Titre du document / Document title

A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity

Auteur(s) / Author(s)

GUILLAUME Daniel ⁽¹⁾ ; VAN HAVENBERGH Anthony ⁽²⁾ ; VLOEBERGHS Michael ⁽³⁾ ; VIDAL Joan ⁽⁴⁾ ; ROESTE Geir ⁽⁵⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Centre Neurologique et de Réadaptation Fonctionnelle, Fraiture-en-Condroz, BELGIQUE
⁽²⁾ University Hospital Antwerp, Antwerp, BELGIQUE
⁽³⁾ Queen's Medical Centre, Nottingham, ROYAUME-UNI
⁽⁴⁾ Guttmann Institute, Barcelona, ESPAGNE
⁽⁵⁾ National Hospital, Oslo, NORVEGE

Résumé / Abstract

Objective: To determine the impact of intrathecal baclofen (ITB) therapy on outcomes of functional independence, pain, subjective improvement, performance, and standard measures of spasticity. Design: A noncomparative, multicenter, prospective cohort trial of patients with implanted pumps followed up over a 12-month period for the assessment of spasticity, pain, and function. Setting: Twenty-four European centers of neurology or rehabilitation familiar with implantable pump technique participated. Participants: Patients with intractable spasticity (N=138) who responded positively to a trial dose of baclofen (n= 133) and who began ITB therapy (n=129) were enrolled. Intervention: Implantation of a Medtronic SynchroMed Infusion System with the administration of ITB therapy. Main Outcome Measures: Ashworth Scale assessment, Penn Spasm Frequency Scale scores, pain assessment, FIM instrument scores or WeeFIM scores for children, Canadian Occupational Performance Measure (COPM), and subjective ratings of overall relief were the tools administered. Results: Muscle tone, spasm scores, and pain intensity reductions were observed. Overall FIM scores increased significantly in cognitive and motor function. COPM scores for both performance and satisfaction also improved significantly. Patients reported increased relief from pain and spasticity, supported by physician reports. Forty-three percent of patients reported adverse events, mostly related to patients' underlying conditions (20%), the device implant surgery (10%), or complications with the catheter (9%). Conclusions: ITB therapy using a programmable pump is clinically effective and well tolerated, despite a seemingly high level of adverse events, in patients with intractable spasticity of spinal or cerebral origin and may offer improvements in pain relief and function.

Revue / Journal Title

Archives of physical medicine and rehabilitation   ISSN 0003-9993   CODEN APMHAI 

Source / Source

2005, vol. 86, n^o11, pp. 2165-2171 [7 page(s) (article)] (40 ref.)

Langue / Language

Anglais

Editeur / Publisher

Elsevier, New York, NY, ETATS-UNIS  (1953) (Revue)

Mots-clés anglais / English Keywords

Public health ; Work safety ; Muscle tonus alteration ; Neurological disorder ; Nervous system diseases ; Striated muscle disease ; Gabaergic agonist ; Gabaergic receptor B ; Agonist ; Antispasmodic agent ; Muscle relaxant ; Dose ; Technique ; Neurology ; Rehabilitation center ; Reeducation ; Rehabilitation(human) ; Europe ; Implant ; Human ; Clinical trial ; Cohort study ; Performance evaluation ; Improvement ; Pain ; Independence ; Prognosis ; Intrathecal administration ; Spasticity ; Intrathecal ; Symptomatology ; Baclofen ;

Mots-clés français / French Keywords

Santé publique ; Sécurité travail ; Trouble tonus ; Trouble neurologique ; Système nerveux pathologie ; Muscle strié pathologie ; Stimulant gabaergique ; Récepteur gabaergique B ; Agoniste ; Spasmolytique ; Myorelaxant ; Dose ; Technique ; Neurologie ; Service soins de suite et réadaptation ; Rééducation ; Réadaptation ; Europe ; Implant ; Homme ; Essai clinique ; Etude cohorte ; Evaluation performance ; Amélioration ; Douleur ; Indépendance ; Pronostic ; Voie intrarachidienne ; Hypertonie spastique ; Intrarachidien ; Symptomatologie ; Baclofène ;

Mots-clés espagnols / Spanish Keywords

Salud pública ; Seguridad trabajo ; Trastorno tono muscular ; Trastorno neurológico ; Sistema nervioso patología ; Músculo estriado patología ; Estimulante gabaérgico ; Receptor gabaminérgico B ; Agonista ; Espasmolítico ; Relajante muscular ; Dosis ; Técnica ; Neurología ; Centro de rehabilitación ; Reeducación ; Readaptación ; Europa ; Implante ; Hombre ; Ensayo clínico ; Estudio cohorte ; Evaluación prestación ; Mejora ; Dolor ; Independencia ; Pronóstico ; Vía intraraquídea ; Hipertonia espástica ; Intratecal ; Sintomatología ; Baclofeno ;

Mots-clés d'auteur / Author Keywords

Baclofen; Infusion pumps ; implantable; Muscle spasticity; Pain; Rehabilitation ;

Localisation / Location

INIST-CNRS, Cote INIST : 8199, 35400013518239.0150