Neuromodulation: Technology at the Neural Interface

Received: July 14, 2015 Revised: February 24, 2016 Accepted: March 2, 2016

(onlinelibrary.wiley.com) DOI: 10.1111/ner.12437

Best Practices for Intrathecal

Baclofen Therapy: Screening Test
Aaron L. Boster, MD*; Susan E. Bennett, PT, DPT, EdD, NCS, MSCS†;
Gerald S. Bilsky, MD‡; Mark Gudesblatt, MD§; Stephen F. Koelbel, MD¶;
Maura McManus, MD**; Michael Saulino, MD, PhD††
Introduction: Intrathecal baclofen (ITB) screening assesses response to a test dose of ITB on spasticity and function and identifies
adverse reactions.
Method: An expert panel consulted on best practices after conducting an extensive literature search and conducting an online
survey.
Results: A successful trial may confirm predetermined goals, which may include improved mobility/positioning, decreased time/
improved independence for activities, less home exercise, better wheelchair tolerance, decreased caregiver time, improved sleep,
and reduced pain, or may modify goals and expectations. Individuals should not be tested in the presence of active medical issues
(e.g., MS exacerbations, active urinary tract infection, nonhealing wounds). Oral antispasmodics can be weaned before trial if a
goal is to eliminate them. The standard baclofen test dose is a 50-mcg bolus, 25 mcg in very small children or patients who rely
on spasticity for mobility. Patients unresponsive to the standard dose may require 75 mcg or 100 mcg; 24 hours should elapse
between bolus doses. Cardiopulmonary parameters should be checked frequently during the first two hours postinjection, and
spasticity measures assessed at least twice within four hours. Observation continues until the patient is stable and recovers from
hypertonia. Adverse events include spinal headaches, nausea/vomiting, urinary retention, hypotension, seizures, drowsiness/
sedation, respiratory depression, and coma. Before implantation, team members must discuss starting dose, drug concentration,
delivery mode, pump size and location, and catheter tip placement. Patients/caregivers should understand the commitment nec-
essary for ITB therapy.
Conclusions: Screening helps identify appropriate candidates for ITB.

Keywords: Clinical protocols, consensus, implantable, infusion pump, intrathecal baclofen, muscle spasticity, spinal
Conflict of Interest: The following authors have a management/advisory relationship: Michael Saulino, MD, PhD: SPR Therapeutics;
Susan E. Bennett, PT, DPT, EdD, NCS, MSCS: Acorda Therapeutics; Gerald S. Bilsky, MD: Medtronic. The following authors have a
paid consulting relationship: Michael Saulino, MD, PhD: Medtronic, Jazz Pharmaceuticals, Independent Blue Cross, Mallinckrodt;
Aaron Boster, MD: Medtronic, Jazz Pharmaceuticals, Mallinckrodt, Novartis; Susan E. Bennett, PT, DPT, EdD, NCS, MSCS: Medtronic,
Acorda Therapeutics; Gerald S. Bilsky, MD: Medtronic; Mark Gudesblatt, MD: Genzyme Corporation, Acorda Therapeutics, Biogen
Idec, EMD Serono, Teva Neuroscience, Lundbeck, Medtronic, Auspex Pharmaceuticals, Novartis; Stephen F. Koelbel, MD: Medtronic,
Allergan, Merz; Maura McManus, MD: Medtronic.

INTRODUCTION
With over three decades of use, intrathecal baclofen (ITB) therapy
is well documented as an effective and reliable treatment option for
severe spasticity (1–9). The management of ITB therapy proceeds in
steps. This article is the second of four to explore best practices in
ITB therapy management not well represented in the existing medi-
cal literature. The first article describes patient selection (10). The
next step for suitable candidates is to undergo a screening test via a
lumbar puncture with injection of baclofen. This manuscript reviews
the important aspects of screening, including procedure planning,
the screening test dose, assessments during screening, and postin-
jection communication. All of these aspects are covered because the
ITB test dose is often administered by a physician who did not par-
ticipate in patient selection for trialing and will not implant the
616
Address correspondence to: Aaron L. Boster, MD, Neurology MS Program, Ohio-
Health Neurological Physicians, 3535 Olentangy River Road, Suite S1501, Colum-
bus, OH 43214, USA. Email: Aaron.boster@ohiohealth.com
* OhioHealth Neurological Physicians, Columbus, OH, USA;
†
State University of New York (SUNY) at Buffalo, Buffalo, NY, USA;
‡
The Shepherd Center, Atlanta, GA, USA;
§
Brookhaven Memorial Hospital Medical Center, South Shore Neurologic
Associates, Islip, NY, USA;
¶
Braintree Rehabilitation Hospital, Braintree, MA, USA;
** Alfred I DuPont Hospital for Children, The Sidney Kimmel Medical College,
Thomas Jefferson University, Wilmington, DE, USA; and
††
MossRehab, Elkins Park, PA, 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

Source(s) of financial support: Medtronic provided funding for the panel work-
device or manage long-term therapy. Subsequent articles describe shop and technical writing.

