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ENGLISH APPLICATION OF SPARK WAVE ® THERAPY FOR ORTHOPEDIC INDICATIONS USER GUIDE - ORTHOPEDICS ORTHOGOLD 100 ORTHOPEDICS

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Page 1: User GUide - OrthOpedics orthoGold 100 · User GUide - OrthOpedics orthoGold 100 orthopEdics. 2 While Mts uses reasonable efforts to include ac- ... ing skin lesions in a few selected

English

ApplicAtion of spArk WAvE® thErApy for orthopEdic indicAtions

User GUide - OrthOpedics

orthoGold100

orthopEdics

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While Mts uses reasonable efforts to include ac-curate and up-to-date information in this user gui-de, it makes no representations as to the accuracy, timeliness or completeness of that information. By using this user guide, you agree that its information and services are provided „as is, as available“ without warranty, express or implied, and that you use this guide at your own risk.

you further agree that Mts and any other parties invol-ved in creating, maintaining, and delivering this guide‘s contents have no liability for direct, indirect, incidental, punitive, or consequential damages with respect to the information, services, or content contained herein or otherwise accessed through this user guide.

Mts makes no warranty, representation or guaran-ty regarding the content, sequence, accuracy, time-liness or completeness of any of the data provided herein. the user should not rely on the data provided. Mts explicitly disclaims any representations and warranties, including, without limitation, the implied warranties of merchantability and fitness for a parti-cular purpose. Mts shall assume no liability for any errors, omissions, or inaccuracies in the information provided regardless of how caused. Mts shall as-sume no liability for any decisions made or actions taken or not taken by the user in reliance upon any information or data furnished hereunder.

© 2014, all rights reserved, Mts Medical UG

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tABlE of contEnts

1. iNtrOdUctiON .................................................................................................................................5

1.1. What are spark Waves®? ......................................................................................................................... 6

1.2. What are the effects of spark Waves®? ................................................................................................... 6

1.3. Are there any side effects of EsWt? ........................................................................................................ 7

2. GeNerAL treAtMeNt iNFOrMAtiON ..............................................................................................7

2.1. Energy and numbers of shocks Used ..................................................................................................... 8

2.2. treatment area ......................................................................................................................................... 8

2.3. Applicators ............................................................................................................................................... 9

2.4. staging of treatments. ............................................................................................................................. 9

3. pAtieNt prepArAtiON ....................................................................................................................9

3.1. regional anesthetics or sedation ............................................................................................................ 9

3.2. site preparation for orthopedic conditions. ........................................................................................... 10

3.3. post therapy recommendations. ............................................................................................................ 10

4. treAtMeNt prOtOcOLs................................................................................................................11

4.1. shoulder tendinopathies with or without calcification ......................................................................... 11

4.2. radial epicondylopathy (tennis elbow) .................................................................................................. 12

4.3. Achilles tendon ....................................................................................................................................... 13

4.4. plantar fasciitis with / without heel spur............................................................................................... 14

4.5. greater trochanteric pain syndrome ..................................................................................................... 15

4.6. patella tendon ........................................................................................................................................ 16

4.7. Myofascial syndrome (trigger) .............................................................................................................. 17

4.8. stress fractures ..................................................................................................................................... 18

4.9. delayed bone healing ............................................................................................................................ 19

4.10. Adductor syndrome ................................................................................................................................ 20

4.11. pes anserinus syndrome ....................................................................................................................... 21

4.12. peroneal tendon syndrome .................................................................................................................... 22

4.13. osgood schlatter (apophysitis) .............................................................................................................. 23

4.14. spasticity ................................................................................................................................................ 24

4.15. Early stage osteochondritis dissecans (od), post-skeletal maturity .................................................... 25

5. LiterAtUre FOr speciFic iNdicAtiONs ......................................................................................26

6. AdditiONAL LiterAtUre ..............................................................................................................28

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introdUction

this manual is designed to accompany the orthog-old100® Extracorporeal spark Wave® therapy (EsWt) device and to provide the user with practical informa-tion regarding its operation and application in medi-cal practice. EsWt is not a new modality and has been widely used in human orthopedics for the last fifteen years. there are currently more than two thousand devices being used worldwide in the field of medicine. our understanding of EsWt is constantly expanding as more experience is gained. this manual puts for-ward our best recommendations at this time for the use of EsWt. these recommendations are based on current clinical experience and will be updated from time to time as more information becomes available. this is meant as a general guide and should be used discerningly. currently a wide variety of indications is being treated with spark Waves®. they range from tendinopathies with or without calcifications to mus-cular indications to bone and joint indications. sev-eral indications have received fdA approval while some other highly specialized indications are in clin-ical trials, e.g. spasticity and osgood schlatter. the wide range of indications for spark Waves® and the investigation of working mechanisms show both the influence on biological systems on a very fundamen-tal level and the potential for spark Wave® applica-tion in various other medical fields.

since the end of 2004 EsWt has been used for treat-ing skin lesions in a few selected centers in Europe. preliminary results were presented at the 8th con-gress of the isMst (international society for Medical shockwave treatment) in vienna in 2005.

