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1.  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
2.  Assessing Sleep Disturbance in Low Back Pain: The Validity of Portable Instruments 
PLoS ONE  2014;9(4):e95824.
Although portable instruments have been used in the assessment of sleep disturbance for patients with low back pain (LBP), the accuracy of the instruments in detecting sleep/wake episodes for this population is unknown. This study investigated the criterion validity of two portable instruments (Armband and Actiwatch) for assessing sleep disturbance in patients with LBP. 50 patients with LBP performed simultaneous overnight sleep recordings in a university sleep laboratory. All 50 participants were assessed by Polysomnography (PSG) and the Armband and a subgroup of 33 participants wore an Actiwatch. Criterion validity was determined by calculating epoch-by-epoch agreement, sensitivity, specificity and prevalence and bias- adjusted kappa (PABAK) for sleep versus wake between each instrument and PSG. The relationship between PSG and the two instruments was assessed using intraclass correlation coefficients (ICC 2, 1). The study participants showed symptoms of sub-threshold insomnia (mean ISI = 13.2, 95% CI = 6.36) and poor sleep quality (mean PSQI = 9.20, 95% CI = 4.27). Observed agreement with PSG was 85% and 88% for the Armband and Actiwatch. Sensitivity was 0.90 for both instruments and specificity was 0.54 and 0.67 and PABAK of 0.69 and 0.77 for the Armband and Actiwatch respectively. The ICC (95%CI) was 0.76 (0.61 to 0.86) and 0.80 (0.46 to 0.92) for total sleep time, 0.52 (0.29 to 0.70) and 0.55 (0.14 to 0.77) for sleep efficiency, 0.64 (0.45 to 0.78) and 0.52 (0.23 to 0.73) for wake after sleep onset and 0.13 (−0.15 to 0.39) and 0.33 (−0.05 to 0.63) for sleep onset latency, for the Armband and Actiwatch, respectively. The findings showed that both instruments have varied criterion validity across the sleep parameters from excellent validity for measures of total sleep time, good validity for measures of sleep efficiency and wake after onset to poor validity for sleep onset latency.
doi:10.1371/journal.pone.0095824
PMCID: PMC3998977  PMID: 24763506
3.  Multiplex Cytokine Concentration Measurement: How Much Do the Medium and Handling Matter? 
Mediators of Inflammation  2013;2013:890706.
Cytokine concentrations are thought to be affected by methods of sampling and processing and by storage conditions. In this study we compared 17 cytokine concentrations obtained from plasma and serum at baseline and after a controlled thaw condition. We found that absolute agreement was poor between concentrations of cytokines in plasma and serum, except for MIP1β. A thaw condition significantly changed the concentrations of most cytokines, but serum appeared less affected by this than plasma was. Closer examination using Bland-Altman analyses revealed that for each comparison, agreement was moderately good for many cytokine concentrations. This is important because measures of agreement must be interpreted based on the required precision, which may differ between clinical and research demands. We also identified that for some cytokines, the relationship between serum and plasma is affected by concentration, thus advocating for the use of appropriate methods when performing such comparisons in studies such as systematic reviews and meta-analyses.
doi:10.1155/2013/890706
PMCID: PMC3804442  PMID: 24191133
4.  Inflammation in complex regional pain syndrome 
Neurology  2013;80(1):106-117.
Objectives:
We conducted a systematic review of the literature with meta-analysis to determine whether complex regional pain syndrome (CRPS) is associated with a specific inflammatory profile and whether this is dependent on the duration of the condition.
Methods:
Comprehensive searches of the literature using MEDLINE, Embase, Scopus, Web of Science, and reference lists from published reviews identified articles that measured inflammatory factors in CRPS. Two independent investigators screened titles and abstracts, and performed data extraction and risk of bias assessments. Studies were subgrouped by medium (blood, blister fluid, and CSF) and duration (acute and chronic CRPS). Where possible, meta-analyses of inflammatory factor concentrations were performed and pooled effect sizes were calculated using random-effects models.