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V Neuromodulation 2016; 19: 616–622

Figure 1. Use of a screening test with ITB therapy (N 5 42). Nearly 70% of survey respondents always or often used a screening test for ITB therapy, and 26% some-
times did. Physical medicine and rehabilitation specialists were more likely than other physicians to use a screening test. *Indicates very small base size (<30).
dosing and long-term ITB therapy management (11), and trouble-
shooting (12).
METHODS
The authors were members of one of four working groups con-
vened as The ITB Therapy Best Practices Expert Consensus Panel to
provide expert consensus on ITB therapy. The entire Expert Consen-
sus Panel comprised 21 multidisciplinary clinicians in private practice
and at academic medical centers 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 currently manag-
ing more than 3200 patients receiving ITB therapy. The best practice
recommendations from the working groups were further developed,
aligned within the full panel, and served as the basis for this
manuscript.
Literature Search and Online Survey
Before the full panel convened, a broad, structured, English peer-
reviewed literature search was performed in PubMed and Science-
Direct during October 2013 (10). The complete list of 543 articles
with abstracts was distributed to participants, who then selected
130 papers relevant to screening for ITB therapy. An online survey
was also deployed to 42 neurologists, pain medicine and rehabilita-
tion specialists with experience currently managing at least 25
patients each in ITB therapy. Results of this survey were compiled
and will be reported here to illustrate variations in practice. Finally,
authors updated the selected papers to include articles published
between October 2013 and August 2015. These supplemental
articles included an Interdisciplinary Consensus Table 2013 for the
use of ITB in children and adolescents produced by a German group
managing more than 400 patients (13). They used the American
Academy for Cerebral Palsy and Developmental Medicine evidence
levels to evaluate the peer-reviewed literature on ITB therapy. They
found no level I evidence (randomized controlled trials [RCTs], sys-
tematic review of RCTs) and the preponderance of evidence was
level III (cohort studies, systematic reviews of case-control studies),
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V Neuromodulation 2016; 19: 616–622
BEST PRACTICES FOR ITB SCREENING TEST
level IV (case series, cohort study without concurrent control group,
case-control study), or level V (expert opinion).
Most ITB screening trials consist of single-shot bolus injections,
but continuous trialing (which if off-label in the United States) has
received some attention in the literature. Two case series describe
experience with inpatient continuous infusion using a temporary
catheter. The first detailed three complicated cases of hemiparetic
spasticity (14). All patients had a significant improvement in spastic-
ity, while preserving motor strength and coordination in unaffected
limbs. One patient would have been missed with a single-shot trial,
as she required a higher baclofen dose to obtain efficacy. More
recently, Phillips et al. reported on 57 patients with refractory spas-
ticity that underwent a continuous ITB trial (15). Spasticity signifi-
cantly decreased during trial, with 34% of ambulatory patients
progressing to a less restrictive assistive device by trial’s end. Pumps
were implanted in 86% of patients. At the time of this publication,
the panel did not feel that continuous ITB trialing was a best prac-
tice for most patients, although it may evolve into a best practice
for selected patients.
THE DEBATE ABOUT SCREENING
Although we believe that conducting a screening test prior to
implant is a best practice to ascertain the patient’s response to a tem-
porary exposure to ITB, this conclusion is debatable (13,16). Arguments
for preimplantation testing, supported by level II and IV evidence (13),
include the ability to assess what effect on hypertonia can be reason-
ably expected, tolerability, and gaining acceptance of ITB from patients
and caregivers. Prager et al. considered a screening trial a best practice
for all candidates for intrathecal drug delivery (IDD) for pain, but noted
that a trial is only part of the evaluation for suitability of IDD (17). Their
conclusion related specifically to pain management with on-label use
of preservative-free morphine or ziconotide.
The arguments against testing include the fact that it does not
provide a reliable prediction of long-term therapeutic outcome, the
risk of infection, and the time delay between testing and pump
implantation. Nearly 70% of our survey respondents always or often
used a screening test, with the remainder sometimes using one
(Fig. 1). Pain medicine and rehabilitation physicians were more likely
617
to always use a screening test. Respondents cited the utility of
 BOSTER ET AL.
