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1.  Detecting insomnia in patients with low back pain: accuracy of four self-report sleep measures 
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.
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.
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.
The Pittsburgh questionnaire and Insomnia index had similar ability to screen for insomnia in patients with low back pain.
PMCID: PMC3701511  PMID: 23805978
Low back pain; Insomnia; Diagnosis; Questionnaire; Accuracy
2.  A randomized controlled trial of tai chi for long-term low back pain (TAI CHI): Study rationale, design, and methods 
Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain.
Methods and design
The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes)/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0–10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452
This study will be the first trial in this area and the information on its effectiveness will allow patients, clinicians and treatment funders to make informed choices regarding this treatment.
Trial Registration
This trial has been registered with Australian New Zealand Clinical Trials Registry. ACTRN12608000270314
PMCID: PMC2702312  PMID: 19473546
3.  The effect of motor control exercise versus placebo in patients with chronic low back pain [ACTRN012605000262606] 
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.
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.
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.
PMCID: PMC1291370  PMID: 16271149
4.  Back Complaints in the Elders (BACE); design of cohort studies in primary care: an international consortium 
Although back complaints are common among older people, limited information is available in the literature about the clinical course of back pain in older people and the identification of older persons at risk for the transition from acute back complaints to chronic back pain.
The aim of this study is to assess the course of back complaints and identify prognostic factors for the transition from acute back complaints to chronic back complaints in older people who visit a primary health care physician.
The design is a prospective cohort study with one-year follow-up. There will be no interference with usual care. Patients older than 55 years who consult a primary health care physician with a new episode of back complaints will be included in this study.
Data will be collected using a questionnaire, physical examination and X-ray at baseline, and follow-up questionnaires after 6 weeks and 3, 6, 9 and 12 months.
The study 'Back Complaints in the Elders' (BACE) will take place in different countries: starting in the Netherlands, Brazil and Australia. The research groups collaborate in the BACE consortium. The design and basic objectives of the study will be the same across the studies.
This consortium is a collaboration between different research groups, aiming to provide insight into the course of back complaints in older people and to identify prognostic factors for the transition from acute back complaints to chronic back complaints in older persons. The BACE consortium allows to investigate differences between older people with back complaints and the health care systems in the different countries and to increase the statistical power by enabling meta-analyses using the individual patient data. Additional research groups worldwide are invited to join the BACE consortium.
PMCID: PMC3182961  PMID: 21854620
5.  A randomised clinical trial of a comprehensive exercise program for chronic whiplash: trial protocol 
Whiplash is the most common injury following a motor vehicle accident. Approximately 60% of people suffer persistent pain and disability six months post injury. Two forms of exercise; specific motor relearning exercises and graded activity, have been found to be effective treatments for this condition. Although the effect sizes for these exercise programs, individually, are modest, pilot data suggest much larger effects on pain and disability are achieved when these two treatments are combined. The aim of this study is to investigate the effectiveness and cost-effectiveness of this comprehensive exercise approach for chronic whiplash.
A multicentre randomised controlled trial will be conducted. One hundred and seventy-six participants with chronic grade I to II whiplash will be recruited in Sydney and Brisbane, Australia. All participants will receive an educational booklet on whiplash and in addition, those randomised to the comprehensive exercise group (specific motor relearning and graded activity exercises) will receive 20 progressive and individually-tailored, 1 hour exercise sessions over a 12 week period (specific motor relearning exercises: 8 sessions over 4 weeks; graded activity: 12 sessions over 8 weeks). The primary outcome to be assessed is pain intensity. Other outcomes of interest include disability, health-related quality of life and health service utilisation. Outcomes will be measured at baseline, 14 weeks, 6 months and 12 months by an assessor who is blinded to the group allocation of the subjects. Recruitment is due to commence in late 2009.
The successful completion of this trial will provide evidence on the effectiveness and cost-effectiveness of a simple treatment for the management of chronic whiplash.
