Neuromodulation: Technology at the Neural Interface

Received: July 14, 2015 Revised: February 23, 2016 Accepted: April 2, 2016

(onlinelibrary.wiley.com) DOI: 10.1111/ner.12447

Best Practices for Intrathecal Baclofen Therapy:

Patient Selection
Michael Saulino, MD, PhD*; Cindy B. Ivanhoe, MD†‡; John R. McGuire, MD§;
Barbara Ridley, RN, FNP¶; Jeffrey S. Shilt, MD**; Aaron L. Boster, MD††
Introduction: When spasticity interferes with comfort, function, activities of daily living, mobility, positioning, or caregiver assis-
tance, patients should be considered for intrathecal baclofen (ITB) therapy.
Methods: An expert panel consulted on best practices.
Results: ITB can be considered for problematic spasticity involving muscles/muscle groups during all phases of diseases, includ-
ing progressive neurologic diseases. ITB alone or with other treatments should not be exclusively reserved for individuals who
have failed other approaches. ITB combined with rehabilitation can be effective in certain ambulatory patients. ITB is also highly
effective in managing spasticity in children, who may suffer limb deformity, joint dislocation, and poor motor function from spas-
ticity and muscle tightness on the growing musculoskeletal system. Spasticity management often allows individuals to achieve
higher function. When cognition is impaired, ITB controls spasticity without the cognitive side effects of some oral medications.
Goal setting addresses expectations and treatment in the framework of pathology, impairment, and disability. ITB is contraindi-
cated in patients with hypersensitivity to baclofen, which is rare, or active infection. Some patients with an adverse reaction to
oral baclofen may be mistakenly classified as having an allergic reaction and may benefit from ITB. Relative contraindications
include unrealistic goals, unmanageable mental health issues, psychosocial factors affecting compliance, and financial burden.
Vascular shunting for hydrocephalus is not a contraindication, but concurrent use may affect cerebrospinal fluid flow. Seizures or
prior abdominal or pelvic surgery should be discussed before proceeding to an ITB screening test.
Conclusions: ITB should be considered when spasticity interferes with comfort or function.

Keywords: Clinical protocols, consensus, implantable, infusion pumps, intrathecal baclofen, muscle spasticity
Conflict of Interest: Dr. Saulino has a management/advisory relationship with SPR Therapeutics. Dr. Saulino has a paid consulting
relationship with Medtronic, Jazz Pharmaceuticals, Independent Blue Cross and Mallinckrodt. Dr. Boster has a paid consulting rela-
tionship with Medtronic, Jazz Pharmaceuticals, Mallinckrodt and Novartis. Dr. Ivanhoe has a paid consulting relationship with
Medtronic. Dr. McGuire has a paid consulting relationship with Medtronic, Allergan and Merz. Ms. Ridley has a paid consulting rela-
tionship with Medtronic. Dr. Shilt has a paid consulting relationship with Medtronic.

INTRODUCTION
Intrathecal baclofen therapy (ITB) is approved by the U.S. Food
and Drug Administration and indicated for the management of
severe spasticity of spinal and cerebral origins, and licensed in the
European Union for children between ages 4 and 18 years suffering
from severe chronic spasticity that is unresponsive to oral antispas-
modics. The Polyanalgesic 2012 Consensus Conference, which
included a literature review and discussion of ITB therapy for spastic-
ity, concluded that it appeared to be effective in treating both cere-
bral- and spinal-associated spasticity (1). More recently, Mathur et al.
(2) found high levels of satisfaction with ITB therapy among patients
treated for at least 10 years and as long as 24 years. Despite this
extensive clinical experience, there are few randomized controlled
trials providing high-level evidence on which to base recommenda-
tions for ITB therapy.
Several interdisciplinary groups have sought to address this defi-
ciency. An international group convened in 2011 identified and pub-
lished best practices related to the safety of intrathecal morphine or
ziconotide delivery for chronic intractable pain (3). They did not
Address correspondence to: Aaron L. Boster, MD, Systems Medical Chief, Neuro-
immunology, OhioHealth Neurological Physicians, 3535 Olentangy River Road,
Suite S1501, Columbus, OH 43214, USA. Email: Aaron.boster@ohiohealth.com
* Intrathecal Therapy Services, MossRehab, Elkins Park, PA, USA;
†
Baylor College of Medicine, Houston, TX, USA;
‡
Mentis Neuro Health Brain Injury and Stroke Program at TIRR-Memorial
Hermann, Houston, TX, USA;
§
Physical Medicine and Rehabilitation, Medical College of Wisconsin,
Milwaukee, WI, USA;
¶
Spasticity Management Program, Alta Bates Summit Medical Center, Berkeley,
CA, USA;
** Department of Orthopedic and Scoliosis Surgery, Baylor College of Medicine
and Texas Children’s Hospital, Houston, TX, USA; and
††
Systems Medical Chief, Neuroimmunology, OhioHealth Multiple Sclerosis
Program, Columbus, OH, USA
For more information on author guidelines, an explanation of our peer review
process, and conflict of interest informed consent policies, please go to http://
www.wiley.com/WileyCDA/Section/id-301854.html
607

Source(s) of financial support: Medtronic provided administrative and editorial

address the use of ITB for severe spasticity, although some of their support, and funding support for the panel workshop.