Figure 2. Utility of ITB screening test results (N 5 40).
screening results for developing goals for ITB therapy, demonstrat-
ing reduced spasticity and enhanced functionality, and assessing
patient/caregiver interest in proceeding with ITB therapy (Fig. 2).
PLANNING FOR ITB SCREENING
Patients referred for administration of an ITB screening dose have
already been deemed suitable candidates for ITB therapy. Figure 3
depicts the steps involved specifically in ITB screening and assumes
coordination between the test dose administrator and the referring
physician, as well as the implanter and long-term therapy manager
if the screening test is successful.
Goal Setting for ITB Screening
While the most common goals of ITB therapy include a reduction
in tone and/or a reduction in spasms, there is also the potential for
improved functional capacity. The panel recommends developing
realistic, individualized patient goals, which may include both active
and passive targets (Table 1). The long-term goals of ITB infusion
may not be fully appreciated during the screening test. Rehabilita-
tion during the immediate postimplant and long-term phases of ITB
infusion is of paramount importance for attaining functional
improvement. Given the brief nature of the screening test, func-
tional enhancement is observed inconsistently. It is even conceiva-
ble for a patient to demonstrate a decline in function during the
screening test due to the sudden alteration of the neuromuscular
system. This observation does not represent a contraindication to
chronic infusion. Rather, such patients require careful dosing man-
agement and perhaps extended rehabilitation.
Spasticity Assessment During ITB Screening
The assessment of spasticity varies from straightforward to prob-
lematic. Spasticity can be affected by many factors, including tem-
perature, emotional status, time of day, level of pain, body position,
and the amount of prior stretching. In practice, the survey respond-
ents were most likely to use deep tendon reflexes, manual muscle
test, and the Ashworth or Ashworth Modified Score (Fig. 4). Hyperto-
nia can be evaluated clinically using a number of well-established
rating scales and other measures. The most commonly utilized spas-
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ticity scales include the Ashworth (18), Modified Ashworth (19), and
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V Neuromodulation 2016; 19: 616–622
Tardieu Scales (20,21). Table 2 summarizes these scales (1–4,22,23).
The inter- and intrarater reliability of these scales is generally consid-
ered fair to good, with occasional reports of suboptimal consistency.
One potential criticism of the Ashworth and Modified Ashworth
scales is the inability to distinguish between the rheologic properties
of the soft tissues and the neural contributions to hypertonia. The
Tardieu Scale attempts to address that difficulty. Subjective meas-
ures include patient assessment of spasm intensity and/or logs of
spasm frequency. The correlation between subjective report and
objective measures of spasticity is inconsistent.
A baseline assessment should be performed before administering
the test dose and periodically throughout the screening test day.
The assessment should consist of a complete history and physical
examination with particular emphasis on musculoskeletal and neu-
rological components. Many panel members encouraged assistance
from physical and occupational therapists for functional assess-
ments. Additionally, functional mobility evaluations (bed mobility,
transfers, ambulation, etc.) are crucial in high-performing patients.
During the assessments it is a best practice to repeat the goals of
the test dose to the patient and family/caregiver, describe what con-
stitutes a successful screening test, and explain the difference
between the screening dose and long-term ITB infusion.
Contraindications to Lumbar Puncture
Individuals should not be trialed if there are active medical issues
that can confound or obscure the effects of the screening test, such
as exacerbations of multiple sclerosis, active urinary tract infections,
nonhealing wounds, and so forth. These abnormalities may elevate
hypertonicity above the “baseline” levels, which can make the
results of the screening test appear overly beneficial or may present
excessive risks of adverse effects during the test. A brief preproce-
dure laboratory assessment, such as complete blood count and uri-
nalysis may be warranted. Of note, many patients with spastic
hypertonia may also have neurogenic bladder function. Asymptom-
atic bacterial colonization should not be an absolute contraindica-
tion for a screening test. Decubitus ulcers in close proximity to the
lumbar puncture site would be a contraindication.
Management of Antispasmodic and Anticoagulation
Medications During ITB Screening
One of the potential goals of long-term ITB therapy may be to
eliminate oral antispasmodic medications. Therefore, temporary
 BEST PRACTICES FOR ITB SCREENING TEST

