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

2 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

3 Orthopaedic indications for RSWT ® (2) Supraspinatus tendon Common extensor tendon Patella tendon Achilles tendon Plantar fascia

4 RSWT ® : RCTs with positive outcome Chronic plantar fasciopathy: Gerdesmeyer et al., Am J Sports Med 2008; 36: Chow and Cheing, Clin Rehab 2007;21: Greve et al., Clinics 2009; 64: Midportion Achilles tendinopathy: Rompe et al., Am J Sports Med 2007;35: Rompe et al., Am J Sports Med 2009;37: 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: Rompe et al., Am J Sports Med 2009;37: Subacromial pain syndrome: Engebretsen et al., Brit Med J 2009:339:b3360

5 RSWT ® for chronic plantar fasciopathy (1) n=251 (129 vs. 122)

6 RSWT ® for chronic plantar fasciopathy (2) n=251 (129 vs. 122)

7 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)

8 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

9 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

12 Calcifying tendonitis of the shoulder (1) Palpation of the painful region (the same recommendations apply for the subacromial pain syndrome)

13 Treatment with the Radial handpiece Applicator: 15 mm Number of treatments: 3 (at weekly intervals) Number of impulses per treatment: 2,000 Frequency: Hz Air pressure: bar Literature: Magosch et al., 2003 Z Orthop 141: (in PubMed) (the same recommendations apply for the subacromial pain syndrome) Calcifying tendonitis of the shoulder (4)

14 (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: Hz Air pressure: bar Literature: Magosch et al., 2003 Z Orthop 141: (in PubMed)

Tennis elbow (Epicondylitis humeri radialis)

16 Treatment with the Radial handpiece Applicator: 15 mm Number of treatments: 3 (at weekly intervals) Number of impulses per treatment: 2,000 Frequency: Hz Air pressure: 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 Tennis elbow (Epicondylitis humeri radialis) (4)

Greater trochanteric pain syndrome

18 Greater trochanteric pain syndrome (1) Palpation of the painful region

19 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: Hz Air pressure: bar Literature: Furia et al., 2009 Am J Sports Med 37: ; Rompe et al., 2009 Am J Sports Med 2009;37: (both in PubMed)

Patella tip syndrome

21 Patella tip syndrome (1) Palpation of the painful region

22 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: Hz Air pressure: bar Literature: Lohrer et al., 2002 Sportverl Sportschad 16: (in PubMed)

Osgood-Schlatter disease

24 Osgood-Schlatter disease (1) Palpation of the painful region

25 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: Hz Air pressure: bar Literature: Titov and Litvinenko (2007) Abstracts 10th International Congress of the International Society for Musculoskeletal Shockwave Therapy, Toronto, Canada, 2007, pp

Medial tibial stress syndrome

27 Medial tibial stress syndrome (1) Palpation of the painful region

28 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: Hz Air pressure: bar Literature: Rompe et al., 2010 Am J Sports Med 38: (in PubMed)

Insertional Achilles tendinopathy

30 Insertional Achilles tendinopathy (1) Palpation of the painful region

31 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: Hz Air pressure: bar Literature: Rompe et al., 2008 J Bone Joint Surg Am 90:52-61 (in PubMed)

Midportion Achilles tendinopathy

33 Midportion Achilles tendinopathy (1) Palpation of the painful region

34 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: Hz Air pressure: bar Literature: Rompe et al., 2007 Am J Sports Med 35: ; Rompe et al., 2009 Am J Sports Med 37: (both in PubMed)

Plantar fasciopathy

36 Plantar fasciopathy (1) Palpation of the painful region

37 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: Hz Air pressure: bar Literature: Gerdesmeyer et al., 2008 Am J Sports Med 36: ; Ibrahim et al., 2010 Foot & Ankle Int 31: (both in PubMed)

38 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: Hz Air pressure: bar Literature: Gerdesmeyer et al., 2008 Am J Sports Med 36: ; Ibrahim et al., 2010 Foot & Ankle Int 31: (both in PubMed)

Myofascial pain syndrome / trigger point treatment

40 Myofascial pain syndrome / trigger point treatment (1) (treatment of the piriformis muscle shown as example) Palpation of the painful region

41 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: Hz Air pressure: 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 Myofascial pain syndrome / trigger point treatment (4) (treatment of the piriformis muscle shown as example)

Idiopathic lower back pain / pseudoradicular syndrome

43 Idiopathic lower back pain / pseudoradicular syndrome (1) Palpation of the painful region

44 Treatment with the Radial handpiece Applicator: 15 mm Number of treatments: 3 (at weekly intervals) Number of impulses per treatment: 2,000 Frequency: Hz Air pressure: 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 Idiopathic lower back pain / pseudoradicular syndrome (4)

Peyronie‘s disease (Induratio penis plastica)

46 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: Hz Air pressure: bar Literature: Haupt et al., 2001 Abstracts 19th World Congress on Endourology and SWL, Bangkok, Thailand, 2001.

