Presentation on theme: "Systematic Review – Management of Spasticity"— Presentation transcript:
1The Management of Spasticity after SCI A Systematic Review of the literature, 2000-2010
2Systematic Review – Management of Spasticity Compiled by the Shepherd Center Study Group in Atlanta, GA. Innovative Knowledge Dissemination & Utilization Project for Disability & Professional Stakeholder Organizations/ NIDRR Grant # (H133A050006) at Boston University Center for Psychiatric Rehabilitation.
3Systematic Review – Management of Spasticity A review was conducted using a system for rating the rigor and meaning of disability research (Farkas, Rogers and Anthony, 2008).The first instrument in this system is: “Standards for Rating Program Evaluation, Policy or Survey Research, Pre-Post and Correlational Human Subjects” (Rogers, Farkas, Anthony & Kash, 2008) and “Standards for Rating the Meaning of Disability Research” (Farkas & Anthony, 2008).
5Glossary of Abbreviations GeneralSCI - Spinal cord injuryASIA – American Spinal Injury AssociationAIS – ASIA Impairment ScaleISNCSCI – International Standards for the Neurological Classification of Spinal Cord Injury Assessment (formerly ASIA exam)
6Glossary of Abbreviations Research Studies and InterventionsRCT – Randomized control trialLE – Lower extremityROM – Range of motionTENS – Transcutaneous electrical nerve stimulationrTMS - Repeated transcranial magnetic stimulationeSCS - Spinal cord electrical stimulationFES – Functional electrical stimulationWBV – Whole body vibration
7Glossary of Abbreviations Outcome Measures for Research StudiesAS – Ashworth ScaleMAS – Modified Ashworth ScaleCSS - Composite spasticity score (based on several AS scores)VAS – Visual Analog ScaleMPSFS – Modified Penn Spasm Frequency ScaleSCATS – Spinal Cord Assessment Tool for Spastic ReflexesSCI-SET – Spinal Cord Injury Spasticity Evaluation ToolHmax/Mmax – Electrophysiological ratio measure of neural excitabilityEMG - Electromyography
8Definitions of Spasticity Involuntary muscle firingVelocity-dependentIncrease resistance to stretchAbnormal processing of sensory input within networks of neurons in the spinal cord networks.There are many definitions of spasticity, but the most referenced:Lance, 1980:“Spasticity is a motor disorder characterized by a velocity- dependent increase in tonic stretch reflexes (muscle tone) with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex, as one component of the upper motor neuron syndrome.”
9Other DefinitionsDecq’s definition, 2003 : “…a symptom of the upper motor neuron syndrome characterized by an exaggeration of the stretch reflex secondary to hyperexcitability of spinal reflexes.” It separates:Intrinsic tonic spasticity: exaggeration of the tonic component of the stretch reflex (hypertonia).Intrinsic phasic spasticity: exaggeration of the phasic component of the stretch reflex (hyper-reflexia, clonus, velocity-dependent resistance).Extrinsic spasticity: exaggeration of extrinsic flexion or extension spinal reflexes (spasms, withdrawal reflex).Adams & Hicks, Spinal Cord, 2005Don’t think we need this slide for payers
10Positive Effects of Spasticity Spasticity may:Be used to help with transfers, standing, walking, and ADLs.Help prevent muscle atrophy.Muscles may appear to be healthier compared to those without spasticity.
11Negative Effects of Spasticity However, spasticity may also lead to:Decreased range of motion (ROM)Inability to position the limbs safelyLimited mobilityDifficulty performing personal hygieneDiscomfort and painandgodlaughs.blogspot.com
12Is Treatment Necessary? If mild, wait and see?Questions to ask:Does it cause pain?Interfere with sleep?Make function unsafe?Cause secondary issues of -Poor posture / asymmetric seating?Pressure sores?Make care difficult?Affect hygiene?Will treatment improve quality of life and safety?