the results of a feasibility study for the use of EsWt for non-healing wounds were very promising and the authors concluded “the ability to effectively achieve wound closure and implement spark Wave® technol-ogy as either an adjunct to standard therapy or as a stand-alone treatment for complex wounds needs to be evaluated in controlled trials that are currently underway. We are cautiously optimistic that this tech-nology may advance wound care in a similar fashion as the introduction of vacuum assisted wound clo-sure did a decade ago.” [lit i]

table 1 contains a list of the orthopedic conditions currently being treated using EsWt, according to the June 2008 consensus statement of the isMst, di-gEst (german-speaking society for EsWt) and the

other national societies. these conditions will be covered in detail later in the manual.

table 1. conditions currently being treated with esWt

Approved standard indications in Orthopedics• tendinitis calcarea• radial epicondylopathy (tennis elbow)• greater trochanteric pain syndrome• patella tendon• Achilles tendon• plantar fasciitis with or without heel spur• stress fractures• delayed bone healing• Early stage of avascular bone necrosis (native

X-ray without pathology)• Early stage osteochondritis dissecans (od)

post-skeletal maturity

common empirically tested clinical uses in Orthopedics• Ulnar epicondylopathy• Adductor syndrome• pes anserinus syndrome• peroneal tendon syndrome• Myofascial syndrome (fibromyalgia excluded)

exceptional indications / expert indications• spasticity• Apophysitis (osgood schlatter)

this table is not an exhaustive list and it is expected that with increasing experience and understanding of the technology and its mechanisms of action, EsWt applications in medicine will continue to expand.

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introdUction

1.1. What are spark Waves®?

spark Waves® are high-energy acoustic waves that behave much like other sound waves except that they have much greater pressure and energy. As with sound waves, spark Waves® can easily travel great distances as long as the acoustic impedance stays the same. however, when the acoustic im-pedance changes, energy is released; the greater the change in impedance the greater the release of energy. there is a much higher release of energy at a soft tissue / bone interface than at a muscle / fas-cia interface. the release of energy from the spark Wave® within the region of the affected tissues and the resultant compression and tension of cells cre-ates a positive physiological effect. Mechano-trans-duction is the physiological effect thought to be res-ponsible for stimulating normal and injured cells to produce healing factors. see: [lit ii] and [lit iii]

1.2. What are the effects of spark Waves®?

EsWt has been documented to have various effects on bone and soft tissue. generally speaking, in sub-acute and chronic conditions, it stimulates the re-initiation of stagnant healing processes as well as re-modeling, and hence promotes healing. in acute conditions, it appears to initiate a more rapid and effective healing phase. it also creates transient and incomplete anal-gesia. the mechanisms by which these effects are cre-ated are not completely understood, however they are thought to:

• increase blood supply to the treated area by stimu-lation of neovascularization and growth factors

• influence the expression of growth factors and -in-dicators such as e-nos, tgf-ß, BMp, vEgf, pcnA

• re-initiate stagnant healing processes in chronicinjuries

• decrease inflammatory processes• stimulate osteoclasts and fibroblasts to rebuild in-

jured tissues• facilitates resorption of calcifications in tendons

and ligaments• stimulates migration (differentiation) of stem cellssee: [ lit iv] and [lit v]

fig. 1 Effects of spark Waves® according to [lit v]

neovascularizationpcnAvEgfenosBMp

improved blood supply

tissue regeneration

tendon repairBone repair

Biological responses

physical s.W.energy

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introdUction

1.3. Are there any side effects of esWt?

no serious side effects have been reported by clinici-ans even when using highest energy settings, howe-ver the following minor side effects have been obser-ved in isolated cases:

• Minor petechial bleedings may occur if the cou-pling between the probe cushion and skin is notair exclusive

• occasional soft tissue swellings over treated ten-dons

• pulmonary tissue tearing and extra-systoles• some patients experience a three to four day pe-

riod of incomplete and transient pain reductionafter EsWt.

• numbness over the treated area

no correlation to outcome or future responses to therapy has been established in cases where soft tis-sue swelling occurs. Aiming at pulmonary tissues or the trachea should be avoided.

the result of EsWt is not analgesia, but rather pain reduction. during this period it is important that pa-tients rest in order to avoid over-working an injury thus risking re-injury. this should be taken into con-sideration prior to performing EsWt on an athlete.

fig. 2 the numbers of neo-vessels and cells with positive enos, BMp-2, vEgf and pcnA expres-sions are significantly higher in the high-energy shockwave group than in the control and low-ener-gy groups. data from the low-energy group did not differ significantly from the control group. the bio-logical effects of shockwaves appeared to be do-se-dependent. [lit v]

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2. GeNerAL treAtMeNt iNFOrMAtiON

EsWt involves using a hand held probe to focus spark Waves® on the affected tissue and surrounding healthy tissue, to induce a physiological response that will initiate healing. it is important to accurately define the treatment area through good diagnostics e.g. history, palpation, x-rays, ultrasound, Mri etc. to ensure the most effective delivery of spark Waves® into that affected region.

