK pain in children, but some show promise. Several national surveys have shown that adolescents with MSK pain commonly seek care and use medications for their condition. Some studies have revealed a link between MSK pain in adolescents and chronic pain in adults.
Conclusion
Musculoskeletal pain conditions are often recurrent in nature, occurring throughout the life-course. Attempts to understand these conditions at a time close to their initial onset may offer a better chance of developing effective prevention and treatment strategies.
doi:10.1590/bjpt-rbf.2014.0149
PMCID: PMC4946844  PMID: 27437719
children; adolescents; musculoskeletal pain; burden; epidemiology
4.  Effects of Air Temperature on Climate-Sensitive Mortality and Morbidity Outcomes in the Elderly; a Systematic Review and Meta-analysis of Epidemiological Evidence 
EBioMedicine  2016;6:258-268.
Introduction
Climate change and rapid population ageing are significant public health challenges. Understanding which health problems are affected by temperature is important for preventing heat and cold-related deaths and illnesses, particularly in the elderly. Here we present a systematic review and meta-analysis on the effects of ambient hot and cold temperature (excluding heat/cold wave only studies) on elderly (65 + years) mortality and morbidity.
Methods
Time-series or case-crossover studies comprising cause-specific cases of elderly mortality (n = 3,933,398) or morbidity (n = 12,157,782) were pooled to obtain a percent change (%) in risk for temperature exposure on cause-specific disease outcomes using a random-effects meta-analysis.
Results
A 1 °C temperature rise increased cardiovascular (3.44%, 95% CI 3.10–3.78), respiratory (3.60%, 3.18–4.02), and cerebrovascular (1.40%, 0.06–2.75) mortality. A 1 °C temperature reduction increased respiratory (2.90%, 1.84–3.97) and cardiovascular (1.66%, 1.19–2.14) mortality. The greatest risk was associated with cold-induced pneumonia (6.89%, 20–12.99) and respiratory morbidity (4.93% 1.54–8.44). A 1 °C temperature rise increased cardiovascular, respiratory, diabetes mellitus, genitourinary, infectious disease and heat-related morbidity.
Discussion
Elevated risks for the elderly were prominent for temperature-induced cerebrovascular, cardiovascular, diabetes, genitourinary, infectious disease, heat-related, and respiratory outcomes. These risks will likely increase with climate change and global ageing.
Highlights
•Heat and cold exposure elevates elderly risk of cardiovascular and cerebrovascular deaths and respiratory deaths and morbidity.•Climate change and ageing will likely increase the risk of diabetes, renal, infectious disease and heat-induced morbidity.•Temperature risks for elderly populations in Africa, Middle East, Asia and South America are under-represented.
We applied a rigorous search strategy on three relevant databases following the PRISMA protocol. The search retrieved 18 mortality, and 30 morbidity publications eligible for meta-analysis, representing 3,933,398 deaths and 12,157,782 morbidity cases. Robust risk estimates were calculated for a wide range of temperature-sensitive health outcomes in the elderly. Temperature was found to significantly elevate cerebrovascular, cardiovascular, diabetes, genitourinary, and especially respiratory mortality or morbidity risks in the elderly. This study highlights considerable adverse health risks from temperature exposure in a large vulnerable population and provides impetus for climate change policy to address these risks.
doi:10.1016/j.ebiom.2016.02.034
PMCID: PMC4856745  PMID: 27211569
Temperature; Climate change; Mortality; Morbidity; Elderly; Meta-analysis
5.  Development and validation of a screening tool to predict the risk of chronic low back pain in patients presenting with acute low back pain: a study protocol 
BMJ Open  2015;5(7):e007916.
Introduction
Around 40% of people presenting to primary care with an episode of acute low back pain develop chronic low back pain. In order to reduce the risk of developing chronic low back pain, effective secondary prevention strategies are needed. Early identification of at-risk patients allows clinicians to make informed decisions based on prognostic profile, and researchers to select appropriate participants for secondary prevention trials. The aim of this study is to develop and validate a prognostic screening tool that identifies patients with acute low back pain in primary care who are at risk of developing chronic low back pain. This paper describes the methods and analysis plan for the development and validation of the tool.
