Fetal alcohol spectrum disorders (FASD) are underdiagnosed in Australia, and health professionals have endorsed the need for national guidelines for diagnosis. The aim of this study was to develop consensus recommendations for the diagnosis of FASD in Australia.
A panel of 13 health professionals, researchers, and consumer and community representatives with relevant expertise attended a 2-day consensus development workshop to review evidence on the screening and diagnosis of FASD obtained from a systematic literature review, a national survey of health professionals and community group discussions. The nominal group technique and facilitated discussion were used to review the evidence on screening and diagnosis, and to develop consensus recommendations for the diagnosis of FASD in Australia.
The use of population-based screening for FASD was not recommended. However, there was consensus support for the development of standard criteria for referral for specialist diagnostic assessment. Participants developed consensus recommendations for diagnostic categories, criteria and assessment methods, based on the adaption of elements from both the University of Washington 4-Digit Diagnostic Code and the Canadian guidelines for FASD diagnosis. Panel members also recommended the development of resources to: facilitate consistency in referral and diagnostic practices, including comprehensive clinical guidelines and assessment instruments; and to support individuals undergoing assessment and their parents or carers.
These consensus recommendations provide a foundation for the development of guidelines and other resources to promote consistency in the diagnosis of FASD in Australia. Guidelines for diagnosis will require review and evaluation in the Australian context prior to national implementation as well as periodic review to incorporate new knowledge.
Fetal alcohol spectrum disorder; Diagnosis; Consensus
The Lililwan Project is the first population-based study to determine Fetal Alcohol Spectrum Disorders (FASD) prevalence in Australia and was conducted in the remote Fitzroy Valley in North Western Australia. The diagnostic process for FASD requires accurate assessment of gross and fine motor functioning using standardised cut-offs for impairment. The Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2) is a norm-referenced assessment of motor function used worldwide and in FASD clinics in North America. It is available in a Complete Form with 53 items or a Short Form with 14 items. Its reliability in measuring motor performance in children exposed to alcohol in utero or living in remote Australian Aboriginal communities is unknown.
A prospective inter-rater and test-retest reliability study was conducted using the BOT-2 Short Form. A convenience sample of children (n = 30) aged 7 to 9 years participating in the Lililwan Project cohort (n = 108) study, completed the reliability study. Over 50% of mothers of Lililwan Project children drank alcohol during pregnancy. Two raters simultaneously scoring each child determined inter-rater reliability. Test-retest reliability was determined by assessing each child on a second occasion using predominantly the same rater. Reliability was analysed by calculating Intra-Class correlation Coefficients, ICC(2,1), Percentage Exact Agreement (PEA) and Percentage Close Agreement (PCA) and measures of Minimal Detectable Change (MDC) were calculated.
Thirty Aboriginal children (18 male, 12 female: mean age 8.8 years) were assessed at eight remote Fitzroy Valley communities. The inter-rater reliability for the BOT-2 Short Form score sheet outcomes ranged from 0.88 (95%CI, 0.77 – 0.94) to 0.92 (95%CI, 0.84 – 0.96) indicating excellent reliability. The test-retest reliability (median interval between tests being 45.5 days) for the BOT-2 Short Form score sheet outcomes ranged from 0.62 (95%CI, 0.34 – 0.80) to 0.73 (95%CI, 0.50 – 0.86) indicating fair to good reliability. The raw score MDC was 6.12.
The BOT-2 Short Form has acceptable reliability for use in remote Australian Aboriginal communities and will be useful in determining motor deficits in children exposed to alcohol prenatally. This is the first known study evaluating the reliability of the BOT-2 Short Form, either in the context of assessment for FASD or in Aboriginal children.
Fetal alcohol spectrum disorders; Fetal alcohol syndrome (FAS); Alcohol related neurodevelopmental disorder; Australian Aborigine; Maternal use of alcohol; School-aged children; Reproducibility of results; Culture; Motor skills; Child development
Paracetamol (acetaminophen) is recommended in most clinical practice guidelines as the first choice of treatment for low back pain, however there is limited evidence to support this recommendation. The PACE trial is the first placebo controlled trial of paracetamol for acute low back pain. This article describes the statistical analysis plan.
