shock wave therapy for treatment of foot and ankle conditions€¦ · shock wave therapy for...
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Techniques ill Fool alld Ankle S"rge/y 5(1):60-65, 2006 © 2006 Lippincott WilliallIs & Wilkins; Phi/adelphia-.----------.---------------------------------------------_. __ .__.~.---~-_.-""*
Shock Wave Therapy for Treatment of Footand Ankle ConditionsAlastair Younger, MB, ChB, FRCSCBe's Foot and Ankle ProgramProvidence Health Care
Department of OrthopaedicsUniversity of British ColumbiaVancouver, BC, Canada
!i£l AJBS'JrRA CT
Shock wave therapy is a relatively new treatment of footand ankle pain. An acoustic sound wave similar to oneused for lithotripsy can cause a hyperanalgesia effect reducing pain and can cause breakdown and neovascularization of c1u'onically damaged tissue. T1u'ee commercialsources are available for musculoskeletal applications.To date, the treatment seams to be effective for soft tissuepain. Within the United States shock wave therapy hasbeen licensed for plantar fasciitis and has been usedoutside the United States for other foot and ankle
tendonopathies. The pain must be well localized to Iarea for effective treatment. This article reviews the
physics, indications, techniques, and documented outcomes to date.
Keywords: plantar fasciitis, shock wave therapy,extracorporeal, tendonitis, fasciitis
8Jl lIUSTOJl.UCAIL JP'ROSlPECrJlVE
Extracorporeal shock wave therapy (ESWT) was used
initially in th~ fragmentation of renal stones in thekidney and urinary tract for the treatment of renal colic.The first machine was produced commerciaJly byDornier in 1984.1.2 Stones in the gall bladder, pancreas,bile ducts, and salivary glands have been treated bylithotripsy using ESWT. Observation showed that while
in some cases th~ stone. did not fragment or pass, thepatient had significant symptom relief. The effect ofshock waves was used in an animal model in 1986 to
determine the effects on skin defect healing: Low doseshaving a positive effect and high doses inhibitinghealing.3 The tec1mology was applied thereafter to thetreatment of delayed bone healing and pseudoartlu'osisafter appropriate animal studies.3-5 Treatments startedin 1988, with 70 of 82 nonunions being successfullytreated.6 Other bony orthopedic applications included
Address correspondence and reprints request to: Alanstair Younger.MB. ChB. FRCSe, Suite SOD, 1144 BUlTard Street, Vancouver BeV5Z 2E8. E-mail: [email protected].
loose hip artlu'oplasties, and osteochondrosis includingOCD lesions of the knee and talus, and Kohler, Perthes,
and Osgood-Schlatter diseases.3Subsequently, the treatment was applied to tendo
nopathies including plantar fasciitis, shoulder impingement, and tennis elbow.7•8 Dahmen3 wrote the first
paper in 1992 on shock wave treatment of tendonopathies, with 30 different syndromes being included in a512 patient series.
The urological generators were not ideal for musculoskeletal treatments, hence newer generations of impulse generators were developed for treatment ofmusculoskeletal conditions (Fig. 1). Siemens producesthe Soncur (Sonorex, Vancouver, British Columbia,
and Siemens, Erlagen, Germany), Dornier the EposUltra (Dornier Medtech America Inc, Kennesaw, GA,USA, and Dornier Medtech, Wessling, Germany), andHealthtronics the OssaTron (High Medical Technologies, Lengwil, Switzerland, and Healthtronics, Austin,TX, USA). FDA approval has been granted forSonocur treatment of lateral epicondylitis. The EposUltra and OssaTron have been approved for treatment
of clu'onic plantar fasciitis with symptoms present for6 months and failure of conservative treatment.
The therapeutic ultrasound wave has a fast pressure riseand a high pressure maximum. This transfers energy tothe focused area within the patient. The shock wavegenerator must be coupled to the patient using a fluidbarrier. In urology this is achieved by immersing the'
patient in water. In the generators developed formusculoskeletal applications, the coupling has beenachieved using a water-filled diaphragm applied to theskin with acoustic gel placed on the skin surface. TIlegenerator and coupling device are all on the end'of anarticulating arm and on a mobile base, allowing "the machine to be positioned to precisely deliver the shock waveto the area of discomfort.2
60 Techl1iques ill Foot al1d All/de Surge.)'
Shock Wave Therapy for Treatment of Foot and Ankle Conditions
~ iNDICA TIONS
interface is seen in rabbits 10 and in dogs. I I Within bone,high doses can cause avascular necrosis and hematomaformation in animal studies. Only hematoma formationhas been seen in doses used in patients.
tPr
Pmax
to
compression
P
t
rarefactionFIGURE 2. The shock wave profile.