Methods/analysis
The prognostic screening tool will be developed using methods recommended by the Prognosis Research Strategy (PROGRESS) Group and reported using the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement. In the development stage, we will use data from 1248 patients recruited for a prospective cohort study of acute low back pain in primary care. We will construct 3 logistic regression models to predict chronic low back pain according to 3 definitions: any pain, high pain and disability at 3 months. In the validation stage, we will use data from a separate sample of 1643 patients with acute low back pain to assess the performance of each prognostic model. We will produce validation plots showing Nagelkerke R2 and Brier score (overall performance), area under the curve statistic (discrimination) and the calibration slope and intercept (calibration).
Ethics and dissemination
Ethical approval from the University of Sydney Ethics Committee was obtained for both of the original studies that we plan to analyse using the methods outlined in this protocol (Henschke et al, ref 11-2002/3/3144; Williams et al, ref 11638).
doi:10.1136/bmjopen-2015-007916
PMCID: PMC4513486  PMID: 26179647
EPIDEMIOLOGY; PRIMARY CARE
6.  Responder analyses in randomised controlled trials for chronic low back pain: an overview of currently used methods 
European Spine Journal  2014;23(4):772-778.
Purpose
To provide an overview and a critical appraisal of the use of responder analyses in published randomised controlled trials (RCTs) of interventions for chronic low back pain (LBP). The methodology used for the analyses, including the justification, as well as the implications of responder analyses on the conclusions was explored.
Methods
A convenience sample of four systematic reviews evaluating 162 RCTs of interventions for chronic LBP was used to identify individual trials. Randomised trials were screened by two reviewers and included if they performed and reported a responder analysis (i.e. the proportion of participants achieving a pre-defined level of improvement). The cutoff value for responders, the period of follow-up, and the outcome measure used were extracted. Information on how RCT authors justified the methodology of their responder analyses was also appraised.
Results
Twenty-eight articles (17 %) using 20 different definitions of responders were included in this appraisal. Justification for the definition of responders was absent in 80 % of the articles. Pain was the most frequently used domain for the definition of response (50 %), followed by back-specific function (30 %) and a combination of pain and function (20 %). A reduction in pain intensity ≥50 % was the most common threshold used to define responders (IQR 33–60 %).
Conclusions
Few RCTs of interventions for chronic LBP report responder analyses. Where responder analyses are used, the methods are inconsistent. When performing responder analyses authors are encouraged to follow the recommended guidelines, using empirically derived cutoffs, and present results alongside mean differences.
doi:10.1007/s00586-013-3155-0
PMCID: PMC3960418  PMID: 24419902
Randomised trial; Back pain; Analysis; Responder; Outcomes
7.  Accuracy of clinical tests in the diagnosis of anterior cruciate ligament injury: a systematic review 
Background
Numerous clinical tests are used in the diagnosis of anterior cruciate ligament (ACL) injury but their accuracy is unclear. The purpose of this study is to evaluate the diagnostic accuracy of clinical tests for the diagnosis of ACL injury.
Methods
Study Design: Systematic review. The review protocol was registered through PROSPERO (CRD42012002069).
Electronic databases (PubMed, MEDLINE, EMBASE, CINAHL) were searched up to 19th of June 2013 to identify diagnostic studies comparing the accuracy of clinical tests for ACL injury to an acceptable reference standard (arthroscopy, arthrotomy, or MRI). Risk of bias was appraised using the QUADAS-2 checklist. Index test accuracy was evaluated using a descriptive analysis of paired likelihood ratios and displayed as forest plots.
Results
A total of 285 full-text articles were assessed for eligibility, from which 14 studies were included in this review. Included studies were deemed to be clinically and statistically heterogeneous, so a meta-analysis was not performed. Nine clinical tests from the history (popping sound at time of injury, giving way, effusion, pain, ability to continue activity) and four from physical examination (anterior draw test, Lachman’s test, prone Lachman’s test and pivot shift test) were investigated for diagnostic accuracy. Inspection of positive and negative likelihood ratios indicated that none of the individual tests provide useful diagnostic information in a clinical setting. Most studies were at risk of bias and reported imprecise estimates of diagnostic accuracy.
Conclusion
Despite being widely used and accepted in clinical practice, the results of individual history items or physical tests do not meaningfully change the probability of ACL injury. In contrast combinations of tests have higher diagnostic accuracy; however the most accurate combination of clinical tests remains an area for future research.
Clinical relevance
Clinicians should be aware of the limitations associated with the use of clinical tests for diagnosis of ACL injury.
doi:10.1186/s12998-014-0025-8
PMCID: PMC4152763  PMID: 25187877
Anterior cruciate ligament; Diagnosis; Medical history taking; Physical examination; Diagnostic test accuracy
8.  Pain education to prevent chronic low back pain: a study protocol for a randomised controlled trial 
BMJ Open  2014;4(6):e005505.
