Spasticity Management

Goal Setting

Patient Selection Guidelines:

Setting Appropriate & Realistic Goals For ITB Therapy; and other Treatment Options for Spasticity

SPASTICITY: TREATMENT DECISIONS:

When developing a treatment program, consider:
is the spasticity preventing function or independence?
Is the spasticity painful?
What treatment options have already been employed and what were the results?
Then, consider these other factors:
severity of the problem
scope of the problem: local vs regional vs generalized
cost - benefit and risk - benefit ratio
limitations and side effects of treatment
overall health of patient
therapeutic goals

PYRAMID OF CARE IN SPASTICITY MANAGEMENT
Prevention of Nociception
Physical Modalities: ROM, Static Stretching, Splinting, Serial Casting
Oral Medications: Baclofen, Diazepam, Tizanide, Clonidine, Dantrolene
Motor Point Blocks: Phenol, BOTOX®
Nerve Blocks: Phenol
Neurectomy, Temnotomy, Myotomy
Intrathecal Baclofen Pump
Rhizotomy, Cordotomy, Myelotomy

GOALS OF THERAPY

Clinical goals: to maintain muscle tone as close to normal as possible while permitting maximum function, to minimize frequency and severity of spasms.

Inclusion Criteria for ITB Therapy

ITB Therapy may be indicated for patients with severe spasticity regardless of etiology
It is important to distinguish between spasticity and other movement disorders
Accurate differential diagnosis of spasticity is important in patient selection
Treatment decisions must take into account the patient’s entire clinical & social situation as well as
chronicity
severity
distribution
locus of injury
co-morbidities

Clinical Stability

Patients should be clinically stable prior to evaluation for therapy
Clinical experience suggests waiting approximately 1 year after injury before screening Brain Injury patients for ITB Therapy

Chronicity

Duration impacts treatment goals & choice of intervention
Spasticity is neither immediate or universal - development depends on a variety of factors, it may evolve, or resolve , if improving rapidly - consider short term treatment to delay contracture, aide rehabilitation
Chronic spasticity may benefit from long term management - but may be less amenable to treatment (contractures, heterotopic ossification) or patient may have already developed compensatory strategies
spasticity reduction following recent injury may help delay contracture and aid rehabilitation during period of maximum central nervous system plasticity

Clinical and Functional Severity

ITB is indicated for spasticity that is clinically severe and that impairs function.
Severe spasticity operationally defined as a score of >/= 3 on the Ashworth scale measure of muscle tone
Severity:

Mild spasticity

Mild spasticity is rarely an indication for ITB Therapy
Mild spasticity is often advantageous for transferring or ambulating
Often considered adaptive or compensatory mechanism after injury
Mild spasticity can be treated with combination range of motion (ROM), splinting, orthotics, oral medication

Severe Spasticity

Severe spasticity may cause pain and interrupt sleep
Severe spasticity may interfere with posture or movement
Severe spasticity may interfere with urinary catheterization or hygiene procedures
Severe spasticity may interfere with many activities of daily living
Severe spasticity may require more aggressive measures to produce significant change in function

Distribution

The distribution of spasticity influences whether to treat focally or globally - and the specific intervention chosen
In severe wide-spread spasticity, focal chemodenervation may not improve function unless it accompanies global tone reduction

Locus of injury

Spasticity of spinal cord origin responds to oral medication better than cerebral origin spasticity

SCALES

ASHWORTH SCALE

1 - No increase in tone
2 - Slight increase in tone, giving a “catch” when moved in flexion or extension
3 - More marked increase in tone but affected part(s) easily flexed 4 - Considerable increase in tone; passive movement difficult
5 - Affected part(s) rigid in flexion or extension

SPASM SCALE

0 - No spasms
1 - No spontaneous spasms (except with vigorous motor stimulation)
2 - Occasional spontaneous spasms and easily induced spasms
3 - More than 1 but less than 10 spontaneous spasms per hour
4 - More than 10 spontaneous spasms per hour

Hygiene Score

0 - Independent with self-care
1 - One person is able to clean and catheterize with ease
2 - One person is able to clean and catheterize with effort
3 - One person is able to clean and catheterize only with major difficulty
4 - Two people required, but together they clean and catheterize easily
5 - Two people clean and catheterize with difficulty