Results:
Twenty-two studies were included in the systematic review and 15 in the meta-analysis. In acute CRPS, the concentrations of interleukin (IL)-8 and soluble tumor necrosis factor receptors I (sTNF-RI) and II (sTNF-RII) were significantly increased in blood. In chronic CRPS, significant increases were found in 1) TNFα, bradykinin, sIL-1RI, IL-1Ra, IL-2, sIL-2Ra, IL-4, IL-7, interferon-γ, monocyte chemoattractant protein-1 (MCP-1), and sRAGE (soluble receptor for advanced glycation end products) in blood; 2) IL-1Ra, MCP-1, MIP-1β, and IL-6 in blister fluid; and 3) IL-1β and IL-6 in CSF. Chronic CRPS was also associated with significantly decreased 1) substance P, sE-selectin, sL-selectin, sP-selectin, and sGP130 in blood; and 2) soluble intercellular adhesion molecule-1 (sICAM-1) in CSF. Most studies failed to meet 3 or more of our quality criteria.
Conclusion:
CRPS is associated with the presence of a proinflammatory state in the blood, blister fluid, and CSF. Different inflammatory profiles were found for acute and chronic cases.
doi:10.1212/WNL.0b013e31827b1aa1
PMCID: PMC3589200  PMID: 23267031
5.  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
7.  No Pain Relief with the Rubber Hand Illusion 
PLoS ONE  2012;7(12):e52400.
The sense of body ownership can be easily disrupted during illusions and the most common illusion is the rubber hand illusion. An idea that is rapidly gaining popularity in clinical pain medicine is that body ownership illusions can be used to modify pathological pain sensations and induce analgesia. However, this idea has not been empirically evaluated. Two separate research laboratories undertook independent randomized repeated measures experiments, both designed to detect an effect of the rubber hand illusion on experimentally induced hand pain. In Experiment 1, 16 healthy volunteers rated the pain evoked by noxious heat stimuli (5 s duration; interstimulus interval 25 s) of set temperatures (47°, 48° and 49°C) during the rubber hand illusion or during a control condition. There was a main effect of stimulus temperature on pain ratings, but no main effect of condition (p = 0.32), nor a condition x temperature interaction (p = 0.31). In Experiment 2, 20 healthy volunteers underwent quantitative sensory testing to determine heat and cold pain thresholds during the rubber hand illusion or during a control condition. Secondary analyses involved heat and cold detection thresholds and paradoxical heat sensations. Again, there was no main effect of condition on heat pain threshold (p = 0.17), nor on cold pain threshold (p = 0.65), nor on any of the secondary measures (p<0.56 for all). We conclude that the rubber hand illusion does not induce analgesia.
doi:10.1371/journal.pone.0052400
PMCID: PMC3527497  PMID: 23285026
8.  The prognosis of acute and persistent low-back pain: a meta-analysis 
Background:
Although low-back pain is a highly prevalent condition, its clinical course remains uncertain. Our main objective was to systematically review the literature on the clinical course of pain and disability in patients with acute and persistent low-back pain. Our secondary objective was to investigate whether pain and disability have similar courses.
Methods:
We performed a meta-analysis of inception cohort studies. We identified eligible studies by searching MEDLINE, Embase and CINAHL. We included prospective studies that enrolled an episode-inception cohort of patients with acute or persistent low-back pain and that measured pain, disability or recovery. Two independent reviewers extracted data and assessed methodologic quality. We used mixed models to determine pooled estimates of pain and disability over time.
Results:
Data from 33 discrete cohorts (11 166 participants) were included in the review. The variance-weighted mean pain score (out of a maximum score of 100) was 52 (95% CI 48–57) at baseline, 23 (95% CI 21–25) at 6 weeks, 12 (95% CI 9–15) at 26 weeks and 6 (95% CI 3–10) at 52 weeks after the onset of pain for cohorts with acute pain. Among cohorts with persistent pain, the variance-weighted mean pain score (out of 100) was 51 (95% CI 44–59) at baseline, 33 (95% CI 29–38) at 6 weeks, 26 (95% CI 20–33) at 26 weeks and 23 (95% CI 16–30) at 52 weeks after the onset of pain. The course of disability outcomes was similar to the time course of pain outcomes in the acute pain cohorts, but the pain outcomes were slightly worse than disability outcomes in the persistent pain cohorts.