Introduction
Low back pain (LBP) is the leading cause of disability worldwide. Of those patients who present to primary care with acute LBP, 40% continue to report symptoms 3 months later and develop chronic LBP. Although it is possible to identify these patients early, effective interventions to improve their outcomes are not available. This double-blind (participant/outcome assessor) randomised controlled trial will investigate the efficacy of a brief educational approach to prevent chronic LBP in ‘at-risk’ individuals.
Methods/analysis
Participants will be recruited from primary care practices in the Sydney metropolitan area. To be eligible for inclusion participants will be aged 18–75 years, with acute LBP (<4 weeks’ duration) preceded by at least a 1 month pain-free period and at-risk of developing chronic LBP. Potential participants with chronic spinal pain and those with suspected serious spinal pathology will be excluded. Eligible participants who agree to take part will be randomly allocated to receive 2×1 h sessions of pain biology education or 2×1 h sessions of sham education from a specially trained study physiotherapist. The study requires 101 participants per group to detect a 1-point difference in pain intensity 3 months after pain onset. Secondary outcomes include the incidence of chronic LBP, disability, pain intensity, depression, healthcare utilisation, pain attitudes and beliefs, global recovery and recurrence and are measured at 1 week post-intervention, and at 3, 6 and 12 months post LBP onset.
Ethics/dissemination
Ethical approval was obtained from the University of New South Wales Human Ethics Committee in June 2013 (ref number HC12664). Outcomes will be disseminated through publication in peer-reviewed journals and presentations at international conference meetings.
Trial registration number
https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12612001180808
doi:10.1136/bmjopen-2014-005505
PMCID: PMC4054624  PMID: 24889854
Pain Management; Preventive Medicine; Primary Care
9.  Musculoskeletal conditions in children and adolescents managed in Australian primary care 
Background
Primary care settings play a vital role in the early detection and appropriate management of musculoskeletal conditions in paediatric populations. However, little data exist regarding these conditions in a primary care context or on the presentation of specific musculoskeletal disorders in children. The aim of this study was to estimate the caseload and describe typical management of musculoskeletal conditions in children and adolescents presenting to primary care in Australia.
Methods
An analysis of data from the Bettering the Evaluation and Care of Health (BEACH) study was performed. The BEACH study is a continuous national study of general practice (GP) activity in Australia. We identified all GP encounters with children and adolescents over the past five years and extracted data on demographic details, the problems managed, and GP management of each problem. SAS statistical software was used to calculate robust proportions and after adjustment for the cluster, the 95% confidence intervals (CIs).
Results
From the period April 2006 to March 2011, there were 65,279 encounters with children and adolescents in the BEACH database. Of the 77,830 problems managed at these encounters, 4.9% (95%CI 4.7% to 5.1%) were musculoskeletal problems. The rate of musculoskeletal problems managed increased significantly with age, however there was a significant decrease for girls aged 15–17 years. Upper and lower limb conditions were the most common, followed by spine and trunk conditions. Spine and trunk conditions were significantly more likely to be managed with medication, but less likely to receive imaging, than upper or lower limb problems.
Conclusions
Musculoskeletal problems in children and adolescents present a significant burden and an important challenge to the primary health care system in Australia. There is variability in rates of presentation between different age groups, gender and affected body region.
doi:10.1186/1471-2474-15-164
PMCID: PMC4032455  PMID: 24885231
Musculoskeletal complaints; Primary care; Child; Adolescence
10.  An international survey of pain in adolescents 
BMC Public Health  2014;14:447.
Background
A common belief is that pain is uncommon and short lived in adolescents. However, the burden of pain in adolescents is unclear because of limitations in previous research. The aim of this study is to estimate the prevalence of headache, stomach-ache and backache in adolescents and to explore the extent to which these three forms of pain coexist based upon a representative sample of adolescents from 28 countries.
Methods
Data were analysed from three consecutive waves (1997/98, 2001/02 and 2005/06) of the Health Behavior in School-aged Children: WHO Collaborative Cross-National survey (HBSC). Prevalence estimates are based upon adolescents who reported experiencing headache, stomach-ache or backache at least monthly for the last 6 months.
