© 2004 International Neuromodulation Society, 1094-7159/04/$15.00/0 Neuromodulation, Volume 7, Number 3, 2004 201–204

Blackwell Publishing, Ltd.

Chronic Intrathecal Baclofen Infusion for

Spasticity: Relationship between Pump and Host

Alessandro Dario, MD*

†

;

�

Daniela Calandrella, MD

†

;

�

Giorgio Bono, MD

†

;

�

Carlo Scamoni, MD*;

�

Marco Picano, MD*;

�

Giustino Tomei, MD*

*

Neurosurgical Clinic and

†

Neurological Clinic, University of Insubria. Varese. Italy

�

A

BSTRACT

Twenty patients with chronic intractable spinal spas-ticity were implanted with a totally implantable pro-grammable pump for intrathecal administration ofbaclofen. The objective of this study was to evaluatethe relationship between pump and the host. Clinicalefficacy of the therapy was evaluated by the Ash-worth Scale, the Spasms Frequency Scale, and theFunctional Independence Measure (FIM) motorscores. All patients were asked to reply to 10 questionsregarding discomfort of their refills, the ease of reha-bilitation after therapy, their fear of pump failure andonset of alarm signals, their discomfort due to ametallic foreign body (the pump), the attitude of theirrelatives and other persons regarding their pump sys-tem, whether they would undergo this therapy again,and whether, in the absence of public health insur-ance, whether they would be willing to pay for theirpump and therapy.The Ashworth scale, the Spasms Frequency Scale,and the FIM motor score showed a significantimprovement in all patients after the onset of therapywith baclofen. The refill procedure was not a problemin all patients while four patients (20%) considered thenumber of refills “uncomfortable.” Rehabilitation wasno problem after the pump was implanted in all patients,10 patients (50%) feared pump failure, while six patients(30%) feared their alarm signals. Three patients (15%)

had some discomfort from their pumps rubbingagainst their belts; two patients (10%) stated thatother people were aware of their pumps; all but twopatients (10%) were ready to have their implantsagain; three patients (15%) would pay for the pumpin case of absence of public health insurance for thetherapy. We conclude that the implant of pumps forchronic intrathecal baclofen infusion is, today, aknown effective procedure. Refill of the pump systemwas not a problem in our patient population, whilethe number of refills did cause some discomfort insome patients. It was shown by our study that thepump did facilitate rehabilitation in our patients, anda certain degree of dependence on the pump didexist. Fifty percent of the patients were afraid ofpump failure and 30% were afraid of their alarmsignals going off. The fact that most patients wouldundergo this therapy again and some would evenpay for it directly in the absence of public insurancefor the therapy were indices of patient satisfactionwith the procedure. Because this was a small study,we believe that larger studies are necessary to cor-roborate our findings.

�

K

EY

W

ORDS

:

intrathecal baclofen

,

quality of life

,

spasticity

.

INTRODUCTION

Chronic intrathecal baclofen infusion by implant-able pump is today an accepted therapeutic toolfor the treatment of severe spinal spasticity (1,2).

Address correspondence and reprint requests to: Alessandro Dario, MD,Via Torriani, 32, 22100 Como, Italy. Email: dario.alessandro@virgilio.it.

202

�

DARIO

ET

AL

.

Few studies have reported improvement in func-tion as well as improvement in quality of life (3–7). Clinical results related to the relationshipbetween the pump system, therapy, and opinionsof the patients undergoing the therapy, the host,have, to date not been reported. We report, in thisstudy, the functional relationships between thepatients and their therapy.

MATERIALS AND METHODS

Twenty patients, 10 males and 10 females,with chronic intractable spinal spasticity wereimplanted with totally implantable, programmablepumps (Synchromed, Medtronic, Inc., Minneapo-lis, MN) for intrathecal administration of baclofenin the standard surgical manner (1). Spasticity wascaused by multiple sclerosis in 14 patients and byspinal trauma in six. Of the patients sufferingfrom multiple sclerosis, three had anesthesiaand eight had hypoesthesia below the levelT6-T8, while, in three patients, there was nosensitivity deficiency. Of the patients with spinaltrauma, four had hypoesthesia and two had anes-thesia below the level T8-T10. Only one patientwith multiple sclerosis had spastic quadraparesis,while the others suffered from paraparesis. Neuro-motor deficits of muscle strength ranged from 1to 2 with patients who suffered from spinal cord

injury and from 1 to 3 with those patients whohad multiple sclerosis. One patient with multiplesclerosis still worked and four with spinal cordinjury still worked. All other patients were totallydisabled with pensions from social assistance.