2.1. energy and numbers of shocks used

the number of shocks applied and the energy of each shock varies according to the nature of the condition being treated. these variables are:

• type of tissue affected• depth of lesion• size or “volume” of the lesion (this is a product

of the surface area and cross sectional area of the lesion)

• vascularity of the tissue and• Acuteness or chronicity of condition

the following general rules apply to the type and number of spark Waves® required:

• the larger the volume of the lesions – the greater the number of shocks required

• the less vascular the tissue – the greater the number of shocks required

• Bony injuries require a higher number of shocks and higher energy than soft tissue injuries

• the more chronic the condition – the greater the number of shocks required and the higher the energy

• the more acute the condition – the lower the energy levels required

• chronic lesions tend to respond slower than acu-te lesions

• After the per-acute stage, EsWt can be used at any stage of the healing process to aid the quality of healing and to decrease the healing time.

specific information about the energy and number of spark Waves® required to treat specific conditions will be covered as the treatment of specific condi-tions is discussed. however, it should be noted that

the energy settings listed in the treatment tables are data from literature based on clinical experience, and they may vary as EsWt use progresses and develops.

2.2. treatment area

When using the orthogold100® EsWt probe the aim is to traverse the spark Wave® focus through the af-fected region as well as some of the adjacent healthy tissue. this will ensure delivery of maximum pressu-re and energy to the affected area.

once the affected tissues have been accurately iden-tified the probe is placed firmly onto the prepared skin (see 3.2. site preparations) over the desired tre-atment area. the probe handle is then slowly “pivo-ted” in a circular motion.

the goal is to fan the focal zone throughout the desi-red treatment region while maintaining firm contact with the skin to avoid an influx of air between the probe membrane and the skin. When treating large areas it may be necessary to reposition the membra-ne to various areas or to slowly move or “walk” the probe along the treatment area e.g. down a tendon. the probe should always be moved with the grain of the hair and can be angled up to 20 degrees away from the perpendicular when being pivoted through a lesion. throughout the treatment care must be taken to ensure good coupling between the probe and the skin (see 3.2. site preparations).Areas must be treated in accordance with their ana-tomical structure, bearing in mind that the best re-sults will be achieved by minimizing the amount of tissue between the affected region and the probe.

gEnErAl trEAtMEnt inforMAtion

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pAtiEnt prEpArAtion

2.3. Applicators

the orthogold100® is available with various applicators or therapy heads, providing a range of penetration depth, energy and focal size. probe selection can be determined with the aid of ultrasound to measure depth of the intended target.

fig. 3: typical focal dimension of the -6dB zone for the focused ap-plicator oE050 (up to 8 x 44mm)

fig. 4: typical focal dimension of the -6dB zone for the soft-focused ap-plicator oE035 (up to 9.8 x 79mm)

fig. 5: typical focal dimension of the 5Mpa zone for the unfocused applicator op155 (up to 18 x 83mm)

2.4. staging of treatments

some lesions respond extremely well to just one tre-atment with EsWt, while others may require some additional treatments. the following is generally true:

• Bones typically require only one treatment at high energy levels

• Most sub-acute or chronic injuries require two treatments with a 20-40 day interval

• Acute tendon injuries respond well with 2 to 4 treatments at 5-7 day intervals.

3. pAtieNt prepArAtiON

3.1. regional anesthetics or sedation?

the amount of patient discomfort during EsWt has decreased over the years because the intensity of

the spark Waves® being used has been reduced and focal shape adapted accordingly. for orthope-dic indications, mild sedation or local anesthesia might be necessary. please note that local infilt-ration of anesthetics in the treatment area might decrease the success rate of the therapy [lit vi]. however, careful consideration of whether to use sedation or local anesthetics is important for both patient and operator. the following is generally in-dicated:

• treatment involving periosteum tends to be most painful

if EsWt is applied without sedation or regional anesthesia it is recommended to start at a lower energy and frequency setting and work up to the higher energy settings during the treatment ses-sion.

A full description of the applicators and their functions is available in the orthogold100® User Manual.

Applicator oE050 Applicator oE035 Applicator op155

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pAtiEnt prEpArAtion

3.2. site preparations for orthopedic conditions

After the treatment area has been determined using standard diagnostic procedures, the following steps should be taken:

• shave hair, if necessary, to avoid air bubbles in the coupling area

• localize the treatment area by x-ray, ultrasound or palpation

• Measure depth of the affected region set the membrane pressure accordingly.

• Use skin markings as described in the device user manual

• Apply suitable amount of bubble free ultrasound gel and begin therapy

3.3. post therapy recommendations

After treatment remove the ultrasound gel and in-struct the patient about post-therapeutic ”do’s and don’ts”.

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shoUldEr tEndinopAthiEs With or WithoUt cAlcificAtion

1) GeNerAL iNFOrMAtiONshoulder tendinitis or tendinopa-thies with or without calcification show excellent results when tre-ated with spark Waves®. regional anesthetics should not be used unless the patient cannot tolerate the procedure.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied to the most painful spot and sur-rounding tissue. Do NOT apply Spark Waves in the direction of the lung boundary due to the po-tential to damage lung tissue. Make sure no tendon rupture that requires surgery is present. Aim directly at the calcification using high-energy settings.