Results
There were a total of 404,206 participants with a mean (±SD) age of 13.6 (±1.7) years (range 9.8 to 17.3 years). The prevalence of headache was 54.1%, stomach-ache 49.8%, backache 37%, and at least one of the three pains 74.4%. Girls had a higher prevalence of the three pains than boys and the prevalence of pain increased with age. Headache, stomach-ache and backache frequently coexist, for example, of those with headache: 21.2% had headache alone, 31% suffered from both headache and stomach-ache, 12.1% suffered from backache and headache, and 35.7% had all three pains.
Conclusions
Somatic pain is very common in adolescents, more often coexisting than occurring in isolation. Our data supports the need for further research to improve the understanding of these pains in adolescents.
doi:10.1186/1471-2458-14-447
PMCID: PMC4046513  PMID: 24885027
Pain; Adolescent; Prevalence; Epidemiology; World Health Organisation; HBSC
11.  Red flags to screen for malignancy and fracture in patients with low back pain: systematic review 
The BMJ  2013;347:f7095.
Objective To review the evidence on diagnostic accuracy of red flag signs and symptoms to screen for fracture or malignancy in patients presenting with low back pain to primary, secondary, or tertiary care.
Design Systematic review.
Data sources Medline, OldMedline, Embase, and CINAHL from earliest available up to 1 October 2013.
Inclusion criteria Primary diagnostic studies comparing red flags for fracture or malignancy to an acceptable reference standard, published in any language.
Review methods Assessment of study quality and extraction of data was conducted by three independent assessors. Diagnostic accuracy statistics and post-test probabilities were generated for each red flag.
Results We included 14 studies (eight from primary care, two from secondary care, four from tertiary care) evaluating 53 red flags; only five studies evaluated combinations of red flags. Pooling of data was not possible because of index test heterogeneity. Many red flags in current guidelines provide virtually no change in probability of fracture or malignancy or have untested diagnostic accuracy. The red flags with the highest post-test probability for detection of fracture were older age (9%, 95% confidence interval 3% to 25%), prolonged use of corticosteroid drugs (33%, 10% to 67%), severe trauma (11%, 8% to 16%), and presence of a contusion or abrasion (62%, 49% to 74%). Probability of spinal fracture was higher when multiple red flags were present (90%, 34% to 99%). The red flag with the highest post-test probability for detection of spinal malignancy was history of malignancy (33%, 22% to 46%).
Conclusions While several red flags are endorsed in guidelines to screen for fracture or malignancy, only a small subset of these have evidence that they are indeed informative. These findings suggest a need for revision of many current guidelines.
doi:10.1136/bmj.f7095
PMCID: PMC3898572  PMID: 24335669
12.  Detecting insomnia in patients with low back pain: accuracy of four self-report sleep measures 
Background
Although insomnia is common in patients with low back pain (LBP), it is unknown whether commonly used self-report sleep measures are sufficiently accurate to screen for insomnia in the LBP population. This study investigated the discriminatory properties of the Pittsburgh Sleep Quality Index (Pittsburgh questionnaire), Insomnia Severity Index (Insomnia index), Epworth Sleepiness Scale (Epworth scale) and the sleep item of the Roland and Morris Disability Questionnaire (Roland item) to detect insomnia in patients with LBP by comparing their accuracy to detect insomnia to a sleep diary. The study also aimed to determine the clinical optimal cut-off scores of the questionnaires to detect insomnia in the LBP population.
Methods
Seventy nine patients with LBP completed the four self-reported questionnaires and a sleep diary for 7 consecutive nights. The accuracy of the questionnaires was evaluated using Receiver Operator Characteristic (ROC) curves with the Area Under the Curve (AUC) used to examine each test’s accuracy to discriminate participants with insomnia from those without insomnia.
Results
The Pittsburgh questionnaire and Insomnia index had moderate accuracy to detect insomnia (AUC = 0.79, 95% CI = 0.68 to 0.87 and AUC = 0.78, 95% CI = 0.67 to 0.86 respectively), whereas the Epworth scale and the Roland item were not found to be accurate discriminators (AUC = 0.53, 95% CI = 0. 41 to 0.64 and AUC = 0.64, 95% CI = 0.53 to 0.75 respectively). The cut-off score of > 6 for the Pittsburgh questionnaire and the cut-off point of > 14 for the Insomnia index provided optimal sensitivity and specificity for the detection of insomnia.
