Foot dystonia is frequently observed in patients suffering from Parkinson'disease. It is characterized by an abnormal involuntary movement which is very uncomfortable (difficult to walk) and painful for the patient. Botulinum toxin injections seem to be efficient to treat this dystonia. However studies on this topic are few and very imprecise (many muscle injected, especially the Flexor digitorum longus, different doses used, heterogeneous population with many types of dystonia included, open studies).
Study progress : After an inclusion visit, patients are randomized in one of the 3 following groups : * First group (PL : placebo) : * J0 : Patient will receive 1 injection of placebo in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae * J+1month : First evaluation * J+3 months : Patient will receive again 1 injection of placebo in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae * J+4 months : Last evaluation * Second group (ME : Extrinsic muscle) * J0 : Patient will receive 1 injection of Botulinum toxin (100U) in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae * J+1 month : First evaluation * J+3 months : Patient will receive again 1 injection of Botulinum toxin (100U) in the Flexor digitorum longus and 1 injection of placebo in the Flexor digitorum brevis or in the quadratus plantae * J+4 months : Last evaluation * Third group (MI : Intrinsic muscle) * J0 : Patient will receive 1 injection of placebo in the Flexor digitorum longus and 1 injection of Botulinum toxin (100U) in the Flexor digitorum brevis or in the quadratus plantae * J+1 month : First evaluations * J+3 months : Patient will receive again 1 injection of placebo in the Flexor digitorum longus and 1 injection of Botulinum toxin (100U) in the Flexor digitorum brevis or in the quadratus plantae * J+4 months : Last evaluations During injections (J0 and J+3M), we will measure the pain induced by injections (EVA) For each evaluation (J+1M and J+4M), following evaluations will be made: clinical improvement (CGI), dystonia evaluation (duration and severity, Burke scale), pain (EVA) and quality of life (PDQ39).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
45 patients with an Idiopathic Parkinson's disease and a foot dystonia. Double blind, randomized study
Placebo injection
CHU Purpan
Toulouse, Toulouse, France
NOT_YET_RECRUITINGCHU Gabriel-Montpied
Clermont-Ferrand, France
RECRUITINGHôpital La Pitié Salpétrière
Paris, France
NOT_YET_RECRUITINGHôpital Haut-Levêque
Pessac, France
NOT_YET_RECRUITINGIn a controlled double blind and randomized study, we want to show that intramuscular injections of botulinum toxin are beneficial to reduced dystonia and associated pain in patient with foot dystonia (compared to placebo injections).
Time frame: one month after the injection of botulinum toxin/placebo
Efficiency comparison of injections made in leg muscle (Flexor digitorum longus) between injections made directly in foot muscle (Flexor digitorum brevis or quadratus plantae) - Effects of injections on pain and quality of life.
Time frame: one month after injections of placebo or Botulinum toxin
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