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V Neuromodulation 2016; 19: 607–615
 SAULINO ET AL.
recommendations may be applicable. An interdisciplinary group
from 14 German centers focused specifically on ITB in children and
adolescents, producing tables of recommendations assigning levels
of evidence, defined by the American Academy for Cerebral Palsy
and Developmental Medicine, to the supporting literature (4). As
only a minority of the recommendations could be based on high-
level (I or II) evidence, the group worked toward expert consensus
given the existing evidence. These authors noted a wide range of
clinical practices in ITB therapy.
This article is the first of four companion articles focusing on key
aspects of ITB therapy formulated by an expert consensus health
care provider group (5–7). This manuscript examines the definition
of severe spasticity, timing of interventions, factors influencing
patient selection, patient and family education, goal setting, failure
of other therapies, and contraindications, and recommends a best
practice for each. The other texts address the screening trial (5),
chronic maintenance therapy (6), and optimizing ITB therapy (7).
METHODS
Expert Panel
The ITB Therapy Best Practices Expert Consensus Panel comprised
21 multidisciplinary clinicians in private practice and academic medi-
cal centers in the United States who manage pediatric and adult
patients with spasticity; participants represented physical medicine
and rehabilitation, neurology, orthopedic surgery, neurosurgery,
physical therapy, and advanced nursing practice (see Appendix),
and collectively had over 315 years of experience managing more
than 3200 patients with ITB therapy. Four working groups within the
panel each focused on a key phase of ITB therapy management:
patient selection, screening test administration, postimplantation
dosing and long-term management, and therapy troubleshooting.
The best practice expert consensus recommendations from each
working group were further developed, approved by the full panel,
and served as the basis for this and three other manuscripts (5–7).
This article presents the recommendations of the Best Practices
Expert Consensus Panel on patient selection, supported by a review
of the medical literature. The utility of the recommendations must
always be placed within the setting of local resources and expertise.
Furthermore, the opinions of the group should not be construed as
an attempt to define minimum standards or medically acceptable
care.
Literature Search
Before the full panel convened, a broad, structured English litera-
ture search was performed in PubMed and ScienceDirect during
October 2013. The search used indexing, keywords and truncation,
and identified 7439 articles. Duplicates were removed from the list,
and additional references identified by reviewing reference lists,
books in the subscription e-library service, electronic media, and
publications by key authors/panel members. Winnowing continued
by applying a new list of exclusion terms and manually reviewing
the remaining 2980 articles. Selection criteria included: within
scope/relevant to topic; population (pediatric and adult patients
with spasticity due to multiple sclerosis, spinal cord injury, brain
injury [traumatic >1 year after injury], cerebral palsy, or stroke); treat-
ment (intrathecal baclofen delivery); publication type (clinical stud-
ies, review papers, consensus/expert opinion/guidelines, and case
series/case reports). The resulting list of 543 articles with abstracts
was distributed to participants, who then selected papers relevant
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to their working group. A total of 285 peer-reviewed papers regard-
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V Neuromodulation 2016; 19: 607–615
ing patient selection remained. These were later updated to include
papers published between October 2013 and August 2015, which
were subjected to the same selection process.
Surveys
Panel members participated in a qualitative survey designed to
summarize points of consensus and divergence related to best prac-
tices in ITB therapy for severe spasticity. An online quantitative sur-
vey was also deployed in 2013 to 42 physicians (21 neurologists, 21
pain medicine and rehabilitation specialists) recruited by the expert
panel. Survey respondents had been in practice for >2 years, spent
>50% of their time in direct patient care, and each managed >25
ITB patients being treated for cerebral palsy, brain injury, stroke,
multiple sclerosis, or spinal cord injury. The results of this survey
were compiled and distributed to each of the working groups, and
will be reported here to illustrate variations in practice.
DEFINITIONS
Spasticity
Despite its ubiquity, spasticity is a challenging entity to define
and the definition has evolved. While an extended discussion of the
term spasticity is beyond the scope of this consensus paper, readers
should refer to the medical literature to gain an understanding of
this complexity (8–10). The difficulties in defining spasticity are not
unduly surprising. The disease processes classically associated with
this phenomenon are clearly somewhat divergent. Additionally,
most medical publications fail to define spasticity precisely in their
methodology (11). Ultimately, the word spasticity likely represents
an umbrella term for a multiplicity of movement disorders. Clinicians
must recognize the limitations of the term spasticity when consider-
ing ITB or any other spasticity-modulating therapy.
The consensus opinion of this panel was that the 2005 SPASM
consortium definition best represented the most current view. This
group defined spasticity as “disordered sensori-motor control, result-
ing from an upper motor neuron lesion, presenting as intermittent
or sustained involuntary activation of muscles” (12). This definition
shifts the focus away from measurement of stiffness to the measure-
ment of the abnormal muscle activity. Thus, terms such as clonus,
co-contraction, associated reaction, dystonia, and spasms could be
included as part of spasticity. This definition attempts to exclude the
negative sign of muscle weakness associated with the upper motor
neuron syndrome, as well as the changes in the rheologic properties
of soft tissue.
Severe Spasticity
Given that ITB therapy is approved to treat patients with severe
spasticity of cerebral or spinal origin, it is worth discussing what
severe implies despite the vagaries of the spasticity definition already
described. Colloquial definitions of severe include terminology such
as “causing discomfort or hardship” as well as “very painful or
harmful.” It is certainly reasonable to consider spasticity as severe
when it is problematic, interfering with comfort, function, or caregiv-
ing. Spasticity intensity can include both the clinician’s impression as
well as the patient’s perception. The panel felt that severe was best
described as how problematic the spasticity is to the patient/
caregiver, rather than solely relying on a numerical rating of a partic-
ular spasticity assessment measure. For example, modest resistance
to passive motion, which could be evaluated as mild to the physi-
cian, may have a significant functional impact for the patient, who
could describe the same phenomena as severe. Even mild degrees

