title: Effects of severe spasticity treatment with intrathecal Baclofen in multiple sclerosis patients: Long term follow-up.
abstract: BACKGROUND
  Intrathecal Baclofen is available to treat severe generalized spasticity in Multiple Sclerosis (MS) unresponsive to oral drug delivery.
  
  
  OBJECTIVE
  The aims of this study were to investigate the effects and the drug dosage of intrathecal Baclofen in a selected population of MS patients, affected by severe spasticity at long term follow-up.
  
  
  METHODS
  A prospective cohort study of 14 MS patients is presented. Spasticity and pain were periodically assessed and the Baclofen dosage was adjusted.
  
  
  RESULTS
  The initial Baclofen dosage was 136.2 ± 109.3 μg, then it was increased at 12 months to 228.6 ± 179.2 μg (p < 0.05). The subsequent dose adjustments did not result in significant changes up to 76 months. Spasticity on the lower limbs decreased significantly from pre-implantation assessment (median: 3.5, IQR: 3.0-4.0) to 12 months evaluation (median: 0.5, IQR: 0.0-2.0) (p < 0.001); no further decrease was observed after 24 months (median: 0.5, IQR: 0.0-1.5); when pain was present, it decreased. Some effects on cerebellar symptoms were observed. Botulinum toxin injections were used with intrathecal Baclofen therapy.
  
  
  CONCLUSIONS
  A reduced spasticity and pain was observed after the intrathecal Baclofen infusion for at least 76 months. To obtain these results a dosage adjustment was needed only in the first year after the implantation.
authors.affiliation: Center for Spinal Cord Injured persons, Pisa University Hospital, Pisa, Italy.
authors.forename: Giulia
authors.initials: G
authors.lastname: Stampacchia
authors.affiliation: Center for Spinal Cord Injured persons, Pisa University Hospital, Pisa, Italy.
authors.forename: Adriana
authors.initials: A
authors.lastname: Gerini
authors.affiliation: The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Mazzoleni
mesh_terms: D000328:Adult; D001418:Baclofen / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015918:Infusion Pumps, Implantable; D007278:Injections, Spinal; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy*; D009125:Muscle Relaxants, Central / Q000627:therapeutic use*; D009128:Muscle Spasticity / Q000188:drug therapy*; D010147:Pain Measurement; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D009125:Muscle Relaxants, Central; D001418:Baclofen
keywords: Multiple sclerosis; botulinum toxin; chronic progressive; intrathecal implant; muscle spasticity; pain