4.1. shOULder teNdiNOpAthies With Or WithOUt cALciFicAtiON

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE050oE035

0.15-0.27 mJ/mm2

14 - 16 (oE035)10 - 16 (oE050)Membrane 4-6

1000-2000 2-4 weeks standard 1, maximum 3

4. treAtMeNt prOtOcOLs

the following pages contain specific treatment protocols for treating the conditions listed in table 1.

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1) GeNerAL iNFOrMAtiONtennis or golfer’s elbow show good to excellent results when treated with spark Waves®. re-gional anesthetics should not be used unless the patient cannot tolerate the procedure. the ulna-ris seems to have less favorable results and requires more energy and more sessions. Avoid focu-sing directly on the ulnar nerve by putting your finger in the sulcus during treatment.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied to the most painful spot typically directly to the epicondyle and sur-rounding tissue (cave ulnar ner-ve).

rAdiAl EpicondylopAthy

4.2. rAdiAL epicONdYLOpAthY

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035op155

0.10-0.16 mJ/mm2

12 - 16 (oE035)10 - 15 (op155)Membrane 4-6

1000-1500 2-4 weeks standard 1, maximum 3

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AchillEs tEndon

1) GeNerAL iNFOrMAtiONAchilles tendonitis treated with spark Waves® shows excellent results, reducing the swelling and pain in the treated area. regional anesthetics should not be used unless the patient does not tole-rate the procedure.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied to the most painful spot and sur-rounding tissue. inform the pati-ent to avoid overloading for 4 – 6 weeks to avoid reinjury (rupture) during healing process.

4.3. AchiLLes teNdON

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035op155

0.10-0.19 mJ/mm2

12 - 16 (oE035)10 - 16 (op155)Membrane 8-10

1000 - 2000 2-4 weeks standard 1, maximum 3

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plAntAr fAsciitis With / WithoUt hEEl spUr

1) GeNerAL iNFOrMAtiONthe treatment of heel spurs with spark Waves® was the first in-dication approved by the fdA for this therapy. it shows excellent results, reducing the swelling and pain in the treated area. regional anesthetics should not be used unless the patient cannot tolerate the procedure.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied to the most painful spot and sur-rounding tissue.

4.4. plAntAr fAsciitis With / WithoUt hEEl spUr

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035 oE050op155

0.10-0.27 mJ/mm2

12 - 16 (oE035)7 - 16 (oE050)10 - 16 (op155)Membrane 4-6

1000-1500 2-4 weeks standard 1, maximum 3

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grEAtEr trochAntEric pAin syndroME

1) GeNerAL iNFOrMAtiONgtps treated with spark Waves® shows excellent results, reducing the pain in the treated area. re-gional anesthetics should not be used unless the patient cannot to-lerate the procedure.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOL spark Waves® should be applied to the most painful spot and sur-rounding tissue.

4.5. GreAter trOchANteric pAiN sYNdrOMe

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035oE050 op155

0.15-0.27 mJ/mm2

15 - 16 (oE035)10 - 16 (oE050)14 - 16 (op155)Membrane 4 - 6

1000 - 2000 2-4 weeks standard 1, maximum 3

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pAtEllA tEndon

1) GeNerAL iNFOrMAtiONpatella tip syndrome treated with spark Waves® shows excellent re-sults, reducing the pain in the tre-ated area. regional anesthetics should not be used unless the patient cannot tolerate the proce-dure.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied to the most painful spot and sur-rounding tissue. inform the pati-ent to avoid overloading for 4 – 6 weeks to avoid reinjury (rupture) during healing process.

4.6. pAteLLA teNdON

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035op155

0.10-0.19 mJ/mm2

12 - 16 (oE035)10 - 16 (op155)Membrane 6-10

1000-1500 2-4 weeks standard 1, maximum 3

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MyofAsciAl syndroME

1) GeNerAL iNFOrMAtiONMyofascial triggers are muscles with hardening and contraction of the fibers also known as myogelo-sis. some triggers can be found at the patient’s back, therefore it is critical to avoid affecting the lung tissue when using spark Waves® therapy to treat these triggers.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied to the most painful spot and sur-rounding tissue.

4.7. MYOFAsciAL sYNdrOMe

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035op155

0.05-0.19 mJ/mm2

6 - 16 (oE035)6 - 16 (op155)Membrane 6-10

500-1000 per muscle, maximum 2000

1 week 1-6 treatments

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strEss frActUrEs

1) GeNerAL iNFOrMAtiONstress fractures are incomple-te bone fractures. they can be described as a very small sliver or crack in the bone and are so-metimes also called “hairline fractures”. they typically occur in weight bearing bones such as the tibia or the metatarsals. patient activity should be restricted for a period of 4 – 8 weeks and appro-priate auxiliary measures should be taken such as casting or a wal-king boot. Activities should only be resumed gradually after that period since the remodeling pro-

cess of the bone might take seve-ral months.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied along the fracture line. Usually sedation is necessary.

treAtMeNt OF stress FrActUresrequires higher energy and the-refore larger devices. We recom-

mend using the orthogold280® de-vice for these indications. Average overall success rate for bone in-dications using the orthogold100® is less than 65% compared to 81% with the orthogold280®. please contact us if you are interested in treating long bone stress fractu-res.