Figure 1. Factors used to determine patient suitability for intrathecal baclofen therapy.
of spasticity can lead to a profound inability to perform basic activ-
ities of daily living, including hygiene, dressing, and toileting. In
addition, involuntary movement and spasms can cause pain, inter-
rupt sleep, negatively impact mood, and impair mobility. Clinicians
should recognize all of these factors when considering spasticity-
reduction techniques such as ITB. The panel therefore proposes to
define severe spasticity in terms of the functional limitations the
condition has on the patient and caregivers.
Panel members concurred that any patient who demonstrates
spasticity that interferes with comfort, active or passive function,
activities of daily living, mobility, positioning, or caregiver assistance
should be considered for interventions including ITB therapy. This
position is in agreement with the German consensus group who
proposed that patients with Gross Motor Function Classification Sys-
tem IV and V, “therapy primarily aims at the functional level to
reduce spasticity and at the activity level to improve general well-
being, reduce pain, and facilitate patient care and everyday activ-
ities, acknowledged as important aspects for quality of life” (4).
TIMING OF INTERVENTION
Traditionally, ITB therapy may have been reserved exclusively for
individuals who had failed a host of conservative therapies, as well
as delayed for a certain amount of time after an inciting upper
motor neuron injury. More recently, this approach has been chal-
lenged (13,14). The premise of postponing ITB therapy until the
chronic phase of the disease process is based on the assumption
that a) patients in the early phase of injury would be too sick and
that the risk/benefit ratio encouraged deferment, and that b) all nat-
ural processes of recovery should be completed before intervening.
While formal labeling requires waiting one year after traumatic brain
injury before undertaking ITB therapy, several studies have
described the safety of early exposure to ITB therapy in appropri-
ately selected patients (13–16). Modern theories of neuroplasticity
suggest that maladaptive patterns of recovery also occur in the early
recovery phase (17).
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BEST PRACTICES FOR ITB PATIENT SELECTION
There are musculoskeletal consequences in delayed or noninter-
vention, including contracture, ankylosis, and skin breakdown
(18–20). These detrimental processes could potentially overwhelm
any potential benefits of ITB therapy. As with all medical decision-
making, clinicians should weigh the risks and benefits of early vs.
late exposure to ITB therapy with the understanding that reserving
this intervention to later phases may be unduly restrictive. For pedi-
atric patients, consideration of both normal and abnormal develop-
mental processes must also be taken into consideration.
FACTORS AFFECTING PATIENT SELECTION
FOR ITB THERAPY
Many factors affect the patient selection process for ITB therapy,
as documented in our survey (Fig. 1) and by the German consensus
group (4). The disease course should be evaluated in the context of
several factors, in particular, the degree of body involvement, pro-
gressive or static disease, and spasticity of cerebral or spinal origin.
Once these factors are analyzed, ITB therapy can be weighed as the
preferred treatment among other modalities. A brief review of other
spasticity-management modalities is warranted to facilitate the dis-
cussion of optimal patient selection for ITB therapy. Nonpharmaco-
logic methods include bracing, casting, occupational therapy,
physiotherapy, and surgery. These methods fail to eliminate the
underlying muscle overactivity, though they do allow for support-
ive care, substitution for weak muscle groups, and maintenance of
joint range of motion. Musculoskeletal surgical interventions can
also be utilized but, similarly, do not directly address spasticity.
These procedures should be considered as salvage methods to
optimize outcomes once spasticity has been adequately treated.
Surgical intervention is particularly pertinent in the pediatric popu-
lation where repeated lengthening of the musculotendinous unit
in a growing child has the possibility of permanently weakening
the muscle unit. Selective dorsal rhizotomy is another surgical
option for spasticity management. It has historically been reserved
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for children with spastic diplegia who have very good strength.
 SAULINO ET AL.
Most patients who utilize ITB therapy are likely to also use these
nonpharmacologic techniques for management.
Oral Antispasmodic Medications
Traditionally, oral medications have been the most widely used
method of spasticity treatment. Commonly used oral medications
include GABA agonists such as baclofen and benzodiazepines, mus-
cle relaxants such as dantrolene, and a2-adrenergic agonists such as
clonidine and tizanidine (21). Oral medications are most utilized in
the treatment of generalized spasticity. Oral therapy has several
advantages, including relative ease of prescribing without the need
for specialized technical expertise, noninvasiveness, and utility as a
breakthrough strategy. Oral therapy allows the patient to exert a
degree of self-control in an effort to manage irregular spasticity pat-
terns. Oral medications also address secondary indications such as
pain, insomnia, epilepsy, and mood disorders. The majorities of oral
agents are generic, inexpensive, and not controlled or scheduled
medications. However, many individuals are intolerant of oral ther-
apy due to adverse effects such as sedation (22). Care must be exer-
cised following brain injury as sedation may mask cognitive
recovery. Lastly, oral medication therapy can result in inconsistent
tonal reduction. While formal labeling requires a failure of oral medi-
cations prior to initiating ITB in spasticity of spinal origin (23), there
is no precise definition as to the duration of oral medication trial
required. The panel felt strongly that appropriately selected patients
