1. Aetna considers neurosurgical procedures medically necessary for the management of members with refractory spasticity when all of the following selection criteria are met:

   1. The member has good intrinsic lower extremity motor power, but is limited in ambulation by spasticity; and
   2. The member has the functional capacity and motivation to participate in post-operative rehabilitation; and

   3. The member has tried and failed non-surgical, medical management for spasticity including baclofen or other muscle relaxants.

   Aetna considers the following procedures medically necessary for the management of members with spasticity:

   1. Longitudinal myelotomy
   2. Microsurgical dorsal root entry zone lesion (DREZotomy)
   3. Percutaneous radiofrequency (or thermal) rhizotomy
   4. Peripheral neurotomy

   5. Selective posterior (dorsal) rhizotomy*

   Members 2 to 6 years of age are optimal candidates for selective posterior rhizotomy.

   * Based on a review of the medical literature, Aetna considers selective posterior rhizotomy experimental and investigational when the member has any of the following contraindications:

   1. Concomitant dystonia or rigidity; or
   2. Profound weakness in lower extremity muscles such that the spasticity actually serves to assist in standing; or
   3. Progressive neurological disorders, choreoathetosis, or cerebellar ataxia; or
   4. Severe damage to basal ganglia; or

   5. Severe fixed joint deformities or scoliosis.

2. Aetna considers selective posterior rhizotomy experimental and investigational for the treatment of spasticity in children with hemiplegic cerebral palsy because these children are unlikely to benefit from this procedure.

3. Aetna considers spinal cord stimulation (dorsal column stimulator) or neurectomy experimental and investigational for the treatment of spasticity because the effectiveness of these approaches has not been established.

4. Aetna considers magnetic stimulation (transcranial or peripheral) experimental and investigational for the treatment of spasticity due to multiple sclerosis and other causes because the effectiveness of these approaches has not been established.

5. Aetna considers the use of whole-body vibration experimental and investigational for individuals with spasticity associated with multiple sclerosis or spinal cord injury and other indications because its effectiveness has not been established.

6. Aetna considers kinesiotaping for lower extremity spasticity experimental and investigational because its effectiveness has not been established.

7. Aetna considers tibial nerve neurotomy experimental and investigational as treatment for spastic equinovarus foot because its effectiveness has not been established.

See also CPB 0113 - Botulinum Toxin, CPB 0161 - Infusion Pumps, and CPB 0677 - Functional Electrical Stimulation and Neuromuscular Electrical Stimulation.

Cerebral palsy (CP) refers to a wide variety of non-progressive brain disorders resulting from insults to the central nervous system during the perinatal period.  Traditionally, the adverse effects of spasticity such as contractures and bony deformities in patients with CP are managed by means of drug therapy, phenol injections, spinal blocks, physical therapy, bracing, and orthopedic surgeries.  In the last 3 decades, selective posterior rhizotomy (SPR) has been used in the management of these patients for reduction of spasticity which may result in an improvement of their active functional mobility.  The use of total posterior rhizotomies of lumbar and sacral nerve roots in reducing lower limb spasticity commenced approximately 80 years ago.  However, the lack of functional improvement despite a reduction in spasticity as well as the adverse side effects such as stasis ulceration, sensory ataxia, and hypesthesia (sensory loss) stimulated the development of partial rhizotomy and SPR is the most sophisticated version of the partial rhizotomy.  Currently, SPR is increasing being used for the treatment of lower extremity spasticity in patients with CP.