PACE is a randomized double dummy placebo controlled trial that investigates and compares the effect of paracetamol taken in two regimens for the treatment of low back pain. The protocol has been published. The analysis plan was completed blind to study group and finalized prior to initiation of analyses. All data collected as part of the trial were reviewed, without stratification by group, and classified by baseline characteristics, process of care and trial outcomes. Trial outcomes were classified as primary and secondary outcomes. Appropriate descriptive statistics and statistical testing of between-group differences, where relevant, have been planned and described.
A standard analysis plan was developed for the results of the PACE study. This plan comprehensively describes the data captured and pre-determined statistical tests of relevant outcome measures. The plan demonstrates transparent and verifiable use of the data collected. This a priori plan will be followed to ensure rigorous standards of data analysis are strictly adhered to.
Australia and New Zealand Clinical Trials Registry ACTRN12609000966291
Acetaminophen; Back pain; Paracetamol; Statistical analysis plan; Randomised controlled trial
Australia’s commitment to consumer and community participation in health and medical research has grown over the past decade. Participatory research models of engagement are the most empowering for consumers.
As part of a project to develop a diagnostic instrument for fetal alcohol spectrum disorders (FASD) in Australia (FASD Project), the Australian FASD Collaboration (Collaboration), including a consumer advocate and two consumer representatives, was established. On completion of the FASD Project an on-line survey of Collaboration members was conducted to assess their views on consumer involvement. Women in the community were also invited to participate in Community Conversations to discuss real life situations regarding communications with health professionals about alcohol and pregnancy. Community Conversation feedback was analysed qualitatively and attendees were surveyed about their views of the Community Conversation process.
The on-line survey was completed by 12 members of the Collaboration (71%). Consumer and community participation was considered important and essential, worked well, and was integral to the success of the project. The 32 women attending the Community Conversations generated 500 statements that made reference to prevention, how information and messages are delivered, and appropriate support for women. Nearly all the attendees at the Community Conversations (93%) believed that they had an opportunity to put forward their ideas and 96% viewed the Community Conversations as a positive experience.
The successful involvement of consumers and the community in the FASD Project can be attributed to active consumer and community participation, which included continued involvement throughout the project, funding of participation activities, and an understanding of the various contributions by the Collaboration members.
Consumer participation; Fetal alcohol spectrum disorder; Research
Sciatica is a type of neuropathic pain that is characterised by pain radiating into the leg. It is often accompanied by low back pain and neurological deficits in the lower limb. While this condition may cause significant suffering for the individual, the lack of evidence supporting effective treatments for sciatica makes clinical management difficult. Our objectives are to determine the efficacy of pregabalin on reducing leg pain intensity and its cost-effectiveness in patients with sciatica.
PRECISE is a prospectively registered, double-blind, randomised placebo-controlled trial of pregabalin compared to placebo, in addition to usual care. Inclusion criteria include moderate to severe leg pain below the knee with evidence of nerve root/spinal nerve involvement. Participants will be randomised to receive either pregabalin with usual care (n = 102) or placebo with usual care (n = 102) for 8 weeks. The medicine dosage will be titrated up to the participant’s optimal dose, to a maximum 600 mg per day. Follow up consultations will monitor individual progress, tolerability and adverse events. Usual care, if deemed appropriate by the study doctor, may include a referral for physical or manual therapy and/or prescription of analgesic medication. Participants, doctors and researchers collecting participant data will be blinded to treatment allocation. Participants will be assessed at baseline and at weeks 2, 4, 8, 12, 26 and 52. The primary outcome will determine the efficacy of pregabalin in reducing leg pain intensity. Secondary outcomes will include back pain intensity, disability and quality of life. Data analysis will be blinded and by intention-to-treat. A parallel economic evaluation will be conducted from health sector and societal perspectives.
This study will establish the efficacy of pregabalin in reducing leg pain intensity in patients with sciatica and provide important information regarding the effect of pregabalin treatment on disability and quality of life. The impact of this research may allow the future development of a cost-effective conservative treatment strategy for patients with sciatica.
