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2.  PRECISE - pregabalin in addition to usual care for sciatica: study protocol for a randomised controlled trial 
Trials  2013;14:213.
Background
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.
Methods/Design
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.
Discussion
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.
Trial registration
ClinicalTrial.gov, ACTRN 12613000530729
doi:10.1186/1745-6215-14-213
PMCID: PMC3711833  PMID: 23845078
Sciatica; Pregabalin; Neuropathic pain; Randomised control trial
3.  Compliance with clinical guidelines for whiplash improved with a targeted implementation strategy: a prospective cohort study 
Background
Implementation strategies for clinical guidelines have shown modest effects in changing health professional’s knowledge and practice, however, targeted implementations are suggested to achieve greater improvements. This study aimed to examine the effect of a targeted implementation strategy of the Australian whiplash guidelines on health professionals’ knowledge, beliefs and practice and to identify predictors of improved knowledge.
Methods
94 health professionals (Physiotherapists, Chiropractors and Osteopaths) who manage whiplash participated in this study. Prior to their inclusion in the study, health professionals were classified as compliant with clinical guidelines for whiplash (n = 52) or non-compliant (n = 42), according to a record of clinical practice. All participants completed a 2- day interactive workshop with outcomes measured at baseline and 3 months following the workshop. The workshop was delivered by opinion leaders, with the educational content focused on the pre-identified knowledge and practice gaps in relation to clinical guidelines for whiplash. Knowledge and health professional beliefs were assessed by a questionnaire and professional practice by record of clinical practice.
Results
Participants significantly increased knowledge (p < 0.0001) and were more likely to be compliant with the guidelines at follow-up (compliant at baseline 58%, follow-up 79%, p = 0.002). Health professional belief systems significantly changed to be more behavioural (p = 0.02) and less biomedical (p = 0.000). Predictors of improved knowledge were baseline knowledge (parameter estimate = -0.6, p = 0.000) and profession (parameter estimate = -3.8, p = 0.003) (adj R2 = 35%).
Conclusions
A targeted implementation strategy improved health professional’s knowledge and clinical practice so that they became more compliant with clinical guidelines for whiplash. In addition health professionals’ belief systems significantly changed to be more behavioural in orientation. Baseline knowledge and profession predicted 35% of the variance in improved knowledge.
doi:10.1186/1472-6963-13-213
PMCID: PMC3734039  PMID: 23758939
Implementation; Interactive education; Clinical guidelines; Whiplash
5.  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
6.  Triggers for an episode of sudden onset low back pain: study protocol 
Background
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.
Methods/design
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).
Discussion
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.
doi:10.1186/1471-2474-13-7
PMCID: PMC3292970  PMID: 22273001
7.  How is recovery from low back pain measured? A systematic review of the literature 
European Spine Journal  2010;20(1):9-18.
Recovery is commonly used as an outcome measure in low back pain (LBP) research. There is, however, no accepted definition of what recovery involves or guidance as to how it should be measured. The objective of the study was designed to appraise the LBP literature from the last 10 years to review the methods used to measure recovery. The research design includes electronic searches of Medline, EMBASE, CINAHL, Cochrane database of clinical trials and PEDro from the beginning of 1999 to December 2008. All prospective studies of subjects with non-specific LBP that measured recovery as an outcome were included. The way in which recovery was measured was extracted and categorised according to the domain used to assess recovery. Eighty-two included studies used 66 different measures of recovery. Fifty-nine of the measures did not appear in more than one study. Seventeen measures used pain as a proxy for recovery, seven used disability or function and seventeen were based on a combination of two or more constructs. There were nine single-item recovery rating scales. Eleven studies used a global change scale that included an anchor of ‘completely recovered’. Three measures used return to work as the recovery criterion, two used time to insurance claim closure and six used physical performance. In conclusion, almost every study that measured recovery from LBP in the last 10 years did so differently. This lack of consistency makes interpretation and comparison of the LBP literature problematic. It is likely that the failure to use a standardised measure of recovery is due to the absence of an established definition, and highlights the need for such a definition in back pain research.
doi:10.1007/s00586-010-1477-8
PMCID: PMC3036032  PMID: 20552378
Recovery; Low back pain; Outcome measurement; Systematic review
8.  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
9.  Individual, physical and psychological risk factors for neck pain in Australian office workers: a 1-year longitudinal study 
European Spine Journal  2009;18(10):1532-1540.