Clinical efficacy of intrathecal baclofen infusionwas evaluated by using the modified AshworthScale (AS) (8), the Spasms Frequency Scale (SFS),and the Functional Independence Measure (FIM)motor scores (9). Eleven patients in our series hadspasms. All parameters were assessed beforeintrathecal therapy and every 6 months afterpump implantation.

At last follow-up (mean 24.7 months, range 12–46 months) all patients were asked to reply to 10yes and no questions with room for comments.See Table 1. No severe cognitive deficits werefound using an Italian translation of the seven-subtest short forms of the Wechsler Adult Intelli-gence Scale-III (WAIS-3) (10). Statistical analysiswas performed using the Wilcoxon sign rank testto evaluate differences between baseline valuesand those observed at last follow-up.

RESULTS

The mean age of our patients in this study was37.1

±

11.8 years. At last follow-up, the mean ASscore decreased from a preoperative value of

Table 1. Questions and Answers

Questions Yes No Comments

Would you carry out the 18 2* *One patient had sexual problems, the other had hopedsame operation again? to regain mobility in his legs.

Would you pay for the pump in the 3 17* *These patients would have been unable to meet theabsence of public health insurance? financial costs.

Is there any discomfort when 0 20the pump is refilled?

Are the refills too numerous? 4 16Do you ever consider the problem 10 10

of the failure of the pump?Are you afraid of the onset 6 14

of the alarm signal?Is there any discomfort caused 3 17 Only 10 patients usually wore belts.

by a metallic foreign body?Does the pump cause any discomfort 0 20

during the rehabilitation stages?Do you relate to the pump 13 7

as a foreign body?Do you consider that people 2 18

are aware of the pump?

Relationship between Pump and Host

�

203

4.3

±

0.6 to a postoperative value of 1.7

±

0.7; theSFS score in 14 patients decreased from a pre-operative value of 2.4

±

0.5 to a post-therapy valueof 0.5

±

0.7. These differences were statisticallysignificant (

p

<

0.01). The FIM motor score in-creased from a preoperative mean of 35.7

±

9.6 toa post-therapy mean of 57.8

±

12.7 (

p

<

0.05).Eighteen patients (90%) stated that they wouldhave their implants again, but two (10%) wouldnot. One patient with multiple sclerosis was notpleased with his pump because his expectation ofwalking again was not met with this therapy andthe other had sexual problems as a result of thetherapy. Three patients were prepared to coverthe costs of the implant in the absence of publichealth insurance, while the others were unable tocover these financial costs.

None of the patients suffered any discomfort atpump refill, while four (20%) believed that refillswere too numerous (every month). Ten patients(50%) feared the failure of their pump, whilesix (30%) were afraid of the pump alarm (indicat-ing lack of drug within the pump). Three patients(15%) complained of discomfort due to the pres-ence of a metallic foreign body within their bodies.All three of these patients usually wore a belt.There was no particular discomfort reportedduring rehabilitation. Thirteen patients (65%) relatedto the pump as a foreign body. Two patients (10%)stated that other people were aware of thepump.

DISCUSSION

Intrathecal baclofen used for spasticity is an effec-tive treatment for severe spasticity due to spinaldisorders with proven quality of life improvement(6). Presently intrathecal infusion of baclofen isan accepted therapy worldwide (1,2). Our resultsusing baclofen for spinal spasticity are in agree-ment with previous papers. Baclofen can improvespasticity in patients by as much as 85% (2,6). Inour study the mean FIM regarding bathing, dress-ing the lower body, and transferring improved, asdescribed by Azouvi et al. (4). Two of our patientswho were previously employed were able toresume their same line of work.

While the clinical effectiveness of intrathecalbaclofen therapy has been proven, no studieshave reported on the functional relationship

between pump, therapy, and patient, in particular,how patients live their daily lives with the pump.If the clinical and functional improvement of ourpatients is demonstrated by medical scales, thepositive clinical results considered by the patientsis exemplified by the positive reply by 90% of ourpatients to the question of whether they wouldhave the pump implanted again and the positiveresponse of our patients to the question ofwhether they would be willing to pay for thepump privately in the absence of public insur-ance. Fifteen of 17 patients unable to pay for thecosts of the pump said that they would pay for itif they could.

The pump was considered a foreign body bythe majority of patients (65%). That is to say thatthese patients considered their pumps as onlytherapeutic tools; on the contrary seven patients(35%) felt the pump as part of their bodies. Fourpatients (20%) thought that refills of the pumpswere too numerous; these patients needed to havetheir pumps refilled more frequently (every 1–2 months) due to their clinical degree of increasedspasticity.

Our results showed that the presence of pumpsdid not interfere with either rehabilitation or thewearing of belts or tight clothing during the refillprocess. There were no differences observedbetween patients with looser skin (four patientswith multiple sclerosis had copious subcutaneoustissue) when compared to patients with skin andsubcutaneous thinness. Nevertheless, in the twopatients who stated that other people were awareof the presence of their pumps, the subcutaneoustissue was particularly thin.

