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Intrathecal Baclofen Pump & other management strategies for Spasticity William O McKinley MD Director, SCI Rehabilit PowerPoint Presentation
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Intrathecal Baclofen Pump & other management strategies for Spasticity William O McKinley MD Director, SCI Rehabilitation Medicine Dept. PM&R VCU / MCV. What is Spasticity ?.

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Intrathecal Baclofen Pump & other management strategies for SpasticityWilliam O McKinley MDDirector, SCI Rehabilitation Medicine Dept. PM&RVCU / MCV

what is spasticity
What is Spasticity ?
  • Abnormal, velocity-dependent increase in resistance to passive movement of peripheral joints due to increased muscle activity.
spasticity etiology diagnosis
Spasticity: Etiology (Diagnosis)
  • Spinal Cord Injury
  • Traumatic Brain Injury
  • Stroke
  • Multiple Sclerosis
  • Cerebral Palsy
pathophysiology
Pathophysiology
  • Intrinsic hyperexcitability of alpha motor neurons within the spinal cord secondary to damage to descending pathways
    • cortico, vestibulo, reticulospinal
  • CNS modification
    • neuronal sprouting
    • denervation hypersensitivity
symptoms of spasticity
NEGATIVE SX’s

Weakness

Function

Sleep

Pain

Skin, hygiene

Social, Sexuality

contractures

USEFUL SX’s

Stability

Function

Circulation

Muscle “bulk”

Symptoms of Spasticity
spasticity treatment decisions
Spasticity: Treatment Decisions
  • Is Spasticity:
    • Preventing function?, Painful?
    • A result of underlying treatable stimulus
    • A set-up for further complications?
  • What Rx has been tried?
  • Limitations and SE’s of Rx…
  • Therapeutic goals
goals of therapy
Goals of Therapy
  • Ease function (ambulation, ADL)
  • Decrease Pain, contracture
  • Facilitate ROM, hygiene
spasticity scales
“Modified” Ashworth