The rationale for SPR is that intra-operative electro-stimulation of spinal nerve rootlets in conjunction with electromyographic (EMG) monitoring and direct observation of muscle activity in the lower extremity allow for the identification of afferent posterior rootlets that terminate on relatively uninhibited alpha motoneurones.  Direct observation allows for identification of the diffusion of contraction to other muscle groups.  If these uninhibited rootlets are severed, spasticity can be reduced without the unacceptable side effects.  This technique employs microsurgical dissection of nerve rootlets from the level of L2 to S1 or S2 (if there is a spastic toe flexion).  Individual sensory rootlets (usually 3 to 8 comprising the posterior roots from L2 to S1) are isolated and electrically stimulated.  Those rootlets which produce an abnormal response are cut, while those generating a normal response are preserved.  Responses which are considered to be abnormal include (i) clonus, (ii) contraction of ipsilateral muscles not normally innervated by that nerve, (iii) contralateral muscle contraction, (iv) clinical or EMG contraction that continues after the cessation of stimulation, and (v) an EMG crescendo pattern during the stimulus.  If no abnormal responses are observed, the 30 to 60 % of the rootlets giving the strongest tetanic contraction are severed.  In general, no more than 75 % of the sensory rootlets are sectioned.

There is sufficient evidence that selective posterior rhizotomy is safe and effective for the management of children with CP.  Studies have consistently shown that selective posterior rhizotomy can reduce spasticity and improve motor function.  Additionally, if performed during early childhood, it may prevent the development of muscle contractures and orthopedic deformities.  On the other hand, due to the minimal degree of their impairment, children with hemiplegic CP are unlikely to benefit from this procedure.

In a review published in the New England Journal of Medicine, Park and Owen (2002) concluded that SPR can reduce spasticity and improve motor function, and if the operation is performed during early childhood, it may prevent the development of muscle contractures and orthopedic deformities.  Additionally, a Diagnostic and Therapeutic Technology Assessment of SPR published by the American Medical Association stated that in selected patients who have ambulatory potential, this procedure can reduce spasticity and facilitate walking and other movement (Brown, 1990).

An assessment of SPR by the National Institute for Health and Clinical Excellence (2006) concluded that current evidence on the safety of SPR for spasticity in cerebral palsy "appears adequate; however, there is evidence of only limited efficacy."  The assessment cites the results of a meta-analysis of 3 randomized controlled trials (McLaughlin et al, 2002) comparing physiotherapy and SPR with physiotherapy alone, which found that, compared with physiotherapy alone, gross motor function improved by an additional 4 % with physiotherapy and SPR (8 % and 4 % improvements, respectively; p = 0.008).  The follow-up period in the primary studies was 9 to 12 months.  Specialist advisors to NICE commented that there is some controversy about the role of SPR in relation to other management options for spasticity in CP.  They also commented that a reduction in spasticity does not always improve motor function.  The NICE assessment noted that adverse events seen clinical studies of SPR included bladder and bowel disturbances, severe postoperative pain, and dysthesia.  The specialisty advisors to NICE also noted among adverse events limb weakness, joint subluxation, progressive scoliosis or kyphosis, and sensory disturbance.  Theoretical adverse events included paralysis, dividing the wrong nerve rootlets, hypotonicity, weight gain and death.

Appropriate candidates for SPRs should have tried and failed other more conservative types of medical management for spasticity including baclofen or other muscle relaxants.  In addition, candidates should have good intrinsic lower extremity motor power, but are limited in ambulation by spasticity.  It is also important that candidates  have capacity and motivation to participate in post-operative rehabilitation.  Children 2 to 6 years of age are optimal candidates for this procedure.

Patients with one or more of the following condition(s) are generally not considered candidates for selective posterior rhizotomy: concomitant dystonia or rigidity; severe damage to basal ganglia; severe fixed joint deformities or scoliosis; progressive neurological disorders, choreo-athetosis, or cerebellar ataxia; or profound weakness in lower extremity muscles, and spasticity serves to assist in standing.