~DA appI:oval has been obtained for plantar fasciitisfor OssaTron in 2000 (high energy), Dornier Epos forplantar fasciitis in 2002, and Siemens Sonocur (lowenergy) for lateral epicondylitis in 2002. The FDAapproval includes at least 6 months of existence ofdisease and failure of conservative treatment.
Soft Tissue EffectsWithin muscle and tendons, shock wave increases TGF
p and IL-I expression in rat Achilles tendonitis model. 12
Paratendinous fluid is also seen after treatment, and anincreased diameter in the tendon. Histological changesincluded fibrinoid necrosis, fibrosis in the paratenon,ancl infiltration of inflammatory cells.13
Shock wave therapy is thought to be effective inpain relief by a counter irritation or hyperstimulationanalgesia effect. For low doses the hyperstimulationactivates nonmyelinated C fibers, causing inhibition offurther pain reception by inhibitor fibers. At moderateenergy intensity, pain may be relieved by direct andindirect mechanisms. The direct effect includes disruption of the mechanical source of pain, such as scarformation in the Achilles insertion, or calcificationwithin a tendon or fascia. Neovascularization removes
the breakdown products of the scar or calcification. Indirectly, including the hyperstimulation analgesia, vascularization and macrophage immigration inducescellular repair of the degenerate tissue.2
Bone Effects
Within bone this cellular damage results in microfractures and osteoblast stimulation. Hematomas can becreated. Increased neovascularization at a bone tendon
The actual shock wave is generated within themachine by either an electromagnetic, electrohydraulic,or piezoelectric system. The electrohydraulic wave isgenerated similar to an automobile spark plug; thepiezoelectric system uses oscillation of quartz crystals,and the electromagnetic generator uses deflection of ametal membrane similar to a speaker for a soundsystem? The source causes a membrane to be rapidlyrepelled, the shock wave traveling through water to anacoustic focusing lens. The shock wave has a suddenpressure increase causing the local tissue effect (Fig. 2).The lens focuses the shock wave to a focal point at aknown distance from the lens. All devices have water
filled coupling bellow that can vary the distance betweenthe lens and the skin surface. This allows the operatorto vary the depth of the focal point within the patient.Shocks can be varied in intensity and frequency.9
Subsequent developments have focused on methodsof application and determining the conect dose size andfrequency to achieve a maximal clinical effect.
Cellular EffectsThe effect at the cellular'level is related to dose, with
high energy levels causing significant cell necrosis.Lower doses cause cellular changes. These includeenhanced membrane permeability, mitochondrial, endoplasmic reticulum, and cell nucleus changes. Theseinclude vacuolation within the cytoplasm and lesions inthe actin and vimentin filaments?
FiGlJiBE 'j. A patient undergoing low dose shock wavetherapy treatment of the heel showing the coupling head,bellows, and gel.
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Younger
Outside the United States, shock wave therapywithin foot and ankle is used to treat Achilles tendonitis,
Morton neuroma, stress fractures, peroneal, and tibialisposterior tendonitis. In general, shock wave therapy isused for treatment of enthesopathies, tendonopathies,and overuse injuries.
fii'.l CONTRAINDICATIONS
Patients on anticoagulants or with a known clottingdisorder have a relative contraindication to shock wave
therapy as bleeding may be stimulated by the treatment.Pregnancy is considered a contraindication as the effectof shock wave on pregnancy has not been evaluated.Infection in the site or an open wound over the treatmentsite excludes the patient from shock wave therapy.
Otherwise patients unable to. localize pain have arelative contraindication to treatment. These include
patients with Alzheimer disease or other brain conditions preventing pain localization, or patients withdiffuse pain, or many sites of pain making localizationof the origin impossible.
~ PRETREA TMENT PLANNING
Low energy shock wave therapy requires that the painbe well localized to 1 or 2 discrete areas. The area
should be identifiable by palpation. There should be ananatomic correlation to the pain, the area of pain shouldbe consistent, and the patient should be able tocooperate in the localization of the area of discomfort.
Patients should be imaged before treatment to ruleout any malignancy. This may include plain radiographsand MRI.