could proceed quickly to ITB therapy. The panel also supported the
combined use of oral medication with ITB therapy in appropriate
scenarios such as irregular spasticity presentations or the secondary
indications noted above.
Botulinum Toxin and Injections and Chemodenervation
Focal spasticity may respond to localized intramuscular injections
of botulinum toxin, alcohol, and phenol. Botulinum toxins take effect
2 to 3 days after injection, peak in 4 to 6 weeks, and gradually wear
off at 3 to 4 months. The transient nature of therapeutic effect can
lead to staggered results. In patients with good selective motor con-
trol, the positive results can persist beyond the pharmacologic effect.
Alcohol and phenol are both nonselective chemodenervating
agents and are less diffusive than botulinum toxins (24). Alcohol and
phenol are less costly options compared to botulinum toxins and
are advantageous in their rapid onset and localized potency but
pose the possibility of soft tissue fibrosis development as well as
dysesthesia. The effects of phenol are irreversible, may reduce con-
traction during voluntary movements, and produce scarring, granu-
loma formation, and edema.
Persons with spasticity that is limited primarily to muscle groups
in one limb are excellent candidates for neuromuscular blockade
with botulinum toxin, phenol, or a combination of the two. In
patients with selective motor control, a more aggressive approach is
reasonable, with repeat injections accompanied by physical therapy,
bracing, electrical stimulation, and other supportive modalities.
Injections should be continued on a regular basis up to three or four
times per year. Individuals with unsuccessful trials of focal treatment
or inconsistent spasticity despite these efforts should be considered
for ITB therapy. This includes individuals afflicted by stroke, brain
injury, and hemiplegic/diplegic cerebral palsy. Neuromuscular block-
ade can be utilized as an adjunctive therapy alongside ITB therapy,
selective dorsal rhizotomy, and musculoskeletal surgery. For patients
with both global and focal presentations, the neurolytic procedures
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can easily be combined with ITB therapy.
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Considerations for Ambulatory Patients
For patients whose locomotor function is impaired by spasticity, a
reduction in spasticity through ITB therapy may improve the ambu-
lation status or gait performance with concurrent intensive therapy.
The need for associated rehabilitative services cannot be underesti-
mated. On the other hand, diminished spasticity may be counterpro-
ductive to patients who rely on spastic co-contraction for support
during walking and standing, particularly at larger doses among
patients with multiple sclerosis and incomplete spinal cord injury.
The published scientific literature currently provides few definitive
answers to these questions. Isolated case reports describe nonam-
bulatory individuals with spasticity that regained an ability to walk
after implantation of the ITB pump (25,26). Such occurrences are rel-
atively infrequent, and the prognosis for improving ambulatory
function appears to favor those who have better baseline ambula-
tory function over those with slower baseline gait velocity (27). Most
of the larger studies report mixed results, with some patients signifi-
cantly improving in walking, a smaller percentage significantly wor-
sening, and the largest subgroup demonstrating no significant
changes overall (28–31). Clinicians should counsel their patients
extensively on the potential for ITB to affect ambulatory capacity.
Pediatric Considerations
Significant consideration must be applied to pediatric patients
who have significant growth or neurologic maturation remaining
(32). There is substantial difference in the impact of spasticity on
children vs. adults (4). In adults who experience spasticity, inherent
muscle length is present, and there is no deficiency in normal mus-
cle length and architecture. The effects of spasticity in children can
be substantially more devastating due to the effects of muscle tight-
ness on the growing musculoskeletal system. Unlike bone, muscle
does not have a growth plate and muscle growth is directed by the
tensile forces of the bone pulling under physiological loading as
the bone elongates, which subsequently causes relaxed muscles
to stretch. Therefore, muscle grows at the rate of bone growth.
While children with cerebral palsy have preserved musculoskeletal
dimensions at birth, the spasticity that occurs during rapid growth
prevents normal bone and muscle development. The muscle short-
ening can be substantial. This restricted longitudinal muscle growth
and increased tension of the muscle can result in limb deformities,
joint dislocations and poor motor function. Early treatment of spas-
ticity potentially reduces the need for orthopedic surgery for con-
tracture or torsion deformity in children with severe spasticity from
cerebral palsy (18).
When considering ITB therapy in the pediatric population, preop-
erative discussion should include baseline evaluations for scoliosis,
hip status, hydrocephalus, and urodynamic status. The impact of ITB
on scoliosis development or progression is controversial. Much of
this controversy exists because there are no baseline radiographic
studies documenting presence of scoliosis at implant, nor a prospec-
tive, matched cohort of patients with which to compare implanted
patients. Consequently, baseline radiographs are recommended in
patients before pump implantation. If clinically indicated, baseline
studies evaluating the ventricle and bladder are likewise suggested.
Considerations for Progressive Disease States
In patients with progressive processes (e.g., multiple sclerosis), the
goals of treatment may be different from those of static diseases.
Furthermore, it is important to recognize that although the underly-
ing neurological process may be static (such as cerebral palsy), the
musculoskeletal ramifications of the upper motor neuron lesions