Valle et al (2007) examined the use of low- and high-frequency repetitive transcranial magnetic stimulation (TMS) for the treatment of spasticity.  A total of 17 subjects (8 males, 9 females; mean age of 9 years 1month) with CP and spastic quadriplegia were randomized to receive sham, active 1-Hz, or active 5-Hz repetitive TMS of the primary motor cortex.  Stimulation was applied for 5 consecutive days (90 % of motor threshold).  The results showed that there was a significant reduction of spasticity after 5-Hz, but not sham or 1-Hz, stimulation as indexed by the degree of passive movement; however this was not evident when using the Ashworth scale, although a trend for improvement was seen for elbow movement.  The safety evaluation showed that stimulation with either 1-Hz or 5-Hz did not result in any adverse events as compared with sham stimulation.  The authors stated that results of this trial provide initial evidence to support further trials exploring the use of cortical stimulation in the treatment of spasticity.

Ness and Field-Fote (2009) stated that individuals with spinal cord injury (SCI) often have involuntary, reflex-evoked muscle activity resulting in spasticity.  Vibration may modulate reflex activity thereby decreasing spasticity.  These researchers examined the feasibility of using whole-body vibration (WBV) to decrease quadriceps spasticity in individuals with SCI.  Participants were individuals (n = 16) with spastic quadriceps hypertonia due to chronic SCI (greater than 1 year).  Quadriceps spasticity was measured by gravity-provoked stretch (Pendulum Test) before (initial) and after (final) a 3 day/week, 12-session WBV intervention.  In addition, differences between immediate (immediate post-WBV) and delayed (delayed post-WBV) within-session effects were quantified.  Finally, these investigators assessed response differences between subjects who did and those who did not use anti-spastic agents.  There was a significant decrease in quadriceps spasticity after participation in a WBV intervention that persisted for at least 8 days.  Within a WBV session, spasticity was reduced in the delayed post-WBV test compared to the immediate post-WBV test.  The WBV intervention was associated with similar changes in quadriceps spasticity in subjects who did and those who did not use anti-spastic agents.  The authors concluded that vibration may be a useful adjunct to training in those with spasticity.  They stated that future studies should directly compare the anti-spastic effects of vibration to those of anti-spastic agents.

In a randomized cross-over pilot study, Schyns et al (2009) examined the effectiveness of WBV on tone, muscle force, sensation and functional performance in people with multiple sclerosis (MS).  A total of 16 individuals with MS were randomly allocated to one of two groups.: (i) group 1 received 4 weeks of WBV plus exercise 3 times per week, 2 weeks of no intervention and then 4 weeks of exercise alone 3 times per week, and (ii) group 2 were given the 2 treatment interventions in the reverse order to group 1.  Ten-meter walk, Timed Up and Go Test, Modified Ashworth Scale, Multiple Sclerosis Spasticity Scale (MSSS-88), lower limb muscle force, Nottingham Sensory Assessment and Multiple Sclerosis Impact Scale (MSIS-29) were used before and after intervention.  The exercise program had positive effects on muscle force and well-being, but there was insufficient evidence that the addition of WBV provided any further benefit.  The Modified Ashworth Scale was generally unaffected by either intervention, although, for each group, results from the MSSS-88 showed WBV and exercises reduced muscle spasms (p = 0.02).  Although results for the 10-meter walk and Timed Up and Go Test improved, this did not reach statistical significance (p = 0.56; p = 0.70, respectively).  For most subjects, sensation was unaffected by WBV. The authors concluded that exercise may be beneficial to those with MS, but there is limited evidence that the addition of WBV provides any additional improvements.  They stated that further larger scale studies into the effects of WBV in people with MS are essential.

In a single-center, randomized, and double-blind study, Karadag-Saygi and colleagues (2010) evaluated the effect of kinesiotaping as an adjuvant therapy to botulinum toxin A (BTX-A) injection in lower extremity spasticity.  A total of 20 hemiplegic patients with spastic equinus foot were enrolled into the study and randomized into 2 groups.  The first group (n = 10) received BTX-A injection and kinesiotaping, and the second group (n = 10) received BTX-A injection and sham-taping.  Clinical assessment was done before injection and at 2 weeks and 1, 3, and 6 months.  Outcome measures were modified Ashworth scale (MAS), passive ankle dorsiflexion, gait velocity, and step length.  Improvement was recorded in both kinesiotaping and sham groups for all outcome variables.  No significant difference was found between groups other than passive range of motion (ROM), which was found to have increased more in the kinesiotaping group at 2 weeks.  The authors concluded that there is no clear benefit in adjuvant kinesiotaping application with botulinum toxin for correction of spastic equinus in stroke.

