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Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration.
Arch Phys Med Rehabil. 2019 05; 100(5):837-843.AP

Abstract

OBJECTIVE

To report our experience using continuous intrathecal baclofen (ITB) administration prior to a possible ITB device implantation.

DESIGN

Retrospective open label study. Mean duration of follow-up 64 months.

SETTING

Primary-care and referral center, ambulatory and hospitalized care.

PARTICIPANTS

Patients (N=116) undergoing continuous ITB trials between 2006 and 2017.

INTERVENTIONS

Continuous application of baclofen via a temporary intrathecal catheter connected to an external pump.

MAIN OUTCOME MEASURES

Assessment of the modified Ashworth Scale and range of movement prior versus end of ITB trial. According to the Barthel Index, definition of high-level patients (60-100 scoring points) and low-level patients (0-55 scoring points). Calculation of the Rivermead Mobility Index in high-level patients prior versus end of ITB trial. Evaluation of occurring adverse events.

RESULTS

A total of 119 ITB trials were performed in 116 patients (78 men, mean age 41±16), 113 patients completed the trials (31 of 113 high level, 82 of 113 low level). The median modified Ashworth scale improved from 4 (interquartile range [IQR] 3-4) to 2 (IQR 1-2; P≤.001), the range of movement from 2 (IQR 1-3) to 3 (IQR 3-3; P≤.001). The Rivermead Mobility Index increased from 9 (IQR 6-12) to 10 (IQR 7-12.5; P=.004) in high-level patients. Eighty-eight out of 113 patients (78%) were appropriate candidates for ITB device surgery, 75 of 88 (85%) proceeded to an implantation. A total of 69 adverse events occurred in 57 of 119 trials (48%), 37 of 69 (54%) were drug related, 32 of 69 (46%) were procedure related, and 42 of 69 (61%) were minor. The ITB device was implanted in 69 of 75 patients (92%) at last follow-up.

CONCLUSIONS

Continuous administration of ITB is an effective and useful alternative to ITB bolus application during ITB screening period. Half of the patients experienced adverse events; the majority were minor events.

Authors+Show Affiliations

Department of Neurology, Hochzirl Hospital, Zirl, Austria. Electronic address: elke.pucks-faes@tirol-kliniken.at.Department of Neurology, Hochzirl Hospital, Zirl, Austria.Department of Neurology, Hochzirl Hospital, Zirl, Austria.Department of Neurology, Hochzirl Hospital, Zirl, Austria.Department of Neurology, Hochzirl Hospital, Zirl, Austria.Department for Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Innsbruck, Austria.Department for Medical Statistics, Informatics and Health Economics, Medical University of Innsbruck, Innsbruck, Austria.Department of Neurology, Hochzirl Hospital, Zirl, Austria; Research Unit for Neurorehabilitation, South Tyrol, Bolzano, Italy.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31030729

Citation

Pucks-Faes, Elke, et al. "Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration." Archives of Physical Medicine and Rehabilitation, vol. 100, no. 5, 2019, pp. 837-843.
Pucks-Faes E, Matzak H, Hitzenberger G, et al. Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration. Arch Phys Med Rehabil. 2019;100(5):837-843.
Pucks-Faes, E., Matzak, H., Hitzenberger, G., Genelin, E., Halbmayer, L. M., Fava, E., Fritz, J., & Saltuari, L. (2019). Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration. Archives of Physical Medicine and Rehabilitation, 100(5), 837-843. https://doi.org/10.1016/j.apmr.2018.09.124
Pucks-Faes E, et al. Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration. Arch Phys Med Rehabil. 2019;100(5):837-843. PubMed PMID: 31030729.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intrathecal Baclofen Trial Before Device Implantation: 12-Year Experience With Continuous Administration. AU - Pucks-Faes,Elke, AU - Matzak,Heinrich, AU - Hitzenberger,Gabriel, AU - Genelin,Eleonora, AU - Halbmayer,Lucas-Michael, AU - Fava,Elena, AU - Fritz,Josef, AU - Saltuari,Leopold, Y1 - 2018/10/26/ PY - 2018/07/15/received PY - 2018/09/18/revised PY - 2018/09/23/accepted PY - 2019/4/30/entrez PY - 2019/4/30/pubmed PY - 2020/1/8/medline KW - Baclofen KW - Catheters KW - Muscle spasticity KW - Rehabilitation SP - 837 EP - 843 JF - Archives of physical medicine and rehabilitation JO - Arch Phys Med Rehabil VL - 100 IS - 5 N2 - OBJECTIVE: To report our experience using continuous intrathecal baclofen (ITB) administration prior to a possible ITB device implantation. DESIGN: Retrospective open label study. Mean duration of follow-up 64 months. SETTING: Primary-care and referral center, ambulatory and hospitalized care. PARTICIPANTS: Patients (N=116) undergoing continuous ITB trials between 2006 and 2017. INTERVENTIONS: Continuous application of baclofen via a temporary intrathecal catheter connected to an external pump. MAIN OUTCOME MEASURES: Assessment of the modified Ashworth Scale and range of movement prior versus end of ITB trial. According to the Barthel Index, definition of high-level patients (60-100 scoring points) and low-level patients (0-55 scoring points). Calculation of the Rivermead Mobility Index in high-level patients prior versus end of ITB trial. Evaluation of occurring adverse events. RESULTS: A total of 119 ITB trials were performed in 116 patients (78 men, mean age 41±16), 113 patients completed the trials (31 of 113 high level, 82 of 113 low level). The median modified Ashworth scale improved from 4 (interquartile range [IQR] 3-4) to 2 (IQR 1-2; P≤.001), the range of movement from 2 (IQR 1-3) to 3 (IQR 3-3; P≤.001). The Rivermead Mobility Index increased from 9 (IQR 6-12) to 10 (IQR 7-12.5; P=.004) in high-level patients. Eighty-eight out of 113 patients (78%) were appropriate candidates for ITB device surgery, 75 of 88 (85%) proceeded to an implantation. A total of 69 adverse events occurred in 57 of 119 trials (48%), 37 of 69 (54%) were drug related, 32 of 69 (46%) were procedure related, and 42 of 69 (61%) were minor. The ITB device was implanted in 69 of 75 patients (92%) at last follow-up. CONCLUSIONS: Continuous administration of ITB is an effective and useful alternative to ITB bolus application during ITB screening period. Half of the patients experienced adverse events; the majority were minor events. SN - 1532-821X UR - https://www.unboundmedicine.com/medline/citation/31030729/Intrathecal_Baclofen_Trial_Before_Device_Implantation:_12_Year_Experience_With_Continuous_Administration_ DB - PRIME DP - Unbound Medicine ER -