Neck pain is more prevalent in office workers than in the general community. To date, findings from prospective studies that investigated causal relationships between putative risk factors and the onset of neck pain in this population have been limited by high loss to follow-up. The aim of this research was to prospectively evaluate a range of risk factors for neck pain in office workers, using validated and reliable objective measures as well as attain an estimate of 1-year incidence. We assembled a cohort of 53 office workers without neck pain and measured individual, physical, workplace and psychological factors at baseline. We followed participants for 1 year to measure the incidence of neck pain. We achieved 100% participant follow-up. Cox regression analysis was applied to examine the relationship between the putative risk factors and the cumulative incidence of neck pain. The 1-year incidence proportion of neck pain in Australian office workers was estimated in this study to be 0.49 (95% CI 0.36–0.62). Predictors of neck pain with moderate to large effect sizes were female gender (HR: 3.07; 95% CI: 1.18–7.99) and high psychological stress (HR: 1.64; 95% CI: 0.66–4.07). Protective factors included increased mobility of the cervical spine (HR: 0.44; 95% CI: 0.19–1.05) and frequent exercise (HR: 0.64; 95% CI: 0.27–1.51). These results reveal that neck pain is common in Australian office workers and that there are risk factors that are potentially modifiable.
doi:10.1007/s00586-009-1011-z
PMCID: PMC2899383  PMID: 19399537
Neck pain; Risk factors; Incidence; Office workers
10.  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
11.  Global Rating of Change Scales: A Review of Strengths and Weaknesses and Considerations for Design 
Most clinicians ask their patients to rate whether their health condition has improved or deteriorated over time and then use this information to guide management decisions. Many studies also use patient-rated change as an outcome measure to determine the efficacy of a particular treatment. Global rating of change (GRC) scales provide a method of obtaining this information in a manner that is quick, flexible, and efficient. As with any outcome measure, however, meaningful interpretation of results can only be undertaken with due consideration of the clinimetric properties, strengths, and weaknesses of the instrument. The purpose of this article is to summarize this information to assist appropriate interpretation of the GRC results and to provide evidence-informed advice to guide design and administration of GRC scales. These considerations are relevant and applicable to the use of GRC scales both in the clinic and in research.
PMCID: PMC2762832  PMID: 20046623
Clinimetrics; Global Rating of Change; Outcome Measure
12.  A systematic review of paracetamol for non-specific low back pain 
European Spine Journal  2008;17(11):1423-1430.
The objective of this study was to assess the efficacy of paracetamol (acetaminophen) in the treatment of pain and disability in patients with non-specific low back pain. We conducted a systematic review of randomized controlled trials to assess the efficacy of paracetamol in the treatment of pain and disability in patients with non-specific low back pain. A search for randomized controlled trials was conducted using the Medline, Embase and CINAHL databases. Trials were eligible if they were randomized controlled trials comparing paracetamol to no treatment, placebo or another treatment in patients with non-specific low back pain. Two of the authors independently assessed trials for methodological quality on the PEDro Scale and extracted data. Continuous pain and disability data were converted to a common 0–10 scale; ordinal data were dichotomized (e.g., no pain, pain). The data was analyzed using the MIX version 1.61 meta-analysis software. Out of 205 unique articles found in the searches, 7 eligible trials were identified. The trials enrolled a total of 676 participants with 5 investigating acute low back pain, 1 investigating chronic low back pain and 1 investigating both. No trial provided data comparing paracetamol to placebo and only one trial compared paracetamol to no treatment. In general the trials were small (only 1 trial had >25 subjects per group) and of low methodological quality (only 2 had a score above 6 on the quality scale). All but one of the trials provided imprecise estimates of the effects of treatment with confidence intervals spanning clinically important beneficial and also harmful effects of paracetamol. No trial reported a statistically significant difference in favor of paracetamol. There is insufficient evidence to assess the efficacy of paracetamol in patients with low back pain. There is a clear need for large, high quality randomized controlled trials evaluating paracetamol, to provide reliable evidence of paracetamol’s effectiveness in patients with low back pain and to establish the validity of the recommendations in clinical guidelines.
doi:10.1007/s00586-008-0783-x
PMCID: PMC2583194  PMID: 18797937
Low back pain; Paracetamol; Acetaminophen; Review
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.  Musculoskeletal conditions in children and adolescents managed in Australian primary care 
Background
Primary care settings play a vital role in the early detection and appropriate management of musculoskeletal conditions in paediatric populations. However, little data exist regarding these conditions in a primary care context or on the presentation of specific musculoskeletal disorders in children. The aim of this study was to estimate the caseload and describe typical management of musculoskeletal conditions in children and adolescents presenting to primary care in Australia.