4.8. stress FrActUres

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE050 0.15-0.27 mJ/mm2

10 – 16 (oE0 50)Membrane 4-8

1000 - 2000 per centimeter of fracture line

12 - 24 weeks Up to 3 treatments

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dElAyEd BonE hEAling

1) GeNerAL iNFOrMAtiONBone nonunions (e.g. scaphoid nonunions) can be treated with the orthogold® and show good results, reducing the pain in the treated area and stimulating bone healing. regional anesthesia or sedation is usually required

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied directly to the fracture gap from

one to several directions cover-ing the entire fracture gap. the applicator should be selected ac-cording to the desired penetration depth. Mark the fracture gap with a biocompatible pen under X-ray exposure and treat along the mar-ked line. delayed nonunions re-quire immobilization such as that necessary for fresh fractures.treatment of bone indications re-quires higher energy and therefo-re larger devices. We recommend using the orthowave280® device for these indications. Average overall success rate for bone in-

dications using the orthogold100® is less than 65% compared to 81% with the orthogold280®. please contact us if you are interested in treating long bone pseudarthro-sis.

4.9. deLAYed BONe heALiNG

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE050 0.20-0.27 mJ/mm2

12 - 16 (oE050)Membrane 1-10

2500-4000 12 - 24 weeks Up to 3 treatments

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AddUctor syndroME

1) GeNerAL iNFOrMAtiONAdductor syndrome, also cal-led adductor insertion avulsion syndrome or thigh splints is ty-pically sports-related, caused by overuses and occuring at the posteromedical midfemo-ral diaphysis. Mri findings may include bone marrow edema, adjacent enhancing periostitis, and stress fractures.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied directly to the painful area from one to several directions cover-ing the entire insertion of the related muscle(s).

4.10. AddUctOr sYNdrOMe

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035oE050op155

0.10-0.16 mJ/mm2

12 - 16 (oE035)6 - 11 (oE050)10 - 15 (op155)Membrane 1-4

1000 - 2000 1-6 weeks not limited

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pEs AnsErinUs syndroME

1) GeNerAL iNFOrMAtiONpes anserinus syndrome at the upper third of the medial tibia is painful inflammation of the mu-scle insertion of three muscles. spark Waves® therapy leads to a pain relief of the sore area and has a positive influence on the in-flammatory process.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied directly to the painful area from one to several directions covering the entire insertion of the related muscles.

4.11. pes ANseriNUs sYNdrOMe

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035op155

0.10-0.16 mJ/mm2

12 - 16 (oE035)10 - 15 (op155)Membrane 7-10

800-1200 1-6 weeks not limited

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pEronEAl tEndon syndroME

1) GeNerAL iNFOrMAtiONperoneal tendon syndrome or peroneal tendonits using spark Wave® therapy leads to pain re-lief of the sore area and has a positive influence on the inflam-matory process.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied directly to the painful area from one to several directions cover-ing the entire insertion of the related muscles.

4.12. perONeAL teNdON sYNdrOMe

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035op155

0.10-0.16 mJ/mm2

12 - 16 (oE035)10 - 15 (op155)Membrane 8-10

800-1200 1-6 weeks not limited

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osgood schlAttEr (Apophysitis)*

1) GeNerAL iNFOrMAtiONpain relief of osgood schlatter in children who participate in sports can be treated using spark Wa-ves®. since the treatment area lies close to the still open epiphy-sis care should be taken not to ap-ply spark Waves® to the epiphysis. please note however that the cur-rent research does not report any negative effects of spark Waves® on the epiphysis [lit vii].

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied directly to the painful area from one to several directions cover-ing the entire area. rest for 4 – 6 weeks.

* NOte: this is an expert indicati-on according to the isMst and the national societies.

4.13. OsGOOd schLAtter (ApOphYsitis)*

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035op155

0.10-0.19 mJ/mm2

12 - 16 (oE035)10 - 16 (op155)Membrane 7-10

1000-1500 1-6 weeks Up to 3 treatments

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spAsticity*

1) GeNerAL iNFOrMAtiONspasticity following brain injury is usually permanent and if unma-naged results in contractures or fixed deformities. there have been suggestions that EsWt can help decrease these contractures as-sociated with spasticity. Because spasticity occurs in a wide range of muscles from the small mu-scles of the hand to large muscles of the legs it is uncertain as to the techniques required, the optimal equipment design, the muscle groups with the greatest potential for treatment and the study design.

2) site prepArAtiONsee 3.2 site preparations for or-thopedic conditions

3) treAtMeNt prOtOcOLspark Waves® should be applied directly to the affected muscles to achieve a muscle relaxation. Based on the patient’s reaction to treat-ment it may be necessary to reduce the energy levels and number of shocks below those stated above.

* NOte: this is an expert indicati-on according to the isMst and the national societies.

