Evidence of the effects of intrathecal baclofen for spastic and dystonic cerebral palsy

Butler, Charlene; Campbell, Suzann K.; Adams, Richard P.; Abel, Mark F.; Chambers, Henry G.; Goldstein, Murray; Leach, Judy; Darrah, Johanna; Msall, Michael E.; Edgar, Terrance; McLaughlin, John F.; Damiano, Diane L.; Stott, N. Susan; Samson‐Fang, Lisa; Logan, Lynne Romeiser; Albright, Leland; Armstrong, R. B.; O’Donnell, Maureen

doi:10.1111/j.1469-8749.2000.tb00371.x

Cited by 52 publications

(68 citation statements)

References 32 publications

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“…8 In 2000, the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) published a systematic review on the degree of evidence about ITB treatment for spasticity in individuals with CP. 9 They concluded that except for two case reports, none of the studies solely concerned children. They underlined the need for further prospective, randomized trials that used valid and reliable outcome measures, in well described and homogeneous patient groups.…”

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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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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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“…Over the last few years, there has been continuing development of interventions in children with dyskinetic CP, including intrathecal baclofen, [10][11][12] deep brain stimulation, 13,14 oral medication, 15-17 ventral rhizotomies, 18 and botulinum toxin injections. 19 However, objective evidence supporting these interventions is only preliminary.…”

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confidence: 99%

“…Specific assessment of dystonia has mostly relied on the Barry-Albright Dystonia Scale (BADS). 20 Operationally, the BADS has become a criterion standard for scoring dystonia in CP, but several studies [10][11][12][13][14][15][16][17] have reported the difficulty of measuring dystonia reliably and ⁄ or questioned the sensitivity of the BADS.…”

mentioning

confidence: 99%

The Dyskinesia Impairment Scale: a new instrument to measure dystonia and choreoathetosis in dyskinetic cerebral palsy

Monbaliu

Ortibus

Cat

et al. 2012

Develop Med Child Neuro

116

134

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AIM The aim of this study was to examine the reliability and validity of the Dyskinesia Impairment Scale (DIS). The DIS consists of two subscales: dystonia and choreoathetosis. It measures both phenomena in dyskinetic cerebral palsy (CP).METHOD Twenty-five participants with dyskinetic CP (17 males; eight females; age range 5-22y; mean age 13y 6mo; SD 5y 4mo), recruited from special schools for children with motor disorders, were included. Exclusion criteria were changes in muscle relaxant medication within the previous 3 months, orthopaedic or neurosurgical interventions within the previous year, and spinal fusion. Interrater reliability was verified by two independent raters. For interrater reliability, intraclass correlation coefficients were assessed. Standard error of measurement, the minimal detectable difference, and Cronbach's alpha for internal consistency were determined. For concurrent validity of the DIS dystonia subscale, the Barry-Albright Dystonia Scale was administered. RESULTSThe intraclass correlation coefficient for the total DIS score and the two subscales ranged between 0.91 and 0.98 for interrater reliability. The reliability of the choreoathetosis subscale was found to be higher than that of the dystonia subscale. The standard error of the measurement and minimal detectable difference values were adequate. Cronbach's alpha values ranged from 0.89 to 0.93. Pearson's correlation between the dystonia subscale and Barry-Albright Dystonia Scale was 0.84 (p<0.001).INTERPRETATION Good to excellent reliability and validity were found for the DIS. The DIS may be promising for increasing insights into the natural history of dyskinetic CP and evaluating interventions. Future research on the responsiveness of the DIS is warranted.Cerebral palsy (CP) is worldwide the most common neuromotor disorder in children, with an incidence of 2 to 3 per 1000 live births.1,2 CP can be categorized into spastic, dyskinetic, and ataxic groups. Dyskinetic CP is further differentiated into dystonia and choreoathetosis. 1,3 Spastic CP is by far the most common type of CP, with a prevalence of approximately 80%, 4 and is followed by dyskinetic CP with a prevalence between 6.5% 5 and 14. 4%. 4 According to the Surveillance of Cerebral Palsy in Europe (SCPE), 6 dyskinetic CP is characterized by involuntary, uncontrolled, recurring, occasionally stereotyped movements, in which the primitive reflex patterns predominate and muscle tone varies. 6 The SCPE described dystonia in CP as dominated by abnormal postures that may give the impression of hypokinesia and muscle tone that is fluctuating (but with easily elicitable tone increase). Characteristics are involuntary movements, distorted voluntary movements, and abnormal postures due to sustained muscle contractions. Choreoathetosis in CP is dominated by hyperkinesia and tone fluctuation (but mainly decreased). Chorea refers to rapid, involuntary, jerky, often fragmented movements. Athetosis means slower, constantly changing, writhing, or contorting movements.6,7 These SCPE...

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“…2,11 Pump delivery systems allow a patient to receive lower doses of baclofen at a constant rate with fewer side effects than the enteral route. 5 Placement of an ITB pump is an invasive procedure associated with significant complications; 2,9,14,16,[18][19][20]24,27 therefore, high-quality patient selection is vital.…”

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confidence: 99%

Intrathecal baclofen trials: complications and positive yield in a pediatric cohort

Sayer

Lumsden

Perides

et al. 2016

PED

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OBJECT Intrathecal baclofen (ITB) is an effective management option for childhood hypertonia. Given the potential complications of implanted ITB pumps, trials of ITB are usually performed as part of the workup for ITB pumps. Two methods are used for ITB trials, lumbar puncture (LP) and catheter insertion into the intrathecal space. Little has been written to date on the number of positive trials and complications in trials. This study aimed to report the outcomes and complications in ITB trials for childhood hypertonia (dystonia, spastic, or mixed). METHODS A retrospective case notes review was conducted of all patients who underwent ITB trials at the Evelina London Children’s Hospital between 2005 and 2012 (inclusive). Positive trials were defined as a reduction in Modified Ashworth Scale by a minimum of 1 point in at least 2 muscle groups and improvement reported by the caregivers in the areas of goals agreed upon between professionals and the families. RESULTS Our patient group comprised children with dystonia (n = 7), mixed spasticity/dystonia (n = 29), spasticity (n = 4), and pain (n = 1). A total of 47 trials were attempted in 41 children. Forty trials were successfully completed, with 39 being positive. Thirty-three were catheter trials, and 14 were LPs. The overall complication rate in the 47 attempted trials was 53%: 61% in catheter trials, and 36% in LP trials. This difference was not statistically significant. The most common complications were vomiting (n = 9) and CSF leak (n = 4). The most serious complication was meningitis (n = 1) in a catheter trial. No patients experienced a permanent injury. CONCLUSIONS There is a high risk of minor self-limiting complications with ITB trials, which needs to be factored into the decision process of progression to trials. The rate of positive trials in this study was 98%, of which 21% did not progress to pump implantation. While the authors would still advocate for ITB trials prior to ITB pump insertion to aid parental decision-making, this figure suggests that with good patient selection, ITB pumps could be placed without a preceding trial.

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Evidence of the effects of intrathecal baclofen for spastic and dystonic cerebral palsy

Cited by 52 publications

References 32 publications

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

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

The Dyskinesia Impairment Scale: a new instrument to measure dystonia and choreoathetosis in dyskinetic cerebral palsy

Intrathecal baclofen trials: complications and positive yield in a pediatric cohort

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