Interventions+for+the+Treatment+of+Spasticity+in+Children+with+Cerebral+Palsy

The purpose of this wiki is to show three different treatments for the management of spasticity in Cerebral Palsy and how they compare to one another to allow for the progression of physical therapy goals. The three treatments reviewed are: Botulinum toxin, selective dorsal rhizotomy, and oral and intrathecal Baclofen.
 * // What is the best intervention for spasticity management in children with cerebral palsy? //**

__ Cerebral Palsy __ “The term CP refers to a heterogeneous group of disorders of the development of movement and posture that are permanent and attributable to nonprogressive disturbances that occurred in the developing fetal or infant brain. The primary disorder in the brain is associated with abnormal muscle tone, most often hypertonia, accompanied by loss of selective motor control, muscle weakness and impaired balance. The motor disorders contribute to secondary musculoskeletal problems including muscle contractures, bony deformities, and joint instability.” [|Cerebralpalsy.org] Cerebral Palsy Prognosis wiki

__ Spasticity __ “ Spasticity refers to a constellation of clinical findings involving increased tone, hyperactive reflexes, weakness, and poor coordination.” This results from impaired signals from the brain to the muscles and because of this, the stretch reflex is not inhibited enough. Therefore, you see the presentation of increased muscle tone with movement. Over time the muscles will become stiff due to being resisted and unmoved which also contributes to tone and ultimately contractures. [|Phisiopedia: Spasticty] Once contractures set in it is very hard for patients to maintain function. They have problems doing anything without assistive devices or without assistance from others. media type="custom" key="25487820" Because of these impairments, it is important that we first remove the contractures and manage the spasticity and then do physical therapy. By doing this, we can have the most optimal outcome for our patients. media type="custom" key="25487842" __** Botulinum Toxin **__ Botulinum toxin is a poisonous neurotoxin that is produced by the bacterium Clostridium botulinum. C. botulinum produces eight exotoxins; the most commonly used serotype used for medical purposes is botulinum toxin- A. The weakness induced by botulinum toxin is commonly used to manage medical conditions such as headaches, hyperhidrosis, strabismus, cosmological correction of lines, and spastic movement disorders.

Botulinum toxin affects each of the above fore mentioned disorders differently at a cellular level. Specifically for the symptoms of spasticity the toxin must be inserted intramuscularly at the motor end plate. There, the serotypes inhibit the release of acetylcholine from presynaptic motor neurons, and inhibiting gamma neurons in muscle spindles. [4]

Botulinum toxin is often referred to by a common brand name, BOTOX®. Botulinum toxin is injected into specific muscles, the larger the mass the higher the dose required and more injection sites. After injection the toxin becomes effective after 24-72 hours, peak effect occurs at 10days, and the effects last 8-12 weeks. [4]

Rest is advised after a series of injections to avoid the dislodging of toxins due to increased circulation. Some adverse effects are erythema and edema at injection site, nausea, headache, and flu like symptoms. The most severe adverse effect would be unwanted weakness in nearby muscles. [4] Some contraindications of botulinum toxin injections are any preexisting motor neuron disease, history of a reaction to the toxin, pregnancy and lactating females, infection, and neuropathies.



__ Benefits of using botulinum toxin for spasticity management in children with cerebral palsy __ Botulinum toxin relieves spasticity symptoms by disrupting a hyperactive spinal reflex arch at the neuromuscular junction. The toxin binds to the acetylcholine receptor and blocks the release of acetylcholine into the neuromuscular junction, causing muscle paralysis. This is a reversible chemodenervation of muscle. Botulinum toxin is an effective treatment for decreasing muscle tone and hyper-reflexivity.

Botulinum toxin is a good treatment option for children with cerebral palsy and hypertonicity because of the ability to be selective in choosing the areas where spasticity is reduced. The localized injections allow for more precise motor control and ability to balance muscle strength.

Common lower extremity sites for injection are gastrocnemius, soleus, posterior tibialis, adductors, rectus femoris, hamstrings, gracilis, and psoas. Optimal injection area for gastrocnemius, soles, posterior tibialis, rectus femoris Gastrocnemius muscle belly after cholinesterase staining. Dots represent motor end plates, according to Christensen. __ Evidence for the use of botulinum toxin __ Botulinum toxin injection into the gastrocnemius in children with CP is effective in reducing energy expenditure and improving walking. The reduction in tone from the effects of the toxin allows for an increase in ankle dorsiflexion and plantarflexion and allows for a more normative gait pattern. It was also found that there was a marked reduction in the amount of oxygen used by the gastrocnemius after the use of botulinum toxin. Reducing spasticity and improving ankle range of motion during stance all results in improved function.