ClinicalTrial.gov, ACTRN 12613000530729
Sciatica; Pregabalin; Neuropathic pain; Randomised control trial
A battery of clinical assessments was used in the Lililwan* Project, Australia’s first population-based Fetal Alcohol Spectrum Disorders (FASD) prevalence study, conducted in the remote Fitzroy Valley, Western Australia. One objective was to develop and assess test-retest reliability of an acceptable questionnaire for collecting health information in remote Aboriginal communities feasible for use in the Lililwan Project.
A questionnaire was developed by paediatricians to assist in diagnosis of FASD. Content was based on a literature review of FASD diagnostic criteria, existing questionnaires and risk factors for FASD and birth defects. Aboriginal community members, including qualified Aboriginal language interpreters, adapted the questionnaire to ensure language and cultural components were appropriate for use in the Fitzroy Valley. Locally developed pictorial aids were used for gathering accurate information on alcohol use. Aboriginal ‘community navigators’ assisted researchers to translate the questions into Kimberley Kriol or local Aboriginal languages depending on participant preference.
A subset of 14 questions was assessed for test-retest reliability in 30 parents/carers of children in the Lililwan Project cohort, who were interviewed by one rater using the entire questionnaire, then by a second rater who repeated 14 critical questions at least 6 hours later.
The full questionnaire contained 112 items and took 50 minutes to administer. For a subset of 14 items from the full questionnaire percent exact agreement between raters ranged from 59-100%, and was below 70% for only 1 question. Test-retest reliability was excellent (Kappa 0.81-1.00) for 5 items, substantial (Kappa 0.61-0.80) for 5 items, and moderate, fair or slight (Kappa ≤0.60) for the remaining 4 items tested. Test-retest reliability for questions relating to alcohol use in pregnancy was excellent. When questions had moderate, fair or slight agreement, information was obtained from alternate sources e.g. medical records. Qualitative feedback from parents/carers confirmed acceptability of the questionnaire.
This questionnaire had acceptable test-retest reliability and could be used to collect demographic, socio-cultural and biomedical information relevant to the diagnosis of FASD in Aboriginal communities throughout Australia and elsewhere. Community input is crucial when developing and administering questionnaires for use in cross-cultural contexts.
*Lililwan is a Kimberley Kriol word meaning ‘all the little ones’. Kimberley Kriol is the main language spoken by Aboriginal people in the Fitzroy Valley.
Fetal alcohol syndrome (FAS); Fetal alcohol spectrum disorders (FASD); Aboriginal and Torres Strait Islander; Indigenous; Questionnaire development; Diagnosis; Reliability testing; Reproducibility of results; Test-retest; Percent exact agreement
The purpose of this study is to investigate if lumbar disc pathology identified on MRI scans is more common in patients with acute, likely discogenic, low back pain than matched controls.
We compared rates of MRI findings between 30 cases with low back pain and 30 pain-free controls. Cases were patients presenting for care with likely discogenic low back pain (demonstrated centralisation with repeated movement testing), of moderate intensity and with minimal past history of back pain. Controls were matched for age, gender and past history of back pain. Cases and controls underwent MRI scanning which was read for the presence of a range of MRI findings by two blinded assessors.
The presence of disc degeneration, modic changes and disc herniation significantly altered the odds of a participant being a case or control. For example subjects were 5.2 times more likely to be a case than a control when disc degeneration grade of ≥3 was present, and 6.0 times more likely with modic changes. The presence of a high-intensity zone or annular tear was found to significantly alter odds for one assessor but not the other assessor.
MRI findings including disc degeneration, modic changes and herniation are more common in selected people with current acute (likely discogenic) low back pain than in controls without current low back pain. Further investigation of the value of MRI findings as prognostic factors and as treatment effect modifiers is required to assess the potential clinical importance of these findings.
Low back pain; Magnetic resonance imaging; Case–control study; Diagnosis; Sensitivity; Disc degeneration
There is little reliable information on the prevalence of fetal alcohol spectrum disorders (FASD) in Australia and no coordinated national approach to facilitate case detection. The aim of this study was to identify health professionals’ perceptions about screening for FASD in Australia.
A modified Delphi process was used to assess perceptions of the need for, and the process of, screening for FASD in Australia. We recruited a panel of 130 Australian health professionals with experience or expertise in FASD screening or diagnosis. A systematic review of the literature was used to develop Likert statements on screening coverage, components and assessment methods which were administered using an online survey over two survey rounds.