Interpretation:
Patients who presented with acute or persistent low-back pain improved markedly in the first six weeks. After that time improvement slowed. Low to moderate levels of pain and disability were still present at one year, especially in the cohorts with persistent pain.
doi:10.1503/cmaj.111271
PMCID: PMC3414626  PMID: 22586331
9.  Prevalence of sleep disturbance in patients with low back pain 
European Spine Journal  2010;20(5):737-743.
Low back pain (LBP) is a common health condition that is often associated with disability, psychological distress and work loss. Worldwide, billions of dollars are expended each year trying to manage LBP, often with limited success. Recently, some researchers have reported that LBP patients also report sleep disturbance as a result of their LBP. However, as most of this evidence was obtained from highly selected groups of patients or from studies with small samples, high quality data on prevalence of sleep disturbance for patients with LBP are lacking. It is also unclear whether sleep disturbance is more likely to be reported by patients with recent-onset LBP than by patients with persistent LBP. Finally, it is not known whether high pain intensity, the most relevant condition-specific variable, is associated with higher rates of reported sleep disturbance. The present study aimed to determine the prevalence of reported sleep disturbance in patients with LBP. In addition, we aimed to determine whether sleep disturbance was associated with the duration of back pain symptoms and whether pain intensity was associated with reported sleep disturbance. Data from 1,941 patients obtained from 13 studies conducted by the authors or their colleagues between 2001 and 2009 were used to determine the prevalence of sleep disturbance. Logistic regression analyses explored associations between sleep disturbance, the duration of low back symptoms and pain intensity. The estimated prevalence of sleep disturbance was 58.7% (95% CI 56.4–60.7%). Sleep disturbance was found to be dependent on pain intensity, where each increase by one point on a ten-point visual analogue scale (VAS) was associated with a 10% increase in the likelihood of reporting sleep disturbance. Our findings indicate that sleep disturbance is common in patients with LBP. In addition, we found that the intensity of back pain was only weakly associated with sleep disturbance, suggesting that other factors contribute to sleep problems for LBP patients.
doi:10.1007/s00586-010-1661-x
PMCID: PMC3082679  PMID: 21190045
LBP; Sleep; Disturbance; Pain; Prevalence; Chronic pain
10.  Responsiveness of the 24-, 18- and 11-item versions of the Roland Morris Disability Questionnaire 
European Spine Journal  2010;20(3):458-463.
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.
doi:10.1007/s00586-010-1608-2
PMCID: PMC3048224  PMID: 21069545
Low back pain; Questionnaires; ROC curve; Validity
11.  PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial 
Background
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.
Methods/Design
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.
Discussion
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.
Trail registration
ACTRN12609000966291.
doi:10.1186/1471-2474-11-169
PMCID: PMC2918542  PMID: 20650012
12.  The effectiveness of the McKenzie method in addition to first-line care for acute low back pain: a randomized controlled trial 
BMC Medicine  2010;8:10.
Background
Low back pain is a highly prevalent and disabling condition worldwide. Clinical guidelines for the management of patients with acute low back pain recommend first-line treatment consisting of advice, reassurance and simple analgesics. Exercise is also commonly prescribed to these patients. The primary aim of this study was to evaluate the short-term effect of adding the McKenzie method to the first-line care of patients with acute low back pain.
Methods
A multi-centre randomized controlled trial with a 3-month follow-up was conducted between September 2005 and June 2008. Patients seeking care for acute non-specific low back pain from primary care medical practices were screened. Eligible participants were assigned to receive a treatment programme based on the McKenzie method and first-line care (advice, reassurance and time-contingent acetaminophen) or first-line care alone, for 3 weeks. Primary outcome measures included pain (0-10 Numeric Rating Scale) over the first seven days, pain at 1 week, pain at 3 weeks and global perceived effect (-5 to 5 scale) at 3 weeks. Treatment effects were estimated using linear mixed models.
