A phase IIb, randomized, double-blind, multicenter study evaluating the efficacy of botulinum toxin versus placebo on pain and health related quality of life of patients with piriformis muscle syndrome

Piriformis muscle syndrome

The change in sciatic pain intensity, from baseline, at 6 weeks after injection. The sciatic pain will be measured by VAS (100mm scale). The patient will answer the following question: “What was the average intensity of your pain over the last 24 hours?”.

Change in buttock pain intensity (assessed on Visual Analog Scale value, 0 = no pain, 10 = worst pain), from baseline, at 6 weeks after injection., Variations from baseline in Health-related quality of life (HRQoL) (EQ-5D) at 6 weeks after injection as well as over a period of 6 months. HRQoL will be assessed at each visit (at inclusion and at 6, 12, 18 and 24 weeks of follow-up after injection)., Variations from baseline, over the 6-month follow-up, in sciatic pain intensity (VAS value), in buttock pain intensity (on VAS), in quality of life (HRQoL, EQ-5D) at 6 weeks after injection as well as over a period of 6 months, in physical functioning (BPI and PGI-I), in anxiety and depression (HADS) over 6 months in disability (ODI), in the tolerance of the sitting position assessed at each visit, consumption of painkillers., Number of patients requiring a second injection (botulinum toxin) at 12 weeks in each arm., Side effects of treatment during follow-up in each arm.

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