13Treatment Goals Relieve signs & symptoms Decrease frequency and severity of spasticityImprove functionGaitPostureReach and grasp for ADLsImprove ease of care
14Patient Evaluation and Treatment Planning Evaluate Patient:Does spasticity/ overactivity interfere significantly with function?Measures must include all aspects of spasticityWill it lead to musculoskeletal deformity?Patient EvaluationandTreatment PlanningNo treatment necessaryNoYesPatient and Caregiver ObjectivesIdentify patient and caregiver goalsFunctional ObjectivesImprove gait, hygiene, ADLs, pain relief, ease of careDecrease spasm frequency & severityTechnical ObjectivesPromote tone reduction, improved range of motion, joint positionDecrease spasm frequencyDecrease hyper-reflexiaSpasticity Management ProgramMODIFIED from Spasticity Treatment Planning. WEMOVE.org, 2005.
15Spasticity is an ongoing problem, despite treatment options. Traditional and surgical treatment options are routinely used to decrease spasticity…Yet, many persons with SCI continue to have problems related to spasticity:More than half of all persons surveyed with chronic SCI report symptoms and sequelae of spasticity (Sköld, et al ; Maynard, et al. 1990).Persons with cervical and motor incomplete injuries seem to have spasticity that is more frequent and more severe.
16Conservative Treatment Options Pharmacological ManagementBaclofen – oral or pump (intrathecal)Adjunct Dantrolene, Zanax, or ValiumPhysical and Occupational TherapyRange of motion (ROM) exercises & prolonged stretchingCasting or splintingElectrical stimulation - transcutaneous nerve stimulation (TENS)AcupunctureMassage
17If other options don’t work… Surgery involves cutting pathways in the nervous system thought to be involved in spasticity.However, forms of electrical stimulation to the spinal cord (epidural spinal cord stimulation) and electromagnetic stimulation to the brain (transcutaneous magnetic stimulation - TMS) may mimic the effects of surgical interventions.
18Spasticity and its management in SCI is multi-faceted. Spasticity is no longer just an extremity’s resistance to quick movement.It includes spasms, overall hypertonia, hyper- reflexia, and clonus.The optimal treatment for each of these different aspects of spasticity is not yet clear.The literature related to spasticity has not been evaluated in terms of what is meaningful to persons with SCI.
19Purpose of ReviewTo evaluate all published research from the past 10 years related to the management of spasticity after spinal cord injury (SCI) to determine which evidence may be:Meaningful to persons with SCI who have spasticity (e.g. includes level and completeness of injury).Related to any type of spasticity a person may experience (velocity-dependent resistance, spasms, hypertonia, clonus).
20Definitions of types of spasticity used in this review Velocity-dependent resistance = phasic (quick and short lasting) spasticity of resistance felt when an extremity is moved quicklyHypertonia = tonic (longer lasting, co-contraction) spasticity of increased resistance to movement throughout rangeSpasms = phasic spasticity of body movement into a flexor or extensor patternClonus = phasic spasticity of repeated movement of a body part when positioned with the muscle stretchedHyper-reflexia = increased reflex response (e.g. the knee reflex response)
21The Review Conducted by 7 clinicians. Included all articles published between 2000 and related to the treatment of spasticity in persons with SCI.All articles rated on quality of the science & meaningfulness to persons with SCI, or their caregivers and clinicians, or payers.Any article of high quality that was meaningful was considered for this summary.
22Study Designs Accepted for Review Experimental: Employed methods including a random assignment and a control group or a reasonably constructed comparison group.Quasi-experimental: No random assignment, but either with a control group or a reasonably constructed comparison group.Descriptive: Neither a control group, nor randomization, is used. These included case studies and reports, studies employing repeated measures, and pre-post designs.
23Search Results Of 49 papers reviewed: Seven papers met criteria of quality and meaningfulness.Only 3 of the 7 papers defined spasticity, and these all differed.Each of the 7 papers used different outcome measures of spasticity.These are ongoing problems with research in this area.