may be progressive. In all situations, consideration of early exposure
to ITB therapy is warranted to prevent musculoskeletal consequen-
ces of spasticity, which magnify future biomechanical limitations.
For example, patients with multiple sclerosis or progressive muscu-
lar dystrophies, who are implanted prior to significant joint contrac-
ture formation, weakness, or muscle imbalance, might demonstrate
maintenance of function for longer periods (33–35).
Other Important Variables
In many patients with upper motor neuron injury, spasticity can
be a critical impediment that must be removed for individuals striv-
ing to reach higher function. However, isolated spasticity manage-
ment to improve function ignores the complex web of additional
variables necessary for functional improvement. Cognitive function
is an important consideration. Intrathecal baclofen treatment is a
well-established means of decreasing tone to improve the care and
comfort in individuals with profound cognitive impairment and
severe spasticity. When cognition is impaired, ITB provides spasticity
control while potentially avoiding cognitive side effects commonly
associated with oral medications. Additionally, individuals with
spasticity can demonstrate weakness, impaired motor control and
decreased endurance (36). Other variables include: necessary envi-
ronmental infrastructure, individual desire and motivation to partici-
pate in necessary therapy and lifestyle changes, appropriate level of
residual neurologic ability following injury, and access to appropri-
ate care.
PATIENT AND FAMILY EDUCATION
The panel agreed that patient/family education plays a vital role
in patient selection, and recommends that managing clinicians
schedule extended initial appointments to allow for this instruction.
Patients need to understand how spasticity is impairing their func-
tion or increasing the difficulty of caregiving tasks. The specific ways
in which spasticity is making it more difficult to walk, transfer, or per-
form activities of daily living should be identified. The clinician needs
to review how this may be different from the effect of weakness or
other movement disorders, depending on the underlying patho-
physiology. The various factors impacting each disease process have
already been described. It may also be appropriate to review how
untreated spasticity can to lead to future musculoskeletal complica-
tions. Education should focus on the difference in effectiveness of
intrathecal vs. oral administration and the reduced incidence of sed-
ative side effects (37,38).
The potential risks of ITB therapy must also be reviewed. These
include infection, catheter malfunctions, skin protrusion, meningitis,
and the risk of underdose and overdose (4). Particular emphasis
must be placed on attending all scheduled appointments due to
concerns of withdrawal from a low or empty reservoir. Other issues
that are typically ITB dose-dependent include urinary retention, con-
stipation, drooling, weakness, and loss of trunk balance. Of particular
note, the effect of ITB exposure on bowel and bladder function is
highly variable (39,40). Because ITB therapy can be perceived as a
high-tech option, some patients or family members may uncon-
sciously imagine it to be a cure for their underlying disease process.
The panel recommends addressing these misconceptions early to
pre-empt unrealistic expectations. It is also important to stress that
ITB does not cure spasticity; it can, however, provide relief from the
symptoms as long as the therapy is maintained.
When considering ITB therapy, patients, family members, and
other key caregivers should understand all stages of therapy includ-
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BEST PRACTICES FOR ITB PATIENT SELECTION
ing a screening test, implantation, postimplantation rehabilitation,
and chronic maintenance therapy. Long-term therapy will necessi-
tate subsequent surgeries, either due to battery replacement or
repositioning of the intrathecal catheter, which is a possibility in
growing children. The nature of these stages is discussed in the
companion manuscripts (5–7), but patients should be aware of these
requirements before proceeding to a screening test. The panel rec-
ommends fairly detailed discussions of all components of ITB ther-
apy early in the process in an effort to avoid undue obstacles later. If
there are likely to be difficulties in traveling to the managing center,
or taking time off from work or school, these must be addressed
before a decision is made to proceed with implantation. The need
to communicate changes in telephone numbers, addresses, living
situation, or caregivers must be emphasized. Most centers include a
social worker on the team who can address these issues, as well as
any concerns about the patient/family responsibility for insurance
co-pays and deductibles, and the cost of the therapy both in the
implantation and maintenance stages. In the absence of formal
social worker intervention, other health care professionals can assist
in these matters.
Patients may present to the spasticity specialist with preconceived
notions or information about ITB derived from unreliable discussion.
Patients can be reassured that once the initial healing of the surgical
scars occurs, they will be able to resume all previous activities
including swimming, sports, and travel. Patients should be coun-
seled that there are restrictions on only a few activities. Examples
include those events that entail significant changes in atmospheric
pressure, such as scuba diving and skydiving. Normal household
appliances such as TVs, microwaves, or computers will not affect
intrathecal delivery. It is useful to ask what they already know about
the therapy to focus the discussion. Patients or family members
should be directed to more reliable websites such as www.baclofen-
pump.com or those run by disease-specific organizations such as
the MS Society (www.NMSS.org) or the National Stroke Association
(www.stroke.org).
The panel recommended the use of the educational brochures
and DVDs provided by device manufacturers, and these can be
offered early in the selection process to allow patients to return with
questions or concerns. Providers should have a demonstration
pump available so patients can see what it looks like. Perhaps the
most effective teaching tool is to introduce the patient to an individ-
ual who is currently utilizing the therapy. This can help allay fears
about life after implantation, and highlight the benefits of the ther-
apy. Ideally, patients should be introduced to someone with a simi-
lar functional level, to avoid encouraging unrealistic expectations
about response to ITB (41). Smaller centers without a large pool of
implanted patients to draw on may utilize patient ambassador pro-
grams offered through the pump manufacturers to connect patients
considering the pump with patients who currently utilize ITB ther-
apy and have a similar diagnosis.
Goal Setting
Figure 2 ranks the most common goals set by clinicians for ITB
therapy in our survey. Goals of spasticity and ITB treatment need to
be meaningful to the patient. Ideally, goal setting allows the
patient/caregivers and treating team to plan using a common lan-
guage and approach. Goal setting creates a framework for the why,
where, when, and how of the treatment plan. Many factors reviewed
previously can affect the goals that are identified from the begin-
ning of and throughout treatment. Goals can be reached more
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effectively if considered within the framework of pathology,
 SAULINO ET AL.

