Intrathecal baclofen management of poststroke spastic hypertonia: implications for function and quality of life.
OBJECTIVE
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.


METHODS
Prospective open-label multicenter trial with follow-up at 3 and 12 months.


METHODS
Twenty-four stroke treatment centers in the United States.


METHODS
Ninety-four stroke participants (age range, 24-82 y) with spastic hypertonia. Seventy-four participants underwent ITB pump implantation.


METHODS
Participants were implanted with an ITB pump.


METHODS
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.
Ivanhoe
Cindy B
CB
Brain Injury and Stroke Program, The Institute for Rehabilitation and Research, Houston, TX 77030, USA. cindy.ivanhoe@memorialhermann.org
Francisco
Gerard E
GE
McGuire
John R
JR
Subramanian
Thyagarajan
T
Grissom
Samuel P
SP
D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001418:Baclofen / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D015918:Infusion Pumps, Implantable; D007278:Injections, Spinal; D008297:Male; D008875:Middle Aged; D009122:Muscle Hypertonia / Q000188:drug therapy* / Q000209:etiology*; D009125:Muscle Relaxants, Central / Q000008:administration & dosage / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D020521:Stroke / Q000150:complications*
D009125:Muscle Relaxants, Central; D001418:Baclofen