24Definition of Spasticity provided Aspect of spasticity measured StudyDefinition of Spasticity providedAspect of spasticity measuredBowden & Stokic 2009Based on Lance, 1980: “…a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex with exaggerated tendon jerks, resulting from hyperexcitability of the stretch reflex, as one component of upper motor neuron syndrome”; “…include clonus, involuntary muscle contractions or spasms, and muscle co-contraction.”Passive resistance to stretchSpasm frequency & severityStretch reflex/hyper-reflexiaFlexion withdrawalKumru, et al. 2010Based on Decq, 2003: “…a symptom of upper motor neuron syndrome, characterized by an exaggeration of the stretch reflex, spasms, and resistance to passive movement across a joint, secondary to hyperexcitability of spinal reflexes.”Velocity-dependent resistance to stretchClonusHypertoniaNess & Field-Foté 2009Own definition: “…spastic hypertonia with increased reflex excitability and disordered motor output (i.e. spasticity, clonus, spastic gait patterns)…”Stretch reflex/quadriceps hyper-reflexia
25Definition of Spasticity provided Aspect of spasticity measured StudyDefinition of Spasticity providedAspect of spasticity measuredChung & Cheng 2009none providedVelocity-dependent resistance to stretchPassive resistanceClonusKakebeeke TH, et al. 2005Krause P et al. 2008Passive resistance to stretchStretch reflex/quadriceps hyper-reflexiaPinter MM, et al 2000Spasm frequency
26Experimental Study Design: Overview 2 of 7 studies used a randomized controlled trial (RCT).Both of these studies used electrical stimulation for the treatment.2 studies were longitudinal cohort designs.1 study was a case study.1 study used a pre-post design.1 study used a cross-over design.
27Experimental Study Design: RCT of TENS InterventionStudy DesignOutcome MeasuresParticipant CharacteristicsChung BPH, Cheng BKK 200960 mins active TENS or 60 mins placebo; over the common peroneal nerveRCT,n=18Composite Spasticity ScoreFull range passive ankle dorsiflexionAnkle clonus14 male; 4 female24-77 y.o.C4-T12AIS A, B, C, D4 weeks to 364 weeks (approx. 5.5 years) post-SCI
28Results: Reduction in Resistance and Clonus with TENS TENS group showed significant decrease in:Composite Spasticity Score (29.5%, p=0.017)Resistance to full passive range at ankle dorsiflexion (31%, p=0.024)Ankle clonus (29.6%, p=0.023)Notes:Anti-spasticity medications were allowed.No significant differences between groups at baseline.Chung & Cheng 2009
29Experimental Study Design: RCT of TMS InterventionStudy DesignOutcome MeasuresParticipant CharacteristicsKumru H, Murillo N, Samso JV, et al. 2010Repetitive Transcranial Magnetic Stimulation (TMS)RCT with cross- over for sham group,n=15MASVAS for painMPSFSSCATSCI-SETHmax/Mmax, Reflex (reflex responses on EMG as indicators of neural excitability)Withdrawal Reflex12 male; female15-68 y.o.C4-T12AIS C, D2-17 months post-SCI
30RCT of TMS: Sample Notes 11 of 15 using Baclofen4 of 15 on no anti-spasticity medsNot all traumatic SCIs:4 of 15 etiology = tumor4 of 15 etiology = myelitisKumru et al., 2010
31Results: Decrease in Some Spasticity, Motor Control Still Disordered Neurophysiological function did not change.TMS group, but not sham group, significantly decreased:MAS score (p<0.006)not significantly different between those with traumatic & non- traumatic SCIMPSFS (p=0.01)SCATS (p<0.04)SCI-SET (p=0.003)MAS, SCATS, & SCI-SET results maintained one week after last session (p=0.049).Kumru et al., 2010
32Results (cont.):14 of 15 reported significant improvement in pain on VAS (p<0.002).Was maintained in 13 of 15 at end of the week after TMS (p=0.004)No significant change in measures when sham only.Kumru et al., 2010
33Experimental Study Design: Summary of RCTs In persons with acute or chronic, motor complete or incomplete, paraplegia or tetraplegia, applying electrical stimulation peripherally (i.e. at the common peroneal nerve or the nerve innervating the muscle antagonistic to the spastic muscle, Chung & Cheng, 2009), or electromagnetic stimulation centrally (i.e. over the primary motor cortex, Kumru et al., 2010) for motor incomplete injuries led to a significant reduction in several different aspects of spasticity:Velocity-dependent resistance to stretchSpasmsHypertoniaHyper-reflexiaClonus