Methods
An analysis of data from the Bettering the Evaluation and Care of Health (BEACH) study was performed. The BEACH study is a continuous national study of general practice (GP) activity in Australia. We identified all GP encounters with children and adolescents over the past five years and extracted data on demographic details, the problems managed, and GP management of each problem. SAS statistical software was used to calculate robust proportions and after adjustment for the cluster, the 95% confidence intervals (CIs).
Results
From the period April 2006 to March 2011, there were 65,279 encounters with children and adolescents in the BEACH database. Of the 77,830 problems managed at these encounters, 4.9% (95%CI 4.7% to 5.1%) were musculoskeletal problems. The rate of musculoskeletal problems managed increased significantly with age, however there was a significant decrease for girls aged 15–17 years. Upper and lower limb conditions were the most common, followed by spine and trunk conditions. Spine and trunk conditions were significantly more likely to be managed with medication, but less likely to receive imaging, than upper or lower limb problems.
Conclusions
Musculoskeletal problems in children and adolescents present a significant burden and an important challenge to the primary health care system in Australia. There is variability in rates of presentation between different age groups, gender and affected body region.
doi:10.1186/1471-2474-15-164
PMCID: PMC4032455  PMID: 24885231
Musculoskeletal complaints; Primary care; Child; Adolescence
15.  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
16.  Spinal Manipulative Therapy for Acute Low Back Pain: A Clinical Perspective 
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.
PMCID: PMC2716151  PMID: 19771190
Clinical Decision Making; Clinical Prediction Rules; Screening; Spinal Manipulation
17.  Screening for malignancy in low back pain patients: a systematic review 
European Spine Journal  2007;16(10):1673-1679.
To describe the accuracy of clinical features and tests used to screen for malignancy in patients with low back pain. A systematic review was performed on all available records on MEDLINE, EMBASE, and CINAHL electronic databases. Studies were considered eligible if they investigated a cohort of low back pain patients, used an appropriate reference standard, and reported sufficient data on the diagnostic accuracy of tests. Two authors independently assessed methodological quality and extracted data to calculate positive (LR+) and negative (LR−) likelihood ratios. Six studies evaluating 22 different clinical features and tests were identified. The prevalence of malignancy ranged from 0.1 to 3.5%. A previous history of cancer (LR+ = 23.7), elevated ESR (LR+ = 18.0), reduced hematocrit (LR+ = 18.2), and overall clinician judgement (LR+ = 12.1) increased the probability of malignancy when present. A combination of age ≥50 years, a previous history of cancer, unexplained weight loss, and failure to improve after 1 month had a reported sensitivity of 100%. Overall, there was poor reporting of methodological quality items, and very few studies were performed in community primary care settings. Malignancy is rare as a cause of low back pain. The most useful features and tests are a previous history of cancer, elevated ESR, reduced hematocrit, and clinician judgement.
doi:10.1007/s00586-007-0412-0
PMCID: PMC2078307  PMID: 17566791
Low back pain; Diagnosis; Malignancy; Red flags
18.  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
19.  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
20.  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
21.  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
22.  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
23.  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
24.  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
25.  Advice or exercise for chronic whiplash disorders? Design of a randomized controlled trial 
Background
Whiplash-associated disorder (or "whiplash") is a common condition incurring considerable expense in social and economic terms. A lack of research on effective therapy for patients with chronic whiplash associated disorders prompted the design of the current study. The primary aim of this randomised controlled trial is to determine the effects of a physical activity program for people with chronic (symptoms of > 3 months duration) whiplash. A secondary aim is to determine if pain severity, level of disability and fear of movement/(re)injury predict response to a physical activity program.
Methods / Design
This paper presents the rationale and design of a randomised controlled trial examining the effects of advice and individualized sub-maximal exercise programs in the treatment of whiplash associated disorders.
Discussion
This paper highlights the design, methods and operational aspects of a significant clinical trial in the area of whiplash and chronic pain.
doi:10.1186/1471-2474-4-18
PMCID: PMC194710  PMID: 12932301
Whiplash; Exercise; Advice; Therapy; Neck Pain; Disability.

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