Download Outcome Assessment for Spasticity Management

Outcome Assessment for Spasticity Management in the Patient with Traumatic
Brain Injury
The Question: Can the effects of spasticity management in the patient with Traumatic Brain Injury (TBI)
be measured ?
Past Studies have assessed interventions to treat spasticity (a term used to describe a condition that
causes muscles to be stiff and resistant to stretching) using objective and / or subjective measures.
These outcome measures might reflect improvement in spasticity but may not reflect improvement in the
performance of daily activity functioning that individuals may expect from treatment. In rehabilitation,
measuring the effects on specific impairments is also often assessed. There has been a push and there is
a need for developing outcome measures that reflect overall functional improvement from interventions.
Insurance companies and medical centers have been some of the driving forces behind the development
of objective, functional measures and development of more specific metrics to assess outcomes.
Previous studies suggested the goal for treatment should be improvement in the individual’s ability to be
active and participate in the life he/she wishes to have, i.e., patient-oriented outcomes,
The World Health Organization, in addressing overall health and disability of the general population,
states that diagnosis alone is not enough to predict length of hospital stay, work performance, service
needs, or social integration. There is the need to look at the individual’s level of functioning as a measure
of outcome.
The question arises as to what constitutes a useful outcome measure. Research suggests that it should
be one that is likely to cause a change/improvement in an individual’s abilities as a result of treatment
intervention. It is evident that patients, families, companies, rehabilitation clinicians, engineers, and
insurance companies have varying priorities for different outcome goals, making across the board
comparisons of patients’ outcomes difficult.
Numerous articles are available showing how spasticity outcomes have been viewed in the past. The
Ashworth Scale, and other measurements of spasticity remain in common use today, despite their
functional limitations. Assessment of spasticity outcomes continues to be problematic. The majority of
studies do not report a functional outcome measure; however, researchers continue to re-evaluate
rehabilitation methods to ensure they improve not only motor impairment, but also show an improved
performance in daily living activities.
This Study attempts to identify an organized approach to spasticity outcomes and proposes a set of
appropriate goals for treatment interventions. A literature review (1966-2003) was conducted with over
500 articles, textbooks, websites and books reviewed to assess methods currently used to assess the
outcome of spasticity treatments The authors grouped goals into one of five categories: physiological
measurements (such as changes in electrical signals in the brain, spinal cord or muscles), measures of
passive activity (ability to stretch the person’s muscle tone and passive Range of Motion), measures of
voluntary activity (ability to extend and retract limbs), functional measures (daily activities such as walking
ability) and quality of life measures (over-all satisfaction with life). Ideally, all of these goals should be
addressed but this can sometimes be difficult. Assessment of interventions for spasticity is complicated;
therefore, goal setting must be realistic and reflect other factors which may impact outcomes. The
categories mentioned above should be viewed as general guidelines.
Types of tools and assessment methods used in this study include subjective and objective classifications
(qualitative and quantitative). Subjective methods ‘judge’ resistance to movement and look at severity of
spasticity. Objective methods (real, observable, factual) were used to evaluate spasticity ,when
appropriate. Authors listed forty-three examples of outcome measures for the assessment of spasticity,
which included testing assessment tools (e.g., Ashworth Scales, Emory Functional Ambulation Profiles,
Craig Handicap Assessment and Reporting Technique (CHART) and ability of the individual to perform
certain tasks (e.g., ability to perform self-catherization, sitting balance, timed toe tapping). Categories
included physiological measures, measures of passive activity (muscle tone), measures of voluntary
activity (deliberate movements), functional measures (daily living skills) and quality of life measures.
Twenty of these categories were objective, nineteen were subjective and four were ‘Either.’ Passive
activity included measurement of muscle tone using the Ashworth Scale and Tardieu Scale. They
measured range of motion, stiffness and muscle tone, stretch and stretch reflexes. Tests were given to
measure voluntary activity and the ability of the individual to perform motor tasks and movements. Foot
pressure was measured using Pedobarographs, a tool which looks at foot pressure patterns. It is not just
enough to be able to move a joint. Controlling an extremity requires the ability to change speeds and
direction. Use of measurement devices (special equipment) allows clinicians and scientists to develop a
better understanding of what is required for individuals with spasticity difficulties to perform certain
passive and active functions. It allows treatment professionals and engineers to make better outcome
predictions and plan for necessary interventions. Technology has the potential to increase understanding
of motor control, before treatment and following, and evaluate gait activities (manner of walking or
running), motor abilities (motion) and balance. Usefulness of this in spasticity management has not been
explored.