0= no increased tone

1= slight “catch” in ROM

1+= minimal resistance

2= moderate tone, easy ROM

3= marked tone, difficult ROM

4= Rigid in flexion or extension

Spasm Frequency Scale

0= none

1= mild

2= infrequent

3=> 1 per hour

4= > 10 per hour

Spasticity Scales
rehab evaluation con t
Rehab Evaluation (con’t)
  • Gait patterns
  • Transfer abilities
  • Resting positioning
  • Balance
  • Endurance
management options
Management Options
  • Physical interventions
  • systemic medications
  • chemical denervation
  • Intrathecal agents
  • orthopedic interventions
  • neurosurgical interventions
rehabilitation interventions
Rehabilitation Interventions
  • Positioning (bed, wheelchair)
  • Modalities
    • heat (relaxation)
    • cold (inhibition)
  • Therapeutic Exercise
    • inhibitory to spastic muscles
    • facilatory to opposing muscles
  • Orthotics
non conservative treatment options
Non-Conservative Treatment Options
  • Oral Medications
  • Injections (Phenol , Botox)
  • ITB (Intra-Thecal Baclofen)
  • Surgical (nerve, root, SC)
  • Spinal Cord Stimulator
oral antispasticity medications
Oral Antispasticity Medications
  • Baclofen
  • Dantrium
  • Diazepam
  • Clonidine
  • Tizanidine
  • (limitations: non-selective, side effects)
baclofen lioresal
Baclofen (Lioresal)
  • GABA-B analogue; binds to receptors
  • inhibits release of excitatory neurotransmitters (spasticity control)
    • Ca++ (pre-synaptic inhibition)
    • K+ (post-synaptic inhibition)
  • may also decrease release of substance P (pain control)
dantrium
Dantrium
  • Inhibits Ca++ release at muscle level
  • Preferred : TBI, CVA, CP
  • SE’s - weakness, GI
  • Hepatotoxicity (<1%)
diazepam
Diazepam
  • GABA “potentiation”
  • Usage : SCI, MS
  • SE’s - CNS depression, dependence,
clonidine
Clonidine
  • Alpha-2 receptor blockage
  • Usage : SCI
  • Max dose - .4mg/d (oral & patch)
  • SE’s - OH, syncope, drowsiness
tizanidine zanaflex
Tizanidine (Zanaflex)
  • 1996 - Approved for SCI, MS, CVA
  • Alpha-2 agonist (pre-synaptic inhibition)
  • 1/10 potency of Clonidine In lowering BP
  • Dose: T1/2: 2-5hr, begin 4 mg qhs (max 36 mg)
  • SE’s - Sedation, nausea, LFT’s
chemical neurolysis
Chemical Neurolysis
  • Phenol 5-7%- Motor Point/Nerve block
  • Non-selective destruction of axons/myelin
  • Inds: Local (not general) spasticity
  • Duration: 3-6 months
  • SE’s - dysesthetic pain
botulinum toxin
Botulinum Toxin
  • 1989 FDA approved for strabismus & blepherospasm
  • Botox-A inhibits Ach Release at NMJ
  • Dose: 300-400u total (50-200/muscle)
  • Onset: 2-4 hours, Peak : 2-4 weeks
  • Duration: 3-6 months
  • ? Immunoresistance w/repeated inj’s
spasticity surgical management
Spasticity: Surgical Management
  • Rhizotomy (posterior)
  • Cordotomy
  • Tendon Release
    • (limitations: invasive, bowel/bladder changes, irreversible, effectiveness varies)
intrathecal baclofen and spasticity
Intrathecal Baclofen and Spasticity
  • Intrathecal delivery of baclofen via an inplantable pump is a safe and effective therapy for the management of spasticity !
intrathecal baclofen
Intrathecal Baclofen
  • Indicated for patients unresponsive to oral meds or with SE’s
  • Delivered directly to intrathecal space affording much higher drug concentration
  • Implantable system allows non-invasive monitoring & adjustments
itb successful outcomes
ITB: Successful Outcomes
  • Study results since 1984 demonstrate reduction of Ashworth spasticity scores and spasm scales
  • Other results include improvements in:
    • pain
    • bladder function
    • chronic drug side effects
    • quality of life for patient & caregiver
itb outcome studies
ITB: Outcome Studies
  • “Intrathecal baclofen for spasticity of spinal origin: seven years of experience”…Penn* (J. neurosurg 77:236-40, 1992)
    • 66 patients with intractable spasticity
    • followed for 30 months
    • “It is suggested that long term control of spinal spasticity by intrathecal baclofen can be achieved in most patients”
itb outcome studies26
ITB: Outcome Studies
  • “Intrathecal baclofen for intractable spasticity of Spinal of spinal origin: a long-term multicenter study”…..Coffe* (J. Neurosurg 78; 226-32, 1993)
    • 93 patients with intractable spasticity
    • followed 19 months
    • “Results indicate intrathecal baclofen can be safe and effective for long term management in SCI or MS”
outcome studies meta analysis
Outcome Studies: Meta Analysis
  • *Dijkers- Meta analysis of 37 studies
    • 77% positive response to bolus dose
    • 91% of whom opted for implant