 

Potential functional goals must be identified prior to initiating ITB Therapy
The most seriously involved patients are highly dependent on personal-care attendants and family care givers for nursing care, dressing, feeding, toileting, perineal hygiene, transfer, and joint-stretching exercises to avoid contracture
When these functions are impeded by spasticity, ITB Therapy may be indicated to facilitate caregiving
Functional gains have been reported after ITB
Self feeding, independent toileting, unassisted wheelchair transfer Gain may represent significant reduction in caregivers’ responsibilities or “first” for the patient

Improvements in range of motion in knee extension, upper extremity function, activities of daily living (communicating, dressing, and eating) have been reported in a study on patients capable of self-care
Albright etal., Continuous intrathecal baclofen infusion for spasticity of cerebral origin, JAMA 1993;270:2475-2477

Complications Associated with Immobility

Severe spasticity may place patients at risk for complications associated with immobility including
contractures and heterotopic ossification,
hip dislocation, bony deformity, decubitus ulcer,
respiratory distress, pulmonary embolus,
urinary tract infections, reduced appetite, weight loss
ITB Therapy for those at risk for serious and costly complications may improve patients’ health and reduce health-care costs

Patient Age and Size

Product labeling guidelines allow treatment of patients as young as 4 years
Patients must have sufficient body mass to support either the 18mL reservoir pump titanium disk about 3 inches in diameter and 6 ounces - or a thinner profile pump approximately 17% thinner with a reservoir capacity of 10mL

Treatment Goals

The success of ITB Therapy depends on the ability of the patient, family, caregivers, and treatment team to reach consensus to establish realistic treatment goals prior to initiating treatment
ITB Therapy can be beneficial both for ambulatory and non-ambulatory patients, as well as some in persistent vegetative state
Because ITB Therapy can be indicated for patients with such a broad spectrum of disability, the goals must be individualized and clearly understood
Spasticity should be treated only if it is interfering with some level of functioning, positioning, or comfort
No appropriate treatment decisions can be made without considering the goals of the therapy
Cognitive status may not be a factor if treatment is aimed at improving the ease of caregiving

Clinical Goals

The primary clinical goal of ITB Therapy is to achieve muscle tone that will optimize function with minimum of adverse side effects
Some ambulatory patients with underlying muscle weakness rely on spasticity in extensor muscle groups to bear weight and assist in standing or walking
Titrated dosing with SynchroMed Infusion System provides graduated control of spasticity
This permits such patients to maintain an erect posture and walk despite sub-optimal extremity strength
Nonambulatory patients may also need some degree of spasticity to sit upright in a wheelchair or to transfer
In this situation, the goal is not to abolish spasticity but to diminish it to a level that is useful for optimal function
Nonambulatory patients with severe spastic tetraplegia, maximum reduction of spasticity may be the treatment goal
For patients across a broad spectrum of disability and need, titrated dosing with the SynchroMed Infusion System maximizes therapeutic benefit while simultaneously minimizing both muscle weakness and unpleasant cognitive side effects

Functional Goals

Patients who respond to baclofen injection can expect a lasting reduction in muscle tone
The nature and extent of functional benefits that can occur are more variable and are often closely related to the patients cognition, motivation, and underlying motor skill
Treatment team must work closely with patients, families/caregivers to establish functional goals tailored to the patients level of disability
Goals should be realistic, explicit and established prior to pump implant
Unstated and/or unrealistic expectations may lead to disappointment and perceptions of treatment failure

Goals

Ambulatory patients: improving balance, gait, energy expenditure, reducing dependence on assistive devices
Non-Ambulatory patients: independent transfer or improved seating that would ease use of wheelchairs
Individuals Incapable of Self-Care: improving movement in extremities to facilitate positioning, bathing, dressing, other activities of daily living

 

Co-morbidities

If a patient has good selective motor control underlying spasticity, reducing spasticity may significantly improve mobility
Significant cognitive impairment may result in difficulty complying with requirements of spasticity management program

Some patients with spasticity of cerebral origin experience pain as a consequence of the spasticity and/or spasms or associated with voluntary movement and joint stretching
Pain may diminish quality of life, interfere with rehabilitation, and interfere with sleep
Pain reduction is a realistic goal for many of these patients

