ABSTRACT:A prospective trial to demonstrate the efficacy of intrathecal baclofen therapy by implanted pump for adults with spasticity due to spinal cord injury or multiple sclerosis was initiated in our hospital. Of the 140 patients assessed, 7 met the following criteria for inclusion in the study: a modified Ashworth score > 3, a spasm frequency score > 2, and an inadequate response to oral antispasticity drugs, (i.e., baclofen, clonidine and cyproheptadine). All patients responded to intrathecal bolus injection of baclofen in the double blind, placebo-controlled screening phase (mean bolus dose = 42.8 ug). Programmable Medtronic pumps were implanted in 4 patients while 3 patients received nonprogrammable Infusaid pumps. Post-implantation, a marked decrease in spasticity occurred with a significant reduction of the Ashworth score (mean = 1.8, p < .005), a reduced spasm score (mean = 0.8, p < .005), and an improved leg swing in the pendulum test. These effects were maintained during a follow-up of 24 -41 months (average infusion dose = 218.7 ug/day). The gross cost-savings due to reduced hospitalizations related to spasticity was calculated by comparing the cost for the two year period before pump implantation to the same period after treatment for 6 of the 7 patients. The cost of in-hospital implantation as well as the cost of the pumps were deducted from the gross savings. There was a net cost-saving of $153,120. Our findings agree with the reported efficacy and safety of intrathecal baclofen treatment, and illustrate the cost-effectiveness of this treatment. RESUME: Le baclofen intrathecal chez les adultes avec spasticite spinale: efficacite therapeutique et consequences sur les admissions hospitalieres. Cette etude prospective avait pour but de demontrer 1'efficacite du baclofen intrathecal, administre au moyen d'une pompe, chez des adultes avec spasticite due a un traumatisme de la moelle epiniere ou a la sclerose en plaques. Des 140 patients evalues, seulement 7 repondaient a nos criteres d'inclusion au projet soit: pointage a I'echelle Ashworth modifiee > 3, pointage de la frequence des spasmes > 2, reponse inadequate aux medicaments antispastiques oraux tels que le baclofen, la clonidine et la cyproheptadine. Tous les sujets ont repondu a 1'injection d'un bolus intrathecal de baclofen dans la phase de selection impliquant une epreuve a double insu avec placebo (dose moyenne du bolus: 42.8 pg). La pompe programmable Medtronic a ete implantee chez 4 patients et la pompe non programmable Infusaid chez 3 patients. Suite a 1'implantation, nous avons observe 1 une diminution remarquable de la spasticite, une reduction significative du pointage a I'echelle Ashworth (moyenne 1.8, p < 0.005) et de la frequence des spasmes (moyenne 0.8), ainsi qu'une augmentation de Pamplitude du mouvement de la jambe dans I'epreuve pendulaire. Ces effets ont efe maintenus pendant une periode de 24 a 41 mois avec une dose d'infusion moyenne de 218.7 pg/jour. Le cout total des soins hospitaliers pendant les deux ans qui ont precede...

SummaryWe examined the effects of ventilatory muscle endurance trazmng on resting breath ing pattern in 12 C6-C7 traumatic quadriplegics at least 1 year post-injury. All subjects had complete motor loss below the lesion level. Subjects were randomly assigned to a training (N = 6), or a control group (N = 6). Baseline tests included measurement of resting ventilation and breathing pattern using mercury in rubber strain gauges for 20 minutes in a seated position; maximum inspiratory mouth pressure (MIP) at PRC, and sustainable inspiratory mouth pressure for 10 minutes (SIP); lung volumes, and arterial blood gases (ABG's). The training protocol con sisted of breathing through an inspiratory resistor equivalent to 85% SIP for 15 minutes twice daily, 5 days a week for 8 weeks. Both trainers and controls attended the lab every 2 weeks for reassessment of MIP and SIP and the inspiratory resist ance was increased in the training group as SIP increased. At the end of 8 weeks, baseline tests were repeated. All subjects had normal ABG's. There was a significant increase in mean MIP and SIP in both the control group (30% ± 19% and 31% ± 18% respectively), and in the training group (42% ± 24% and 78% ± 49% respectively). Although the absolute values for both MIP and SIP were greater in the training group than in the control group, the differences were not significant. The alterations in resting breathing pattern were also the same in both groups. Mean frequency decreased significantly in the control group (20' 2/min ute to 16'9/minute) and, while insignificant, the change in frequency in the training group was the same, 19'4/minute to 16·4/minute. Mean tidal volume (Vt) in creased 18· 2% of baseline Vt in the control group and 17-0% baseline in the trainers, resulting in no change in minute ventilation. As MIP and SIP increased similarly in both groups, the data from the control and trainers was pooled and timing changes re-evaluated pre-and post-study. A significant decrease in mean Ti/ Ttot was obser ved, while no change in Vt/Ti was found. We concluded that the testing procedure