    • 84% of whom had benefit w/o SE’s
    • Avg Dec’d Ashworth: 3.95-1.53 (P<.0001)
    • negligible effect of LOI
  • * J.Spinal Cord Med:19(2), 138, 1996
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ITB
  • 1992 - FDA Approved ITB for spinal Spasticity
  • 1996 - FDA Approved for Cerebral Etiologies (BI and CP)
itb pharmacokinetics
ITB: Pharmacokinetics
  • Baclofen: GABA-b agonist; inhibits neuronal firing
  • ITB (Lioresal)
    • preservative-free; stable for 90 days
    • half-life 1.5 hours
    • typical dose: 1/100 of oral dose
    • average daily dose: 300-800ug
    • lumbar/cervical ratio 4:1
decision to treat w itb
Decision to Treat w/ ITB
  • Have oral antispasticity meds truly failed?
  • Are their SE’s too great?
  • Can a single definitive surgical procedure accomplish similar goals?
  • Is precise control necessary for functional gains?
  • Does gain in function / comfort justify invasive procedure & maintenance?
exclusion criteria
Exclusion Criteria
  • Severely impaired renal function
  • Pregnancy / nursing mothers
  • Severe Aut. Dysreflexia
  • Hx of Hypersensitivity to baclofen
  • Hx of Noncompliance to regimens or follow-up
trial dose
Trial Dose
  • Trial dose via intrathecal lumbar puncture
  • Begin with 50 ug (if no response, 75-100 ug)
  • Observe 2-8 hrs
  • Positive response = decrease in spasticity
  • also access functional abilities
itb surgical phase
ITB: Surgical Phase
  • Subcutaneous abdominal placement
  • Catheter tunneled to mid-lumbar region below L3 and advanced 10 cm
  • Intra-operative fluoroscopy confirms catheter placement without twisting
  • Total time: 1-2 hours
post operative phase
Post-Operative Phase
  • Pump programming via radio-telemetry and computer begins day one post-imp;ant
  • ITB concentration: 500mcg/ml
  • ITB rate: 2 X bolus response (less if patient had prolonged (>12 hrs) response)
  • Can increase 10-15% every 24 hrs
  • maintenance follow-up: 1-4 weeks
post implant clinical care
Post-Implant Clinical Care
  • Post-Operative Adjustments
  • Pump Dosing Adjustments
  • Taper Oral Meds
  • Pump Refills
  • Patient Education
itb maintenance phase
ITB: Maintenance Phase
  • scheduled follow-ups for pump reassessment, refill and reprogramming
    • percutaneous refill into “port” (template)
    • dose adjustment: portable computer/telemetry
    • calculate next refill date
  • if sudden changes in spasticity occurs, assess for potential infection, bowel/bladder regimen, before increasing dosage
  • consider “drug holiday”
pump adjustments
Pump Adjustments
  • Adjustment parameters include:
    • drug name and concentration
    • reservoir status ( __ ml)
    • alarms (low battery; low reservoir)
    • infusion rate
    • infusion pattern (continuous, intermittent, complex)
    • may increase by up to 15% per adjustment
infusion modes
Infusion Modes
  • Continuous: drug delivered at continuous specified rate
  • Continuous-complex: step-wise increases/decreases at specified times
  • Bolus-delay: drug delivered intermittently at specific intervals
itb side effects
ITB Side Effects
  • Drowsiness
  • Dizziness
  • Blurred Vision
  • Slurred Speech
  • Nausea
  • Orthostasis
  • Confusion
potential pump complications
Potential Pump Complications
  • Drug over-infusion - somnolence, coma
    • no antidote
    • Physostigmine 1-2mg IV (.02 mg/kg) over 5-10 min
    • titrate ITB
  • Pump / Catheter malfunctions (kinking, disconnection, breaks)…often readily correctable under local anesthesia
  • Infections
pump system complications trouble shooting
Pump /System Complications & Trouble-shooting
  • r/o volume discrepancy
    • check pump setting
    • empty & compare fluid reservoir
  • r/o catheter kink, occlusion, disconnection
    • X-Ray catheter / CT intrathecal catheter
    • dye/ contrast study to check patency
    • bolus/infusion w/sereal scans over 12-24 hr
  • r/o pump underinfusion
    • X-Ray “roller” pre/post bolus
pocket complications
Pocket Complications
  • seroma, hematoma, infection
  • Causes
    • post-op swelling
    • inadequate fixation
    • infection
    • pocket too small
    • drug extravasation
suspected csf leak
Suspected CSF Leak
  • headache, dizziness, N/V, spinal swelling / redness
  • RX:
    • X-Ray / CT
    • culture of fluid
    • blood patch
    • surgical revision
advantages of programmable system
Advantages of Programmable System
  • Consistent optimal dosage
  • can be programmed to decrease or increase spasticity at certain times during the day
  • reduces adverse drug effects