New indications for RSWT

Prof. Dr. Christoph Schmitz

Full Professor and Head

Department of Neuroanatomy,

Ludwig-Maximilians University of Munich, Munich, Germany

Adjunct Professor

Department of Neuroscience,

Mount Sinai School of Medicine,New York, NY, USA

Medical Scientific Officer

EMS Electro Medical Systems, Nyon, Switzerland

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Subacromial pain syndrome

Tennis elbow (Epicondilitis humeri radialis)

Patellar tip syndrome Medial tibial stress syndrome

Achilles tendinopathy

Plantar fasciopathy

Orthopaedic indications for RSWT® (1)

Golfer‘s elbow (epicondylitis humeri ulnaris)

Greater trochanteric pain syndrome

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Orthopaedic indications for RSWT® (2)

Supraspinatus tendon Common extensor tendon

Patella tendon Achilles tendon Plantar fascia

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RSWT®: RCTs with positive outcome

Chronic plantar fasciopathy:• Gerdesmeyer et al., Am J Sports Med 2008; 36: 2100-2109• Chow and Cheing, Clin Rehab 2007;21: 131-141• Greve et al., Clinics 2009; 64: 97-103

Midportion Achilles tendinopathy:• Rompe et al., Am J Sports Med 2007;35:374-381• Rompe et al., Am J Sports Med 2009;37:463-470

Insertion Achilles tendinopathy:• Rompe et al., Am J Bone Joint Surg 2008;90:52-61

Medial tibial stress syndrome:• Rompe et al., Am J Sports Med 2009 [Epub Sep 23]

Greater trochanteric pain syndrome:• Furia et al., Am J Sports Med 2009;37:1806-1813• Rompe et al., Am J Sports Med 2009;37:1981-1990

Subacromial pain syndrome:• Engebretsen et al., Brit Med J 2009:339:b3360

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RSWT® for chronic plantar fasciopathy (1)

n=251 (129 vs. 122)

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RSWT® for chronic plantar fasciopathy (2)

n=251 (129 vs. 122)

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RSWT® for chronic insertional Achilles tendinopathy

EL: 3 x 15 repetitions x 2/d x 7d/w x 12w = 7,560 repetitions

n=50 (25 vs. 25)

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RSWT® for chronic midportion Achilles tendinopathy (1)

n=75 (25 vs. 25 vs. 25)

EL: 3 x 15 repetitions x 2/d x 7d/w x 12w = 7,560 repetitions

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RSWT® for chronic midportion Achilles tendinopathy (2)

EL: 3 x 15 repetitions x 2/d x 7d/w x 12w = 7,560 repetitions

n=68 (34 vs. 34)

Approved Indications

• Calcifying tendonitis of the shoulder / subacromial pain syndrome• Tennis elbow (Epicondylitis humeri radialis)• Greater trochanteric pain syndrome• Patella tip syndrome• Osgood-Schlatter disease*• Medial tibial stress syndrome• Insertional Achilles tendinopathy• Midportion Achilles tendinopathy• Plantar fasciopathy• Myofascial pain syndrome / trigger point treatment• Idiopathic lower back pain / pseudoradicular syndrome• Peyronie‘s disease (Induratio penis plastica)*• Acute and chronic soft tissue wounds (including diabetic foot ulcera)*• Primary and secundary lymphedema*• Cellulite*

*Approval for the Swiss Dolorclast Smart (SD Classic and Master will get approval soon)

Calcifying tendonitis of the shoulder

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Calcifying tendonitis of the shoulder (1)

Palpation of the painful region

(the same recommendations apply for the subacromial pain syndrome)

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Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 2 - 4 bar• Literature: Magosch et al., 2003 Z Orthop 141:629-633 (in PubMed)

(the same recommendations apply for the subacromial pain syndrome)

Calcifying tendonitis of the shoulder (4)

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(the same recommendations apply for the subacromial pain syndrome)

Calcifying tendonitis of the shoulder (5)

Treatment with the Power+ handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 1.5 - 3 bar• Literature: Magosch et al., 2003 Z Orthop 141:629-633 (in PubMed)

Tennis elbow (Epicondylitis humeri radialis)

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Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 1.5 - 3 bar• Literature: Söller, 2003 In: Maier M, Gillesberger F: Abstracts 2003

zur Muskuloskelettalen Stosswellentherapie. Kongressband des 3. Dreiländertreffens der Österreichischen, Schweizer und Deutschen Fachgesellschaften. Books on Demand, Norderstedt, 2003, pp 121-122.