impairment, disability, and handicap. Table 1 provides a partial list of
potential goals for spasticity reduction with ITB therapy.
Consideration of ITB therapy should include a thoughtful approach
that integrates the psychosocial, physical, medical, biomechanical,
and functional aspects of each patient. Clinicians are encouraged to
understand spasticity from the patients’ perspective. Spasticity inter-
ventions should be aimed at what matters most to the patient, fam-
ily, and caregivers. Patients themselves may not realize what can be
better until there is a change/improvement in their function.
FAILURE OF OTHER THERAPIES
While it is reasonable to consider the least invasive options first,
unresponsiveness to oral medications or failure of less invasive
options should not be mandated before exploring ITB therapy.
Many patients who could benefit from ITB have a suboptimal
response or inadequate therapeutic benefit from oral medications.
Before a patient with severe spasticity of spinal origin can receive
chronic infusion of intrathecal baclofen via an implantable pump,
clinicians should ensure that oral baclofen is not adequately control-
ling the patient’s spasticity or the patient experiences intolerable
side effects at effective doses. There may be some spasticity reduc-
tion with oral baclofen, but it is unlikely to reach the level of func-
tional improvement one could achieve with intrathecal baclofen.
Intrathecal drug delivery has the potential to deliver a much higher
clinical benefit without the systemic side effects frequently seen
with oral medications. Because of the differences in pharmacoki-
netics and pharmacodynamics, requiring the failure of oral medica-
tion should not preclude the use of ITB.
Figure 2. Most common goals set for intrathecal baclofen therapy patients.
Some practitioners have advocated a sequential approach to
hypertonia. In this algorithm, ITB is reserved until nonpharmacologi-
cal, oral medications, and chemodenervation have been attempted
and proved either unsuccessful or intolerable. The consensus panel
did not advocate this approach. Graham and colleagues used a
matrix configuration to describe the various characteristics of spas-
ticity interventions, contrasting reversible vs. irreversible options and
focal vs. global effects (42). In this model, each modality is utilized
individually, with ITB considered reversible (neural structures are not
surgically altered, and rate of dose administration is adjustable) and
global (CNS effects of ITB distribution are typically observed in all
extremities and the trunk). This is a reasonable approach to manage-
ment but may lack some subtleties with regards to patients who
require multiple approaches for optimal care. An alternative model
applies possible modalities in combination, depending on individual
patient characteristics (see Fig. 3). The role of ITB therapy with this
schema is to potentially combine it with other modalities for syner-
gistic therapeutic effect. We felt that combined therapies depict the
most reasonable approach compared to hierarchical or compart-
mentalized models.
CONTRAINDICATIONS
Hypersensitivity to baclofen or active infection are absolute con-
traindications to ITB therapy. True allergic reactions to baclofen and
implant materials were quite rare. As with all adverse effects experi-
enced by patients, a distinction should be drawn between an
adverse reaction to a medication (such as sedation) and a true aller-
gic response. Some patients with adverse reaction to oral baclofen
may be mistakenly classified as having an allergic reaction. These
patients may benefit greatly from ITB. Clinicians should carefully
probe the patient’s history and exercise appropriate medical de-
cision making in these cases. Patients with chronic microbial colo-
nization, such as neurogenic bladder or decubitus ulcer, can be
implanted in selective circumstances. In fact, ITB may be needed to
manage the spasticity to treat the underlying condition effectively.
Collaborative discussion with infectious disease specialists might be
warranted.
Relative contraindications for ITB therapy include unrealistic goals
by the patient or caregivers, unmanageable mental health issues,
psychosocial factors (i.e., unreliable transportation, inconsistency in
keeping appointments, frequently changing phone numbers, etc.),
and financial burden. These risk factors are potentially modifiable
through the interactions with allied health professionals such as
social workers and case managers.
Ventricular shunting for hydrocephalus is not a contraindication
to ITB therapy, but practitioners should be aware of potential

