Analysis of complications in 430 consecutive pediatric patients treated with intrathecal baclofen therapy: 14-year experience.

OBJECT: This single-center study investigated adverse events that occurred in children and adolescent patients treated with intrathecal baclofen (ITB) therapy for spasticity and/or dystonia. METHODS: In a 14-year period, 430 consecutive patients with a mean age of 13.3 ± 5.9 years received ITB over a mean follow-up period of 8.6 ± 3.8 years (range 12 months to 14 years). Eighty-nine percent of these patients had cerebral palsy. Major complications, defined as those that required a surgical intervention, were infections, CSF leaks, and device problems related to the catheter or pump. Assessing infections, the authors compared the 2 groups of patients implanted with an ITB system by either the subcutaneous or subfascial technique. The temporal distribution of events related to the catheter was also considered. RESULTS: At least 1 complication was present in 25% of the patients: 9.3% experienced an infection, 4.9% a CSF leak, 15.1% a problem with the catheter, and 1% a problem related to the pump. Five percent of the assessed patients suffered more than 1 complication. The rate of infections was significantly lower (p < 0.001) in patients with the pump placed subfascially compared with those with the pump placed subcutaneously. A higher rate of infection was found after pump replacement compared with the first pump implantation (10.6% vs 6%, respectively). Catheter problems were the most common complication and occurred more frequently during the 1st year after the implant. CONCLUSIONS: While ITB is an effective treatment to manage spasticity of different origins, adverse events may occur and need to be managed. The surgical procedure should be meticulous and different techniques may have a diverse impact on the infection rate, which is the most critical complication. Despite the adverse events that occurred in this study, the majority of patients were satisfied with the treatment received.

Intrathecal baclofen and motor function in cerebral palsy.

AIM: The aim of this retrospective analysis was to determine the impact of intrathecal baclofen (ITB) therapy on motor function in patients with cerebral palsy (CP). METHOD: We studied 37 patients (18 males, 19 females) with CP treated with ITB (mean age at implant 13 y 7 mo, SD 7 y). Eighteen patients were affected by spastic diplegia, 12 by spastic quadriplegia, six by dystonic quadriplegia, and one by hemidystonia. Nine participants were in Gross Motor Function Classification System (GMFCS) level II, 13 in level III, seven in level IV, and eight in level V. Motor function was assessed by the Gross Motor Function Measure (GMFM) before the treatment and 12 months after the implant. RESULTS: The collected data showed an increase in the total median GMFM score in the overall population (p<0.001) and in every GMFM dimension (p<0.05) except for dimension D (standing). The analysis by degree of impairment revealed that patients with severe impairment and those with mild to moderate impairment improved the total median GMFM score (p<0.001 and p<0.05 respectively). Analysis by age showed that the best improvements in GMFM scores were reached by patients younger than 18 years old (p<0.05). Spasticity and dystonia, assessed by means of the Ashworth and Barry-Albright Dystonia scales, significantly decreased 12 months after the implant (p<0.001 and p<0.05 respectively). Finally, a subjective questionnaire administered to patients/caregivers revealed an overall improvement in participants' functional abilities. INTERPRETATION: The results suggest that ITB therapy is an effective treatment for managing spasticity and dystonia, and for improving motor function in children with CP.

Forced-use, without therapy, in children with hemiplegia: preliminary study of a new approach for the upper limb.

BACKGROUND: Forced use (FU) is an emerging treatment for children with hemiplegic cerebral palsy (CP). It involves constraining the unaffected arm and no additional treatment of the affected arm. Our study examined a new approach to FU in children with hemiplegic CP: that is, restraint of the unaffected limb and no rehabilitation. METHODS: Ten children with hemiplegic CP aged between 5 and 9 years were compared with 10 control children (aged between 5 and 8 y). All participants were classified as MACS level II.The FU group wore a fixed cast, on the unaffected arm for 21 consecutive days, and, such as the control group, did not receive any physical therapy.All participants were assessed by the Melbourne Assessment of Unilateral Upper Limb Function and the Shriners Hospital Upper Extremity Evaluation. RESULTS: A statistically significant increase in both the functional scales was already apparent after cast removal and was maintained during follow-ups. The total Melbourne Assessment of Unilateral Upper Limb Function percentage score increased significantly to 9.5% and 12.3% on 3-week and 3-month follow-up examinations, respectively (P<0.05). A statistically significant increase was observed in 2 of the 3 parts of the Shriners Hospital Upper Extremity Evaluation: spontaneous use (P<0.05) and the ability of the involved limb to grasp and release (G/R) (P<0.05). CONCLUSIONS: These preliminary results suggest that FU without rehabilitation improves the spontaneous use and function of the affected upper limb. In children with hemiplegia, this approach may be an economically viable means of upper limb treatment that has no side effects. LEVEL OF EVIDENCE: Therapeutic Level III. See Instructions to Authors for complete description of level of evidence.

Upper limbs function after intrathecal baclofen therapy in children with secondary dystonia.

BACKGROUND: Different studies show the efficacy of intrathecal baclofen therapy (ITB) in patients with secondary dystonia because of cerebral palsy. These studies only report improvements related to dystonia reduction; however, none of them have assessed whether such benefit is reflected in limb function. The purpose of our study is to determine whether the effects ITB therapy in patients with secondary dystonia to cerebral palsy, in addition to reducing dystonia, may also improve upper limb function. METHODS: Eleven patients with secondary dystonia, classified as levels 3 and 4 of the Gross Motor Function Classification System, were treated with ITB. The mean age at implant was 11.3 (SD+/-3.02) years.Before treatment and 12 months after implant, the patients were evaluated by the Melbourne Assessment of Unilateral Upper Limb and the Barry Albright scale to assess upper limb function and dystonia, respectively. RESULTS: We found a statistically significant improvement in both scales. The Melbourne scale total percentage score, for both limbs, increased in all patients (P<0.05). Dystonia assessed by the Barry Albright scale scale decreased significantly by 15% from baseline to 12 months follow-up (P<0.05). CONCLUSIONS: In patients with secondary dystonia treated with ITB, functional improvement of the upper limbs was observed in addition to dystonia reduction. In patients with secondary dystonia, ITB is a treatment that aims to achieve a general reduction of dystonia; this study want to show the influence that this reduction has to functional ability of patient. LEVEL OF EVIDENCE: Therapeutic study: level 4.

Upper limb function after intrathecal baclofen treatment in children with cerebral palsy.

BACKGROUND: The literature shows that intrathecal baclofen (ITB) treatment in patients with cerebral palsy (CP) is able to reduce spasticity. The purpose of this work is to evaluate the motor function of the upper limbs in patients with CP treated with ITB. METHODS: A consecutive series of 20 patients with spastic CP (mean age at implant, 11.4 years) implanted with pumps in our center was studied. These patients were classified using the Gross Motor Function Classification System. The patients were followed up over a 12-month period for assessment of the upper limb function with the Melbourne Assessment of Unilateral Upper Limb Function scale. RESULTS: The data show a reduction of upper limb spasticity in all 20 patients (P < 0.05). The Melbourne scale shows a statistically significant improvement of the total score (P < 0.05) and an improvement of the subskills of range of movement, target accuracy, and fluency. Twenty-five percent of patients showed a clinically significant improvement. CONCLUSION: The subjects with CP of different degrees of severity had an improvement in the quality of the upper limb function and showed overall satisfaction with the results achieved. The study also shows the importance of evaluating the quality of upper limb function in children with CP treated with ITB therapy.