Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life. Arch Phys Med Rehabil 2006 Nov;87(11):1509-15
Date
11/07/2006Pubmed ID
17084128DOI
10.1016/j.apmr.2006.08.323Scopus ID
2-s2.0-33750479523 (requires institutional sign-in at Scopus site) 63 CitationsAbstract
OBJECTIVES: To evaluate the impact of intrathecal baclofen (ITB) on function and quality of life (QOL) and to obtain efficacy and safety data in poststroke spastic hypertonia.
DESIGN: Prospective open-label multicenter trial with follow-up at 3 and 12 months.
SETTING: Twenty-four stroke treatment centers in the United States.
PARTICIPANTS: Ninety-four stroke participants (age range, 24-82 y) with spastic hypertonia. Seventy-four participants underwent ITB pump implantation.
INTERVENTION: Participants were implanted with an ITB pump.
MAIN OUTCOME MEASURES: FIM instrument and QOL (Sickness Impact Profile [SIP]) changes, spastic hypertonia (Ashworth Scale), and safety.
RESULTS: FIM scores improved overall in repeated-measures analysis of variance (ANOVA) (P = .005) and by 3.00 +/- 7.69 (P = .001) at 3 months and by 2.86 +/- 10.13 (P = .017) at 12 months. Significant improvements in SIP scores were noted overall (repeated-measures ANOVA, P < .001) and at 3 (P = .003) and 12 months (P < .001). The combined average Ashworth Scale score of the upper and lower limbs decreased by 1.27 +/- 0.76 (P < .001) at 3 months and by 1.39 +/- 0.73 (P < .001) at 12 months from baseline, which was significant overall (repeated-measures ANOVA, P<.001). Strength in the unaffected side did not change overall (repeated-measures ANOVA, P = .321) or at either 3 (P = .553) or 12 months (P = .462). Minimal adverse events and device complications were reported.
CONCLUSIONS: There was significant improvement in function, QOL, and spastic hypertonia at 3 and 12 months after implant, without adversely affecting muscle strength of the unaffected limbs. Data suggest that ITB therapy is a safe and efficacious treatment for spastic hypertonia resulting from stroke.
Author List
Ivanhoe CB, Francisco GE, McGuire JR, Subramanian T, Grissom SPAuthor
John R. McGuire MD Professor in the Physical Medicine and Rehabilitation department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Activities of Daily LivingAdult
Aged
Aged, 80 and over
Baclofen
Female
Humans
Infusion Pumps, Implantable
Injections, Spinal
Male
Middle Aged
Muscle Hypertonia
Muscle Relaxants, Central
Prospective Studies
Quality of Life
Stroke