Intrathecal Baclofen for Intractable Cerebral Spasticity: A Prospective Placebo-controlled, Double-blind Study

P, Van Schaeybroeck; Nuttin, Bart; Lagae, Lieven; Schrijvers, E; Borghgraef, Cindy; Feys, Peter

doi:10.1097/00006123-200003000-00017

Cited by 121 publications

(74 citation statements)

References 19 publications

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“…1,2,9,11,23,24,26,33,43 Although it has been very effective in treating spasticity, the therapy does entail certain risks, 4,14,21,22 with approximately 25%-30% of patients experiencing a complication. 4,[22][23][24] These complications can be from dosing (overdose or underdose), mechanical failure of the pump or catheter, and infection of the hardware or local tissues.…”

Section: Discussionmentioning

confidence: 99%

Baclofen pump catheter leakage after migration of the abdominal catheter in a pediatric patient with spasticity

Dastgir

Ranalli

MacGregor

et al. 2015

PED

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The authors report an unusual case of intrathecal baclofen withdrawal due to the perforation and subsequent leakage of a baclofen pump catheter in a patient with spastic cerebral palsy. A 15-year-old boy underwent an uncomplicated placement of an intrathecal baclofen pump for the treatment of spasticity due to cerebral palsy. After excellent control of symptoms for 3 years, the patient presented to the emergency department with increasing tremors following a refill of his baclofen pump. Initial evaluation consisted of radiographs of the pump and catheter, which appeared normal, and a successful aspiration of CSF from the pump’s side port. A CT dye study revealed a portion of the catheter directly overlying the refill port and extravasation of radiopaque dye into the subfascial pocket anterior to the pump. During subsequent revision surgery, a small puncture hole in the catheter was seen to be leaking the drug. The likely cause of the puncture was an inadvertent perforation of the catheter by a needle during the refilling of the pump. This case report highlights a unique complication in a patient with an intrathecal baclofen pump. Physicians caring for these patients should be aware of this rare yet potential complication in patients presenting with baclofen withdrawal symptoms.

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Section: Discussionmentioning

confidence: 99%

Baclofen pump catheter leakage after migration of the abdominal catheter in a pediatric patient with spasticity

Dastgir

Ranalli

MacGregor

et al. 2015

PED

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“…Its efficiency has been shown in cases of spinal cord injury and multiple sclerosis, but not yet in a patient with stroke [120,121]. It is also more often used for spasticity of the lower limbs and the trunk.…”

Section: Intrathecal Baclofen Pompmentioning

confidence: 99%

Spasticity after stroke: Physiology, assessment and treatment

et al. 2013

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Background: Spasticity following a stroke occurs in about 30% of patients. The mechanisms underlying this disorder, however, are not well understood. Method: This review aims to define spasticity, describe hypotheses explaining its development after a stroke, give an overview of related neuroimaging studies as well as a description of the most common scales used to quantify the degree of spasticity and finally explore which treatments are currently being used to treat this disorder. Results: The lack of consensus is highlighted on the basis of spasticity and the associated absence of guidelines for treatment, use of drugs and rehabilitation programmes. Conclusions: Future studies require controlled protocols to determine the efficiency of pharmacological and non-pharmacological treatments for spasticity. Neuroimaging may help predict the occurrence of spasticity and could provide insight into its neurological basis.

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“…Furthermore, this one-point reduction had to last for two successive measurements on the same day. 2,10,11 On the day that a positive clinical response was observed, the test treatment ended and the study medication code was broken. Only if this positive clinical response was observed on the first test day did the child and caregivers have the opportunity to experience the results of the second test day before the test treatment was ended.…”

Section: Participants and General Study Designmentioning

confidence: 99%

Intrathecal baclofen in children with spastic cerebral palsy: a double‐blind, randomized, placebo‐controlled, dose‐finding study

Hoving¹,

Raak²,

Spincemaille³

et al. 2007

Develop Med Child Neuro

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Intrathecal baclofen (ITB) therapy can be very effective in the treatment of intractable spasticity, but its effectiveness and safety have not yet been thoroughly studied in children with cerebral palsy (CP). The aims of this double‐blind, randomized, placebo‐controlled, dose‐finding study were to select children eligible for continuous ITB infusion, to assess the effective ITB bolus dose, and to evaluate the effects, side effects, and complications. Outcome measures included the original Ashworth scale and the Visual Analogue Scale for individually formulated problems. We studied nine females and eight males, aged between 7 and 16 years (mean age 13y 2mo [SD 2y 9mo]). Twelve children had spastic CP and five had spastic‐dyskinetic CP. One child was classified on the Gross Motor Function Classification System at Level III, two at Level I V, and 14 at Level V. The test treatment worked successfully for all 17 children with an effective ITB bolus dose of 12.5μg in one, 20μg in another, 25μg in 10, and 50μg in five children. ITB significantly reduced muscle tone, diminished pain, and facilitated ease of care. The placebo did not have these effects. Nine side effects of ITB were registered, including slight lethargy in seven children. Fourteen children had symptoms of lowered cerebrospinal fluid pressure. We conclude that ITB bolus administration is effective and safe for carefully selected children with intractable spastic CP.

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Intrathecal Baclofen for Intractable Cerebral Spasticity: A Prospective Placebo-controlled, Double-blind Study

Abstract: Intrathecal administration of baclofen is a safe and effective treatment for spasticity of cerebral origin. Functional improvement was demonstrated. The presence of a placebo effect on the spasticity scores suggests the need for double-blind screening in each patient.

Cited by 121 publications

References 19 publications

Baclofen pump catheter leakage after migration of the abdominal catheter in a pediatric patient with spasticity

Baclofen pump catheter leakage after migration of the abdominal catheter in a pediatric patient with spasticity

Spasticity after stroke: Physiology, assessment and treatment

Intrathecal baclofen in children with spastic cerebral palsy: a double‐blind, randomized, placebo‐controlled, dose‐finding study

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