early as the same day as the screening test. Patients who may be candi-
dates for ITB therapy may also utilize neurolytic procedures for tone
management, including phenol blocks, alcohol blocks, and botulinum
toxin injections. Consideration should be given to timing of these proce-
dures relative to an ITB screening test, so that the effects of these proce-
dures do not interfere with the effects of the ITB bolus.
For patients receiving anticoagulant or antiplatelet therapy, the
risks and benefits of discontinuing or modifying therapy must be
weighed against the potential risk of bleeding following a lumbar
puncture (24). While the risk of serious bleeding from a lumbar
puncture is rare, the panel recommends that the decision be made
in partnership with the clinician prescribing the anticoagulation
medication. The risk of clinically significant bleeding during a lumbar
puncture increases with age, female sex, associated abnormalities of
the spinal cord or vertebral column, the presence of an underlying
coagulopathy, larger spinal needles, and difficulty during needle
placement. Guidelines for discontinuance of specific agents during
neuraxial anesthesia provide a reasonable guideline and are exten-
sively described by Horlocker (25) and Narouze et al. (24).

PROCEDURE DETAILS
The ITB screening test can be conducted in any location that
ensures the safe delivery of medication, monitoring, and evaluation
of the patient. This includes inpatient hospital, inpatient rehabilita-
tion center, ambulatory surgical centers, and outpatient clinics,
depending on local resources and the ability to ensure safety. Equip-
ment requirements include a hospital bed or stretcher for perform-
ance of the lumbar puncture and cardiopulmonary (pulse, blood
pressure) monitoring apparatus. Ideally, a handicapped-accessible
bathroom and space for gait evaluation are in close proximity. For
more technically challenging lumbar punctures, access to fluoro-
scopic or sonographic equipment is desirable. Patients with previous
spinal fusion surgeries, for example, may be referred for lumbar
puncture injection under fluoroscopy. Fluoroscopy guidance is both
accurate and reliable, but may be logistically cumbersome. Ultra-
sound guidance facilitates clinically reliable and convenient bedside
lumbar puncture.
The procedure can be performed with the patient in a number of
positions including prone, sitting with a forward flexed posture, and
lateral decubitus with a forward flexed posture. Additional factors

Table 1. Goal Setting for ITB Therapy.

Examples of Goals Potentially Achieved With Intrathecal Baclofen

Therapy
ACTIVE GOALS
Improved mobility: speed,
Figure 3. ITB therapy screening test algorithm. safety, and quality in the
home and the
community
Increased ability and
discontinuation of these drugs during the screening test may provide a Independence for ADLs:
more realistic picture of what to expect with ITB therapy. The panel rec- dressing, eating, hygiene
ommends that consideration be given to weaning oral antispasmodic Decreased time for ADLs
medications leading up to the screening test. The weaning process Reduced stretching time
should be customized for each patient. Some individuals could continue during home exercise
oral agents and temporarily stop them on the morning of the screening
test. Other patients may require a more gradual weaning a few days
before the screening test. Oral medications can be restarted or titrated
PASSIVE GOALS
Improved positioning
Improved wheelchair tolerance
Prevention of complications such as
contractures
Decreased caregiver burden and time
Improved quality of sleep
Reduced spasticity-related pain
Discontinuation of oral antispasmodics
619

ADLs 5 activities of daily living.

back to baseline levels as the hypertonia returns to baseline, perhaps as

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 BOSTER ET AL.

Figure 4. Measures used to assess spasticity. Surveyed physicians most often used deep tendon reflexes, manual muscle test (MMT), and Ashworth/Modified
Ashworth score to assess generalized spasticity.

