Most osteoporotic patients complain of back pain one year after a fragility vertebral fracture and the frequency of chronic back pain increases with increasing age. The use of the lowest effective dose of an analgesic which is able to control symptoms seems to be a possible solution in order to limit potential side effects in multi-treated elderly patients. Non-steroidal anti-inflammatory drugs (NSAIDs) have a proven efficacy in the treatment of back pain associated with fragility vertebral fractures and diclofenac is available at low-dose subcutaneous injective formulation. This is the rational of ImPAVeDic study, acronym of Improvement of back Pain Associated with fragility Vertebral fractures with low-dose Diclofenac, an observational study that will be performed in a group of 50 elderly (≥ 65 years), male and female osteoporotic patients with symptomatic fragility vertebral fractures. The objective of the study is to evaluate the improvement of back pain in the study population treated with low-dose diclofenac and regularly monitored for 2-6 months. Visual Analogic Scale (VAS) and Numerical Rating Scale (NRS) will be used for pain monitoring. The reduction of the risk of occurrence of drug side effects can favour the optimization of elderly patients' care.
Keywords: back pain; diclofenac; elderly patients; fragility fractures; longitudinal study; osteoporosis; vertebral fractures.