Table 1. Goals That May Be Potentially Achieved With Intrathecal Baclofen Therapy.

Improved body functions & structure Improved participation Improved activities of daily living

Improved skin integrity Improved endurance Improved ease of hygiene

Improved standing capacity Improved standing capacity Improved standing capacity
Improved or maintained range of motion Improved ambulation speed Improved ambulation speed
Improved orthotic tolerance Improved sitting balance/tolerance Improved quality of ambulation
Reduced startle response Improved orthotic tolerance Improved sitting balance/tolerance
Reduced musculoskeletal pain Improved cosmesis Reduced falls
Reduced need for oral anti-spasticity
612

medications

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V Neuromodulation 2016; 19: 607–615

Figure 3. Synergistic model of spasticity management.
interactions between the devices that could affect cerebrospinal
fluid flow (43,44). Intrathecal baclofen can also be used in patients
with seizures with the understanding that it has been occasionally
associated with an increased risk of seizures (45,46). Similarly, prior
abdominal or pelvic surgery (gastrostromy, suprapubic tube place-
ment, etc.) that is relatively commonplace in neurologic patients
does not represent a contraindication for intrathecal pump place-
ment, but may require some consideration during surgical place-
ment. Patients and caregivers should be fully apprised of these
issues to make sound decisions before proceeding to an intrathecal-
screening test.
TRIALING
The majority of physicians managing ITB therapy believe that a
screening test before implant is a best practice to ascertain the
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V Neuromodulation 2016; 19: 607–615
BEST PRACTICES FOR ITB PATIENT SELECTION
patient’s response to a temporary exposure to baclofen. In a recent
survey, nearly 70% of the respondents always or often used a
screening test (47). Aims of preimplantation testing, supported by
level II and IV evidence (4), include the ability to assess what effect
baclofen will have on spasticity, tolerability, and gaining acceptance
of ITB from patients and caregivers. Nonetheless, some physicians
maintain that trialing does not provide a reliable indication of long-
term therapeutic outcome and risks infection. A much more exten-
sive discussion of the pros and cons of screening and of best prac-
tices for trialing appear in a companion article (5).
CONCLUSIONS
Intrathecal baclofen therapy is a well-recognized technique for
the management of problematic spasticity. As with virtually all inter-
613
ventions in medicine, it is crucial to apply this intervention to the
 SAULINO ET AL.
right individual under the right circumstances. Intrathecal baclofen
therapy should not be exclusively reserved for those individuals
who have failed other approaches. It should be considered, either
as monotherapy or in combination with other spasticity-reduction
methods, for any patient who demonstrates the capacity to benefit
from the unique advantages of the therapy. Clinicians should apply
the principles described here in their decision-making when consid-
ering ITB treatment for patients with severe spasticity.
SUMMARY OF BEST PRACTICES
• The 2005 SPASM consortium description of spasticity should be
adopted as the standard operational definition.
• Severe spasticity should be defined as any spasticity condition
that is unduly troublesome/problematic to patients or caregivers.
• Consideration of intrathecal baclofen (ITB) therapy should be
