Milani et al. Journal of Brachial Plexus and Peripheral Nerve Injury 2010, 5:11 http://www.jbppni.com/content/5/1/11
JOURNAL OF BRACHIAL PLEXUS AND PERIPHERAL NERVE INJURY
Progesterone - new therapy in mild carpal tunnel syndrome? Study design of a randomized clinical trial for local therapy
Paolo Milani*1,2,3, Mauro Mondelli4, FedericaGinanneschi1, Riccardo Mazzocchio1 and Alessandro Rossi1
Abstract Background: Local corticosteroid injection for carpal tunnel syndrome (CTS) provides greater clinical improvement in symptoms one month after injection compared to placebo but significant symptom relief beyond one month has not been demonstrated and the relapse of symptoms is possible.
Neuroprotection and myelin repair actions of theprogesterone 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.
Methods: 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 outcomemeasures 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.
Conclusion: We have designed a randomized controlled study to show the clinical effectiveness of local progesterone in the most frequent human focal peripheral mononeuropathyand to demonstrate the neuroprotective effects of the progesterone at the level of the peripheral nervous system in humans.
Introduction 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. Surgicaldecompression, often considered the definitive solution, leads to positive results in 75% of the cases, but leaves 8% of patients worse than before .
* Correspondence: firstname.lastname@example.org
Dept. Neurological, Neurosurgical and Behavioural Sciences, Neurophysiology Clinic Section, University of Siena, Siena, Italy
Full list of author information is available at the end of the article
Openrelease 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 around the median nerve, or incorrect diagnosis [2-4]. Open release is not without complications, these produce symptoms different from those present beforesurgery and can be very disabling and difficult to treat. The "major" complications are rare and consists in lesion of the recurrent motor branch, severance of the palmar cutaneous branch of the median nerve or of palmar terminal branches of the median or ulnar nerves with or without neuroma, bowstringing of the flexor retinaculum, tendon or artery injuries, reflex
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