IMPORTANCEThe effects of altered neural processing, defined as altering neural networks responsible for perceptions of pain and function, on chronic pain remains unclear.OBJECTIVE To estimate the effect of a graded sensorimotor retraining intervention (RESOLVE) on pain intensity in people with chronic low back pain. DESIGN, SETTING, AND PARTICIPANTSThis parallel, 2-group, randomized clinical trial recruited participants with chronic (>3 months) nonspecific low back pain from primary care and community settings. A total of 276 adults were randomized (in a 1:1 ratio) to the intervention or sham procedure and attention control groups delivered by clinicians at a medical research institute in Sydney, Australia. The first participant was randomized on December 10, 2015, and the last was randomized on July 25, 2019. Follow-up was completed on February 3, 2020.INTERVENTIONS Participants randomized to the intervention group (n = 138) were asked to participate in 12 weekly clinical sessions and home training designed to educate them about and assist them with movement and physical activity while experiencing lower back pain. Participants randomized to the control group (n = 138) were asked to participate in 12 weekly clinical sessions and home training that required similar time as the intervention but did not focus on education, movement, and physical activity. The control group included sham laser and shortwave diathermy applied to the back and sham noninvasive brain stimulation. MAIN OUTCOMES AND MEASURESThe primary outcome was pain intensity at 18 weeks, measured on an 11-point numerical rating scale (range, 0 [no pain] to 10 [worst pain imaginable]) for which the between-group minimum clinically important difference is 1.0 point. RESULTS Among 276 randomized patients (mean [SD] age, 46 [14.3] years; 138 [50%] women), 261 (95%) completed follow-up at 18 weeks. The mean pain intensity was 5.6 at baseline and 3.1 at 18 weeks in the intervention group and 5.8 at baseline and 4.0 at 18 weeks in the control group, with an estimated between-group mean difference at 18 weeks of −1.0 point ([95% CI, −1.5 to −0.4]; P = .001), favoring the intervention group. CONCLUSIONS AND RELEVANCEIn this randomized clinical trial conducted at a single center among patients with chronic low back pain, graded sensorimotor retraining, compared with a sham procedure and attention control, significantly improved pain intensity at 18 weeks. The improvements in pain intensity were small, and further research is needed to understand the generalizability of the findings.
Preliminary data suggest that combining treatments that target central nervous system function with traditional interventions is a promising approach to chronic low back pain treatment. In the context of modest effects on pain intensity from most available treatments, this approach may lead to improved clinical outcomes for people with chronic low back pain. The trial will determine which, if either, of two treatment programs that combine central nervous system-directed and traditional interventions is more effective at reducing pain intensity in a chronic low back pain cohort. Central nervous system-directed interventions constitute a completely new treatment paradigm for chronic low back pain management. The results have the potential to be far reaching and change current physiotherapy management of chronic low back pain in Australia and internationally.
Background In 2009, mandatory folic acid fortification of bread-making flour was introduced in Australia to reduce the birth prevalence of preventable neural tube defects (NTDs) such as spina bifida. Before the introduction of the policy, modelling predicted a reduction of 14-49 NTDs each year. Objective Using real-world data, this study provides the first ex-post evaluation of the cost effectiveness of mandatory folic acid fortification of bread-making flour in Australia. Methods We developed a decision tree model to compare different fortification strategies and used registry data to quantify the change in NTD rates due to the policy. We adopted a societal perspective that included costs to industry and government as well as healthcare and broader societal costs. ResultsWe found 32 fewer NTDs per year in the post-mandatory folic acid fortification period. Mandatory folic acid fortification improved health outcomes and was highly cost effective because of the low intervention cost. The policy demonstrated improved equity in outcomes, particularly in birth prevalence of NTDs in births from teenage and indigenous mothers. Conclusions This study calculated the value of mandatory folic acid fortification using real-world registry data and demonstrated that the attained benefit was comparable to the modelled expected benefits. Mandatory folic acid fortification (in addition to policies including advice on supplementation and education) improved equity in certain populations and was effective and highly cost effective for the Australian population.
Objective: To estimate the cost-effectiveness of a strength and balance exercise programme (SUNBEAM) which has been shown to be clinically effective in reducing the rate of falls in residents of aged care facilities. Design: An economic evaluation was conducted alongside a pragmatic cluster randomized controlled trial that included 16 residential care facilities and 221 participants. Mean participant age was 86 years, 65% were female and 78% relied on a mobility aide. A cost-effectiveness analysis examined the costs of providing the exercise programme and costs of health service use arising from falls in each arm (intervention and usual care) over 12 months. Main measures: Incremental cost-effectiveness ratios were calculated for the cost per fall avoided. Costs were bootstrapped to obtain adjusted confidence intervals for the incremental cost-effectiveness ratios. Results: Of 63 facilities contacted, 16 met the eligibility criteria and were randomized to the intervention or usual care (1:1). There were 142 falls in the intervention group and 277 in the usual care group. 72 injurious falls occurred in the intervention group versus 157 with usual care. Delivery of the SUNBEAM programme cost $463 per participant. The mean total cost of each fall (regardless of group) was $400.09 and the mean cost of each injurious fall was $708.27. The incremental cost-effectiveness ratio was $22 per fall per person avoided with the mean bootstrapped incremental cost-effectiveness ratio $18 per fall avoided (95% CI: −$380.34 to $417.85). Conclusion: The SUNBEAM programme can be considered cost-effective, relative to other fall-prevention interventions in older adults.
Community-based nurse-delivered infant sleep consultations aid infant sleep, improve maternal quality of life, and are cost-effective compared with usual care and lead to improvements in quality of life through a reduction in postnatal depression.
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