undertaken in all patients with inadequately controlled, problem-
atic spasticity, in all phases of disease processes.
• Spasticity management is not a linear or hierarchical process.
䊊 Application of various techniques is based on advantages and
disadvantages of each method.
䊊 ITB therapy can be considered under a variety of conditions,
being best applied to individuals with problematic spasticity
involving several muscles or muscle groups.
䊊 Techniques can be applied as monotherapy or in combination.
• dosing and long-term management. Neuromodulation 2016;19:623–631.
ITB therapy can be an effective tool in improving ambulatory func-
tion in certain patients. Rehabilitative therapy should be applied
concomitantly in ambulatory patients.
• ITB therapy is a highly effective tool for spasticity reduction in the
pediatric population. The unique characteristics of this group
require specialized attention, including baseline evaluations for
scoliosis, hip status, hydrocephalus, and urodynamic status.
• While not a directly disease-modifying treatment, ITB should be
considered early to potentially avoid or delay musculoskeletal and
functional consequences of spasticity.
• fen therapy for treating spastic hypertonia due to acquired brain injury. Brain Inj
ITB therapy must always be considered in the context of other fac-
tors affecting patients with spasticity, with cognitive ability being
of paramount significance.
• Patient/family/caregiver education is a crucial process in ITB ther-
apy. Centers must create a supportive instructive environment
that utilizes all available resources to accomplish the education
goals effectively.
• Goal setting is necessary for patients and clinicians to approach
the utilization of ITB therapy in a meaningful and effective way.
• Clinicians must consider the absolute and relative contraindica-
tions for ITB therapy and, if needed, develop appropriate strat-
egies for addressing these issues.
Acknowledgements
The authors would like to thank Dr. Linda Krach for her
support during the panel workshop. Sarah Staples, MA, ELS
and Liz Dabruzzi assisted with manuscript preparation.
Authorship Statements
All authors participated in the 2-day ITB Best Practices Panel work-
614
shop and professionally facilitated discussions designed to build
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V Neuromodulation 2016; 19: 607–615
consensus. All authors contributed expert opinion, manuscript
review and revision, and approved the final version. Dr. Saulino was
the team lead for the Patient Selection workgroup. Dr. Boster and
Dr. Saulino chaired the ITB Best Practices Panel and provided senior
editor leadership for final manuscript review and approval.
How to Cite this Article:
Saulino M., Ivanhoe C.B., McGuire J.R., Ridley B., Shilt J.S.,
Boster A.L. 2016. Best Practices for Intrathecal Baclofen
Therapy: Patient Selection.
Neuromodulation 2016; 19: 607–615
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***
ing; Dec. 2015; Las Vegas, NV. This article is well done. I continue to have concern that this type of
article should have a significant analysis and recommendations in relation
to trialing. Other prior concerns are well addressed. For this paper to have
APPENDIX maximum impact trialing is an essential ingredient.

Participants in the ITB Therapy Best Practices Panel Joshua Prager, MD, MS
Roy L. Adair, MD, Adult Physical Medicine & Rehabilitation Los Angeles, CA, USA
David J. Anderson, MD, Pediatric Orthopaedic Surgery Comments not included in the Early View version of this paper.

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