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Abstract
Objective. To study the efficacy and safety of intrathecal baclofen therapy (ITB) in wheelchair-dependent adults with cerebral palsy.
Patients and methods. A retrospective analysis and clinical examination of 25 wheelchair-assisted adults with cerebral palsy receiving ITB
initiated between 1999 and 2009 in three different cities in western France.
Results. ITB improves spasticity and facilitates wheelchair comfort and nursing care. The therapy has an effect on motor disorders and pain.
Eighty percent of the ITB patients were satisfied. Dissatisfaction was related to complications or adverse events and not lack of efficacy.
Complications occurred in 32% of the patients and transient interruption of the treatment or surgical removal of the ITB pump was necessary in
16% of cases.
Discussion and conclusion. Wider use of ITB in this indication is likely and should lead to a better understanding of the drugs pharmacological
effects on motor disorders and pain. Use of the Goal Attainment Assessment Scale or Caregiver Questionnaire can help us.
# 2010 Elsevier Masson SAS. All rights reserved.
Keywords: Intrathecal Baclofen; Cerebral palsy; Spasticity; Adult; Caregiver; Wheelchair
Resume
Objectifs. Etudier lefficacite et la tolerance du Baclofe`ne intrathecal au long cours chez les patients adultes paralyses cerebraux non marchants.
Patients. Analyse retrospective des dossiers et examen clinique de 25 patients paralyses cerebraux adultes non marchants implantes dune
pompe a` Baclofe`ne intrathecal et suivis a` Angers, Le Mans ou Nantes entre 1999 et 2009.
Resultats. Le Baclofe`ne intrathecal est efficace sur la spasticite et ameliore par ce biais la station assise et le nursing. Il existe un effet du
Baclofe`ne intrathecal sur les mouvements anormaux et les douleurs. Quatre-vingt pour cent des patients porteurs de pompe a` Baclofe`ne intrathecal
sont satisfaits et linsatisfaction provient du fait de complications ou deffets secondaires et non pas du manque defficacite. Les complications
surviennent chez 32 % des patients necessitant larret ou lablation de la pompe dans 16 % des cas.
* Corresponding author.
E-mail address: tasseel-ponche.sophie@chu-amiens.fr (S. Tasseel Ponche).
1877-0657/$ see front matter # 2010 Elsevier Masson SAS. All rights reserved.
doi:10.1016/j.rehab.2010.07.007
484
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
Discussion et conclusion. Le developpement du Baclofe`ne intrathecal dans cette indication est probable et justifie une meilleure comprehension
des effets pharmacologiques sur les mouvements anormaux et la douleur. Lutilisation du Goal Assessment Scale ou dechelles de quantification de
soins peuvent permettre de faciliter levaluation de lefficacite du Baclofe`ne intrathecal et son suivi personnalise au long cours.
# 2010 Elsevier Masson SAS. Tous droits reserves.
Mots cles : Baclofe`ne intrathecal ; Paralysie cerebrale ; Spasticite ; Adulte ; Satisfaction ; Confort
1. English version
1.1. Introduction
Cerebral palsy (CP) is caused by nonprogressive damage to
the motor control centres of the developing brain. Regardless of
the conditions etiology, CP can occur during pregnancy, during
childbirth or up until to the age of about three. Indeed, CP is an
umbrella term encompassing a group of motor conditions
which cause physical disability (mainly in the various areas of
body movement and in the presence or absence of mental
handicap) and problems in intrauterine development [20]. CP is
the leading cause of childhood disability in industrialized
countries, with an incidence of 2 per 1000 live births. Despite
progress in neonatal care, this value has remained stable over
recent years. Life expectancy is barely over 30 in 87% of cases.
The condition limits the patients activity and has a negative
impact on quality of life [22,24,35,65].
