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A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity.
Arch Phys Med Rehabil. 2005 Nov; 86(11):2165-71.AP

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.

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  • Publisher Full Text

    • Authors+Show Affiliations

    Guillaume D
    Centre Neurologique et de Réadaptation Fonctionnelle, Fraiture-en-Condroz, Belgium.
    Van Havenbergh A
    No affiliation info available
    Vloeberghs M
    No affiliation info available
    Vidal J
    No affiliation info available
    Roeste G
    No affiliation info available

    MeSH

    AdolescentAdultAgedBaclofenChildChild, PreschoolCognitionFemaleHumansInfusion Pumps, ImplantableInjections, SpinalMaleMiddle AgedMotor ActivityMuscle Relaxants, CentralMuscle SpasticityPainPatient SatisfactionTreatment Outcome

    Pub Type(s)

    Clinical Trial, Phase IV
    Journal Article
    Multicenter Study
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    16271565

    Citation

    Guillaume, Daniel, et al. "A Clinical Study of Intrathecal Baclofen Using a Programmable Pump for Intractable Spasticity." Archives of Physical Medicine and Rehabilitation, vol. 86, no. 11, 2005, pp. 2165-71.
    Guillaume D, Van Havenbergh A, Vloeberghs M, et al. A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity. Arch Phys Med Rehabil. 2005;86(11):2165-71.
    Guillaume, D., Van Havenbergh, A., Vloeberghs, M., Vidal, J., & Roeste, G. (2005). A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity. Archives of Physical Medicine and Rehabilitation, 86(11), 2165-71.
    Guillaume D, et al. A Clinical Study of Intrathecal Baclofen Using a Programmable Pump for Intractable Spasticity. Arch Phys Med Rehabil. 2005;86(11):2165-71. PubMed PMID: 16271565.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A clinical study of intrathecal baclofen using a programmable pump for intractable spasticity. AU - Guillaume,Daniel, AU - Van Havenbergh,Anthony, AU - Vloeberghs,Michael, AU - Vidal,Joan, AU - Roeste,Geir, PY - 2004/12/07/received PY - 2005/04/15/revised PY - 2005/05/25/accepted PY - 2005/11/8/pubmed PY - 2005/12/16/medline PY - 2005/11/8/entrez SP - 2165 EP - 71 JF - Archives of physical medicine and rehabilitation JO - Arch Phys Med Rehabil VL - 86 IS - 11 N2 - 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. SN - 0003-9993 UR - https://www.unboundmedicine.com/medline/citation/16271565/A_clinical_study_of_intrathecal_baclofen_using_a_programmable_pump_for_intractable_spasticity_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0003-9993(05)00562-9 DB - PRIME DP - Unbound Medicine ER -