Of the panel members surveyed, 95 (73%) responded to the questions on screening in the first survey round and, of these, 81 (85%) responded to the second round. Following two rounds there was consensus agreement on the need for targeted screening at birth (76%) and in childhood (84%). Participants did not reach consensus agreement on the need for universal screening at birth (55%) or in childhood (40%). Support for targeted screening was linked to perceived constraints on service provision and the need to examine the performance, costs and benefits of screening.
For targeted screening of high risk groups, we found highest agreement for siblings of known cases of FASD (96%) and children of mothers attending alcohol treatment services (93%). Participants agreed that screening for FASD primarily requires assessment of prenatal alcohol exposure at birth (86%) and in childhood (88%), and that a checklist is needed to identify the components of screening and criteria for referral at birth (84%) and in childhood (90%).
There is an agreed need for targeted but not universal screening for FASD in Australia, and sufficient consensus among health professionals to warrant development and evaluation of standardised methods for targeted screening and referral in the Australian context. Participants emphasised the need for locally-appropriate, evidence-based approaches to facilitate case detection, and the importance of ensuring that screening and referral programs are supported by adequate diagnostic and management capacity.
To evaluate health professionals' agreement with components of published diagnostic criteria for fetal alcohol spectrum disorders (FASD) in order to guide the development of standard diagnostic guidelines for Australia.
A modified Delphi process was used to assess agreement among health professionals with expertise or experience in FASD screening or diagnosis. An online survey, which included 36 Likert statements on diagnostic methods, was administered over two survey rounds. For fetal alcohol syndrome (FAS), health professionals were presented with concepts from the Institute of Medicine (IOM), University of Washington (UW), Centers for Disease Control (CDC), revised IOM and Canadian diagnostic criteria. For partial FAS (PFAS), alcohol-related neurodevelopmental disorder (ARND), and alcohol-related birth defects (ARBD), concepts based on the IOM and the Canadian diagnostic criteria were compared.
130 Australian and 9 international health professionals.
Of 139 health professionals invited to complete the survey, 103 (74.1%) responded, and 74 (53.2%) completed one or more questions on diagnostic criteria. We found consensus agreement among participants on the diagnostic criteria for FAS, with the UW criteria most commonly endorsed when compared with all other published criteria for FAS. When health professionals were presented with concepts based on the Canadian and IOM diagnostic criteria, we found consensus agreement but no clear preference for either the Canadian or IOM criteria for the diagnosis of PFAS, and no consensus agreement on diagnostic criteria for ARND. We also found no consensus on the IOM diagnostic criteria for ARBD.
Participants indicated clear support for use of the UW diagnostic criteria for FAS in Australia. These findings should be used to develop guidelines to facilitate improved awareness of, and address identified gaps in the infrastructure for, FASD diagnosis in Australia.
Despite the availability of five guidelines for the diagnosis of fetal alcohol spectrum disorders (FASD), there is no national endorsement for their use in diagnosis in Australia. In this study we aimed to describe health professionals’ perceptions about the adoption of existing guidelines for the diagnosis of FASD in Australia and identify implications for the development of national guidelines.
We surveyed 130 Australian and 9 international health professionals with expertise or involvement in the screening or diagnosis of FASD. An online questionnaire was used to evaluate participants’ familiarity with and use of five existing diagnostic guidelines for FASD, and to assess their perceptions about the adoption of these guidelines in Australia.
Of the 139 participants surveyed, 84 Australian and 8 international health professionals (66.2%) responded to the questions on existing diagnostic guidelines. Participants most frequently reported using the University of Washington 4-Digit Diagnostic Code (27.2%) and the Canadian guidelines (18.5%) for diagnosis. These two guidelines were also most frequently recommended for adoption in Australia: 32.5% of the 40 participants who were familiar with the University of Washington 4-Digit Diagnostic Code recommended adoption of this guideline in Australia, and 30.8% of the 26 participants who were familiar with the Canadian guidelines recommended adoption of this guideline in Australia. However, for the majority of guidelines examined, most participants were unsure whether they should be adopted in Australia. The adoption of existing guidelines in Australia was perceived to be limited by: their lack of evidence base, including the appropriateness of established reference standards for the Australian population; their complexity; the need for training and support to use the guidelines; and the lack of an interdisciplinary and interagency model to support service delivery in Australia.