Conservative treatment should be exhausted before
treatment. For plantar fasciitis this should include antiinflammatories, physiotherapy and stretching, activitymodification, and orthotics, but not necessarily steroidinjections. 14
Contraindications to treatment include poorly localized pain, pregnancy, malignancy, age under 18, andbleeding disorders. Patients on Coumadin should suspend anticoagulation if shock wave therapy is peIformedto prevent hematoma formation.
m TECHNIQUE OF TREATMENT
Types of Musculoskeletal SourceEnergy source may be low or high energy: Low energyis applied by a technician, requires no anesthesia orimaging, and has a lower cost using 3 treatment regimes.The lower energy sources allow the technician to focusthe signal onto the area of maximum discomfort as noanesthetic is used. The Sonocur plus is a low energysource.
High energy requires a physician to operate it andanesthesia is required as it is painful. Imaging is requiredto focus the beam. For the Epos Ultra local anesthetic isinstilled in the heel before treatment. For the Epos ultrauses an electromagnetic generator. The OssaTron uses a .spark plug. All generators use water-filled diaplu'agms tocontact the skin. The OssaTron is more painful andtherefore requires a greater degree of anesthesia, increasing the cost. The water-filled diaplu'agm can be changedin depth focusing the beam within the patient.
The operator can direct the shock wave at the area ofdiscomfort and can also vary the depth of penetration ofthe wave. For the Epos Ultra, the area of tenderness isidentified using clinical exam, and an ultrasound probe isused to confirm the positioning of the center of shockwave application. For the OssaTron, the area is identifiedbefore anesthesia and the physician directs treatment tothe area. The higher dose may result in a higher fieldbeing affected, causing a greater degree of pain relief.
For the Sonocur, direct feedback is used, as no anes
thesia is required, the operator changing the depth anddirection of treatment to hit the area of maximum pain.
Gel is applied to the area to couple the diaphragm tothe· skin preventing shock wave attenuation. Thediaphragm of the device is applied to the skin and thedepth of penetration altered until the area of discomforthas been localized. This is harder to achieve for the
OssaTron. The Epos Ultra uses ultrasound to focus thebeam, whereas patient feedback is used for the Sonocur.The energy level of the shock wave is increased and2000 shocks are applied per treatment. The source isadjusted during treatment to ensure that the area ofmaximum tendemess is treated. The treatment is
repeated up to 3 times.
Complications-transientIn the FDA study, the patients reported a number ofadverse events. This included pain, nausea, and reactionat the application site, sweating, and dizziness. Somereactions were the same in the control group. Otherreported complications include petechiae, skin discoloration, dull pain, and paraesthesia.
Posttreatment ManagementPatients activity can be as tolerated after treatment. Oneof the major benefits of shock wave therapy is thatpatients can continue activities immediately after treatment and minimal time off work is required corrlpareclwith a surgical release. Adjuvant treatments aTe continued during and after treatment" including ice andphysiotherapy. There is no literature to date documenting any particular risk of rupture after shock wavetherapy so physiotherapy and activities are encouragedto be continued as normal.
Techniques i'l Foot alld A1zkle.SlIIge.y
Shock Wave Therapy for Treatment of Foot and Ankle Conditions
./
Delayed ImagingMRI before and immediately after treatment shows
increase in soft tissue oedema but not bone oedema:
high energy. 15
Ultrasound at 6 months shows significant attenua
tion of signal after shock wave therapy compared withbefore-treatment approaches same as opposite side.
Thickness of plantar fascia correlated with the degree
of pain.16
IiiIJ S10MlVlARY OF OUTCOME DATATO DATE
Two papers have shown no difference between treat~
ment groups: one published in the lournal of theAmerican Medical Association,17 the second in the
British Medical Journal. IS Both used the Dornier Epos
Ultra with local anesthetic block. The lAMA paper used
a low dose versus regular dose treatment, and the BM]
article used a polyethylene foil in the control group.
Both papers studied patients early in the treatment orwith minimal symptoms, potentially confounding theresults. The lAMA article used 6 weeks instead of
6 months as an inclusion criterion. The BMJ article had
only 1 patient in each group going on to surgery and did
not outline the duration of prior treatment. Ultrasound
and MRI abnonnalities may not be the main area of pain
and as a result may have missed the source of pain.