A wide range of methods can be used to assess functional performance. Particularly useful is the fact that
real-life activities can be studied rather than artificial movements. An objective way to measure mobility is
timed ambulation (six-minute walk over level surfaces, steps, curbs, looking for balance and watching for
falls).Subjective methods might include the Likert Scale, which can focus on a specific function and the
difficulty with which the individual performs the daily living task.
Quality of (QOL) Life improvement is sometimes difficult to measure for rehabilitation interventions.
However, achieving quality of life is very important. The Satisfaction with Life Scale is a questionnaire,
which includes a short-form health survey and a survey of an individual’s satisfaction with life (QOL) . This
form has not been used for evaluating spasticity outcomes in the TBI population, but has been used when
doing an overall assessment of recovery postinjury.
Who May Be Affected By These Findings: People with brain injury, caregivers, researchers, health
professionals, community providers, scientists and engineers working on devices for spasticity.
Caveats: Further work is needed to develop measures that have clinical significance for clinicians and
individuals being treated. Lack of objectivity continues as a problem, as well as the lack of communication
between clinicians and engineers working to provide services to people with TBI having spasticity
problems. Authors call for more clinically relevant information about treatment effects which realistically
assess functional recovery.
Bottom Line: Authors found mixed results measuring the amount of improvement using new techniques
with previous standards of measurement. They found the equipment used to determine outcomes was
bulky, heavy and the results were of limited value . These tests, which assess amount of improvement in
an individual’s functioning, are time-consuming and require a large test space, making places such as
clinics and small offices unacceptable for testing. There is lack of communication between clinicians and
scientists, which reflects a limited relationship to traditional and/or functional outcomes of spasticity.
Positive progress is being made in the development of assessment devices. Authors recommend a new
test of spasticity that includes discussing questions that identify the goal of the test and develops
qualitative and quantitative (quality and quantity) outcome measures.
Find This Study: Elovic, E.P., Simone, L.K., Zafonte, R. (2004). Outcome Assessment for Spaticity
Management in the Patient with Traumatic Brain Injury. J Head Trauma Rehabilitation, 19, 155-177.
First Study: Tizanidine Medication Appears to Reduce Abnormal Excessive
Muscle Tone
The Question: Does orally delivered tizanidine medication reduce abnormal excessive muscle tone (“spasticity”)
caused by injury to the brain?
Past Studies demonstrate that the medication tizanidine hydrochloride (Zanaflex) is effective for reducing spasticity
for persons with spinal cord syndromes and multiple sclerosis. “Spasticity” is a term used to describe a condition that
causes muscles to be stiff and resist stretch. As a result of injury to the brain, those muscles that become spastic are
unable to “relax” or “stretch out.” Because of this, persons with spasticity may not be able to straighten out or bend
their arm or leg joints, even if they have the strength to do the task. For instance, the muscles necessary to straighten
the arm may actually be working, but if the muscles that bend the arm are spastic, they can be so powerful that
individuals cannot overcome the force generated by the spastic muscles and are unable to strengthen their arms.
When spasticity limits a person’s body movements, it can decrease functional abilities and also can lead to medical
problems such as pain, sleep disturbances, and skin conditions. Spasticity can be treated for some people. Many
spasticity medications have been tested over the years.
Oral dose anti-spasticity medications tend to disperse throughout the body and, because of this, are appropriate for
treating overall body spasticity, rather than spasticity that is located in one place. Oral dose anti-spasticity medication
use among persons with traumatic brain injuries has been limited because of potential negative side effects than can
effect recovery and cognition (thought processing or thinking skills).
Tizanidine can be taken in an oral dose and is fairly affordable. Other spasticity treatment medications can require
surgery or repeated injections. Although other medications for treating spasticity experienced by persons with brain
injuries have been evaluated, the safety and efficacy of oral Tizanidine had not been studied.
This Study is the first of its kind using Tizanidine (Zanaflex) to treat spasticity in the arms and legs of persons with
traumatic brain injuries and stroke. Tizanidine is one of several anti-spasticity medications, is relatively affordable,
and can be taken easily in an oral dose. The researchers found that Tizanidine appeared to be effective for
decreasing spasticity; however, dosing was limited by the side effect of drowsiness. Overall, they found that
Tizanidine appeared to have fewer side effects than other antispasticity medications and was effective in treating
spasticity as a result of brain injury.