Participants indicated some support for the adoption of the University of Washington or Canadian guidelines for FASD diagnosis; however, concerns were raised about the adoption of these diagnostic guidelines in their current form. Australian diagnostic guidelines will require evaluation to establish their validity in the Australian context, and a comprehensive implementation model is needed to facilitate improved diagnostic capacity in Australia.
Anecdotal reports suggest that high-risk drinking in pregnancy is common in some remote Australian communities. Alcohol is teratogenic and may cause a range of lifelong conditions termed ‘fetal alcohol spectrum disorders’ (FASD). Australia has few diagnostic services for FASD, and prevalence of these neurodevelopmental disorders remains unknown. In 2009, Aboriginal leaders in the remote Fitzroy Valley in North Western Australia identified FASD as a community priority and initiated the Lililwani Project in partnership with leading research organisations. This project will establish the prevalence of FASD and other health and developmental problems in school-aged children residing in the Fitzroy Valley, providing data to inform FASD prevention and management.
Methods and analysis
This is a population-based active case ascertainment study of all children born in 2002 and 2003 and residing in the Fitzroy Valley. Participants will be identified from the Fitzroy Valley Population Project and Communicare databases. Parents/carers will be interviewed using a standardised diagnostic questionnaire modified for local language and cultural requirements to determine the demographics, antenatal exposures, birth outcomes, education and psychosocial status of each child. A comprehensive interdisciplinary health and neurodevelopmental assessment will be performed using tests and operational definitions adapted for the local context. Internationally recognised diagnostic criteria will be applied to determine FASD prevalence. Relationships between pregnancy exposures and early life trauma, neurodevelopmental, health and education outcomes will be evaluated using regression analysis. Results will be reported according to STROBE guidelines for observational studies.
Ethics and dissemination
Ethics approval has been granted by the University of Sydney Human Research Ethics Committee, the Western Australian Aboriginal Health Information and Ethics Committee, the Western Australian Country Health Service Board Research Ethics Committee and the Kimberley Aboriginal Health Planning Forum Research Sub-committee. Results will be disseminated widely through peer-reviewed manuscripts, reports, conference presentations and the media.
To establish the need for prevalence data on FASD in remote Australia and for improved awareness and diagnosis of FASD.
To describe the protocol used in Australia's first population-based study of FASD prevalence using active case ascertainment in remote Aboriginal communities.
To demonstrate a process of community consultation and clinical research that respects the priorities, language and culture of Aboriginal communities.
Accurate prevalence data on FASD and other health and developmental outcomes will inform prevention, service provision and policy in child health, education and justice.
This research will provide immediate and direct benefits to participants and the broader community, including a feasible and transferable model of FASD diagnosis and a model for culturally responsive research with Aboriginal communities.
Strengths and limitations of this study
The study was a response to a local community initiative and followed extensive community consultation.
The population-based active method of case ascertainment will provide the most accurate prevalence data for diagnoses on the entire FASD spectrum and other health and developmental outcomes.
Standardised and locally developed clinical assessments whose interpretation is less biased by culture and language have been chosen carefully with cross-cultural considerations in mind and are considered valid for the purpose of the study.
There are no normative data for Aboriginal children for the assessments used in the study.
Study findings may not generalise to all children born in the Fitzroy Valley following the introduction of community-led alcohol restrictions in 2007, after which time FASD prevalence may have decreased.
Lack of standardization of terminology in low back pain (LBP) research has significantly impeded progress in this area. The diversity in existing definitions for a ‘recurrence of an episode of LBP’ and ‘recurrent LBP’ is an important example. The variety of definitions used by researchers working in this area has prevented comparison of results between trials and made meta-analyses of this data unfeasible. The aim of this study was to use a modified Delphi approach to gain consensus on definitions for a ‘recurrence of an episode of LBP’ (e.g. outcome event) and for ‘recurrent LBP’ (e.g. patient population). Existing definitions for both constructs were classified into the main features comprising the definition (e.g. ‘duration of pain’) and the items that defined each feature (e.g. ‘pain lasting at least 24 h’). In each round, participants were asked to rate the importance of each feature to a definition of a ‘recurrence of an episode of LBP’, and a definition of ‘recurrent LBP’ and rank the items (defining each feature) in order of decreasing importance. Forty-six experts in LBP research, from nine different countries, participated in this study. Four rounds were completed with responses rates of 94, 91, 83, and 97% in rounds 1, 2, 3, and 4, respectively. Consensus definitions were reached in both areas with 95% of panel members supporting the definition of a ‘recurrence of an episode of LBP’ and 92% of panel members supporting the definition of ‘recurrent LBP’. Future research is necessary to evaluate these definitions.