Conclusions
The Pittsburgh questionnaire and Insomnia index had similar ability to screen for insomnia in patients with low back pain.
doi:10.1186/1471-2474-14-196
PMCID: PMC3701511  PMID: 23805978
Low back pain; Insomnia; Diagnosis; Questionnaire; Accuracy
13.  Trends over time in the size and quality of randomised controlled trials of interventions for chronic low-back pain 
European Spine Journal  2011;21(3):375-381.
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.
doi:10.1007/s00586-011-2023-z
PMCID: PMC3296855  PMID: 22037844
Back pain; Bias; Methodology; Randomised trials
14.  The effect of continuous ultrasound on chronic non-specific low back pain: a single blind placebo-controlled randomized trial 
Background
Non-specific chronic low back pain (NSCLBP) is one of the most common musculoskeletal disorders around the world including Iran. One of the most widely used modalities in the field of physiotherapy is therapeutic ultrasound (US). Despite its common use, there is still inconclusive evidence to support its effectiveness in patients with NSCLBP. The objective of this study was to evaluate the effect of continuous US compared with placebo US additional to exercise therapy for patients with NSCLBP.
Methods
In this single blind placebo controlled study, 50 patients with NSCLBP were randomized into two treatment groups: 1) continuous US (1 MHz &1.5 W/cm2) plus exercise 2) placebo US plus exercise. Patients received treatments for 4 weeks, 10 treatment sessions, 3 times per week, every other day. Treatment effects were assessed in terms of primary outcome measures: 1) functional disability, measured by Functional Rating Index, and 2) global pain, measured by a visual analog scale. Secondary outcome measures were lumbar flexion and extension range of motion (ROM), endurance time and rate of decline in median frequency of electromyography spectrum during a Biering Sorensen test. All outcome variables were measured before, after treatment, and after one-month follow-up. An intention to treat analysis was performed. Main effects of Time and Group as well as their interaction effect on outcome measures were investigated using repeated measure ANOVA.
Results
Analysis showed that both groups had improved regarding function (FRI) and global pain (VAS) (P < .001). Lumbar ROM as well as holding time during the Sorensen test and median frequency slope of all measured paravertebral muscles did not change significantly in either group (P > .05). Improvement in function and lumbar ROM as well as endurance time were significantly greater in the group receiving continuous US (P < .05).
Conclusions
The study showed that adding continuous US to a semi supervised exercise program significantly improved function, lumbar ROM and endurance time. Further studies including a third group of only exercise and no US can establish the possible effects of placebo US.
Trial registration
NTR2251
doi:10.1186/1471-2474-13-192
PMCID: PMC3537701  PMID: 23031570
Low back pain; Ultrasound; Functional disability; Pain; Muscle endurance; Range of motion
15.  Taping patients with clinical signs of subacromial impingement syndrome: the design of a randomized controlled trial 
Background
Shoulder problems are a common complaint of the musculoskeletal system. Physical therapists treat these patients with different modalities such as exercise, massage, and shoulder taping. Although different techniques have been described, the effectiveness of taping has not yet been established. The aim of this study is to assess the effectiveness and cost-effectiveness of usual physical therapy care in combination with a particular tape technique for subacromial impingement syndrome of the shoulder compared to usual physical therapy care without this tape technique in a primary healthcare setting.
Methods and design
An economic evaluation alongside a randomized controlled trial will be conducted. A sample of 140 patients between 18 and 65 years of age with a diagnosis of subacromial impingement syndrome (SAIS) as assessed by physical therapists will be recruited. Eligible patients will be randomized to either the intervention group (usual care in combination with the particular tape technique) or the control group (usual care without this tape technique). In both groups, usual care will consist of individualized physical therapy care. The primary outcomes will be shoulder-specific function (the Simple Shoulder Test) and pain severity (11-point numerical rating scale). The economic evaluation will be performed using a societal perspective. All relevant costs will be registered using cost diaries. Utilities (Quality Adjusted Life Years) will be measured using the EuroQol. The data will be collected at baseline, and 4, 12, and 26 weeks follow-up.
Discussion
This pragmatic study will provide information about the effectiveness and cost-effectiveness of taping in patients presenting with clinical signs of SAIS.
Trial registration
Trial registration number: NTR2575
doi:10.1186/1471-2474-12-188
PMCID: PMC3173405  PMID: 21849055
16.  The effect of continuous ultrasound on chronic low back pain: protocol of a randomized controlled trial 
Background
Chronic non-specific low-back pain (LBP) is one of the most common and expensive musculoskeletal disorders in industrialized countries. Similar to other countries in the world, LBP is a common health and socioeconomic problem in Iran. One of the most widely used modalities in the field of physiotherapy for treating LBP is therapeutic ultrasound. Despite its common use, there is still inconclusive evidence to support its effectiveness in this group of patients. This randomised trial will evaluate the effectiveness of continuous ultrasound in addition to exercise therapy in patients with chronic LBP.