Who May Be Affected By These Findings: Persons with brain injury and upper and lower limb spasticity, their
families and caregivers, healthcare providers, and researchers
Caveats: There was a 41% incidence for the side effect of drowsiness. More research is needed to determine
whether long-term administration would result in a reduction of side effects or beneficial effects. The side effects were
related to the dosage of the medication and were quickly reversed with a reduction in the dosage amount. The use of
Tizanidine in the first few weeks after acquired brain injury has not been established. Some reports indicate that use
of this medication type early after acquired brain injury may actually impair recovery.
Bottom Line: In this study, tizanidine appeared to be effective in decreasing spasticity associated with traumatic
brain injury and stroke. More research is needed to determine dosage to minimize side effects and long-term risks,
long-term benefits, and appropriate accompanying therapeutic interventions.
Find This Study:
Meythaler, J. M.; Guin-Renfroe, S.; Johnson, A.; & Brunner, R. M. (2001). Prospective Assessment of Tizanidine for
Spasticity due to acquired brain injury. Archives of Physical Medicine Rehabilitation, (82), 1155-1162.
Injected Botulinum Toxin A Medication Appears to Reduce Severe Abnormal
Excessive Muscle Tone
The Question: Does injected botulinum toxin A medication (BTXA) reduce severe abnormal excessive muscle tone
(“spasticity”) caused by injury to the brain?
Past Studies describe the successful use of botulinum toxin A (BTXA) for persons with spasticity. “Spasticity” is a
term used to describe a condition that causes muscles to be stiff and resist stretch. As a result of injury to the brain,
spastic muscles are unable to “relax” or “stretch out.” Because of this, persons with spasticity may not be able to
straighten out or bend their arm or leg joints, even if they have the strength to do the task. For instance, the muscles
necessary to straighten the arm may actually be working, but if the muscles that bend the arm are spastic, they can
be so powerful that individuals cannot overcome the force generated by the spastic muscles and are unable to
straighten their arms. When spasticity limits a person’s body movements, it can decrease functional abilities and also
can lead to medical problems such as pain, sleep disturbances, and skin conditions. Spasticity can be treated for
some people. Many spasticity medications have been tested over the years.
Some anti-spasticity medications can be delivered by injection into specific muscles. When injected into the muscle’s
nerves, the medication causes a disconnection between nerves and the muscles. This results in weakening of the
spastic muscle. Once the spasticity has been relieved, the limb has potential for free movement. Injected medications
typically act at the sight of injection, therefore minimizing medication side effects throughout the body. There are
several anti-spasticity medications that can be injected, but few studies have included persons with traumatic brain
injury.
This Study examined the use of Botulinum Toxin A (BTXA), an injectible medication, as a treatment for persons with
spasticity as a result of traumatic brain injury. Participants included 21 adults with traumatic brain injury and severe
spasticity involving the wrist and finger muscles. The participants in this study demonstrated unsatisfactory responses
to other spasticity treatments.
The participants were treated with BTXA and studied for a year. Selected finger, wrist, and elbow muscles were
injected with BTXA. After injection, participants received therapies, splinting, and casting as necessary. If oral
antispasticity medications were administered, dosage was not changed before or after BTXA injection.
In this study, BTXA used with clinical therapy appeared to be highly effective at reducing spasticity in the wrists,
fingers, and elbows of persons with traumatic brain injury. Increased doses of BTXA appeared to increase the length
and intensity of response. The treatment effect lasted for up to 5 months, and averaged approximately 12 weeks for
most participants. The treatments were well tolerated by the participants.
Who May Be Affected By These Findings: Persons with traumatic brain injuries and spasticity, family and
caregivers, health care professionals, researchers
Caveats: Assumptions about BTXA use on other muscle groups should not be made by the results of this study. This
study may have limitations.
Bottom Line: In this study, Botulinum Toxin A used with clinical therapy appeared to be highly effective at
decreasing spasticity in the wrists, fingers, and elbows of persons with traumatic brain injury. Increased doses
appeared to increase the length and intensity of response. Future research will determine dosage amounts, risk
factors, long-term effectiveness, and the usefulness to other muscle groups.
Find This Study:
Yablon, S. A.; Agana, B. T.; Ivanhoe, C. B.; Boake, C. (1996). Botulinum toxin in severe upper extremity spasticity
among patients with traumatic brain injury: An open-ended trial. Neurology (47), 934-944