PACE - The first placebo controlled trial of paracetamol for acute low back pain: design of a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trail registration</p> <p>ACTRN12609000966291.</p

Objective and subjective assessment of sleep in chronic low back pain patients compared with healthy age and gender matched controls: a pilot study

<p>Abstract</p> <p>Background</p> <p>While approximately 70% of chronic low back pain (CLBP) sufferers complain of sleep disturbance, current literature is based on self report measures which can be prone to bias and no objective data of sleep quality, based exclusively on CLBP are available. In accordance with the recommendations of The American Sleep Academy, when measuring sleep, both subjective and objective assessments should be considered as the two are only modestly correlated, suggesting that each modality assesses different aspects of an individual's sleep experience. Therefore, the purpose of this study was to expand previous research into sleep disturbance in CLBP by comparing objective and subjective sleep quality in participants with CLBP and healthy age and gender matched controls, to identify correlates of poor sleep and to test logistics and gather information prior to a larger study.</p> <p>Methods</p> <p>15 CLBP participants (mean age = 43.8 years (SD = 11.5), 53% female) and 15 healthy controls (mean age = 41.5 years (SD = 10.6), 53% female) consented. All participants completed the Pittsburgh Sleep Quality Index, Insomnia Severity Index, Pittsburgh Sleep Diary and the SF36v2. CLBP participants also completed the Oswestry Disability Index. Sleep patterns were assessed over three consecutive nights using actigraphy. Total sleep time (TST), sleep efficiency (SE), sleep latency onset (SL) and number of awakenings after sleep onset (WASO) were derived. Statistical analysis was conducted using unrelated t-tests and Pearson's product moment correlation co-efficients.</p> <p>Results</p> <p>CLBP participants demonstrated significantly poorer overall sleep both objectively and subjectively. They demonstrated lower actigraphic SE (p = .002) and increased WASO (p = .027) but no significant differences were found in TST (p = .43) or SL (p = .97). Subjectively, they reported increased insomnia (p =< .001), lower SE (p =< .001) and increased SL (p =< .001) but no difference between TST (p = .827) and WASO (p = .055). Statistically significant associations were found between low back pain (p = .021, r = -.589), physical health (p = .003, r = -.713), disability levels (p = .025, r = .576), and subjective sleep quality in the CLBP participants but not with actigraphy.</p> <p>Conclusion</p> <p>CLBP participants demonstrated poorer overall sleep, increased insomnia symptoms and less efficient sleep. Further investigation using a larger sample size and a longer period of sleep monitoring is ongoing.</p

Association between sleep quality and cardiovascular health: a door-to-door survey in rural Ecuador

OBJECTIVES: Cardiovascular correlates of sleep disorders have not been well investigated in underserved populations. The aim of this door-to-door survey was to evaluate the association between sleep quality and cardiovascular health status in persons aged ≥40 years living in a village that is representative of rural Ecuador. METHODS: All stroke-free Atahualpa residents aged ≥40 years were screened with a validated Spanish version of the Pittsburgh Sleep Quality Index and the seven cardiovascular health (CVH) metrics proposed by the American Heart Association to assess the CVH status. RESULTS: A total of 635 persons (mean age 59 ± 13 years; 58 % women) were identified. A poor sleep quality was present in 27 % of the subjects (95 % CI 24–31 %) and a poor cardiovascular health in 69 % (95 % CI 63–71 %). In a multivariate logistic regression model, a poor sleep quality was associated with some CVH metrics in the poor range, including smoking status (p = 0.026), physical activity (p = 0.01) and blood glucose levels (p = 0.036). CONCLUSIONS: A poor sleep quality may be linked to individual cardiovascular risk factors in this underserved Latin American population. This finding provides useful insights for the implementation of regional prevention priorities