Trial registration
PMCID: PMC2799382  PMID: 19954546
6.  Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial 
Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient.
This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week) and function (patient-specific functional scale) at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline.
This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient.
Trial registration number
PMCID: PMC2409320  PMID: 18454877
7.  Study protocol: the effects of work-site exercise on the physical fitness and work-ability of older workers 
Older workers have a higher rate and cost of injury than younger workers and with a rapidly ageing work force there is a need to identify strategies to address this problem. Older workers are less physically active and fit than younger workers and so have reduced work ability. The reduced work ability means they are more likely to be fatigued at work and so at greater risk of injury. Exercise could potentially assist this problem. Exercise training has been previously shown to improve fitness in older people however there has been no evaluation of workplace exercise program for older workers. We do not know if the programs are feasible and can improve the fitness and work ability of older workers. We have designed a randomised controlled trial to evaluate whether exercise improves fitness and perceived work-ability of older workers.
This paper describes the protocol for a trial examining the effects of a 12-week physical training program in workers over the age of 45. Participants will be randomized to an exercise or no-intervention control group. The primary outcomes are cardiorespiratory endurance, lifting capacity, upper and lower limb strength and perceived work-ability.
This trial will test the feasibility of implementing a worksite-based exercise program as a means of improving the physical fitness and work-ability of older workers performing physically demanding work. If we demonstrate the feasibility of the program we will conduct a larger trial that additionally measures injury outcomes.
PMCID: PMC1796542  PMID: 17263895
8.  Risk factors for neck pain in office workers: a prospective study 
Persisting neck pain is common in society. It has been reported that the prevalence of neck pain in office workers is much higher than in the general population. The costs to the worker, employer and society associated with work-related neck pain are known to be considerable and are escalating. The factors that place office workers at greater risk of developing neck pain are not understood. The aim of this study is to investigate the incidence and risk factors of work-related neck pain in Australian office workers.
We will conduct a prospective cohort study. A cohort of office workers without neck pain will be followed over a 12 month period, after baseline measurement of potential risk factors. The categories of risk factors being evaluated are physical (cervical spine posture, range of movement, muscle endurance and exercise frequency), demographic (age, sex), work environment (sitting duration, frequency of breaks) and psychosocial (psychological distress and psychosocial work factors). Cox regression analysis will be used to identify risk factors associated with work-related neck pain, and will be expressed as hazard ratios with 95% confidence intervals. The data will also enable the incidence of neck pain in this population to be estimated.
In addition to clarifying the magnitude of this occupational health problem these data could inform policy in workplaces and provide the basis for primary prevention of neck pain in office workers, targeting the identified risk factors.
PMCID: PMC1629016  PMID: 17062165
9.  The McKenzie method for the management of acute non-specific low back pain: design of a randomised controlled trial [ACTRN012605000032651] 
Low back pain (LBP) is a major health problem. Effective treatment of acute LBP is important because it prevents patients from developing chronic LBP, the stage of LBP that requires costly and more complex treatment.
Physiotherapists commonly use a system of diagnosis and exercise prescription called the McKenzie Method to manage patients with LBP. However, there is insufficient evidence to support the use of the McKenzie Method for these patients. We have designed a randomised controlled trial to evaluate whether the addition of the McKenzie Method to general practitioner care results in better outcomes than general practitioner care alone for patients with acute LBP.
This paper describes the protocol for a trial examining the effects of the McKenzie Method in the treatment of acute non-specific LBP. One hundred and forty eight participants who present to general medical practitioners with a new episode of acute non-specific LBP will be randomised to receive general practitioner care or general practitioner care plus a program of care based on the McKenzie Method. The primary outcomes are average pain during week 1, pain at week 1 and 3 and global perceived effect at week 3.
This trial will provide the first rigorous test of the effectiveness of the McKenzie Method for acute non-specific LBP.
PMCID: PMC1274327  PMID: 16221311

Results 1-9 (9)