The combined use of botulinum toxin and strength training is effective in reducing spasticity, improving strength and function, and promoting hypertrophy. The muscles that were injected with the toxin should be targeted for strength training Hypertrophy is difficult to obtain in patients with cerebral palsy. The opportunity to preform strengthening activities is a positive quality of using botulinum toxin as an intervention for spasticity and can result in muscle hypertrophy.

Desloovere et al study investigated the effects of different therapeutic programs after botulinum toxin injections. Three-dimensional gait analysis was preformed before and after injection. This study found that an individually defined neurodevelopment treatment program has more pronounced short-term effects over other more conventional therapeutic treatments. Meaning that an individuals strength deficits and functional impairments are isolated and a therapeutic program is defined specifically for them This type of neurodevelopment treatment program was found to be the most effective after treatment with botulinum toxin.

Willis et al performed a retrospective analysis “to address uncertainties in the literature regarding higher doses BTX-A in children…” This study suggested that doses of 15-25 units/kg of botulinum toxin-A can be administered to children with cerebral palsy and hypertonic lower extremities without any increased risk compared to lower doses A significant change in range of motion for the hamstrings (9.6°), adductors (7.4°), gastrocnemius (0.8°), and soleus (1.2°) after the use of high dose botulinum toxin. The range response was significant for the improvements in all muscle groups. A high dose (15-20 doses) was found to have significant indications but the exact dose necessary for a significant change in range of motion was not clear. [8]

Botox injections have a higher efficacy in children with CP who have a higher level of function, higher cognitive function, and lower level of spasticity. ,,  Gait improvements occur with a focal injection in patients who have occasional flat foot contact and fair to good motor control. [9]

 Botox injections used in patients classified as having limited ability to assist in standing, stepping, and transfers or who are completely dependent for transportation and cannot sit against gravity have been found to improve pain management, various motor functions, standing, walking, transfers, ambulation, ease of hygiene, decrease spasticity, and increase ROM. However, further study of Botox use in non-ambulant children is needed. [11]

 A systematic review of RCTs showed that Botox when combined with physical therapy using a multilevel injection had significant effects in functional outcomes at 6, 12, and 24 weeks after injection. When Botox was injected into the gastrocnemius or soleus and combined with casting, there was no significant functional outcome . 

 In regards to upper extremity motion and functionality, two systematic reviews of the effects of Botox injections when combined with cccupational therapy provide evidence that treatment is enhanced when compared to individual use of Botox injection, placebo injection, cccupational therapy, or no treatment. Spasticity, function, and psychosocial integration can improve when Botox and cccupational therapy are combined with surgical and conservative treatment. ,

 The benefits include reduced caregiver burden, spasticity, and increase in ROM. Active or passive manipulation of muscle following injection increased the efficacy and reduced the travel of Botox to distant muscles. A higher dose of Botox had improved long term outcomes but did not last longer than 3-6 months. <span style="font-family: Arial,Helvetica,sans-serif; font-size: 10px; vertical-align: super;">[14]

__ Discussion __ <span style="font-family: Arial,Helvetica,sans-serif;"> Literature shows that muscle hypertrophy, muscle lengthening, and an increase in range of motion can occur as a result of subsequent reduction in spasticity. During the time of imposed muscle weakness, individualized strengthening programs are most effective for short-term goals, energy expenditure is reduced, and increased range of motion can improve walking. This intervention can improve range of motion, lengthen muscle, reduce contracture, allow for strengthening and hypertrophy. It is still unknown how much long term functional improvements can be obtained from the temporary effects of botulinum toxin. Injection of botulinum toxin into select muscle groups is a safe and effective treatment for spasticity in children with cerebral palsy.

__** Selective Dorsal Rhizotomy **__ <span style="font-family: Arial,Helvetica,sans-serif;"> Selective dorsal rhizotomy is a procedure in neurosurgery usually done at the lumbar level in order to reduce spasticity. It is a procedure that is typically performed in patients with spastic cerebral palsy. During a selective dorsal rhizotomy, the posterior (sensory) lumbosacral rootlets are partially cut. Only part of the lumbosacral rootlets are cut in order to reduce adverse effects on the sensory and sphincter functions. The strands that are cut are differentiated from the strands that are left uncut by electrophysiological stimulation. By cutting the posterior lumbosacral rootlets, the excitatory input to the spinal cord from the legs is reduced. [16] Afferent input from the monosynaptic stretch reflex is also decreased. By leaving the rest of the fibers uncut, sensory function is upheld. [17]