Delphi approach; Recurrence; Recurrent; Low back pain; Standardization; Definitions
Several versions of the 24-item Roland Morris Disability Questionnaire (RMDQ) have been proposed; however, their responsiveness has not been extensively explored. The objective of this study was to compare the responsiveness of four versions of the RMDQ. Perceived disability was measured using the 24-item, two 18-item and an 11-item RMDQ on 1,069 low back pain patients from six randomised controlled trials. Responsiveness was calculated using effect size, Guyatt’s responsiveness index (GRI) and receiver operating characteristics (ROC) curves. Effect size analyses showed that both 18-item versions of the RMDQ were superior to the 24- and 11-item versions of the RMDQ. GRI showed that the 24- and 18-item versions of the RMDQ were similar but more responsive than the 11-item. ROC curves revealed that the 11-item was less responsive than the other three versions, which had similar responsiveness. The results of this study demonstrate that the 24-item and both 18-item versions of the RMDQ have similar responsiveness with all having superior responsiveness to the 11-item.
Low back pain; Questionnaires; ROC curve; Validity
Most research on risk factors for low back pain has focused on long term exposures rather than factors immediately preceding the onset of low back pain. The aim of this study is to quantify the transient increase in risk of a sudden episode of low back pain associated with acute exposure to a range of common physical and psychological factors.
This study uses a case-crossover design. One thousand adults with a sudden onset of low back pain presenting to primary care clinicians will be recruited. Basic demographic and clinical information including exposure to putative triggers will be collected using a questionnaire. These triggers include exposure to hazardous manual tasks, physical activity, a slip/trip or fall, consumption of alcohol, sexual activity, being distracted, and being fatigued or tired. Exposures in the case window (0-2 hours from the time when participants first notice their back pain) will be compared to exposures in two control time-windows (one 24-26 hours and another 48-50 hours before the case window).
The completion of this study will provide the first-research based estimates of the increase in risk of a sudden episode of acute low back pain associated with transient exposure to a range of common factors thought to trigger low back pain.
The primary objective of this study was to determine which questionnaire, the Roland Morris disability questionnaire (RMDQ) or the patient-specific functional scale (PSFS), was better at detecting change in activity limitation in a large cohort of patients with low back pain undergoing rehabilitation. A secondary aim was to determine if the responsiveness of the questionnaires was influenced by the patient’s level of activity limitation at baseline. Responsiveness statistics, including effect size statistics, Pearson’s r correlations and receiver operative characteristic (ROC) curve analysis were used to determine ability to detect change in activity limitation on 831 patients with low back pain. Data were analysed at two time points; directly after treatment (termed short-term) and several weeks post-treatment (termed mid-term). The data were subsequently re-analysed on sub-sets of the full cohort according to the level of activity limitation from RMDQ baseline scores. In the total cohort we found that the PSFS was more responsive than the RMDQ; however, in the subgroup with high activity limitation this pattern was not observed. This is true for time points up to 6 months post-treatment. In conclusion, the RMDQ and PSFS both demonstrate good responsiveness according to the definitions given in previous guidelines. The PSFS is more responsive than the RMDQ for patients with low levels of activity limitation but not for patients with high levels of activity limitation.