that may affect or alter the approach to the lumbar puncture include
prior spinal surgery, scoliosis, hip or knee contractures, spasms, pain
in certain postures, presence of skin decubitus, feeding tube, trache-
otomy, or ventilator. Conscious sedation may be required for chil-
dren, cognitively impaired adults, or for those patients with
hyperkinetic components to their hypertonicity. Intravenous access
should be attained in all patients before trialing and maintained
until the effects of the ITB bolus have waned.
The lumbar puncture is performed using sterile technique, and
liquid baclofen is administered intrathecally as a single bolus. The
standard ITB screening test dose is a 50 mcg bolus. A screening test
dose lower than 50 mcg may be appropriate in some clinical scenar-
ios. For example, very small (pediatric) patients and patients who are
ambulatory and rely on their spasticity for functional mobility may
have sufficient response from a 25 mcg dose to detect a change in
spasticity without becoming hypotonic. For patients who do not
respond to the initial 50 mcg bolus, a higher dose of 75 mcg or sub-
sequently 100 mcg may be required to demonstrate effect. A 75
mcg dose may be indicated in some cases of post-stroke or spinal
cord injury. It is recommended to wait at least 24 hours between
bolus administrations. Many providers will utilize a barbotage tech-
nique during the screening test. This entails sequential aspiration
and instillation of cerebrospinal fluid through the spinal needle in
an effort to improve circulation of the injected liquid baclofen
through the subarachnoid space (26).
The panel recommends checking cardiopulmonary parameters
(i.e., pulse, blood pressure) frequently during the first two hours
postinjection, and then as clinically indicated. The spasticity meas-
ures assessed preinjection are repeated postinjection at least twice
within the first four hours. General observation of the patient should
continue for as long as necessary to ensure medical stability and
recovery from any hypotonia. Rarely, patients may require extended

Table 2. Comparison of Commonly Used Spasticity Scales.

Score Ashworth Scale (Ashworth 1964) Modified Ashworth Scale Tardieu Scale (Tardieu 1954)
(Bohannon & Smith, 1987)
Muscle Tone Muscle Tone Muscle Reaction
0 No increased tone. No increased tone. No resistance to passive ROM.
1 Slight increase in tone causing a Slight increase in tone causing a Slight resistance to passive ROM.
catch when the limb is moved in catch and release or minimal
flexion or extension. resistance at the end range of
the joint in flexion or extension.
11 Slight increase in tone, with a catch,
followed by minimal resistance
throughout the remainder (less
than half) of the range of
movement ROM.
2 Increased tone, with no difficulty Increased tone throughout most Catch followed by a release.
moving limb into flexion. ROM. Affected part is still easy to
move.
3 Considerable increase in tone. Considerable increase in tone. Fatigable clonus (<10 sec).
Passive movement is difficult. Passive movement is difficult.
4 Limb is rigid in flexion or. extension Affected part is rigid in flexion or Infatigable clonus (>10 sec).
extension
620

ROM 5 range of motion.

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V Neuromodulation 2016; 19: 616–622