Acute and chronic soft tissue wounds

48 Acute and chronic soft tissue wounds (1) Perform standard wound cleaning and debridement (treatment of diabetic foot ulcer shown as example)

49 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)

50 Apply sterile coupling gel to the film Acute and chronic soft tissue wounds (3) (treatment of diabetic foot ulcer shown as example)

51 Treatment with the Power + handpiece Applicator: 36 mm Planar Number of treatments: (two treatments per week) Number of impulses per treatment: 1,000 per cm 2 wound area Frequency: Hz Air pressure: bar Literature: Zoech, 2009 JATROS Orthop (1):46-47 Acute and chronic soft tissue wounds (4) (treatment of diabetic foot ulcer shown as example)

52 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

54 Primary and secondary lymphedema (1) Application of coupling gel (no need for palpation and labeling because the treatment area is visually identified)

55 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 cm 2 fibrotic skin Frequency: Hz Air pressure: bar Literature: Michelini et al., 2008 Eur J Lymphol 19:10 Primary and secondary lymphedema (2)

Cellulite

57 Application of coupling gel (no need for palpation and labeling because the treatment area is visually identified) Cellulite (1)

58 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 cm 2 cellulite skin (approximately 3,500 per skin region) Frequency: Hz Air pressure: 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)

61 Golfer‘s elbow (Epicondylitis humeri ulnaris) (1) Palpation of the painful region

62 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: Hz Air pressure: bar

Carpal tunnel syndrome

64 Carpal tunnel syndrome (1) Palpation of the painful region

65 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: Hz Air pressure: 1.5 – 2.5 bar

66 Focused shock waves (EMS Swiss PiezoClast ® ) 11 cm Shock wave focus Cavitation bubbles Secondary shock waves

67 Cavitation zone of the EMS Swiss PiezoClast ®

68 Technical aspect: focus of the EMS Swiss PiezoClast ®

69 Cigar-shaped focus of focused shock waves

70 Physical characteristics of the focus -6 dB focus: three-dimensional region in which at least 50% of the positive peak pressure [P + ] is reached (definition in relative terms) 5 MPa focus: three-dimensional region in which a pressure of more than 5 MPa is obtained (definition in absolute terms)

71  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

72 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 be as small as possible in order to prevent unwanted side effects in adjacent, not affected tissues Characteristics of the cigar („Powerful but small“) Power Size A certain energy flux density must be reached in order to achieve treatment success* *Calcifying tendinitis of the shoulder: EFD between 0.1 and 0.55 mJ/mm 2 (Vavken et al., 2009) Trigger points: EFD between 0.1 and 0.25 mJ/mm 2 (Müller –Ehrenberg, 2009)

73 Example: calcifying tendinitis of the shoulder Vavken et al. (2009)

74 Requirements for the size of the focus (1) 5 cm 2 cm Calcifying tendinitis of the shoulder

75 Requirements for the size of the focus (2) Trigger points (Hong and Simons, 1998) 10 µm

76 Nonunion Requirements for the size of the focus (3)

77 Avascular necrosis of the femoral head Requirements for the size of the focus (4)

78 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 (fx 5MPa max = 10.4 mm) Characteristics of the cigar („Powerful but small“) Power Size Energy flux density Necessary* energy flux density can be reached (EFD max = 0.40 mJ/mm 2 ) Characteristics of the EMS Swiss PiezoClast ® *Calcifying tendinitis of the shoulder: EFD between 0.1 and 0.55 mJ/mm 2 (Vavken et al., 2009) Trigger points: EFD between 0.1 and 0.25 mJ/mm 2 (Müller –Ehrenberg, 2009)

79 Huge maximum output (P + max = 120 MPa) Focusing Focus ways too large for shoulder, trigger points etc. (fx 5MPa 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 (EFD max = 1.50 mJ/mm 2 ) Example of a big shock wave device Characteristics of the...

80 Low maximum output (P + max = 47.7 MPa) Weak focusing Does not reach energy flux densities necessary for good clinical outcome (EFD max = 0.12 mJ/mm 2 ) Focus slightly larger than the focus of the Piezoclast (fx 5MPa 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

81 Less maximum output (P + max = 62.0 MPa) (measured: 51.4 MPa) Focusing Necessary energy flux density can be reached (EFD max = 0.55 mJ/mm 2 ) (measured: mJ/mm 2 ) Focus larger than the focus of the Piezoclast (fx 5MPa 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

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