The Chiropractic Hospital-based Interventions Research Outcomes (CHIRO) Study: a randomized controlled trial on the effectiveness of clinical practice guidelines in the medical and chiropractic management of patients with acute mechanical low back pain
ABSTRACT Evidence-based clinical practice guidelines (CPGs) for the management of patients with acute mechanical low back pain (AM-LBP) have been defined on an international scale. Multicenter clinical trials have demonstrated that most AM-LBP patients do not receive CPG-based treatments. To date, the value of implementing full and exclusively CPG-based treatment remains unclear.
To determine if full CPGs-based study care (SC) results in greater improvement in functional outcomes than family physician-directed usual care (UC) in the treatment of AM-LBP.
A two-arm, parallel design, prospective, randomized controlled clinical trial using blinded outcome assessment. Treatment was administered in a hospital-based spine program outpatient clinic.
Inclusion criteria included patients aged 19 to 59 years with Quebec Task Force Categories 1 and 2 AM-LBP of 2 to 4 weeks' duration. Exclusion criteria included "red flag" conditions and comorbidities contraindicating chiropractic spinal manipulative therapy (CSMT).
Primary outcome: improvement from baseline in Roland-Morris Disability Questionnaire (RDQ) scores at 16 weeks. Secondary outcomes: improvements in RDQ scores at 8 and 24 weeks; and in Short Form-36 (SF-36) bodily pain (BP) and physical functioning (PF) scale scores at 8, 16, and 24 weeks.
Patients were assessed by a spine physician, then randomized to SC (reassurance and avoidance of passive treatments, acetaminophen, 4 weeks of lumbar CSMT, and return to work within 8 weeks), or family physician-directed UC, the components of which were recorded.
Ninety-two patients were recruited, with 36 SC and 35 UC patients completing all follow-up visits. Baseline prognostic variables were evenly distributed between groups. The primary outcome, the unadjusted mean improvement in RDQ scores, was significantly greater in the SC group than in the UC group (p=.003). Regarding unadjusted mean changes in secondary outcomes, improvements in RDQ scores were also greater in the SC group at other time points, particularly at 24 weeks (p=.004). Similarly, improvements in SF-36 PF scores favored the SC group at all time points; however, these differences were not statistically significant. Improvements in SF-36 BP scores were similar between groups. In repeated-measures analyses, global adjusted mean improvement was significantly greater in the SC group in terms of RDQ (p=.0002), nearly significantly greater in terms of SF-36 PF (p=.08), but similar between groups in terms of SF-36 BP (p=.27).
This is the first reported randomized controlled trial comparing full CPG-based treatment, including spinal manipulative therapy administered by chiropractors, to family physician-directed UC in the treatment of patients with AM-LBP. Compared to family physician-directed UC, full CPG-based treatment including CSMT is associated with significantly greater improvement in condition-specific functioning.
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Technical Report: Evaluation de l'efficacité de la pratique de la chiropratique
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ABSTRACT: Objective The purpose of this study was to evaluate changes in methodological quality and sample size in randomized controlled trials (RCTs) of spinal manipulative therapy (SMT) for neck and low back pain over a specified period. A secondary purpose was to make recommendations for improvement for future SMT trials based upon our findings. Methods Randomized controlled trials that examined the effect of SMT in adults with neck and/or low back pain and reported at least 1 patient-reported outcome measure were included. Studies were identified from recent Cochrane reviews of SMT, and an update of the literature was conducted (March 2013). Risk of bias was assessed using the 12-item criteria recommended by the Cochrane Back Review Group. In addition, sample size was examined. The relationship between the overall risk of bias and sample size over time was evaluated using regression analyses, and RCTs were grouped into periods (epochs) of approximately 5 years. Results In total, 105 RCTs were included, of which 41 (39%) were considered to have a low risk of bias. There is significant improvement in the mean risk of bias over time (P < .05), which is the most profound for items related to selection bias and, to a lesser extent, attrition and selective outcome reporting bias. Furthermore, although there is no significant increase in sample size over time (overall P = .8), the proportion of studies that performed an a priori sample size calculation is increasing statistically (odds ratio, 2.1; confidence interval, 1.5-3.0). Sensitivity analyses suggest no appreciable difference between studies for neck or low back pain for risk of bias or sample size. Conclusion Methodological quality of RCTs of SMT for neck and low back pain is improving, whereas overall sample size has shown only small and nonsignificant increases. There is an increasing trend among studies to conduct sample size calculations, which relate to statistical power. Based upon these findings, 7 areas of improvement for future SMT trials are suggested.Journal of Manipulative and Physiological Therapeutics 10/2014; 37(8). DOI:10.1016/j.jmpt.2014.07.007 · 1.25 Impact Factor
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ABSTRACT: Background About 240 million patients undergo surgery every year, worldwide. Roughly 50% of these patients report clinically significant pain. Numerous barriers impede provision of adequate management. Lack of evidence about appropriateness and effectiveness of interventions is one. A registry can provide such information, eventually facilitating better management. This paper reports the development and feasibility of PAIN OUT, the first international acute pain registry, established with funds from the European Commission, and presents preliminary analysis to illustrate the nature of investigations that registry data make possible.Methods On the first postoperative day, 6347 adult patients undergoing orthopaedic or general surgery, in 11 medical centres in Europe and Israel, provided Patient Reported Outcomes (PROs) using a validated questionnaire. Clinical data were abstracted from the patient's chart.ResultsFeasibility worked well. Over a period of 1 year, surveyors accrued targeted data sets and entered them into an online browser. Collaborators could receive online feedback comparing their findings about PROs against anonymized findings from other centres. Missing data for the majority of variables were low. Despite considerable variability between institutions, a large number of patients were treated according to the generic, evidence-based recommendations we assessed. However, this was not sufficient to result in acceptable outcomes for the majority of patients.Conclusion The initial development of PAIN OUT has been achieved. From 2013, it continues as a not-for-profit academic project, open to clinicians and researchers worldwide. The International Association for Study of Pain and PAIN OUT will work together to maintain, disseminate and develop the registry.European journal of pain (London, England) 09/2014; DOI:10.1002/ejp.571 · 3.22 Impact Factor