observation if they remain excessively hypotonic. Patients should
not be discharged until tone levels have begun to return and safe
discharge is assured. Potentially, patients with prolonged effects
could require an overnight hospital admission.
Adverse effects can occur with an ITB screening test. Spinal head-
ache or postlumbar puncture syndrome is a complication of a dural
puncture and is not a direct effect of the medication. Spinal head-
aches occur in up to 30% of patients undergoing a lumbar puncture
and can vary in severity from mild to incapacitating (27). Headache
typically worsens when the patient sits or stands up, and decreases
in the supine position. These headaches typically begin within a few
hours of a lumbar puncture but may be delayed for as long as two
weeks. Spinal headaches can be accompanied by dizziness, neck or
arm pain, cranial nerve palsies, tinnitus, nausea, and distorted vision.
Spinal headaches are more common in younger women with a low
body mass index and in people who have a headache history in
general. The risk of spinal headaches increases with use of larger
needles. The headache resolves spontaneously in the majority of
patients. Supportive measures include bedrest, caffeine, abdominal
binders, and increased oral fluid intake. Epidural blood patch is
reserved for recalcitrant cases (28).
Nausea/vomiting and drowsiness/sedation are the most common
adverse effects observed during ITB screening, with reported inci-
dences of 2–8% (26). Other common adverse events during screen-
ing (occurring in >1% of patients in prospective clinical trials)
include hypotonia, dizziness, paresthesia, hypotension, and respira-
tory depression (26). These complications are more likely related to
a pharmacological effect than the procedure. Protocols should be in
place for management of complications. Since the effects of ITB
screening tests are occasionally prolonged, the practice setting
should have the capacity for extended observation.
POSTINJECTION COMMUNICATION
A successful screening test may confirm achievement of predeter-
mined goals or may uncover modified goals as a secondary result of
screening. Once ITB therapy is established as an appropriate thera-
peutic intervention, the trialing clinician should review the results of
the screening with the patient and caregiver(s). The clinician should
communicate with the implanter regarding starting dose, drug con-
centration, delivery mode, pump size, pump location, and catheter
tip placement. While more research is needed in this area, the panel
recommends the implant team consider low thoracic/upper lumbar
catheter placement for lower extremity spasticity and upper tho-
racic/cervical level catheter placement for upper extremity spasticity.
The trialing provider should also communicate the results of the
screening test to the referring clinician and the long-term managing
clinician.
The information communicated to the implanting team should
also include a discussion of issues that may impact preoperative
preparation, the surgical procedure, and postoperative recovery,
such as significant past medical history, past surgical history, and
body habitus. Patients with previous abdominal surgery, such as G-
tube placement or prior pump explant, may be considered candi-
dates for pump implantation. The implanter should then correspond
with the postoperative managing clinicians regarding the expected
postoperative precautions and the date and location of surgery so
that the appropriate rehabilitation services can be arranged. A num-
ber of individuals may be involved in the process of securing insur-
ance clearance for the implant, including the trialing, implanting,
and managing clinicians.
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V Neuromodulation 2016; 19: 616–622
BEST PRACTICES FOR ITB SCREENING TEST
As described previously, the patient’s medical status should be
optimized before proceeding to implant. Since the implantation pro-
cedure is a more advanced intervention compared to the screening
test, a more detailed preprocedure clearance process may be war-
ranted. Additionally, the nutritional status of the patient should be
evaluated in an effort to mitigate the risks of postoperative infection
and pump erosion through the skin.
Lastly, the patient and family/caregiver should understand the
immediate postoperative instructions, options for pump titration,
and all facets of having an ITB pump, including psychosocial factors,
potential financial responsibilities, adhering to appointment sche-
dules, and being proactive to maximize effectiveness of the
intervention.
CONCLUSIONS
ITB therapy is a safe and effective treatment for severe spasticity.
After a patient is identified as a possible ITB candidate, the next
diagnostic step is to perform an ITB screening test. This process
involves identifying specific spasticity-related and functional goals
with the patient and caregivers. Response to the ITB screening test
is then assessed using a number of evaluative spasticity measures
and predetermined goals. The test dose is a crucial step in clarifying
longer-term ITB therapy goals and expectations.
Summary of Best Practices
• An ITB screening test is a best practice to evaluate clinical
response and achievement of functional goals.
• Do not conduct a screening test if the patient has medical issues
that could confound or obscure response to ITB.
• Check cardiopulmonary parameters (i.e., pulse, blood pressure)
frequently during the first two hours postinjection, and moni-
tor the patient for as long as necessary to ensure medical
stability.
• Develop realistic and individualized patient goals that take into
consideration spasticity, active function, and passive function
(Table 1).
• Provide repeated education to the patient/family/caregiver on
screening test goals, expectations, and the difference between
response to a screening test compared to long-term ITB therapy.
Acknowledgement
We 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 two-day ITB Best Practices Panel
workshop and professionally facilitated discussions designed to
build consensus. All authors contributed expert opinion, manuscript
review and revision, and approved the final version. Dr. Susan Ben-
nett was the team lead for the Screening Test workgroup. Dr. Aaron
Boster and Dr. Michael Saulino chaired the ITB Best Practices Panel
and provided senior editor leadership for final manuscript review
and approval. Medtronic provided administrative and editorial sup-
621
port, and funding support for the panel workshop.
 BOSTER ET AL.