Tennis elbow (Epicondylitis humeri radialis) (4)

Greater trochanteric pain syndrome

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Greater trochanteric pain syndrome (1)

Palpation of the painful region

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Greater trochanteric pain syndrome (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 3 - 4 bar• Literature: Furia et al., 2009 Am J Sports Med 37:1806-1813;

Rompe et al., 2009 Am J Sports Med 2009;37:1981-1990 (both in PubMed)

Patella tip syndrome

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Patella tip syndrome (1)

Palpation of the painful region

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Patella tip syndrome (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 2 - 3 bar• Literature: Lohrer et al., 2002 Sportverl Sportschad 16:108-114

(in PubMed)

Osgood-Schlatter disease

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Osgood-Schlatter disease (1)

Palpation of the painful region

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Osgood-Schlatter disease (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000-3,000• Frequency: 5 - 10 Hz• Air pressure: 2 - 3 bar• Literature: Titov and Litvinenko (2007) Abstracts 10th

International Congress of the International Society for Musculoskeletal Shockwave Therapy, Toronto, Canada, 2007, pp. 46-47.

Medial tibial stress syndrome

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Medial tibial stress syndrome (1)

Palpation of the painful region

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Medial tibial stress syndrome (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 2.5 - 3 bar• Literature: Rompe et al., 2010 Am J Sports Med 38:125-132 (in

PubMed)

Insertional Achilles tendinopathy

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Insertional Achilles tendinopathy (1)

Palpation of the painful region

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Insertional Achilles tendinopathy (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 2.5 - 3 bar• Literature: Rompe et al., 2008 J Bone Joint Surg Am 90:52-61

(in PubMed)

Midportion Achilles tendinopathy

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Midportion Achilles tendinopathy (1)

Palpation of the painful region

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Midportion Achilles tendinopathy (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 2 - 3 bar• Literature: Rompe et al., 2007 Am J Sports Med 35:374-383;

Rompe et al., 2009 Am J Sports Med 37:463-470 (both in PubMed)

Plantar fasciopathy

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Plantar fasciopathy (1)

Palpation of the painful region

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Plantar fasciopathy (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 2.5 - 4 bar• Literature: Gerdesmeyer et al., 2008 Am J Sports Med

36:2100-2109; Ibrahim et al., 2010 Foot & Ankle Int 31:391-397 (both in PubMed)

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Plantar fasciopathy (5)

Treatment with the Power+ handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 2 - 3 bar• Literature: Gerdesmeyer et al., 2008 Am J Sports Med

36:2100-2109; Ibrahim et al., 2010 Foot & Ankle Int 31:391-397 (both in PubMed)

Myofascial pain syndrome / trigger point treatment

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Myofascial pain syndrome / trigger point treatment (1)

(treatment of the piriformis muscle shown as example)

Palpation of the painful region

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Treatment with the Power+ handpiece• Applicator: 15 mm Trigger• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 300 – 1,000 per trigger

point• Frequency: 8 - 20 Hz• Air pressure: 2.5 - 4 bar• Literature: Bauermeister, 2003 In: Maier M, Gillesberger F: Abstracts 2003 zur

Muskuloskelettalen Stosswellentherapie. Kongressband des 3. Dreiländertreffens der Österreichischen, Schweizer und Deutschen Fachgesellschaften. Books on Demand, Norderstedt, 2003, pp 24-28.

Myofascial pain syndrome / trigger point treatment (4)

(treatment of the piriformis muscle shown as example)

Idiopathic lower back pain / pseudoradicular syndrome

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Idiopathic lower back pain / pseudoradicular syndrome (1)

Palpation of the painful region

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Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 8 - 20 Hz• Air pressure: 2 - 3 bar• Literature: Bauermeister, 2003 In: Maier M, Gillesberger F: Abstracts 2003 zur

Muskuloskelettalen Stosswellentherapie. Kongressband des 3. Dreiländertreffens der Österreichischen, Schweizer und Deutschen Fachgesellschaften. Books on Demand, Norderstedt, 2003, pp 29-34.