<span style="font-family: Arial,Helvetica,sans-serif;"> Selective dorsal rhizotomy is an irreversible procedure. It is possible that a selective dorsal rhizotomy could have a negative impact on motor functioning. Because of this, it is important that candidates for selective dorsal rhizotomy are chosen using strict selection criteria. Selecting patients for a selective dorsal rhizotomy is a complicated and time consuming process, but necessary in order to avoid negative outcomes. Selection depends on different issues related to the ICF model, but at this time there is no agreement on what the exact selection criteria for a selective dorsal rhizotomy should be. [17]

Dorsal root before and after selective dorsal rhizotomy __ Benefits of using selective dorsal rhizotomy for spasticity management in children with cerebral palsy __ <span style="font-family: Arial,Helvetica,sans-serif;"> Selective dorsal rhizotomy has been well established as a good treatment option for patients with spastic cerebral palsy. Selective dorsal rhizotomy consistently reduces or even eliminates spasticity. By reducing spasticity, selective dorsal rhizotomy can improve gross motor function in patients with spastic cerebral palsy. It has been found that selective dorsal rhizotomy positively impacts the ICF ‘body structure and function domain. [17] Selective dorsal rhizotomy combined with intensive physical therapy is more beneficial in reducing spasticity than physical therapy interventions alone.<span style="font-family: Arial,Helvetica,sans-serif; font-size: 70%; vertical-align: super;">[19] <span style="font-family: Arial,Helvetica,sans-serif;"> The benefits of a selective dorsal rhizotomy last for at least two years after the surgery.

media type="custom" key="25530596" __ Evidence for the use of selective dorsal rhizotomy __ <span style="font-family: Arial,Helvetica,sans-serif;"> <span style="font-family: Arial,Helvetica,sans-serif;"> Dudley et al found that spasticity is eliminated after selective dorsal rhizotomy. The results of this study suggest that if Gross Motor Function Classification System groups I (see chart below), II, and III undergo selective dorsal rhizotomy at the age of five, then their functional ambulation will improve and the effects will persist throughout adolescence. In the study, 92.3% of patients either improved or maintained their GMFCS classification after selective dorsal rhizotomy. Not only was it found that selective dorsal rhizotomy improves spasticity in the lower extremity, it was also found that following selective dorsal rhizotomy self-care activities also had significant gains. This translates into patients being able to better complete their ADLs and gain independence. Overall, the study found that if selective dorsal rhizotomy is completed at a young age, the patient can be protected from losing function during adolescence and the patient can maintain function into adulthood. <span style="font-family: Arial,Helvetica,sans-serif; font-size: 70%; vertical-align: super;">[20]

<span style="font-family: Arial,Helvetica,sans-serif;"> The systematic review done by Grunt et al concluded that selective dorsal rhizotomy not only reduces spasticity, but also improves passive range of motion, gait, and leads to short term improvement of gross motor function. The studies included in the review both showed that selective dorsal rhizotomy improves short term ICF ‘body structure and functions’ and ‘activity’ domains. One of the studies included showed an improvement in fine motor skills five years post selective dorsal rhizotomy. An improvement in self-care activities was also reported five years post selective dorsal rhizotomy. [16]

<span style="font-family: Arial,Helvetica,sans-serif;"> <span style="font-family: Arial,Helvetica,sans-serif;"> The meta-analysis done by McLaughlin et al reported a clinically significant change in spasticity after selective dorsal rhizotomy. Compared with PT-only, selective dorsal rhizotomy had a statistically significant increase in function. It was found that there appears to be a connection between the amount of dorsal root tissue cut and the increase in function. The meta-analysis found a smaller amount of increase in function than other studies. The studies included had a low rate of adverse effects due to selective dorsal rhizotomy. The authors doubt the validity of the electrophysiological selection during selective dorsal rhizotomy. <span style="font-family: Arial,Helvetica,sans-serif; font-size: 70%; vertical-align: super;">[18]

<span style="font-family: Arial,Helvetica,sans-serif;"> The study done by Bolster et al found that none of the participants in GMFCS group I, II, or III receiving selective dorsal rhizotomy declined in gross motor function after five and ten years post intervention as compared to reference centiles. Some of the participants improved more than expected after five and ten years post selective dorsal rhizotomy. The children in the study still required additional treatment after selective dorsal rhizotomy, but overall the results were positive.

