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1.  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
3.  How little pain and disability do patients with low back pain have to experience to feel that they have recovered? 
European Spine Journal  2010;19(9):1495-1501.
Epidemiological and clinical studies of people with low back pain (LBP) commonly measure the incidence of recovery. The pain numerical rating scale (NRS), scores from 0 to 10, and Roland Morris disability questionnaire (RMDQ), scores from 0 to 24, are two instruments often used to define recovery. On both scales higher scores indicate greater severity. There is no consensus, however, on the cutoff scores on these scales that classify people as having recovered. The aim of this study was to determine which cutoff scores most accurately classify those who had recovered from LBP. Subjects from four clinical studies were categorized as ‘recovered’ or ‘unrecovered’ according to their self-rating on a global perceived effect scale. Odd ratios were calculated for scores of 0, 1, 2, 3 and 4 on the NRS and RMDQ to predict perceived recovery. Scores of 0 on the NRS and ≤2 on the RMDQ most accurately identify patients who consider themselves completely recovered. The diagnostic odds ratio (OR) for predicting recovery was 43.9 for a score of 0 on the NRS and 17.6 for a score of ≤2 on the RMDQ. There was no apparent effect of LBP duration or length of follow-up period on the optimal cutoff score. OR for the NRS were generally higher than those for RMDQ. Cutoffs of 0 on the NRS and 2 on the RMDQ most accurately classify subjects as recovered from LBP. Subjects consider pain more than disability when determining their recovery status.
doi:10.1007/s00586-010-1366-1
PMCID: PMC2989296  PMID: 20229120
Low back pain; Recovery; Pain numerical rating scale; Roland Morris disability questionnaire
4.  EXACT: EXercise or Advice after ankle fraCTure. Design of a randomised controlled trial 
Background
Ankle fractures are common. Management of ankle fractures generally involves a period of immobilisation followed by rehabilitation to reduce pain, stiffness, weakness and swelling. The effects of a rehabilitation program are still unclear. However, it has been shown that important components of rehabilitation programs may not confer additional benefits over exercise alone. The primary aim of this trial is to determine the effectiveness and cost-effectiveness of an exercise-based rehabilitation program after ankle fracture, compared to advice alone.
Methods/Design
A pragmatic randomised trial will be conducted. Participants will be 342 adults with stiff, painful ankles after ankle fracture treated with immobilisation. They will be randomly allocated using a concealed randomisation procedure to either an Advice or Rehabilitation group. Participants in the Advice group will receive verbal and written advice about exercise at the time of removal of immobilisation. Participants in the Rehabilitation group will be provided with a 4-week rehabilitation program that is designed, monitored and progressed by a physiotherapist, in addition to verbal and written advice. Outcomes will be measured by a blinded assessor at 1, 3 and 6 months. The primary outcomes will be activity limitation and quality-adjusted life years.
Discussion
This pragmatic trial will determine if a rehabilitation program reduces activity limitation and improves quality of life, compared to advice alone, after immobilisation for ankle fracture.
doi:10.1186/1471-2474-12-148
PMCID: PMC3146908  PMID: 21726463
5.  Rating the Quality of Trials in Systematic Reviews of Physical Therapy Interventions 
Physical therapists seeking to use evidence to guide their practice may have limited time to read research reports. One way to reduce the time required to identify and read about the research that is relevant to a particular clinical question is to read a systematic review that summarizes multiple studies. This paper explains the process that is used to conduct systematic reviews, which includes the establishment of a protocol, comprehensive searching, appraisal of the quality of the included studies, data extraction and metaanalysis, and consideration of the clinical and research implications of the findings. We also consider how the reader of a systematic review can determine whether the review is likely to provide an unbiased (believable) estimate of the treatment effect. A systematic review of randomized trials of a cardiopulmonary physical therapy intervention is used as an example. The issue of appraisal of quality is then discussed further, with a demonstration of how one validated tool for quality appraisal–the PEDro scale–can be used to evaluate a randomized trial in cardiopulmonary physical therapy.
PMCID: PMC2941354  PMID: 20957075
systematic review; physical therapy
6.  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
7.  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
8.  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
9.  Estimation of transient increases in bleeding risk associated with physical activity in children with haemophilia 
Background
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.
Methods/Design
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.
Discussion
This case-control study will provide estimates of the risk of participation in vigorous physical activity in children with haemophilia.
doi:10.1186/1471-2326-8-2
PMCID: PMC2443707  PMID: 18582359
10.  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
11.  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
12.  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
13.  The effect of an exercise intervention on aerobic fitness, strength and quality of life in children with haemophilia (ACTRN012605000224628) 
Background
Children with haemophilia have lower levels of fitness and strength than their healthy peers. We present the protocol of a study designed to determine whether an exercise intervention improves quality of life, aerobic fitness and strength in children with haemophilia.