Methods and design
A total of 46 patients, between the ages 18 and 65 years old who have had LBP for more than three months will be recruited from university hospitals. Participants will be randomized to receive continuous ultrasound plus exercise therapy or placebo ultrasound plus exercise therapy. These groups will be treated for 10 sessions during a period of 4 weeks. Primary outcome measures will be functional disability and pain intensity. Lumbar flexion and extension range of motion, as well as changes in electromyography muscle fatigue indices, will be measured as secondary outcomes. All outcome measures will be measured at baseline, after completion of the treatment sessions, and after one month.
Discussion
The results of this trial will help to provide some evidence regarding the use of continuous ultrasound in chronic LBP patients. This should lead to a more evidence-based approach to clinical decision making regarding the use of ultrasound for LBP.
Trial registration
Netherlands Trial Register (NTR): NTR2251
doi:10.1186/1471-2474-12-59
PMCID: PMC3069953  PMID: 21406117
18.  Injection therapy and denervation procedures for chronic low-back pain: a systematic review 
European Spine Journal  2010;19(9):1425-1449.
Injection therapy and denervation procedures are commonly used in the management of chronic low-back pain (LBP) despite uncertainty regarding their effectiveness and safety. To provide an evaluation of the current evidence associated with the use of these procedures, a systematic review was performed. Existing systematic reviews were screened, and the Cochrane Back Review Group trial register was searched for randomized controlled trials (RCTs) fulfilling the inclusion criteria. Studies were included if they recruited adults with chronic LBP, evaluated the use of injection therapy or denervation procedures and measured at least one clinically relevant outcome (such as pain or functional status). Two review authors independently assessed studies for eligibility and risk of bias (RoB). A meta-analysis was performed with clinically homogeneous studies, and the GRADE approach was used to determine the quality of evidence. In total, 27 RCTs were included, 14 on injection therapy and 13 on denervation procedures. 18 (66%) of the studies were determined to have a low RoB. Because of clinical heterogeneity, only two comparisons could be pooled. Overall, there is only low to very low quality evidence to support the use of injection therapy and denervation procedures over placebo or other treatments for patients with chronic LBP. However, it cannot be ruled out that in carefully selected patients, some injection therapy or denervation procedures may be of benefit.
doi:10.1007/s00586-010-1411-0
PMCID: PMC2989278  PMID: 20424870
Injection; Back pain; Denervation; Review
19.  Prognosis for patients with chronic low back pain: inception cohort study 
Objectives To describe the course of chronic low back pain in an inception cohort and to identify prognostic markers at the onset of chronicity.
Design Inception cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants The study sample was a subcohort of an inception cohort of 973 consecutive patients presenting to primary care with acute low back pain (<2 weeks’ duration). 406 participants whose pain persisted for three months formed the inception cohort of patients with chronic low back pain.
Main outcome measures Outcomes and putative predictors measured at initial presentation, onset of chronicity (study entry), and follow-up at nine and 12 months. Recovery was determined from measures of pain intensity, disability, and work status. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results Completeness of follow-up was 97% of total person time for all outcomes. The cumulative probability of being pain-free was 35% at nine months and 42% at 12 months and for complete recovery was 35% at nine months and 41% at 12 months. Of the 259 participants who had not recovered from pain related disability at entry to the chronic study, 47% had recovered by 12 months. Previous sick leave due to low back pain, high disability levels or high pain intensity at onset of chronicity, low levels of education, greater perceived risk of persistent pain, and being born outside Australia were associated with delayed recovery.
Conclusion More than one third of patients with recent onset, non-radicular chronic low back pain recover within 12 months. The prognosis is less favourable for those who have taken previous sick leave for low back pain, have high disability levels or high pain intensity at onset of chronic low back pain, have lower education, perceive themselves as having a high risk of persistent pain, and were born outside Australia.
doi:10.1136/bmj.b3829
PMCID: PMC2758336  PMID: 19808766
20.  Prognosis for patients with chronic low back pain: inception cohort study 
The BMJ  2009;339:b3829.
Objectives To describe the course of chronic low back pain in an inception cohort and to identify prognostic markers at the onset of chronicity.