<span style="font-family: Arial,Helvetica,sans-serif;"> <span style="font-family: Arial,Helvetica,sans-serif;">SDR has been shown to decrease spasticity when combined with physical therapy. In a review of 334 studies, spasticity is decreased for up to 12 years following SDR and gait, stride length, and pelvic tilt all improved. Range of motion remained increased up to 5 years in one study, and impact of SDR on change in strength was inconclusive.9 Hip and knee kinematics have remained improved for up to 12 years and spasticity has remained decreased for up to 5 years in multiple studies and for up to 20 years in one study. <span style="font-family: Arial,Helvetica,sans-serif; font-size: 80%; vertical-align: super;">[16]

<span style="font-family: Arial,Helvetica,sans-serif;"> Of three trials, two trials showed that SDR combined with physical therapy demonstrated a significant improvement in function after one year compared to physical therapy alone, and one trial showed that neither SDR combined with physical therapy nor physical therapy alone demonstrated a significant increase in function and that the groups improved equally. After a meta-analysis of the trials it was determined that the use of SDR and physical therapy in children results in significant improvements in function for those between the ages of 4-8 years old after 12 months when compared to physical therapy treatment alone. Overall, the evidence regarding the long term effects of SDR is lacking.

__ Discussion __ In conclusion, the evidence for selective dorsal rhizotomy is very encouraging. Unfortunately, the amount and quality of evidence is only fair at this time and more research needs to be done before a strong conclusion about selective dorsal rhizotomy can be reached. Of the evidence for selective dorsal rhizotomy available, the majority of findings are quite positive. Selective dorsal rhizotomy has been found to decrease spasticity for a longer period of time, although the average length of time is not yet fully known. Selective dorsal rhizotomy yields the best results when used with higher functioning children on the GMFCS scale. When SDR is combined with physical therapy, the outcomes are greater than when physical therapy alone is used. This is important to note in practice. Although SDR is an invasive procedure involving the rootlets of the spinal cord, few adverse effects have been noted. Selective dorsal rhizotomy has been found to often occur at the same time as back pain, but a possible correlation has not yet been traced. Overall, the evidence for the use of selective dorsal rhizotomy in patients with spastic cerebral palsy is promising and future research aimed at the long-term effects of SDR will help further guide clinical practice.

Baclofen is a muscle relaxant and antispasticity drug that is structurally similar to the neurotransmitter gamma- aminobutyric acid (GABA). It can be administered either orally or intrathecaly by infusion directly to the CNS. The “goals of treatment are to decrease spasticity in order to improve range of motion, facilitate movement, reduce energy expenditure and reduce risk of contractures” (Intrathecal Baclofen Pump for Spasticity). The adverse side effects are sedation, excessive weakness, dizziness, mental confusion, and somnolence. For oral baclofen the incidence of side effects ranges from 10-75% and is usually increased with an increase in dosage. Intrathecal baclofen is administered to patients with spasticity unchanged by drug therapy or who experience intolerable side effects from oral baclofen (Intrathecal Baclofen Pump for Spasticity).
 * __ Oral and Intrathecal Baclofen __**

There are several advantages for choosing intrathecal baclofen over the oral option. Intrathecal baclofen allows direct administration to the cerebral spinal fluid (CSF), which increases the drug concentration in the CSF and allows for a lesser dose than the oral option. Because of the decreased dosage, many patients experience fewer negative side effects. Also, intrathecal baclofen allows for an adaptable program dependent on the patient and their needs (Intrathecal Baclofen Pump for Spasticity). <span style="font-family: Arial,Helvetica,sans-serif;">The placement of the intrathecal baclofen pump __<span style="font-family: Arial,Helvetica,sans-serif; font-size: 130%;">Benefits of using intrathecal Baclofen for spasticity management in children with cerebral palsy __ <span style="font-family: Arial,Helvetica,sans-serif;"> Oral baclofen has been found to be ineffective in controlling spasticity when delivered systemically or has the above-mentioned side effects, making the dosage intolerable. Research is finding that intrathecal baclofen treatment is well established for spasticity relief with minimal or no central sedation.

__<span style="font-family: Arial,Helvetica,sans-serif; font-size: 130%;">Evidence for the use of intrathecal Baclofen __ <span style="font-family: Arial,Helvetica,sans-serif;"> <span style="font-family: Arial,Helvetica,sans-serif;">Murphy et al found that intrathecal baclofen (ITB) therapy is effective in the management in spastic cerebral palsy. “In this case series of 25 implanted ITB systems in 23 children with CP, significant and enduring reductions in upper- and lower-extremity average Ashworth scores were noted”. However, in this study there were frequent and potentially severe complications due to the implantation of the ITB pump. <span style="font-family: Arial,Helvetica,sans-serif; font-size: 70%; vertical-align: super;">[22]

<span style="font-family: Arial,Helvetica,sans-serif;"> The study done by Motta and Antonello looked at the adverse effects with the use of intrathecal baclofen therapy. They found that the use of ITB is effective in the management of spasticity, however the adverse effects may occur and need to be managed. Infection was found to be the most critical complication. Despite the adverse effects, the majority of patients were satisfied with their treatment.