Methods/Design
The study will be a randomised, assessor-blinded, controlled trial of exercise treatment. Seventy children aged between 6 and 18 years with haemophilia or von Willebrand disease will be recruited from two paediatric haemophilia clinics in NSW. Each participant will be allocated to an exercise group or a control group using a concealed allocation procedure. The control group will receive usual medical care while the intervention group will receive usual medical care plus an exercise program for 12 weeks. Outcomes (VO2peak, knee extensor strength and quality of life) will be measured at baseline and on completion of the exercise program by a blinded assessor. The primary analysis will be conducted on an intention to treat basis. The effects of the exercise intervention on each of the three primary outcomes will be estimated from between-group differences in the mean outcome adjusted for baseline scores.
Discussion
This study will be the first randomised controlled trial to examine the effects of a structured exercise program on fitness and quality of life in children with haemophilia.
doi:10.1186/1471-2326-6-2
PMCID: PMC1481503  PMID: 16732890
14.  Effectiveness of joint mobilisation after cast immobilisation for ankle fracture: a protocol for a randomised controlled trial [ACTRN012605000143628] 
Background
Passive joint mobilisation is a technique frequently used by physiotherapists to reduce pain, improve joint movement and facilitate a return to activities after injury, but its use after ankle fracture is currently based on limited evidence. The primary aim of this trial is to determine if adding joint mobilisation to a standard exercise programme is effective and cost-effective after cast immobilisation for ankle fracture in adults.
Methods/Design
Ninety participants will be recruited from the physiotherapy departments of three teaching hospitals and randomly allocated to treatment or control groups using a concealed procedure. All participants will perform an exercise programme. Participants in the treatment group will also receive joint mobilisation twice a week for four weeks. Blinded follow-up assessments will be conducted four, 12 and 24 weeks after randomisation. The primary outcome measures will be the Lower Extremity Functional Scale and the Assessment of Quality of Life. Secondary outcomes will include measures of impairments, activity limitation and participation. Data on the use of physiotherapy services and participants' out-of-pocket costs will be collected for the cost-effective and cost-utility analyses. To test the effects of treatment, between-group differences will be examined with analysis of covariance using a regression approach. The primary conclusions will be based on the four-week follow-up data.
Discussion
This trial incorporates features known to minimise bias. It uses a pragmatic design to reflect clinical practice and maximise generalisability. Results from this trial will contribute to an evidence-based approach for rehabilitation after ankle fracture.
doi:10.1186/1471-2474-7-46
PMCID: PMC1538591  PMID: 16729880
15.  Analysis of quality of interventions in systematic reviews 
BMJ : British Medical Journal  2005;331(7515):507-509.
The quality of interventions can affect the results of clinical trials. Reviews of complex interventions need to take this into account
PMCID: PMC1199036  PMID: 16141160
16.  Acute low back pain: systematic review of its prognosis 
BMJ : British Medical Journal  2003;327(7410):323.
Objectives To describe the course of acute low back pain and sciatica and to identify clinically important prognostic factors for these conditions.
Design Systematic review.
Data sources Searches of Medline, Embase, Cinahl, and Science Citation Index and iterative searches of bibliographies.
Main outcome measures Pain, disability, and return to work.
Results 15 studies of variable methodological quality were included. Rapid improvements in pain (mean reduction 58% of initial scores), disability (58%), and return to work (82% of those initially off work) occurred in one month. Further improvement was apparent until about three months. Thereafter levels for pain, disability, and return to work remained almost constant. 73% of patients had at least one recurrence within 12 months.
Conclusions People with acute low back pain and associated disability usually improve rapidly within weeks. None the less, pain and disability are typically ongoing, and recurrences are common.
PMCID: PMC169642  PMID: 12907487
18.  The effect of motor control exercise versus placebo in patients with chronic low back pain [ACTRN012605000262606] 
Background
While one in ten Australians suffer from chronic low back pain this condition remains extremely difficult to treat. Many contemporary treatments are of unknown value. One potentially useful therapy is the use of motor control exercise. This therapy has a biologically plausible effect, is readily available in primary care and it is of modest cost. However, to date, the efficacy of motor control exercise has not been established.
Methods
This paper describes the protocol for a clinical trial comparing the effects of motor control exercise versus placebo in the treatment of chronic non-specific low back pain. One hundred and fifty-four participants will be randomly allocated to receive an 8-week program of motor control exercise or placebo (detuned short wave and detuned ultrasound). Measures of outcomes will be obtained at follow-up appointments at 2, 6 and 12 months after randomisation. The primary outcomes are: pain, global perceived effect and patient-generated measure of disability at 2 months and recurrence at 12 months.
Discussion
This trial will be the first placebo-controlled trial of motor control exercise. The results will inform best practice for treating chronic low back pain and prevent its occurrence.
doi:10.1186/1471-2474-6-54
PMCID: PMC1291370  PMID: 16271149

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