Lombatherm study news of an international randomized trial on low back pain

Abstract

Background and rationaleChronic low back pain is a public health issue as much by the repercussions it has on the functional capacities of patients as by its economic and social cost.A number of recommendations of good clinical practice had proposed the spa treatment in low back pain, mainly on the basis of studies carried out by the University of Nancy in the 90s. Despite their qualities, these ancient works have certain methodological limitations: absence of main criterion, analysis in intention to treat. On the other hand, they used an immediate cure-deferred cure design that could overestimate the effect of the spa treatment. On the other hand, there is little or no study of the older populations that are usually frequented by spas. Primary and secondary objectivesPrimary objective: Evaluation of the therapeutic effect of the thermal treatment in addition to the usual care in chronic low back pain versus usual care Secondary objectives: Evaluation of the therapeutic effect of the thermal treatment, in each of the thermal centers. Evaluation of the side effects of the thermal treatment. Evaluation of the benefit / risk ratio, cost / effectiveness, cost / utility of thermal treatment in chronic low back pain. MethodsMethods (study design, population, inclusion criteria, non-inclusion, main and secondary evaluation criteria, number of topics to be included, statistical analysis...)Design of the study: Multicenter randomized trial. Preference randomization will be replaced by the Zelen method because education was judged difficult to achieve in an international project and placebo intervention are not appropriate in preference trial (too much heterogeneity). Stratification is still by center and by the presence of a professional activity.Population concerned. Adult patients with painful low back pain for at least three months.Investigation method. Randomized controlled study in two parallel arms.