4.14. spAsticitY*

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE035op155

0.04-0.10 mJ/mm2

5 - 12 (oE035)5 - 10 (op155)Membrane 7-10

300-600 per muscle area to achieve relaxation

1-6 weeks not limited

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ostEochondrosis dissEcAns

1) GeNerAL iNFOrMAtiONtreating an od using spark Waves® initiates a better blood supply to the underlying bone and the healing of the lesion. these indications usually present with an insidious onset of pain referred at the site of the bony damage. An Mri (with contrast medium) must be performed before spark Wave® therapy to confirm the diagnosis and locate the lesion.

2) site prepArAtiONsee 3.2 site preparations for orthopedic conditions

3) treAtMeNt prOtOcOLtherapy should be performed precisely at the affected area and without other bone tissue in the spark Wave® path since this would shield the spark Waves® from

the affected area. regional anesthesia or sedation is usually required. no weight bearing for 4 – 6 weeks recommended.

treatment of bone indications requires higher energy and therefore larger devices. We recommend using the orthogold280® device for these indications. Aver-age overall success rate for bone indications using the orthogold100® is less than 65% compared to 81% with the orthogold280®. please contact us if you are inte-rested in treating od.

4.15. eArLY stAGe OsteOchONdritis dissecANs (Od), pOst-skeLetAL MAtUritY

Applicator Energy flux densityEnergy levelMembrane pressure

Number of pulses

Treatment interval

Total number of treatments

oE050 0.20-0.27 mJ/mm2

12 - 16 (oE050)Membrane 1-10

2500-4000 8-24 weeks Up to 3 treatments

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litErAtUrE for spEcific indicAtions

5. Literature for specific indications

Achilles tendon

1 y.-J. chen, c.-J. Wang, k. d. yang, y.-r. kuo, h.-c. huang, y.-t. huang, y.-c. sun, and f.-s. Wang. Ex-tracorporeal shock waves promote healing of col-lagenase-induced achilles tendinitis and increa-se tgf- beta1 and igf-i expression. J orthop res, 22(4):854–861, 2004.

2 J. p. furia. high-energy extracorporeal shock wave therapy as a treatment for insertional achilles ten-dinopathy. Am J sports Med, 34(5):733–740, 2006.

3 J. p. furia. high-energy extracorporeal shock wave therapy as a treatment for chronic nonin-sertional achilles tendinopathy. Am J sports Med, 36(3):502–508, 2008.

4 s. rasmussen, M. christensen, i. Mathiesen, and o. simonson. shockwave therapy for chronic achilles tendinopathy: a double-blind, randomized clinical trial of effcacy. Acta orthop, 79(2):249–256, April 2008.

5 J. rompe, J. furia, and n. Maffulli. Mid-portion achilles tendinopathy - current options for treat-ment. disabil rehabil, pages 1–11, 2008.

6 J. d. rompe. shock wave therapy for chronic achil-les tendon pain: a randomized placebo-controlled trial. clin orthop relat res, 445:276–277, 2006.

7 J. d. rompe, J. furia, and n. Maffulli. Eccentric loading compared with shock wave treatment for chronic insertional achilles tendinopathy. a ran-domized, controlled trial. J Bone Joint surg Am, 90(1):52–61, 2008.

8 J. d. rompe, c. J. kirkpatrick, k. kullmer, M. schwitalle, and o. krischek. dose-related effects of shock waves on rabbit tendo achillis. a sonogra-phic and histological study. J Bone Joint surg Br, 80(3):546–552, 1998.

9 J. d. rompe, B. nafe, J. p. furia, and n. Mafful-li. Eccentric loading, shock-wave treatment, or a wait- and-see policy for tendinopathy of the main body of tendo achillis: a randomized controlled tri-al. Am J sports Med, 35(3):374–383, 2007.

shoulder tendinopathies1 J.-d. Albert, J. Meadeb, p. guggenbuhl, f. Marin,

t. Benkalfate, h. thomazeau, and g. chales. high- energy extracorporeal shock-wave therapy for cal-cifying tendinitis of the rotator cuff: a randomised trial. J Bone Joint surg Br, 89(3):335–341, 2007.

2 l. gerdesmeyer, s. Wagenpfeil, M. haake, M. Maier, M. loew, k. Wortler, r. lampe, r. seil, g. handle, s. gassel, and J. d. rompe. Extracorporeal shock wave therapy for the treatment of chronic cal-cifying tendonitis of the rotator cuff: a randomized controlled trial. JAMA, 290(19):2573–2580, 2003.

3 c. ho. Extracorporeal shock wave treatment for chronic rotator cuff tendonitis (shoulder pain). is-sues Emerg health technol, (96 (part 3)):1–4, 2007.

4 c.-J. hsu, d.-y. Wang, k.-f. tseng, y.-c. fong, h.-c. hsu, and y.-f. Jim. Extracorporeal shock wave therapy for calcifying tendinitis of the shoulder. J shoulder Elbow surg, 17(1):55–59, 2008.

5 J. d. rompe. shock wave therapy for calcific ten-dinitis of the shoulder: a prospective clinical stu-dy with two-year follow-up. Am J sports Med, 31(6):1049–1050, 2003.

6 r. seil, p. Wilmes, and c. nuhrenborger. Extracor-poreal shock wave therapy for tendinopathies. Ex-pert rev Med devices, 3(4):463–470, 2006.