28. Freeman ED, Hoelzer BC, Eldrige JS, Moeschler SM. Fibrin glue to treat spinal fluid
leaks associated with intrathecal drug systems. Pain Practice 2014;14:570–576.
How to Cite this Article:
Boster A.L., Bennett S.E., Bilsky G.S., Gudesblatt M.,
Koelbel S.F., McManus M., Saulino M. 2016. Best Practices COMMENTS
for Intrathecal Baclofen Therapy: Screening Test.
Neuromodulation 2016; 91: 616–622 While the efficacy of trialing for intrathecal therapy remains some-
what clouded for chronic benign pain, with some practitioners opining
that a trial gives little meaningful information as the therapy is titrated to
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10. Saulino M, Ivanhoe CB, McGuire JR, Ridley B, Shilt JS, Boster AL. Best practices for
intrathecal baclofen therapy: patient selection. Neuromodulation 2016;19:607–615. the subject of trialing has never been published. This consensus state-
11. Boster A, Adair RL, Gooch JL et al. Best practices for intrathecal baclofen therapy: ment provides clear instructions to be used as a manual by the entire
dosing and long-term management. Neuromodulation 2016;19:623–631.
12. Saulino M, Anderson DJ, Doble J et al. Best practices for intrathecal baclofen
team involved in patient care.
therapy: troubleshooting. Neuromodulation 2016;19:632–641.
13. Berweck S, Lutjen S, Voss W et al. Use of intrathecal baclofen in children and adoles- Michael Gofeld, MD
cents: interdisciplinary consensus table 2013. Neuropediatrics 2014;45:294–308.
14. Harned ME, Salles SS, Grider JS. An introduction to trialing intrathecal baclofen in Seattle, WA, USA
patients with hemiparetic spasticity: a description of 3 cases. Pain Physician 2011;14:
483–489.
15. Phillips MM, Miljkovic N, Ramos-Lamboy M et al. Clinical experience with continu-
***
ous intrathecal baclofen trials prior to pump implantation. PM R 2015;7:1052–1058.
16. Deer TR, Prager J, Levy R et al. Polyanalgesic Consensus Conference 2012: recom- I applaud the authors for their stellar piece of work and identification
mendations for the management of pain by intrathecal (intraspinal) drug delivery:
report of an interdisciplinary expert panel. Neuromodulation 2012;15:436–466. of best practices to give the practitioner, patient, family, and caregivers
17. Prager J, Deer T, Levy R et al. Best practices for intrathecal drug delivery for pain. clear understanding and realistic expectations of the screening trial.
Neuromodulation 2014;17:354–372.
18. Ashworth B. Preliminary trial of carisoprodol in multiple sclerosis. Practitioner 1964;
It is surprising that only 70% of respondents always use a screening
192:540–542. test before implantation. The arguments about risk of infection, and
19. Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of mus- delay of implantation, are weak. In my experience with several hundred
cle spasticity. Phys Ther 1987;67:206–207.
20. Tardieu G, Shentoub S, Delarue R. Research on a technic for measurement of spas- trials, almost all by intrathecal catheter bolus, there has not been a single
ticity. Rev Neurol (Paris) 1954;91:143–144. infection. Patients who had a positive response to the test dose of ITB all
21. Tardieu G, Rondot P, Mensch J, Dalloz JC, Monfraix C, Tabary JC. Electromyographic had reduction in spasticity after pump implantation. Later increase in
response to stretching of the muscles in the normal subject. Rev Neurol (Paris) 1957;
97:60–62. spasticity was either due to tolerance, disease progression, infection, or
22. Pandyan AD, Johnson GR, Price CI, Curless RH, Barnes MP, Rodgers H. A review of problem with the system.
the properties and limitations of the Ashworth and modified Ashworth Scales as
measures of spasticity. Clin Rehabil 1999;13:373–383.
I understand that there was no consensus with regards to best loca-
23. Haugh AB, Pandyan AD, Johnson GR. A systematic review of the Tardieu Scale for tion for screening. It is, however, advisable to consider inpatient trial for
the measurement of spasticity. Disabil Rehabil 2006;28:899–907. ambulatory patients because the ITB can produce prolonged hypotonia
24. Narouze S, Benzon HT, Provenzano DA et al. Interventional spine and pain proce-
dures in patients on antiplatelet and anticoagulant medications: guidelines from and inability to walk for several hours. Those patients whose level of dis-
the American Society of Regional Anesthesia and Pain Medicine, the European Soci- ability requires them to be brought to the testing center by ambulance
ety of Regional Anaesthesia and Pain Therapy, the American Academy of Pain are also inpatient candidates as they are more likely to need a second
Medicine, the International Neuromodulation Society, the North American Neuro-
modulation Society, and the World Institute of Pain. Reg Anesth Pain Med 2015;40: day of trial to achieve satisfactory reduction in spasticity.
182–212.
25. Horlocker TT. Regional anaesthesia in the patient receiving antithrombotic and anti-
platelet therapy. Br J Anaesth 2011;107 (Suppl. 1):96–106.
Joe Ordia, MD
26. Medtronic. Lioresal Intrathecal (baclofen injection) Full Prescribing Information, 2013. Peabody, MA, USA
http://professional.medtronic.com/pt/neuro/itb/fpi/index.htm.
27. Ahmed SV, Jayawarna C, Jude E. Post lumbar puncture headache: diagnosis and
management. Postgrad Med J 2006;82:713–716. Comments not included in the Early View version of this paper.
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