Most papers apart from these 2 have shown successful outcome of treatment. The studies have been of
higher quality in general, being prospective and random
ized controlled studies for the most part. The Cochranedatabase felt there was little evidence for its use but set a
very high standard for inclusion criteria for the papers. 19
Otherwise, weaker literature evidence presently exists
for the surgical treatment of planar fasciitis so that the
'fAnLE)' SIIIIIII/l1n' o(lJlDs/'eclil't' /,oper.\'f{,r I'/ulliorfilsciilis
44 nil
45 random
86 random
30 Random
Result---+ve
+veDecreasedfasciathickness-ve
+ve
+ve+ve+ve+ve+ve+ve?+ve+ve?+ve
+ve'
-ve-ve
crossRandom
blindedRandom
Random
Randomblinded
Randomblinded
2085
88
35
435
293
150
47256
322 random
165 Random
No. patients Design
115 Random
Dilte JonmalAuthorenergyStndy
2002
Journal of Bone and JointRompe21HighLow vs
Surgery
high dose1995
Archives of Orthopedic andRompe22HighLow vs no
Trauma Surgery
treatment
2003Archives of Orthopedic andHammerl6Shock wavePlantar fascia
Trauma Surgerytherapythickness
2002
JAMA Buckbinder17DornierLow vs highEpos Ultra2002
Foot & Ankle InternationalAlvarez23HighCase seJies2002
Journal of Foot and AnkleWangllHighCase series
Surgery 2002
Foot & Ankle InternationalOgdenl4allMeta-analysis2001
Clinical Orthopaedics andOgden24HighLow vs highRelated Research 2005
Journal of Orthopaedic Rompe25lowLocal anestheticResearch
vs no local
2003American Journal of SportsRompe26LowLow vs placebo
Medicine
runners2005
Journal of Foot and AnkleHyer27DornierCase series
Surgery Theodore28
Epos
2004
Foot and Ankle DomierTreatmentInternational
Eposvs sham
2004
Journal of Bone and JointOgden29HighTreatment
Surgery
energyvs sham
2003
Journal of Orthopaedic Speed30TreatmentResearch
vs sham
2003
Foot and Ankle InternationalLee3lLowTreatment
energy
vs sham
2003
Foot and Ankle InternationalHammer32Crossover2003
EMJ Haakel8Dornier
Crawfordl9
Epos
2003
Cochrane Database of Meta-analysisSystematic Reviews
DeJ'ice
Volume 5, Issue 1 63
Younger
conclusion of the Cochrane review needs to be taken incontext.
In the treatment of failed plantar fasciitis, thecomparative treatment, open surgery, has not had nearlythe same rigorous outcome analysis. The only comparative series on shock wave therapy against surgeryperformed was a study on lateral epicondylitis inworker's compensation patients. This study supportedthe use of ESWT over surgery but has not as yet beenpublished.2o Seventy-six percent of the ESWT groupreturned to work by 6 months compared with 30% in thesurgery group. Low dose source without anesthesia iseffective, and high dose with anesthesia is effective.Low dose with anesthesia is not effective, as shown in a
prospective randomized trial by Rompe?5 Summaries ofoutcomes to date are in Table 1.
!;B CONCLUSION
Shock wave therapy seems to be a viable treatmentalternative for plantar fasciitis. Outcome studies ingeneral have supported a positive outcome. Shock wavetherapy has been used for treatment of well-localizedtenonopathies and soft tissue pain outside the UnitedStates. For example, insertional Achilles tendonitis canbe treated with shock wave therapy as an alternative tosurgery. FDA approval for foot and ankle presently onlycovers plantar fasciitis. Shock wave therapy should beoffered as a second line of treatment to patients withplantar fasciitis, possibly before steroid injection, as thecomplication rates may be lower and the therapeuticeffect higher. Shock wave therapy may have betteroutcomes than surgery for plantar fasciitis. Comparativestudies are needed (surgery vs shock wave therapy)before absolute conclusions can be reached. However,few patients would agree to have the invasive treatmentof surgery if shock wave therapy is also available.
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20. Regan W. Randomized prospective s·tudy of surgeryversus extra corporeal shock wave therapy for chroniclateral epicondylitis in worker's compensation boardpatients. Vancouver, 2004.
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.~ . S_1_1o.ckWave Therapy for Treatment of Foot and Ankle Conditions
21. Rompe lD, Schoellner C, Nafe B. Evaluation of lowenergy extracorporeal shock-wave application for treatment of chronic plantar fasciitis. J Bone Joint Surg Am.2002;84-A:335-341.
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26. Rompe lD, Decking J, Schoellner C, et al. Shock waveapplication for chronic plantar fasciitis in running athletes.A prospective, randomized, placebo-controlled trial. Am JSports Med. 2003;31:268-275.
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shock wave therapy (ESWT) in patients with chronicproximal plantar fasciitis: a 2-year follow-up. Foot AnkleInt. 2003;24:823-828.
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