The clinical symptoms of CP variously include motor
impairments, sensory deficits (pain, loss of sight or hearing,
etc.) and cognitive or intellectual impairments. It may also be
associated with abnormal muscle tone (hypertonia or
hypotonia), involuntary motion (with choreoathetosis or
dyskinesia/dystonia in 7% of cases) and ataxia (in 5% of
cases) [20,42]. The Surveillance for cerebral palsy in Europe
(SCPE) collaboration has proposed a simplified classification
of CP, with five subgroups: unilateral spastic CP, bilateral
spastic CP, dystonic CP, choreoathetotic CP and ataxic
CP [20].
Spastic CP is by far the most common form of the condition
and occurs in 80% of all cases with hypertonia (phasic or tonic
patterns) [20,42]. It triggers painful complications, orthopedic
disorders (muscle retraction, joint deformity, scoliosis, etc.) and
skin disorders (pressure ulcers) and has a negative impact on the
patients comfort and quality of life [1,70].
Intrathecal baclofen therapy (ITB) is a unique treatment for
treating spasticity in which the drug baclofen [4-amino-3-(4chlorophenyl)-butanoic acid] is directly injected into the fluid
surrounding the spinal cord in small, precise doses by an
implanted pump. The technique has been used since 1984 and
received marketing authorization in France in 1995. Its main
indication is severe, generalized, functionally disabling
spasticity which is refractory to conventional therapy [49
51,54]. Compared with oral administration, the improved
bioavailability of ITB limits the drugs side effects on the
central nervous system. On the pharmacological level,
baclofen is a gamma-aminobutyric acid (GABA) agonist. It
decreases the excitability of the spinal and brain stem
motoneurons by regulating excitatory neurotransmitter
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
Table 1
Distribution of the clinical types of cerebral palsy (CP) and functional status
(absolute values).
Clinical types
Unilateral spastic CP
Bilateral spastic CP
Choreo-athetotic CP
Dystonic CP
Ataxic CP
0
21
4
0
0
Lesion level
Quadriplegia
Diplegia
21
4
Wheelchair dependence
Third party dependent
Independent
19
6
485
[(Fig._1)TD$IG]
486
[(Fig._3)TD$IG]
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation
Medicine 53 (2010) 483498
[(Fig._2)TD$IG]
1.3.2. Efficacy
The clinical efficacy of ITB was confirmed by the change
over time in the modified Ashworth scale [from an average of
3.2 0.4 (range: 34) before initiation of therapy to 2 0.6
(range: 14) afterwards (Fig. 3)].
As mentioned above, the limited degree of cooperation by
certain patients with cognitive disorders prompted us to
measure the functional efficacy of ITB was analyzed using a
simple, subjective satisfaction scale (VAS), (Annex I). In terms
of the main objectives set prior to pump implantation, 96% of
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
487
Table 2
Major complications following implantation of the intrathecal baclofen (ITB) pump.
Complications
NBE
Observation
Treatment
End ITB?
Technical
Catheter breakage
No
Yes
Medical
Infection
No
Constipation
DVT
Yes
?
No
Anxious-depressive
Syndrome
Pump stopped
Yes
Yes
Psychiatric
NBE: number of events; DVT: Deep venous thrombosis; MRSA: methicillin-resistant Staphylococcus aureus.
Table 3
Adverse events after ITB pump implantation.
Adverse events
Postoperative
NBE Observation
Spinal tap syndrome 3
CSF effusion
2
Pressure ulcer
1
Pharmacological Bladder/Bowel
Treatment
2
1
Swallowing disorder 2
Pruritus
Edema of the legs
1
1
Medical treatment
Monitoring
Preventing swallowing disorders + treatment
for aspiration pneumonia
Treatment with an H1 antihistamine
Decreased ITB doses + support tights
488
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S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
fact, CP can be associated to personality and body representation disorders, which must be screened for prior to implantation
[19,65].
Technical complications were rare (relative to older series
[52]) because there was only one case of catheter migration and
no pump problems in our study. Technical and surgical
advances will probably decrease the incidence of pump and
catheter complications in the future.