Design Inception cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants The study sample was a subcohort of an inception cohort of 973 consecutive patients presenting to primary care with acute low back pain (<2 weeks’ duration). 406 participants whose pain persisted for three months formed the inception cohort of patients with chronic low back pain.
Main outcome measures Outcomes and putative predictors measured at initial presentation, onset of chronicity (study entry), and follow-up at nine and 12 months. Recovery was determined from measures of pain intensity, disability, and work status. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results Completeness of follow-up was 97% of total person time for all outcomes. The cumulative probability of being pain-free was 35% at nine months and 42% at 12 months and for complete recovery was 35% at nine months and 41% at 12 months. Of the 259 participants who had not recovered from pain related disability at entry to the chronic study, 47% had recovered by 12 months. Previous sick leave due to low back pain, high disability levels or high pain intensity at onset of chronicity, low levels of education, greater perceived risk of persistent pain, and being born outside Australia were associated with delayed recovery.
Conclusion More than one third of patients with recent onset, non-radicular chronic low back pain recover within 12 months. The prognosis is less favourable for those who have taken previous sick leave for low back pain, have high disability levels or high pain intensity at onset of chronic low back pain, have lower education, perceive themselves as having a high risk of persistent pain, and were born outside Australia.
doi:10.1136/bmj.b3829
PMCID: PMC2758336  PMID: 19808766
21.  Screening for malignancy in low back pain patients: a systematic review 
European Spine Journal  2007;16(10):1673-1679.
To describe the accuracy of clinical features and tests used to screen for malignancy in patients with low back pain. A systematic review was performed on all available records on MEDLINE, EMBASE, and CINAHL electronic databases. Studies were considered eligible if they investigated a cohort of low back pain patients, used an appropriate reference standard, and reported sufficient data on the diagnostic accuracy of tests. Two authors independently assessed methodological quality and extracted data to calculate positive (LR+) and negative (LR−) likelihood ratios. Six studies evaluating 22 different clinical features and tests were identified. The prevalence of malignancy ranged from 0.1 to 3.5%. A previous history of cancer (LR+ = 23.7), elevated ESR (LR+ = 18.0), reduced hematocrit (LR+ = 18.2), and overall clinician judgement (LR+ = 12.1) increased the probability of malignancy when present. A combination of age ≥50 years, a previous history of cancer, unexplained weight loss, and failure to improve after 1 month had a reported sensitivity of 100%. Overall, there was poor reporting of methodological quality items, and very few studies were performed in community primary care settings. Malignancy is rare as a cause of low back pain. The most useful features and tests are a previous history of cancer, elevated ESR, reduced hematocrit, and clinician judgement.
doi:10.1007/s00586-007-0412-0
PMCID: PMC2078307  PMID: 17566791
Low back pain; Diagnosis; Malignancy; Red flags
22.  Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study 
BMJ : British Medical Journal  2008;337(7662):154-157.
Objective To estimate the one year prognosis and identify prognostic factors in cases of recent onset low back pain managed in primary care.
Design Cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants An inception cohort of 973 consecutive primary care patients (mean age 43.3, 54.8% men) with non-specific low back pain of less than two weeks’ duration recruited from the clinics of 170 general practitioners, physiotherapists, and chiropractors.
Main outcome measures Participants completed a baseline questionnaire and were contacted six weeks, three months, and 12 months after the initial consultation. Recovery was assessed in terms of return to work, return to function, and resolution of pain. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results The follow-up rate over the 12 months was more than 97%. Half of those who reduced their work status at baseline had returned to previous work status within 14 days (95% confidence interval 11 to 17 days) and 83% had returned to previous work status by three months. Disability (median recovery time 31 days, 25 to 37 days) and pain (median 58 days, 52 to 63 days) took much longer to resolve. Only 72% of participants had completely recovered 12 months after the baseline consultation. Older age, compensation cases, higher pain intensity, longer duration of low back pain before consultation, more days of reduced activity because of lower back pain before consultation, feelings of depression, and a perceived risk of persistence were each associated with a longer time to recovery.
Conclusions In this cohort of patients with acute low back pain in primary care, prognosis was not as favourable as claimed in clinical practice guidelines. Recovery was slow for most patients. Nearly a third of patients did not recover from the presenting episode within a year.
doi:10.1136/bmj.a171
PMCID: PMC2483884  PMID: 18614473
23.  Prognosis in patients with recent onset low back pain in Australian primary care: inception cohort study 
Objective To estimate the one year prognosis and identify prognostic factors in cases of recent onset low back pain managed in primary care.