Idiopathic lower back pain / pseudoradicular syndrome (4)

Peyronie‘s disease (Induratio penis plastica)

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Peyronie‘s disease (Induratio penis plastica)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (in weekly intervals)• Number of impulses: 2,000• Frequency: 10 - 15 Hz• Air pressure: 2 - 3 bar• Literature: Haupt et al., 2001 Abstracts 19th World Congress on

Endourology and SWL, Bangkok, Thailand, 2001.

Acute and chronic soft tissue wounds

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Acute and chronic soft tissue wounds (1)

Perform standard wound cleaning and debridement

(treatment of diabetic foot ulcer shown as example)

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Place a sterile plastic film on the wound and the surrounding tissue (the plastic film should overlap

the wound edges by at least 5 cm)

Acute and chronic soft tissue wounds (2)

(treatment of diabetic foot ulcer shown as example)

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Apply sterile coupling gel to the film

Acute and chronic soft tissue wounds (3)

(treatment of diabetic foot ulcer shown as example)

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Treatment with the Power+ handpiece• Applicator: 36 mm Planar• Number of treatments: 6 - 8 (two treatments per week)• Number of impulses per treatment: 1,000 per cm2

wound area• Frequency: 5 - 15 Hz• Air pressure: 3 - 4 bar• Literature: Zoech, 2009 JATROS Orthop (1):46-47

Acute and chronic soft tissue wounds (4)

(treatment of diabetic foot ulcer shown as example)

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After the treatment:• Remove the plastic film with the coupling gel• Clean with sterile saline• Apply standard wound dressing according to the individual phase of

wound healing

Acute and chronic soft tissue wounds (5)

Primary and secondary lymphedema

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Primary and secondary lymphedema (1)

Application of coupling gel(no need for palpation and labeling because

the treatment area is visually identified)

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Treatment with the Power+ handpiece• Applicator: 36 mm Planar• Number of treatments: 10 (two treatments per week)• Number of impulses per treatment: 200 – 300 per cm2

fibrotic skin• Frequency: 4 - 10 Hz• Air pressure: 3 - 4 bar• Literature: Michelini et al., 2008 Eur J Lymphol 19:10

Primary and secondary lymphedema (2)

Cellulite

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Application of coupling gel(no need for palpation and labeling because

the treatment area is visually identified)

Cellulite (1)

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Cellulite (2)

Treatment with the Power+ handpiece• Applicator: 36 mm Planar• Number of treatments: 8 (two treatments per week)• Number of impulses per treatment: 200 – 300 per cm2

cellulite skin (approximately 3,500 per skin region)• Frequency: 8 - 20 Hz• Air pressure: 3 - 4 bar• Literature: EMS (ongoing clinical study)

Indications that are not approved(for internal use only)

• Golfer‘s elbow (Epicondylitis humeri ulnaris)• Carpal tunnel syndrome• Idiopathic cervical pain

EMS received (oral) case reports by experienced therapists with respect to efficacy and safety of radial shock wave treatment with the EMS Swiss Dolorclast for these indications. Based on these case reports, EMS is currently testing efficacy and safety of radial shock wave treatment with the EMS Swiss Dolorclast for these indications in prospective clinical studies. However, the presently available data are not yet sufficient to approve the Swiss Dolorclast for these indications.

