నైరూప్య

Vertebral puncture reduces vertebral fracture-associated pain-do osteoplastic procedures qualify as successful placebo interventions?

Klein R, Weiss C, Georgescu CE, Tanner M, Schiltenwolf M, Wolfl CG, Nawroth PP & Kasperk C*

Objective: The results of three randomized sham-controlled trials investigating the outcome after osteoplastic procedures demonstrated contradictory results and are flawed by using local anaesthesia as a sham procedure in the placebo- as well as in the osteoplasty cohort. This raises the need for a true sham procedure that eliminates the effect of local anaesthetics in pain relief. Methods: To establish the safety of such a procedure, we performed a study with 14 patients suffering from painful osteoporotic vertebral fractures. These patients underwent sole vertebral puncture with a Jamshidi needle in general anaesthesia. Results: The mean postoperative VAS value decreased from 5.84 ± 2.21 standard deviation (sd) to 3.55 ± 2.53 the next day, 3.25 ± 1.92 after 2 weeks, 3.55 ± 2.25 after 1 month and 2.89 ± 1.71 after 3 months. The observed effects were within the range of published pertinent osteoplasty trials (intervention groups). Conclusions: A “placebo” procedure like vertebral puncture is urgently needed to clarify the impact of non-surgical factors like total muscle relaxation in a prone position and placebo-related effects in osteoplasty.