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Since we intended to use the respiratory inductance plethysmograph (RIP) to study breathing patterns in a single body position, we developed a method to calibrate the RIP in one position (seated) and verified the stability of this calibration procedure during a 60-min period. The subject breathed spontaneously through a pneumotachograph for 1 min during all calibration and verification runs. All inspiratory data from the abdomen and rib cage RIP transducers was analyzed using multiple linear regression analysis to calculate calibration factors for the transducers. Eight normal subjects were studied, and the stability of calibration at 20, 40, and 60 min was determined. The correlation coefficients were all greater than 0.94. The mean slope and mean intercept describing the relationship of the RIP volume to the pneumotachograph volume for all calibration and verification runs were 0.995 +/- 0.074 and 0.012 +/- 0.018 liter, respectively. This calibration method allows a spirogram to be generated from the RIP signals. Therefore, this technique may be valuable in further investigating resting breathing patterns in humans.

The alterations in lung function and breathing pattern were examined in 6 quadriplegics at 3, 6 and greater than 12 months post injury, and were compared to 6 able bodied controls. Subjects were studied in both the seated and supine positions. Functional residual capacity (FRC), forced vital capacity (FVC), inspiratory capacity (IC), and maximum mouth pressure (Pimax) at FRC were measured. Total lung capacity (TLC) and residual volume (RV) were calculated. Resting breathing pattern was assessed for 20 minutes from a spirogram derived from summed rib cage and abdominal strain gauge signals. At 3 months in quadriplegics, TLC was reduced (p less than 0.05), RV increased (p less than 0.01) and FRC was normal in sitting; in supine, only TLC was reduced (p less than 0.05); Pimax was decreased (p less than 0.01) in both positions in quadriplegics at 3 months, but increased over the first year in the seated position (p less than 0.01). There were no alterations in breathing pattern at any time interval in quadriplegics in supine. In contrast, at 3 months post injury in sitting, expiratory time (Te) was shortened (p less than 0.05), tidal volume (Vt) was decreased, and heart rate elevated as compared to controls (p less than 0.05). Inspiratory time (Ti) was not significantly shortened at 3 months in quadriplegics, but a lengthening of Ti occurred between 3 and 6 months (p less than 0.025) resulting in increased Vt, and heart rate decreased to normal. Vt/Ti was reduced, and did not alter with time. The lengthening of Ti/Ttot observed in supine in control subjects (p less than 0.025), was not observed in quadriplegics. Quadriplegics sighed as frequently in supine as did controls at all stages post injury, whereas they decreased sighing frequency in sitting at 3 and 6 months post injury (p less than 0.05). The improvement in resting breathing pattern observed in quadriplegics in sitting with time, may be due to increased accessory muscle function, improved chest wall stability and thoracoabdominal coupling, or a combination of these factors. It is also possible that the alterations in breathing pattern were a response to cardiovascular adjustments occurring in the same time frame. Quadriplegics retain the sigh reflex, but do not take as many big breaths in sitting as they do in supine, probably due to the increased work of breathing in the seated posture.