Answer by Zaina et al. to comments regarding their paper ‘Can bracing help adults with chronic back pain and scoliosis? Short-term results from a pilot study’

We would like to thank the author of the letter for his comments, but we strongly reject his final insinuations.

We did not cite the studies that you have suggested^1,2 as the sample in these papers was mostly characterized by a sagittal disorder, very heterogenous and totally different from the sample in our paper, which also included congenital scoliosis and kyphosis. It was also not possible to make any comparison with our study since all diagnoses in the papers you have cited were merged together and no subgroup analysis was made.^1,2

The statement that evidence coming from the papers by Weiss et al.^1,2 is stronger than ours is surprising. It is common epidemiological knowledge that a prospective experimental study of consecutive patients like ours has less risks of bias and is more reliable than a retrospective uncontrolled study. In fact, even if the introduction of both papers that you cite state that a prospective study was initiated, results are still to be seen. The methods section does not report the design, and the absence of all the typical data of a prospective trial (such as recruitment and drop-out rates) suggests that these are retrospective reports of preliminary results. Moreover, the protocol change between the two papers^1,2 makes the reader assume that these are two pilots of the prospective study.

We thank the author for the suggestion to try to use the two tests ³ developed in their papers. We did not apply them in this study since our population was totally different. It is also important to note that these tests have never been validated and their reliability is not known. At this stage, they can only be considered proposals linked to a specific treatment approach.

We are sorry for not having reported the applied statistical tests: they included the t-test for the Graphical Rating Scale and a Wilcoxon test for the other variables.

We noticed in the printed paper that the conflict of interest (CoI) was indeed not complete for unknown reasons and we requested a corrigendum. ⁴ The fact that our CoI is well known to the author of the letter from all the other publications of ours demonstrates our transparency on the topic.

Regarding the final insinuations: unlike the author of the two cited papers, Dr Negrini has never trademarked any of the braces he has invented or developed. Neither Dr Negrini nor ISICO distributes any brace, and they have no financial association with the orthotists that produce and sell them. In ISICO, braces are prescribed by physicians according to their own decisions without any exclusivity and they include models developed by others, such as SpineCor,^5,6 PASB, ⁵ Maguelone9, ⁷ and Sibilla. ⁸ Finally, this study shows the efficacy of a brace invented, produced, and commercialized by another company.