34Descriptive Study Design: Longitudinal Study, Epidural E-stim InterventionStudy DesignOutcome MeasuresParticipant CharacteristicsPinter et al. 2000Epidural spinal cord electrical stimulation (eSCS)Longitudinal,n=8EMG during passive stretch of LE & Pendulum TestAshworth ScaleClinical rating scale4 male; female18-34 y.o.C5-T6AIS A, B, C19-94 months post-SCI
35Results: Epidural Stim Reduced Some Aspects of Spasticity Significant reduction in:EMG activity in left and right legs (p=0.004, p=0.0035, respectively).Except for quadriceps when analyzed independentlyAshworth score (p=0.0117)7 of 8 participants discontinued anti-spasticity medication.Pinter et al., 2000
36Descriptive Study Design: Case Study with Baclofen InterventionStudy DesignOutcome MeasuresParticipant CharacteristicsBowden M, Stokic DS. 2009Pharma- cologic,intrathecal baclofenSingle subject case reportAshworth ScaleLower extremity strength using ISNCSCIEMGH-Reflex & H/M ratio (reflex responses on EMG as indicators of neural excitability)Plantar Withdrawal ReflexMaximal Voluntary Dorsiflexion1 male41 y.o.T11, AIS D8 years post-SCI
37Strength Decreased, BUT Spasticity Decreased More Dose-dependent decreases in:Ashworth score (p<0.01)Bilateral lower extremity strength (p<0.001)H/M ratioEMG amplitude and duration of the plantar withdrawal reflexDecrease in strength was less than decrease in spasticity.After withdrawal of medication, the rebound in spasticity was less than increase in strength.
38Descriptive Study Design: Pre-Post with Passive LE Cycling InterventionStudy DesignOutcome MeasuresParticipant CharacteristicsKakebeeke et al. 200530 mins passive lower extremity ergometryPre-Post,n=10Muscle strength testing using isokinetic dynamometry (torque) in sitting & lying; movements of leg at 10°/sec & 120°/sec; taken before, after, & 1 week post passive cycling session9 male; female23-60 y.o.C6-T12AIS A, B1-25 years post-SCI
39Results: Strength Same, BUT Reports of Reduced Spasticity No change in elicited peak torque before, immediately after, or one week after passive cycling.6 of 10 participants reported reduced spasticity immediately after cycling.Kakebeeke et al., 2005
40Descriptive Study Design: Cross-over, FES & Passive Cycling InterventionStudy DesignOutcome MeasuresParticipant CharacteristicsKrause P, et al. 2008Functional electrical stimulation cycling, Passive cyclingCross- over,n=5Modified AS of quadsPendulum Test of quads. Also during Pendulum Test:Peak Velocity (deg/s) during first swingRelaxation Index (A1/(1.6 x A0), where A1 & A0 = degrees of first swing in flexion, then extension, respectively)3 male; female37-66 y.o.T3-T7, AIS A3-9 years post-SCI
41Results: Both Active & Passive Cycling Show Some Effects Greater & significant increase in relaxation index (RI) after FES cycling (68%) than after passive cycling (12%) (p=0.01).Peak velocity (PV) significantly increased after FES cycling, unchanged after passive cycling (p=0.01).MAS decreased significantly for both FES cycling (p<0.001) and passive cycling (p<0.05).* Participants were not on anti-spasticity medications.
42Descriptive Study Design: Longitudinal, Whole Body Vibration InterventionStudy DesignOutcome MeasuresSCI Participant CharacteristicsNess LL, Field-Foté EC, 2009Whole body vibration on vibrating platformLongitudinal,n=16Pendulum test14 male; female28-65 y.o.C4-T8AIS C, D> 1 year post-SCI
43Results: Long Lasting Effects with WBV Significant reduction in quadriceps spasticity (p=0.005).Significant reduction within session (range p= to for weeks 1, 2, 4).No significant difference between those on anti- spasticity meds and those not.Effects lasted at least 6-8 weeks post-intervention.Ness LL, Field-Foté EC, 2009
44Medications Varied 7 of 16 on Baclofen 1 of 16 on Tizanidine 9 of 16 on no spasticity medicationNess LL, Field-Foté EC, 2009
45Descriptive Study Design: Summary of Studies These studies provide further support that:stimulating the nervous system (e.g. electrical stimulation), ORaltering the excitability in the nervous system (e.g. Baclofen)can lead to a reduction in spasticity in persons with complete or incomplete tetraplegia or paraplegia.