Many patients might anticipate improvement in upper extremity function, motor skills, ambulation, and speech
Not all goals are relevant or realistic
It is critical to reach a consensus on a set of explicit treatment goals that are suitable for each specific candidate

Motivation and Commitment of Patients and Caregivers

Successful implementation of ITB Therapy is dependent on the motivation of patients and caregivers and their commitment to careful adherence to each element of the treatment plan
They must be diligent with respect to follow-up responsibilities including pump refills, rehabilitation program, and cooperation and understanding of ITB Therapy

Exclusion Criteria for ITB Therapy

Active Infection is a contraindication for ITB Trial or Implantation
Allergy or hypersensitivity to oral baclofen
Pregnancy is a contraindication (nursing is an unknown)
Less than age 4 or insufficient body mass for pump implantation
Psychosis or Schizophrenic is a contraindication

General Clinical Considerations

Cerebral Origin Spasticity: Special Considerations:

Hydrocephalus: s/p VP shunt (no contraindication if stable).
Seizure History: A history of seizures is not a contraindication to ITB Therapy
Other/ prior procedures (g-tube is no contraindication).
Medical problems / conditions (scoliosis may make positioning difficult, active infection or decubitus is a contraindication).

Presence of other devices: The presence of a ventriculoperitoneal (VP) shunt is not a contraindication to ITB Therapy
The presence of a gastrostomy is not a contraindication to pump implantation - but can result in pump implantation on the opposite (right) side.

Trunk and Cervical Weakness

Patients with significant trunk or cervical weakness often require some spasticity to maintain cervical and trunk posture - more common in CP than TBI
Reducing extremity spasticity in these patients must carefully evaluate and consider the potential loss of function if trunk or cervical tone is reduced

Functional Considerations

SynchroMed Infusion System permits graduated control of spasticity with flexibility
Dose can be titrated, intermittently adjusted whenever clinically indicated, requested or required
Individualized dosing can reduce the burden and cost of rehabilitation
The ability to modulate spasticity to a desired level reduces the extent to which patients must relearn movement after treatment
Neuroablative procedures eradicate spasticity completely and often require extensive relearning

Pump Programming to Deliver Variable Dose Schedule

The infusion system can be programmed to deliver the drug on a variable schedule when indicated
pump can deliver more drug in the morning for dressing, and less later for better ambulation or transferring
more drug can be given at night for more relaxed sleep, and less during the day to support functional activities

Effective Treatment for Upper Extremity Spasticity

ITB Therapy reduces upper as well as lower extremity spasticity
Treatment may promote function and facilitate care-giving in tetraplegic as well as diplegic patients

Reversibility of Treatment

Treatment reversibility is one of the most critical features distinguishing ITB Therapy from Neuroablative alternatives
ITB Therapy may be stopped, restarted, pump and catheter can be removed
(if discontinuing, slowly decrease daily dose to avoid withdrawal)

Pain

Pain is a serious, debilitating, intractable problem for many patients - related to spasms or to voluntary movement that involves stretching a joint or limb. Reducing the spasticity may diminish pain
Pain due to other factors may not be alleviated

Psychosocial Considerations

ITB Therapy places demands on patients, families and caregivers
Does the individual possess the stability and resources necessary to meet the demands of ITB Therapy and achieve the goals of Therapy?
Patients, families and caregivers must understand main features of infusion system, implications of intrathecal medication, potential risks, emergency procedures, follow-up procedures and responsibilities, and the likely benefits of ITB Therapy
Careful assessment is necessary whether patients, families, and caregivers are sufficiently motivated to make the investment of time and effort demanded by ITB
Are they prepared for the possibility of adverse events - although often temporary, they can be serious
They must be vigilant for insidious symptoms of overdose or withdrawal (can occur with bolus or incorrect pump programming)
Are they prepared for the possibility of sub-optimal dosing at intervals during the first year, particularly during the initial weeks of ITB Therapy while the dose of baclofen injection is being titrated?
Determine whether the necessary resources are available to the patients and their caregivers including: transportation, financial factors, and insurance benefits

Summary Points