7 A. sems, r. dimeff, and J. p. iannotti. Extracor-poreal shock wave therapy in the treatment of chronic tendinopathies. J Am Acad orthop surg, 14(4):195–204, 2006.

8 c. J. Wang, J. y. ko, and h. s. chen. treatment of calcifying tendinitis of the shoulder with shock wave therapy. clin orthop relat res, (387):83–89, 2001.

9 c.-J. Wang, k. d. yang, f.-s. Wang, h.-h. chen, and J.-W. Wang. shock wave therapy for calcific tendinitis of the shoulder: a prospective clinical study with two-year follow-up. Am J sports Med, 31(3):425–430, 2003.

tennis elbow1 B. chung and J. p. Wiley. Effectiveness of extra-

corporeal shock wave therapy in the treatment of previously untreated lateral epicondylitis: a randomized controlled trial. Am J sports Med, 32(7):1660– 1667, 2004.

2 J. p. furia. safety and effcacy of extracorporeal shock wave therapy for chronic lateral epicondyli-tis. Am J orthop, 34(1):13–19, 2005.

3 J. d. rompe, J. decking, c. schoellner, and c. the-is. repetitive low-energy shock wave treatment for chronic lateral epicondylitis in tennis players. Am J sports Med, 32(3):734–743, 2004.

4 J. d. rompe, o. krischek, p. Eysel, c. hopf, and J. Jage. results of extracorporeal shock-wave application in lateral elbow tendopathy. schmerz,

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12(2):105–111, 1998. 5 J. d. rompe and n. Maffulli. repetitive shock wave

therapy for lateral elbow tendinopathy (tennis el-bow): a systematic and qualitative analysis. Br Med Bul l, 83:355–378, 2007.

6 J. d. rompe, c. riedel, U. Betz, and c. fink. chro-nic lateral epicondylitis of the elbow: A prospec-tive study of low-energy shockwave therapy and low-energy shockwave therapy plus manual the-rapy of the cervical spine. Arch phys Med rehabil, 82(5):578–582, 2001.

7 c.-J. Wang and h.-s. chen. shock wave therapy for patients with lateral epicondylitis of the elbow: a one- to two-year follow-up study. Am J sports Med, 30(3):422–425, 2002.

plantar fasciitis1 i. h. W. chow and g. l. y. cheing. comparison of

different energy densities of extracorporeal shock wave therapy (eswt) for the management of chro-nic heel pain. clin rehabil, 21(2):131–141, 2007.

2 B. chuckpaiwong, E. M. Berkson, and g. h. theo-dore. Extracorporeal shock wave for chronic proxi-mal plantar fasciitis: 225 patients with results and outcome predictors. J foot Ankle surg, 48(9):148–155, 3 2009.

3 h. gollwitzer, p. diehl, A. von korff, v. W. rahlfs, and l. gerdesmeyer. Extracorporeal shock wave therapy for chronic painful heel syndrome: a pro-spective, double blind, randomized trial assessing the effcacy of a new electromagnetic shock wave device. J foot Ankle surg, 46(5):348–357, 2007.

4 i. hofling, A. Joukainen, p. venesmaa, and h. kro-ger. preliminary experience of a single session of low- energy extracorporeal shock wave treat-ment for chronic plantar fasciitis. foot Ankle int, 29(2):150–154, 2008.

5 J. A. ogden, r. g. Alvarez, r. l. levitt, J. E. Johnson, and M. E. Marlow. Electrohydraulic high- energy shock-wave treatment for chronic plantar fasciitis. J Bone Joint surg Am, 86-A(10):2216–2228, 2004.

6 g. J. roehrig, J. Baumhauer, B. f. digiovanni, and A. s. flemister. the role of extracorporeal shock wave on plantar fasciitis. foot Ankle clin, 10(4):699–712, 2005.

7 J. d. rompe. shock-wave therapy for plantar fas-ciitis. J Bone Joint surg Am, 87(3):681–682, 2005.

8 J. d. rompe. repetitive low-energy shock wave treatment is effective for chronic symptomatic plantar fasciitis. knee surg sports traumatol Ar-

throsc, 15(1):107; author reply 108, 2007. 9 J. d. rompe, J. decking, c. schoellner, and B.

nafe. shock wave application for chronic plantar fasciitis in running athletes. a prospective, rando-mized, placebo-controlled trial. Am J sports Med, 31(2):268–275, 2003.

10 J. d. rompe, J. furia, l. Weil, and n. Maffulli. shock wave therapy for chronic plantar fasciopa-thy. Br Med Bul l, 81-82:183–208, 2007.

11 c.-J. Wang, f.-s. Wang, k. d. yang, l.-h. Weng, and J.-y. ko. long-term results of extracorpore-al shockwave treatment for plantar fasciitis. Am J sports Med, 34(4):592–596, 2006.

Nonunions1 t. Bara, M. synder, and M. studniarek. the appli-

cation of shock waves in the treatment of delayed bone union and pseudoarthrosis in long bones. or-top traumatol rehabil, 2(3):54–57, 2000.

