%0 Journal Article
%T Progesterone - new therapy in mild carpal tunnel syndrome? Study design of a randomized clinical trial for local therapy
%A Paolo Milani
%A Mauro Mondelli
%A Federica Ginanneschi
%A Riccardo Mazzocchio
%A Alessandro Rossi
%J Journal of Brachial Plexus and Peripheral Nerve Injury
%D 2010
%I Thieme Medical Publishers
%R 10.1186/1749-7221-5-11
%X Neuroprotection and myelin repair actions of the progesterone was demonstrated in vivo and in vitro study.We report the design of a randomized controlled trial for the local injection of cortisone versus progesterone in "mild" idiopathic CTS.Sixty women with age between 18 and 60 years affected by "mild" idiopathic CTS, diagnosed on the basis of clinical and electrodiagnostic tests, will be enrolled in one centre. The clinical, electrophysiological and ultasonographic findings of the patients will be evaluate at baseline, 1, 6 and 12 months after injection.The major outcome of this study is to determine whether locally-injected progesterone may be more beneficial than cortisone in CTS at clinical levels, tested with symptoms severity self-administered Boston Questionnaire and with visual analogue pain scale.Secondary outcome measures are: duration of experimental therapy; improvement of electrodiagnostic and ultrasonographic anomalies at various follow-up; comparison of the beneficial and harmful effects of the cortisone versus progesterone.We have designed a randomized controlled study to show the clinical effectiveness of local progesterone in the most frequent human focal peripheral mononeuropathy and to demonstrate the neuroprotective effects of the progesterone at the level of the peripheral nervous system in humans.Fifty years after its widespread recognition, a significant minority of patients with carpal tunnel syndrome continue to experience poor outcomes from treatment. Much of the current treatment is supported by inadequate or nonexistent evidence. Surgical decompression, often considered the definitive solution, leads to positive results in 75% of the cases, but leaves 8% of patients worse than before [1].Open release is the preferred surgical procedure. Some patients referred failure to relieve symptoms after decompression surgery, and reoperation is sometimes necessary. This is consequence of incomplete release of the flexor retinaculum, scarring arou
%U http://www.jbppni.com/content/5/1/11