Design Cohort study with one year follow-up.
Setting Primary care clinics in Sydney, Australia.
Participants An inception cohort of 973 consecutive primary care patients (mean age 43.3, 54.8% men) with non-specific low back pain of less than two weeks’ duration recruited from the clinics of 170 general practitioners, physiotherapists, and chiropractors.
Main outcome measures Participants completed a baseline questionnaire and were contacted six weeks, three months, and 12 months after the initial consultation. Recovery was assessed in terms of return to work, return to function, and resolution of pain. The association between potential prognostic factors and time to recovery was modelled with Cox regression.
Results The follow-up rate over the 12 months was more than 97%. Half of those who reduced their work status at baseline had returned to previous work status within 14 days (95% confidence interval 11 to 17 days) and 83% had returned to previous work status by three months. Disability (median recovery time 31 days, 25 to 37 days) and pain (median 58 days, 52 to 63 days) took much longer to resolve. Only 72% of participants had completely recovered 12 months after the baseline consultation. Older age, compensation cases, higher pain intensity, longer duration of low back pain before consultation, more days of reduced activity because of lower back pain before consultation, feelings of depression, and a perceived risk of persistence were each associated with a longer time to recovery.
Conclusions In this cohort of patients with acute low back pain in primary care, prognosis was not as favourable as claimed in clinical practice guidelines. Recovery was slow for most patients. Nearly a third of patients did not recover from the presenting episode within a year.
doi:10.1136/bmj.a171
PMCID: PMC2483884  PMID: 18614473
24.  Low back pain research priorities: a survey of primary care practitioners 
BMC Family Practice  2007;8:40.
Background
Despite the large amount of time and money which has been devoted to low back pain research, successful management remains an elusive goal and low back pain continues to place a large burden on the primary care setting. One reason for this may be that the priorities for research are often developed by researchers and funding bodies, with little consideration of the needs of primary care practitioners. This study aimed to determine the research priorities of primary care practitioners who manage low back pain on a day-to-day basis.
Methods
A modified-Delphi survey of primary care practitioners was conducted, consisting of three rounds of questionnaires. In the first round, 70 practitioners who treat low back pain were each asked to provide up to five questions which they would like answered with respect to low back pain in primary care. The results were collated into a second round questionnaire consisting of 39 priorities, which were rated for importance by each practitioner on a likert-scale. The third round consisted of asking the practitioners to rank the top ten priorities in order of importance.
Results
Response rates for the modified-Delphi remained above 70% throughout the three rounds. The ten highest ranked priorities included the identification of sub-groups of patients that respond optimally to different treatments, evaluation of different exercise approaches in the management of low back pain, self-management of low back pain, and comparison of different treatment approaches by primary care professions treating low back pain.
Conclusion
Practitioners identified a need for more information on a variety of topics, including diagnosis, the effectiveness of treatments, and identification of patient characteristics which affect treatment and recovery.
doi:10.1186/1471-2296-8-40
PMCID: PMC1955444  PMID: 17625004
25.  Prognosis of chronic low back pain: design of an inception cohort study 
Background
Although clinical guidelines generally portray chronic low back pain as a condition with a poor prognosis this portrayal is based on studies of potentially unrepresentative survival cohorts. The aim of this study is to describe the prognosis of an inception cohort of people with chronic low back pain presenting for primary care.
Methods/Design
The study will be an inception cohort study with one year follow-up. Participants are drawn from a cohort of consecutive patients presenting with acute low back pain (less than 2 weeks duration) to primary care clinics in Sydney, Australia. Those patients who continue to experience pain at three months, and are therefore classified as having chronic back pain, are invited to participate in the current study. The cohort will be followed up by telephone at baseline, 9 months and 12 months after being diagnosed with chronic low back pain. Recovery from low back pain will be measured by sampling three different outcomes: pain intensity, interference with function due to pain, and work status. Life tables will be generated to determine the one year prognosis of chronic low back pain. Prognostic factors will be assessed using Cox regression.
Discussion
This study will determine the prognosis of chronic non-specific low back pain in a representative cohort of patients sourced from primary care. The results of this study will improve understanding of chronic low back pain, allowing clinicians to provide more accurate prognostic information to their patients.
doi:10.1186/1471-2474-8-11
PMCID: PMC1800846  PMID: 17288586

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