2 h. gollwitzer, M. roessner, r. langer, t. gloeck, p. diehl, c. horn, A. stemberger, c. von Eiff, and l. gerdesmeyer. safety and effectiveness of extra-corporeal shockwave therapy: results of a rabbit model of chronic osteomyelitis. Ultrasound Med Biol, 35(4):595–602, Apr 2009.

3 h. gollwitzer, M. roeßner, r. langer, t. gloeck, p. diehl, c. horn, c. von Eiff, A. stemberger, and l. gerdesmeyer. safety and effectiveness of extra-corporeal shock wave therapy in the treatment of chronic bone infections: results of an animal mo-del in the rabbit. 2007.

4 A. hofmann, U. ritz, M. h. hessmann, M. Alini, p. M. rommens, and J.-d. rompe. Extracorporeal shock wave-mediated changes in proliferation, differentiation, and gene expression of human os-teoblasts. J trauma, 65(6):1402–1410, dec 2008.

5 M.-Q. liu, X. guo, s.-c. kuang, s.-h. Wang, and g.-w. rong. Application of extracorporeal shock-wave therapy (eswt) in delayed unions and non-unions. Beijing da Xue Xue Bao, 36(3):327–329, 2004.

6 B. Moretti, A. notarnicola, r. garofalo, l. Moretti, s. patella, E. Marlinghaus, and v. patella. shock waves in the treatment of stress fractures. Ul-trasound Med Biol, feb 2009.

7 J. d. rompe, t. rosendahl, c. schollner, and c. theis. high-energy extracorporeal shock wave treatment of nonunions. clin orthop relat res, (387):102–111, 2001.

8 s. sathishkumar, A. Meka, d. dawson, n. house, W. schaden, M. J. novak, J. l. Ebersole, and l.

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litErAtUrE for spEcific indicAtions

kesavalu. Extracorporeal shock wave therapy in-duces alveolar bone regeneration. J dent res, 87(7):687–691, 2008.

9 W. schaden. Extracorporeal shock wave therapy now used to treat non-union fractures. orthopae-dics today international, 1(2):37–38, March/April 1998.

10 W. schaden and h. kuderna. single application of extracorporeal shock waves in delayed healing fractures and non-unions. in proceedings of the 3rd Efort conference 1997. Efort, April 1997.

11 c. schoellner, J. d. rompe, J. decking, and J. hei-ne. high energy extracorporeal shockwave thera-py (eswt) in pseudarthrosis. orthopade, 31(7):658–662, 2002.

12 t. tischer, s. Milz, c. Weiler, c. pautke, J. haus-dorf, c. schmitz, and M. Maier. dose-dependent new bone formation by extracorporeal shock wave application on the intact femur of rabbits. Eur surg res, 41(1):44–53, 2008.

13 c. Wang, k. yang, J. ko, c. huang, h. huang, and f. Wang. the effects of shockwave on bone hea-ling and systemic concentrations of nitric oxide (no), tgf-beta1, vegf and bmp-2 in long bone non-unions. nitric oxide, Mar 2009.

14 c. J. Wang, h. s. chen, c. E. chen, and k. d. yang. treatment of nonunions of long bone fractures with shock waves. clin orthop relat res, (387):95–101, 2001.

6. Additional literature

[Lit i] shock wave therapy for acute and chronic soft tissue wounds: a feasibility study. W. schaden, r. thiele, c. kolpl, M. pusch, A. nissan, c. E. Attinger, M. E. Maniscalco-the-berge, g. E. peoples, E. A. Elster, and A. stoja-dinovic. J surg res, 143(1):1–12, 2007.

[Lit ii] physics and technology of shock wave and pressure wave therapy. othmar Wess in isMst newsletter 2, April 2006, volume 2 issue 1, pp2-12, available on-line from http://www.ismst.com/

[Lit iii] A trial on the Mechanotransductional influ-ence of EsWt on pig skin and fibroblastic Activity under the Aspect of Energy flux den-sity and frequency. Author: s. Marx, h.g. neuland, h.J. duch-stein, r. thiele

[Lit iv] repetitive low-energy shock wave applicati-on without local anesthesia is more effcient than repetitive low-energy shock wave appli-cation with local anesthesia in the treatment of chronic plantar fasciitis. J. d. rompe, A. Meurer, B. nafe, A. hofmann, and l. gerdesmeyer. J orthop res, 23(4):931–941, 2005.

[Lit v] Biological Mechanism of Musculoskeletal shockwaves, c.-J. Wang in: isMst newsletter 1, volume 1, issue 1 , pp.5-11, available online from http://www.ismst.com/ performed using an elec-trohydraulic device (ossatron, hMt) in the year 2005, at an energy flux density of 0.18mJ/mm2 and 2000 and 4000 impulses.

[Lit vi] Anaesthesia for shock wave therapy in or-thopaedics. f. rodola, c. conti, B. gunnella, l. frassanito, A. vergari, and A. chierichini. recenti prog Med, 96(4):183–186, 2005.

[Lit vii] k. nassenstein, i. nassenstein, and r. schle-berger. Effects of high-energy shock waves on the structure of the immature epiphy-sis–a histomorphological study. Z orthop ihre grenzgeb, 143(6):652–655, 2005.

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