Bollens et al (2011) noted that spastic equinovarus foot is a major cause of disability for neurorehabilitation patients, impairing their daily activities, social participation and general quality of life.  Selective tibial nerve neurotomy is a neurosurgical treatment for focal spasticity, whose acceptance as treatment for spastic equinovarus foot remains controversial.  These investigators performed a systematic review of the literature to evaluate the effectiveness of tibial nerve neurotomy as a treatment for adult patients presenting with spastic equinovarus foot.  They queried PubMed, Science Direct, Trip Database and PEDro databases with the following keywords: "equinus deformity" OR "muscle spasticity" AND "neurotomy".  They selected a total of 11 non-randomized and uncontrolled studies, suggesting that neurotomy could be an efficient treatment to reduce impairments in spastic equinovarus foot patients.  The authors noted that their conclusions were based primarily on case series studies.  The effects of tibial nerve neurotomy had not been compared with a reference treatment through a randomized controlled trial, which would be necessary to increase the level of scientific evidence.  Moreover, further studies using quantitative, validated and objective assessment tools are needed to evaluate the effectiveness of tibial nerve neurotomy accurately based on the International Classification of Functioning, Disability and Health from the World Health Organization.

Ashworth et al (2012) systematically reviewed treatments for spasticity in amyotrophic lateral sclerosis (ALS), also known as motor neuron disease.  These investigators searched the Cochrane Neuromuscular Disease Group Specialized Register (July 4, 2011), CENTRAL (2011, Issue 2), MEDLINE (January 1966 to July 2011), EMBASE (January 1980 to July 2011 ), CINAHL Plus (January 1937 to July 2011), AMED (January 1985 to July 2011) and LILACS (January 1982 to July 2011 ).  They reviewed the bibliographies of the randomized controlled trials identified, and contacted authors and experts in the field.  They included quasi-randomized or randomized controlled trials of participants with probable or definite ALS according to the El Escorial diagnostic criteria (or a revised version) or the Airlie House revision.  They included trials of physical therapy, modalities, prescription medications, non-prescription medications, chemical neurolysis, surgical interventions, and alternative therapies.  The primary outcome measure was reduction in spasticity at 3 months or greater as measured by the Ashworth (or modified Ashworth) spasticity scale.  The secondary outcome measures were: validated measures based on history, physical examination, physiological measures, measures of function, measures of quality of life, all adverse events, and measures of cost.  Two authors independently screened the abstracts of potential trials retrieved from the searches.  Two authors extracted the data.  They also contacted the author of the paper and obtained information not available in the published article.  All 3 authors assessed the methodological quality of all included trials independently.  These researchers identified only 1 randomized controlled trial that met inclusion criteria and no further trials were identified in subsequent updates.  The included study was a trial of moderate intensity, endurance type exercise versus "usual activities" in 25 patients with AML.  The risk of bias was high and no adverse events were reported.  At 3 months patients performing the 15-min twice-daily exercises had significantly less spasticity overall (mean reduction of -0.43, 95 % confidence interval (CI): -1.03 to +0.17 in the treatment group versus an increase of +0.25, 95 % CI: -0.46 to +0.96 in the control group) but the mean change between groups was not significant (-0.68, 95 % CI: -1.62 to +0.26), as measured by the Ashworth scale (possible scores 0 to 5, where higher is worse).  The authors concluded that the single trial performed was too small to determine whether individualized moderate intensity endurance type exercises for the trunk and limbs are beneficial or harmful.  No other medical, surgical or alternative treatment and therapy has been evaluated in a randomized fashion in this patient population; more research is needed.