The absence of discomfort with the insertion ofthe refill needle in the abdominal region couldpossibly be due to decreased skin sensitivity (27%of the patients).

We report here that 50% of our patients wereafraid of pump failure and 30% were afraid of theonset of the alarm signal. Since all patients wereadequately informed on how and when the pumpalarm would go off and that when the alarm wentoff there would still be drug in the pump, it hasbeen suggested by this data that this expressedfear could be a sign of anxiety and depression. Asignificant relationship has been found in the liter-ature (11) between the time since spinal injuryand depression; the longer patients had their

204

�

DARIO

ET

AL

.

injury, the less depressive symptomatology theyexhibited. Moreover this relation between timeand depression was not found in those patientssuffering from multiple sclerosis. Because ourseries is small it is difficult to draw any conclu-sions. These fears could not only mean a positiveconsideration of the therapeutic effect of thepump, but could also mean that there was acertain degree of dependence on the pump. Thisdependence, for example, might signal anincrease in anxiety and should be avoided.

There were no statistically significant differ-ences in pump tolerance by patients with MS andpatients with spinal cord injuries.

These devices were considered a useful thera-peutic tool and a certain percentage of our pati-ents considered the pump as a part of their bodies.Other people’s judgment regarding the pumpswithin our patients was irrelevant to most of ourpatients. The various thoughts of our patients re-garding their pumps involved problems that couldbe tied to their pathology, to the neuropsycholo-gical and psychic perception of one’s body, and tothe sense of humor of the patient. These factorscould also be influenced directly by medicationssuch as baclofen (12) or could be secondary tomultiple sclerosis cognitive dysfunction (13).

Larger studies are necessary establish relation-ships between pump and host and the possiblepsychopathological changes such as anxiety anddepression that may occur after implantation.In particular, these evaluation scales of patientswith pumps should include more specific itemsfor elucidation.

REFERENCES

1. Penn RD. Intrathecal baclofen for spasticity ofspinal origin. seven years of experience.

J Neurosurg

1992;77:236–240.2. Coffey RJ, Cahill D, Steers W et al. Intrathecal

baclofen for intractable spasticity of spinal origin:

results of a long-term multicenter study.

J Neurosurg

1993;78:226–232.3. Middel B, Kuipers-Upmeijer H, Bouma J et al.

Effect of intrathecal baclofen delivered by an implantedprogrammable pump on health related quality of life inpatients with severe spasticity.

J Neurol NeurosurgPsychiatry

1997;63:204–209.4. Azouvi P, Mane M, Thiebaut JB, Denys P, Remy-

Neris O, Bussel B. Intrathecal baclofen administrationfor control of severe spinal spasticity. functionalimprovement and long-term follow-up.

Arch Phys MedRehabil

1996;77:35–39.5. Dario A, Scamoni C, Bono G, Ghezzi A, Zaffaroni

M. Functional improvement in patients with severe spi-nal spasticity treated with chronic intrathecal baclofeninfusion.

Funct Neurol

2001;16:311–315.6. Stempien L, Tsai T. Intrathecal baclofen pump

use for spasticity: a clinical survey.

Am J Phys MedRehabil

2000;79:536–541.7. Sampson FC, Hayward A, Evans G, Morton R,

Collett B. Functional benefits and cost/benefit analysisof continuous intrathecal baclofen infusion for themanagement of severe spasticity.

J Neurosurg

2002;96:1052–1057.8. Bohannon RW, Smith MB. Interrated realiability

of a modified Asworth scale of muscle spasticity.

PhysTher

1987;67:206–207.9. Granger CV, Hamilton BB. UDS report; the uni-

form data system for medical rehabilitation report offirst admission for 1990.

Am J Phys Med Rehabil

1992;72:108–113.10. Axelrod BN, Ryan JJ, Ward LC. Evaluation of

seven-subtest short forms of the Wechsler Adult Intelli-gence Scale-III in a referred sample.

Arch Clin Neuro

-

psychol

2001;16:1–8.11. Macleod L, Macleod G. Control cognitions and

psychological disturbance in people with contrastingphysically disabling conditions.

Disabil Rehabil

1998;20:448–456.12. Jamous A, Kennedy P, Psychol C, Grey N. Psycho-

logical and emotional effects of the use of oral baclofen:a preliminary study.

Paraplegia

1994;32:349–353.13. Peyser JM, Rao SM, LaRocca NG, Kaplan E.

Guidelines for neuropsychological research in multiplesclerosis.

Arch Neurol

1990;47:94–97.