Results
One hundred and forty-eight participants were randomized into study groups, of whom 138 (93%) completed the last follow-up. The addition of the McKenzie method to first-line care produced statistically significant but small reductions in pain when compared to first-line care alone: mean of -0.4 points (95% confidence interval, -0.8 to -0.1) at 1 week, -0.7 points (95% confidence interval, -1.2 to -0.1) at 3 weeks, and -0.3 points (95% confidence interval, -0.5 to -0.0) over the first 7 days. Patients receiving the McKenzie method did not show additional effects on global perceived effect, disability, function or on the risk of persistent symptoms. These patients sought less additional health care than those receiving only first-line care (P = 0.002).
Conclusions
When added to the currently recommended first-line care of acute low back pain, a treatment programme based on the McKenzie method does not produce appreciable additional short-term improvements in pain, disability, function or global perceived effect. However, the McKenzie method seems to reduce health utilization although it does not reduce patient's risk of developing persistent symptoms.
Trial Registration
Australian New Zealand Clinical Trials Registry: ACTRN12605000032651
doi:10.1186/1741-7015-8-10
PMCID: PMC2842230  PMID: 20102596
13.  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
14.  Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial 
European Spine Journal  2008;17(7):936-943.
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.
doi:10.1007/s00586-008-0679-9
PMCID: PMC2443269  PMID: 18427840
Low back pain; Spinal manipulative therapy; Subgroup analysis
15.  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
16.  Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial 
Background
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.
Methods
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.
Discussion
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
ACTRN12607000432415
doi:10.1186/1471-2474-9-65
PMCID: PMC2409320  PMID: 18454877
17.  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
18.  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
19.  Efficacy of manipulation for non-specific neck pain of recent onset: design of a randomised controlled trial 
Background
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.
Methods/Design
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.
Discussion
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.
doi:10.1186/1471-2474-8-18
PMCID: PMC1810535  PMID: 17324291
20.  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
21.  Prognosis of acute low back pain: design of a prospective inception cohort study 
Background
Clinical guidelines generally portray acute low back pain as a benign and self-limiting condition. However, evidence about the clinical course of acute low back pain is contradictory and the risk of subsequently developing chronic low back pain remains uncertain. There are few high quality prognosis studies and none that have measured pain, disability and return to work over a 12 month period. This study aims to provide the first estimates of the one year prognosis of acute low back pain (pain of less than 2 weeks duration) in patients consulting primary care practitioners. A secondary aim is to identify factors that are associated with the prognosis of low back pain.
Methods/Design
The study is a prospective inception cohort study. Consecutive patients consulting general medical practitioners, physiotherapists and chiropractors in the Sydney metropolitan region will complete a baseline questionnaire regarding their back pain. Subsequently these patients will be followed up by telephone 6 weeks, 3 months and 12 months after the initial consultation. Patients will be considered to have recovered from the episode of back pain if they have no pain and no limitation of activity, and have returned to pre-injury work status. Life tables will be generated to determine the one year prognosis of acute low back pain. Prognostic factors will be assessed using Cox regression.
Discussion
This study will provide the first estimates of the one year prognosis of acute low back pain in a representative sample of primary care patients.
doi:10.1186/1471-2474-7-54
PMCID: PMC1543628  PMID: 16790069
22.  Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617] 
Background
Acute low back pain is a common condition resulting in pain and disability. Current national and international guidelines advocate general practitioner care including advice and paracetamol (4 g daily in otherwise well adults) as the first line of care for people with acute low back pain. Non-steroidal anti-inflammatory drugs (NSAIDs) and spinal manipulative therapy (SMT) are advocated in many guidelines as second line management options for patients with acute low back pain who are not recovering. No studies have explored the role of NSAIDs and/or SMT in addition to first line management for acute low back pain. The primary aim of this study is to investigate if NSAIDs and/or SMT in addition to general practitioner advice and paracetamol results in shorter recovery times for patients with acute low back pain. The secondary aims of the study are to evaluate whether the addition of SMT and/or NSAIDs influences pain, disability and global perceived effect at 1, 2, 4 and 12 weeks after onset of therapy for patients with significant acute low back pain.
Methods/design
This paper presents the rationale and design of a randomised controlled trial examining the addition of NSAIDs and/or SMT in 240 people who present to their general practitioner with significant acute low back pain.
doi:10.1186/1471-2474-6-57
PMCID: PMC1298305  PMID: 16280089

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