Back pain; Disability; Activity limitation; Rehabilitation; Responsiveness
Recurrent low back pain (recurrent LBP) is a common condition, however, it is unclear if uniform definitions are used in studies investigating the prevalence and management of this condition. The aim of this systematic review was to identify how recurrent LBP is defined in the literature. A literature search was performed on MEDLINE, EMBASE, CINAHL, AMED, and PEDro. Studies were considered eligible if they investigated a cohort of subjects with recurrent LBP or if they were measuring the prevalence of recurrent LBP. Two independent reviewers assessed inclusion of studies and extracted definitions of recurrent LBP. Forty-three studies met the inclusion criteria. The majority of studies (63%) gave an explicit definition of recurrent LBP; however, the definitions varied greatly and only three definitions for recurrent LBP were used by more than one study. The most common feature given as part of the definition was the frequency of previous episodes of low back pain. Only 8% (3/36) of studies used previously recommended definitions for recurrent LBP. Large variation exists in definitions of recurrent LBP used in the literature, making interpretation of prevalence rates and treatment outcomes very difficult. Achieving consensus among experts in this area is required.
Recurrent low back pain; Non-specific low back pain; Definition; Review
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.
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.
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.
Ultrasound (US) measures are used by clinicians and researchers to evaluate improvements in activity of the abdominal muscles in patients with low back pain. Studies evaluating the reproducibility of these US measures provide some information; however, little is known about the reproducibility of these US measures over time in patients with low back pain. The objectives of this study were to estimate the reproducibility of ultrasound measurements of automatic activation of the lateral abdominal wall muscles using a leg force task in patients with chronic low back pain. Thirty-five participants from an existing randomised, blinded, placebo-controlled trial participated in the study. A reproducibility analysis was undertaken from all patients using data collected at baseline and after treatment. The reproducibility of measurements of thickness, muscle activation (thickness changes) and muscle improvement/deterioration after intervention (differences in thickness changes from single images made before and after treatment) was analysed. The reproducibility of static images (thickness) was excellent (ICC2,1 = 0.97, 95% CI = 0.96–0.97, standard error of the measurement (SEM) = 0.04 cm, smallest detectable change (SDC) = 0.11 cm), the reproducibility of thickness changes was moderate (ICC2,1 = 0.72, 95% CI 0.65–0.76, SEM = 15%, SDC 41%), while the reproducibility of differences in thickness changes from single images with statistical adjustment for duplicate measures was poor (ICC2,1 = 0.44, 95% CI 0.33–0.58, SEM = 21%, SDC = 66.5%). Improvements in the testing protocol must be performed in order to enhance reproducibility of US as an outcome measure for abdominal muscle activation.
Ultrasound; Abdominal muscles; Reproducibility; Agreement; Reliability
Whiplash is the most common injury following a motor vehicle accident. Approximately 60% of people suffer persistent pain and disability six months post injury. Two forms of exercise; specific motor relearning exercises and graded activity, have been found to be effective treatments for this condition. Although the effect sizes for these exercise programs, individually, are modest, pilot data suggest much larger effects on pain and disability are achieved when these two treatments are combined. The aim of this study is to investigate the effectiveness and cost-effectiveness of this comprehensive exercise approach for chronic whiplash.
A multicentre randomised controlled trial will be conducted. One hundred and seventy-six participants with chronic grade I to II whiplash will be recruited in Sydney and Brisbane, Australia. All participants will receive an educational booklet on whiplash and in addition, those randomised to the comprehensive exercise group (specific motor relearning and graded activity exercises) will receive 20 progressive and individually-tailored, 1 hour exercise sessions over a 12 week period (specific motor relearning exercises: 8 sessions over 4 weeks; graded activity: 12 sessions over 8 weeks). The primary outcome to be assessed is pain intensity. Other outcomes of interest include disability, health-related quality of life and health service utilisation. Outcomes will be measured at baseline, 14 weeks, 6 months and 12 months by an assessor who is blinded to the group allocation of the subjects. Recruitment is due to commence in late 2009.
The successful completion of this trial will provide evidence on the effectiveness and cost-effectiveness of a simple treatment for the management of chronic whiplash.