Golfer‘s elbow (Epicondylitis humeri ulnaris)

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Golfer‘s elbow (Epicondylitis humeri ulnaris) (1)

Palpation of the painful region

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Golfer‘s elbow (Epicondylitis humeri ulnaris) (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 1.5 - 3 bar

Carpal tunnel syndrome

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Carpal tunnel syndrome (1)

Palpation of the painful region

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Carpal tunnel syndrome (4)

Treatment with the Radial handpiece• Applicator: 15 mm• Number of treatments: 3 (at weekly intervals)• Number of impulses per treatment: 2,000• Frequency: 5 - 10 Hz• Air pressure: 1.5 – 2.5 bar

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Focused shock waves (EMS Swiss PiezoClast®)

11 cm

Shock wave focus

Cavitation bubbles

Secondary shock waves

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Cavitation zone of the EMS Swiss PiezoClast®

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Technical aspect: focus of the EMS Swiss PiezoClast®

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Cigar-shaped focus of focused shock waves

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Physical characteristics of the focus

-6 dB focus:three-dimensional region inwhich at least 50% of thepositive peak pressure [P+] isreached (definition in relative terms)

5 MPa focus:three-dimensional region in which a pressure of more than5 MPa is obtained (definition in absolute terms)

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> The „cigar zone“ should– deliver a sufficient energy flux

density to achieve therapeutic success („powerful“), and

– be no larger than the pathology zone („small“)

> How to reach a sufficient energy flux density within the focus?– make a huge device with a lot of

energy output, or– make the focus small

Requirements for the focus in orthopedics

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Summary of requirements for focused shock waves

Output („the higher the peak pressure the more powerful the shock waves“)

Focusing („the more you focus the smaller the cigar zone“)

Energy flux density

Focus should beas small as possiblein order to preventunwanted side effectsin adjacent, not affectedtissues

Characteristics of the cigar(„Powerful but small“)

Power Size

A certain energyflux densitymust be reached in order to achievetreatment success*

*Calcifying tendinitis of the shoulder: EFD between 0.1 and 0.55 mJ/mm2 (Vavken et al., 2009) Trigger points: EFD between 0.1 and 0.25 mJ/mm2 (Müller –Ehrenberg, 2009)

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Example: calcifying tendinitis of the shoulder

Vavken et al. (2009)

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Requirements for the size of the focus (1)

5 cm

2 cm

Calcifying tendinitis of the shoulder

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Requirements for the size of the focus (2)

Trigger points(Hong and Simons, 1998)

10 µm

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Nonunion

Requirements for the size of the focus (3)

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Avascular necrosis of the femoral head

Requirements for the size of the focus (4)

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Sufficient maximum output(P+ max = 82.2 MPa)

Sharp focusing (by special arrangement of the piezo crystals)

The smallest focus of all focused ESWT devices available commercially (fx5MPa max = 10.4 mm)

Characteristics of the cigar(„Powerful but small“)

Power Size

Energy flux density

Necessary* energyflux densitycan be reached (EFDmax = 0.40 mJ/mm2)

Characteristics of the EMS Swiss PiezoClast®

*Calcifying tendinitis of the shoulder: EFD between 0.1 and 0.55 mJ/mm2 (Vavken et al., 2009) Trigger points: EFD between 0.1 and 0.25 mJ/mm2 (Müller –Ehrenberg, 2009)

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Huge maximum output(P+ max = 120 MPa) Focusing

Focus ways too large for shoulder, trigger points etc.(fx5MPa max = 34.0 mm)

Characteristics of the cigar(„Powerful but small“)

Power Size

Energy flux density

Delivers energy flux densities that can become dangerous to the patient(EFDmax = 1.50 mJ/mm2)

Example of a big shock wave device

Characteristics of the...

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Low maximum output(P+ max = 47.7 MPa) Weak focusing

Does not reach energy flux densities necessary for good clinical outcome(EFDmax = 0.12 mJ/mm2)

Focus slightly larger than the focus of the Piezoclast(fx5MPa max = 11.9 mm)

Characteristics of the cigar(„Powerful but small“)

Power Size

Energy flux density

Characteristics of the...

Example of another table-top device

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Less maximum output(P+ max = 62.0 MPa)(measured: 51.4 MPa)

Focusing

Necessary energyflux densitycan be reached (EFDmax = 0.55 mJ/mm2)(measured: 0.167 mJ/mm2)

Focus larger than the focus of the Piezoclast(fx5MPa max > 40 mm)

Characteristics of the cigar(„Powerful but small“)

Power Size

Energy flux density

Characteristics of the...

Example of another combined radial / focused shock wave device

Thank you for your attention

cschmitz@ems-ch.com