46Methodological Considerations Definitions of spasticity differ:A motor disorder characterized by a velocity-dependent increase in tonic stretch reflex, exaggerated tendon jerks; includes clonus, involuntary muscle contractions or spasms, and muscle co-contraction (Lance, 1980)Includes intrinsic tonic spasticity (i.e. the exaggeration of the tonic component of the stretch reflex, hypertonia), intrinsic phasic spasticity (i.e. the exaggeration of the phasic component of the stretch reflex or hyper-reflexia and clonus), and extrinsic spasticity, (i.e., the exaggeration of extrinsic flexion or extension spinal reflexes, spasms) (Adams & Hicks, 2005).
47Study LimitationsSpasticity syndrome may be worse in people with cervical and incomplete injuries than those with thoracic and complete injuries.(Kirshblum, 1999; Maynard et al, 1990; Sköld et al, 1999).Even though studies included persons with complete and incomplete paraplegia and tetraplegia, as well as acute and chronic injuries, results were averaged and reported as a whole.It remains unknown whether there is a differential response to the interventions.
48Study LimitationsStudies included persons with chronic SCI, who may have musculoskeletal consequences to chronic spasticity.Chronic spasticity has musculoskeletal effects, namely muscle shortening and contractures (Gracies et al., 1997).Musculoskeletal parameters were not assessed in any of these studies. Improvements may have been neural or musculoskeletal or both.Improving one and not the other may preclude maximal improvements.
49Study Limitations There were no functional assessments. Whether reducing spasticity is necessary and sufficient for improving motor control and function remains unclear.There were no studies addressing the cost- effectiveness of treatments for spasticity.
50RecommendationsAny stakeholder interested in the evidence related to the management of spasticity after SCI should consider:Outcome measures differed across all studies.Different aspects of spasticity may be affected by a given intervention.For instance, if spasms are the worse aspect of spasticity, rTMS, eSCS, or baclofen (all with evidence of reducing spasms in persons with SCI) may be pursued.Those with velocity-dependent resistance to stretch may choose TENS or rTMS, but rTMS may give the best results overall if there are multiple areas related to spasticity.
51Recommended Future Research Further study is warranted to determine:the differential responses to interventions in those with varying levels of injury, classifications of injury, and times since injury.the differential effects of interventions on neural and musculoskeletal tissues.the effects of interventions on function.the long-term effects of these interventions.the cost-effectiveness of the various treatments for spasticity.
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53References (cont.)Levin MF, Hui-Chan CW, Relief of hemiparetic spasticity by TENS is associated with impromvement in reflex and voluntary motor functions. Electroencephalogr Clin Neurophysiol, 85(2):Marino R, editor , Reference manual for the international standards for neurological classification of spinal cord injury. Chicago, IL: American Spinal Injury Association.Maynard FM, Karunas RS, Waring WP 3rd , Epidemiology of spasticity following traumatic spinal cord injury. Arch Phys Med Rehabil, 71(8):Ness LL, and Field-Foté EC, Effect of whole-body vibration on quadriceps spasticity in individuals with spastic hypertonia due to spinal cord injury. Restorative Neurology and Neuroscience, 27(6):O'Dwyer NJ, Ada L, Neilson PD, Spasticity and muscle contracture following stroke. Brain, 119(Pt 5):Pinter MM, Gerstenbrand F, Dimitrijevic MR, Epidural electrical stimulation of posterior structures of the human lumbosacral cord: 3. Control of spasticity. Spinal Cord, 38(9):Rogers, E., Farkas, M., Anthony, W., & Kash, M, Standards for Rating Program Evaluation, Policy, Survey, Pre-post, or Correlational Human Subjects Studies. Boston: Boston University, Center for Psychiatric Rehabilitation.Sköld C, Levi R, Seiger A, Spasticity after traumatic spinal cord injury: nature, severity, and location. Arch Phys Med Rehabil. 80(12):Sköld C, Spasticity in spinal cord injury: self- and clinically rated intrinsic fluctuations and intervention-induced changes. Arch Phys Med Rehabil, 81(2):Taricco M, Pagliacci MC, Telaro E, Adone R, Pharmacological interventions for spasticity following spinal cord injury: results of a Cochrane systematic review. Eura Medicophys. 42(1):5-15.