A clinical prediction rule to identify patients most likely to respond to spinal manipulation has been published and widely cited but requires further testing for external validity. We performed a pre-planned secondary analysis of a randomised controlled trial investigating the efficacy of spinal manipulative therapy in 239 patients presenting to general practice clinics for acute, non-specific, low back pain. Patients were randomised to receive spinal manipulative therapy or placebo 2 to 3 times per week for up to 4 weeks. All patients received general practitioner care (advice and paracetamol). Outcomes were pain and disability measured at 1, 2, 4 and 12 weeks. Status on the clinical prediction rule was measured at baseline. The clinical prediction rule performed no better than chance in identifying patients with acute, non-specific low back pain most likely to respond to spinal manipulative therapy (pain P = 0.805, disability P = 0.600). At 1-week follow-up, the mean difference in effect of spinal manipulative therapy compared to placebo in patients who were rule positive rather than rule negative was 0.3 points less on a 10-point pain scale (95% CI −0.8 to 1.4). The clinical prediction rule proposed by Childs et al. did not generalise to patients presenting to primary care with acute low back pain who received a course of spinal manipulative therapy.
Electronic supplementary material
The online version of this article (doi:10.1007/s00586-008-0679-9) contains supplementary material, which is available to authorized users.
Low back pain; Spinal manipulative therapy; Subgroup analysis
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.
Methods and design
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
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.
This trial has been registered with Australian New Zealand Clinical Trials Registry. ACTRN12608000270314
Low back pain (LBP) is an extremely common cause of pain and disability. While many treatments for acute LBP exist, one of the most widely used, but also most controversial, is spinal manipulative therapy (SMT). This therapy includes both high-velocity manipulative techniques and low-velocity mobilization techniques. The literature regarding the use of SMT is often conflicting, which explains the difference in recommendations regarding SMT in international LBP guidelines. The lack of a clear tissue diagnosis in the majority of patients with LBP combined with the unknown mechanism of action of SMT adds to the difficulty for clinicians in providing SMT in a logical and effective manner. Despite these limitations, the existing literature does provide some assistance to clinicians on when to provide SMT and how to provide it in an optimal way. This review aims to summarize the key research literature investigating SMT in LBP in order to help clinicians make informed decisions about the use of SMT for their patients with acute LBP.
Clinical Decision Making; Clinical Prediction Rules; Screening; Spinal Manipulation
Although it is widely appreciated that vigorous physical activity can increase the risk of bleeding episodes in children with haemophilia, the magnitude of the increase in risk is not known. Accurate risk estimates could inform decisions made by children with haemophilia and their parents about participation in physical activity and aid the development of optimal prophylactic schedules. The aim of this study is to provide an accurate estimate of the risks of bleeding associated with vigorous physical activity in children with haemophilia.
The study will be a case-crossover study nested within a prospective cohort study. Children with moderate or severe haemophilia A or B, recruited from two paediatric haematology departments in Australia, will participate in the study. The child, or the child's parent or guardian, will report bleeding episodes experienced over a 12-month period. Following a bleeding episode, the participant will be interviewed by telephone about exposures to physical activity in the case period (8 hours before the bleed) and 2 control periods (an 8 hour period at the same time on the day preceding the bleed and an 8 hour period two days preceding the bleed). Conditional logistic regression will be used to estimate the risk of participating in vigorous physical activity from measures of exposure to physical activity in the case and control periods.
This case-control study will provide estimates of the risk of participation in vigorous physical activity in children with haemophilia.
Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient.
This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week) and function (patient-specific functional scale) at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline.
This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient.
Trial registration number
Manipulation is a common treatment for non-specific neck pain. Neck manipulation, unlike gentler forms of manual therapy such as mobilisation, is associated with a small risk of serious neurovascular injury and can result in stroke or death. It is thought however, that neck manipulation provides better results than mobilisation where clinically indicated. There is long standing and vigorous debate both within and between the professions that use neck manipulation as well as the wider scientific community as to whether neck manipulation potentially does more harm than good. The primary aim of this study is to determine whether neck manipulation provides more rapid resolution of an episode of neck pain than mobilisation.
182 participants with acute and sub-acute neck pain will be recruited from physiotherapy, chiropractic and osteopathy practices in Sydney, Australia. Participants will be randomly allocated to treatment with either manipulation or mobilisation. Randomisation will occur after the treating practitioner decides that manipulation is an appropriate treatment for the individual participant. Both groups will receive at least 4 treatments over 2 weeks. The primary outcome is number of days taken to recover from the episode of neck pain. Cox regression will be used to compare survival curves for time to recovery for the manipulation and mobilisation treatment groups.
This paper presents the rationale and design of a randomised controlled trial to compare the effectiveness of neck manipulation and neck mobilisation for acute and subacute neck pain.