1.4.4. Evaluation of intrathecal baclofen therapy
In CP, evaluating the efficacy of ITB is complicated by the
frequent presence of intellectual deficits, the heterogeneous
nature of the clinical cases, the patients age range (adults and
adolescents) and low degree of independence. We used
standardized evaluation scales (such as the Ashworth scale
for spasticity) because it is easy to use objective scale in clinical
practice. For pain evaluation, observational measurement
scales are more complex, due to the multiple nature of pain
complaints when cognitive disorders are also present. Several
French language scales for pain complaints in adults or
adolescents with multiple disabilities (such as the expression de
la douleur adulte ou adolescent polyhandicape [EDAAP]) are
currently being validated. The EDAAP is based on the Doloplus
scale used in adult patients with cognitive disorders and the San
Salvadour observational pain scale in children with multiple
disabilities [36,73].
These scales measure spasticity as an impairment but do not
evaluate its consequences in terms of patient comfort. To the
best of our knowledge, no functional or quality of life scales
have been specifically validated for patients with CP [70].
Furthermore, generic scales (such as the Functional independence measure) do not show high sensitivity to change in this
population [60]. Questionnaires designed to measure the care
given to the patients (such as the Caregiver Questionnaire) [60]
have also been designed. Other authors have transformed the
latter into the Care and comfort hypertonicity questionnaire
[48].
The objectives of ITB therapy in CP appear to depend on the
nature of the patients impairments and level of personal
independence. Scales such as the Goal attainment scale can
evaluate personalized goals established prior to treatment
initiation by the physician, the patient and his/her family. Some
authors recommend the Goal Attainment Scale as a means of
therapeutic evaluating [66] antispasticity treatments [44,59],
when used by trained, specialist teams [64], this evaluation is
reproducible, has good sensitivity change and could enable
long-term patient monitoring after the implantation of an ITB
pump [55].
1.5. Conclusion
ITB is moderately effective as an antispasticity treatment in
individuals with CP. Even though the efficacy is not as good as
that reported for spinal cord pathologies, this treatment can
improve wheelchair comfort and nursing care of wheelchairassisted CP patients suffering from spasticity which is
refractory to conventional treatments. This therapy requires
489
490
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
0
21
4
0
0
Topographie de latteinte
Quadriplegie
Diplegie
21
4
19
6
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
491
[(Fig._2)TD$IG]
Fig. 2. Doses moyennes, minimales et maximales de Baclofe`ne a` limplantation et a` la premie`re, deuxie`me, troisie`me, cinquie`me annees postimplantation.
[(Fig._3)TD$IG]
492
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
De plus, 88 % des patients (22) beneficie`rent dameliorations supplementaires differentes des objectifs fixes en
pretherapeutiques comme une amelioration des douleurs dans
68 % des cas (15/22), une facilite dans lexecution des
mouvements dans 45 % des cas (dix sur 22) et 23 %
ameliore`rent leur sommeil (cinq sur 22).
De manie`re plus globale, 72 % juge`rent leur qualite de vie
meilleure (Eva qualite de la vie superieure a` 5/10), que leurs
objectifs principaux soient atteints ou non. La satisfaction
globale du traitement par BIT fut notee a` 7/10 3,2 avec 80 %
` la
de patients satisfaits (Eva satisfaction superieure a` 5/10). A
question Le referiez-vous ? , 68 % repondent oui (17/25),
cinq ne le referaient pas et trois nont pu se prononcer. Parmi les
cinq patients qui ne le referaient pas, aucun ne lexplique par un
manque defficacite du BIT mais deux patients rapporte`rent des
complications necessitant des hospitalisations multiples et trois
declare`rent des effets secondaires superieurs aux benefices
attendus.
2.3.3. Complications et effets secondaires
Suite a` limplantation, 72 % des patients ont presente des
eve`nements indesirables (21/25).