<span style="font-family: Arial,Helvetica,sans-serif;"> The analysis done by Health Quality Ontario looks at the effectiveness of ITB. They found level 2 evidence supporting the effectiveness of ITB for the “short-term reduction of severe spasticity in patients who are unresponsive or cannot tolerate oral baclofen” (Intrathecal Baclofen Pump for Spasticity). Level 3 evidence was found for the use of ITB for the “long-term reduction of severe spasticity in patients who are unresponsive or cannot tolerate oral baclofen” (Intrathecal Baclofen Pump for Spasticity). Lastly, level 4 qualitative evidence “demonstrates functional improvement for patients who are unresponsive or cannot tolerate oral baclofen” (Intrathecal Baclofen Pump for Spasticity). Further research is needed to determine true functional use (Intrathecal Baclofen Pump for Spasticity).

<span style="font-family: Arial,Helvetica,sans-serif;"> <span style="font-family: Arial,Helvetica,sans-serif;">In a review of 15 acceptable studies, ITB improves function of patients who are already ambulatory but neither improves non-ambulatory patients to ambulatory level nor reduces level of assistance with ambulation. Gross movements were improved in non-ambulatory patients but were not measured in regards to transfers. More studies are needed before using ITB <span style="font-family: Arial,Helvetica,sans-serif; font-size: 80%;">.

__ Discussion __ <span style="font-family: Arial,Helvetica,sans-serif;"> Overall, the research concludes that the use of intathecal baclofen for the management of spasticity in children with cerebral palsy is effective. However, they also found there are many adverse and serious complications with this treatment option, namely infection. Further research is needed to determine what factors are causing the complications as well as ways to reduce them.

**__ Conclusion __** <span style="font-family: Arial,Helvetica,sans-serif;"> <span style="font-family: Arial,Helvetica,sans-serif;">The evidence supporting the use of Botox in combination with adjunct therapies of casting, orthotics, and physical therapy is limited and the long term effects of Botox injections is unknown due to low level of evidence and lack of strict parameters of each treatment. <span style="font-family: Arial,Helvetica,sans-serif; font-size: 80%; vertical-align: super;">[10],[21], Botox should be used for non-ambulatory patients with spasticity because of its effects on pain management, reducing caregiver burden, improving the ease of transfers, reducing spasticity and improving various motor functions. Botox should also be used in patients who have lower levels of spasticity and higher cognitive function to improve gait patterns and function. Selective dorsal rhizotomy (SDR) may be a more appropriate intervention for patients with high spasticity due to the significant decrease in spasticity that lasts for 12 years or longer. The use of Baclofen is recommended only in patients who are ambulatory to improve current function. Evidence supports the incorporation of occupational or physical therapy with Botox and SDR treatments to improve function in individuals.

Non-Ambulatory: Improved pain management, various motor functions, ADL's, decreased spasticity, increased ROM. || Ambulatory with high spasticity: No improvement in gait Non-Ambulatory: No improvement in prognosis for ambulation || 3-6 months || Good || Non-Ambulatory: decreased spasticity || Non-Ambulatory: No improvement in prognosis for ambulation Strength outcomes are variable Possible correlation with back pain || 5-12 years || Fair || Non-Ambulatory: Increase gross motor movements, decreased spasticity || Adverse reaction to oral medication Not effective when delivered systematically Complications with pump implantation || Short Term || Fair || <span style="font-family: Arial,Helvetica,sans-serif; line-height: 1.5;"> With the reduction in spasticity after the use of Botox, SDR, Balcofen it is imperative to work towards physical therapy goals. All three of these interventions must be used in conjunction with physical therapy to improve strength and function with in the newly gained range of motion. There is limited information regarding these three interventions within the PT Guide. For more information, special tests and modalities regarding spasticity, please see The Guide to PT Practice or Physiopedia.
 * Intervention || Positives || Negatives || Duration of Effectiveness || Evidence Level ||
 * Botox || Ambulatory: Improved gait & function, decreased spasticity
 * SDR || Ambulatory: Better for younger individuals, decreased spasticity
 * Baclofen || Ambulatory: Increased gait quality, decreased spasticity

__ Refe ____ rences __