Huit complications necessite`rent une hospitalisation dont
quatre complications indique`rent larret et/ou lablation de la
pompe ; une section iatroge`ne du catheter et une infection de
pompe toutes deux secondaires a` une arthrode`se vertebrale [18]
et deux demandes darret de traitement suite a` des decompensations psychiatriques. Un cas de constipation chronique majeure
est en cours de discussion afin devaluer les benefices et les
risques pour le patient du traitement par BIT. Le nombre de
complications rapporte au nombre dannees pompe correspond a`
0,07 complications par annee pompe (huit sur 112) (Tableau 2).
Treize effets secondaires ont cede spontanement ou apre`s
traitement symptomatique sans sequelle.
Vingt-huit pour cent (sept sur 25) des patients porteurs de
pompe a` BIT nont eu aucune complication ni effet secondaire
(Tableau 3), parmi les deux patients qui presentaient une
comitialite preoperatoire, celle-ci na pas ete desequilibree par
le traitement.
Tableau 2
Complications majeures post-implantation de pompe a` Baclofe`ne intrathecal.
NBE
Observation
Traitement
Arret
Non
1
1
Constipation
TVP
1
1
Syndrome
anxiodepressif
Complications
Techniques
Medicales
Psychiatriques
Section de catheter
Infection
Oui
Non
?
Non
Arret de la pompe
Oui
Oui
Oui
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
493
Tableau 3
Effets secondaires post-implantation de pompe a` Baclofe`ne intrathecal (BIT).
Effets secondaires
NBE
Observation
Traitement
Postoperatoires
Syndrome post-PL
Fuite LCS
Escarre
3
2
1
Traitement medical
Pharmacologiques
Vesicosphincterien
Trouble de deglutition
2
1
2
Prurit
OMI
1
1
Traitement medical
Surveillance
Prevention troubles de deglutition +
traitement de pneumopathie dinhalation
Traitement par antihistaminique H1
Diminution des doses de BIT + bas
de contention
2.4. Discussion
2.4.1. Quelle population ?
Lechantillon de 25 patients paralyses cerebraux non
marchants des pays de La Loire est representatif des patients
atteints de paralysie cerebrale sur le plan demographique
avec un sex-ratio homme/femme de 1,27 pour 1,3 dans la
litterature [65]. Notre etude concerne exclusivement les
patients adultes non marchants qui representent environ 25 %
des paralyses cerebraux adultes [7], soit en France environ
20 000 personnes en 2008, si lon admet une prevalence de
la paralysie cerebrale de 1,25 adulte/1000 habitants [24].
Lestimation actuelle en Pays-de-la-Loire serait de
1000 paralyses cerebraux adultes non marchants si lon
conside`re que les pays de La Loire representent 5 % de la
population francaise metropolitaine, selon les donnees de
lInstitut national de la statistique et des etudes economiques
(Insee) de janvier 2009. Il ny a donc que 2,5 % des patients
cerebraux leses non marchants actuellement traites alors que
la spasticite est une deficience frequente (85 %) [20]. Le
faible recours au BIT dans cette population peut correspondre
a` une meconnaissance de cette indication, a` une indifference
vis-a`-vis de cette population dependante (tierce personne
pour les deplacements dans 76 % des cas) ou a` lapprehension des risques specifiques plus importants que dans dautres
populations.
Levaluation des patients paralyses cerebraux non marchants est complexe du fait des troubles de la communication
et de deficiences intellectuelles associees dans 66 % des cas
[5] et du fait quaucun consensus nest etabli pour levaluation
de ces patients dependants. Levaluation de lefficacite
subjective du BIT a donc ete realisee par Eva de satisfaction
car cest une echelle simple dutilisation. Celle-ci nous a
permis dinterroger le patient en autoevaluation de`s que cela
etait possible ou heteroevaluation grace a` un membre de la
famille ou du personnel soignant en cas dincapacite du
patient [35,55,62].
Des donnees sont manquantes pour un patient du fait de son
dece`s secondaire a` une pneumopathie. Ce dece`s na pas ete mis
en lien avec la pompe a` BIT. En effet, les infections
pulmonaires sont une cause frequente de dece`s chez les
patients paralyses cerebraux surtout en cas de deficience
intellectuelle et de limitation de la deambulation [27].
494
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
cerebrale scoliose et spasticite sont souvent associees lassociation arthrode`se vertebrale et BIT est donc frequente dans cette
population [14,31,61,68]. Nous avons observe deux complications impliquant ces deux chirurgies : une infection et une section
iatroge`ne de catheter. Cependant, une etude recente retrospective
a` quatre bras (A : 26 arthrode`ses avant BIT, B : 11 arthrode`ses et
BIT simultanes, C : 25 arthrode`ses apre`s BIT et D : 103 BIT seul)
a montre le meme taux de complications infectieuses et de
catheter dans les quatre groupes [14]. Linteraction du BIT sur
levolution de la scoliose est un sujet debattu a` lheure actuelle. Il
na pas ete etudie specifiquement dans ce travail, mais aucun
patient na presente devolution majeure de sa scoliose apre`s
mise en place du traitement [61,31].
Chez les patients paralyses cerebraux, le choix du volume de
la pompe est important compte tenu du risque descarre sur
pompe chez des patients parfois tre`s denutris [65]. De plus,
certains patients sont fragiles sur le plan psychologique et
presentent des decompensations psychiatriques accompagnees
de dysmorphophobie secondaire a` limplantation et au volume
de la pompe [37]. La paralysie cerebrale peut en effet
saccompagner de troubles de la personnalite et de troubles du
schema corporel qui doivent donc etre depistes avant
limplantation [19,65].
Les complications techniques semblent en diminution car il
ny eu quun cas de migration de catheter et aucun proble`me de
pompe dans notre etude, au contraire de ce que nous avions
observe dans une serie plus ancienne [52]. Les progre`s
technologiques et chirurgicaux permettront probablement la
diminution de lincidence des complications techniques de
pompe et de catheter.
2.4.4. Quelle evaluation ?
Dans la paralysie cerebrale, levaluation de lefficacite du BIT
est complexe du fait des deficiences intellectuelles, du caracte`re
heteroge`ne des formes cliniques, de lage des patients (adultes et
dadolescents) et des degres de dependance. Les echelles
dheteroevaluation standardisees de deficiences comme lechelle
dAshworth dans la spasticite sont faciles a` utilisee en pratique.
Sur le plan de levaluation de la douleur, les echelles
dheteroevaluation sont plus complexes du fait de lexpression
polymorphe de la douleur en cas de troubles cognitifs. Plusieurs
echelles sont en cours de validation en langue francaise comme
lechelle Expression de la douleur adulte ou adolescent
polyhandicape (EDAAP) sinspirant de lechelle Doloplus
utilisee chez les patients adultes presentant des troubles cognitifs
et lechelle de San Salvadour chez les patients enfants
polyhandicapes [36,73].
Ces echelles mesurent la spasticite en tant que deficience
mais ne permettent pas devaluer ses consequences en termes
de confort du patient. Il nexiste pas a` notre connaissance
dechelle fonctionnelle ou de qualite de vie specifiquement
validee chez les patients paralyses cerebraux [70]. Et les
echelles generiques comme la mesure dindependance fonctionnelle (MIF) ne sont pas assez sensibles au changement dans
cette population [60]. Des questionnaires ont ete elabores pour
mesurer la charge en soins apportes aux patients, comme le
Caregiver questionnaire (CQ) [60] . Dautres auteurs ont
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
Address:
Phone number:
E-mail:
[TD$INLE]
nursing care
[TD$INLE]
physiotherapy
[TD$INLE]
transfers
[TD$INLE]
wheelchair comfort
[TD$INLE]
[TD$INLE]
meals
[TD$INLE]
bladder/bowel evacuation
[TD$INLE]
sleep quality
[TD$INLE]
495
496
S. Tasseel Ponche et al. / Annals of Physical and Rehabilitation Medicine 53 (2010) 483498
1/ Nom du patient :
3/ Questionnaire rempli par : Cocher la case correspondante
le patient
sa famille
le personnel soignant
&
&
&
Adresse :
Numero de telephone :
E-mail :
&
&
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