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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

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new indications for rswt

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

slide2

Orthopaedic indications for RSWT®(1)

Tennis elbow (Epicondilitis humeri radialis)

Subacromial pain syndrome

Golfer‘s elbow (epicondylitis humeri ulnaris)

Greater trochanteric pain syndrome

Medial tibial stress syndrome

Patellar tip syndrome

Achilles tendinopathy

Plantar fasciopathy

orthopaedic indications for rswt 2
Orthopaedic indications for RSWT®(2)

Common extensor tendon

Supraspinatus tendon

Achilles tendon

Plantar fascia

Patella tendon

slide4

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
slide7

RSWT® for chronic insertional Achilles tendinopathy

n=50 (25 vs. 25)

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

slide8

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

slide9

RSWT® for chronic midportion Achilles tendinopathy (2)

n=68 (34 vs. 34)

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

approved indications

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)
slide12

Calcifying tendonitis of the shoulder (1)

(the same recommendations apply for the subacromial pain syndrome)

Palpation of the painful region

slide13

Calcifying tendonitis of the shoulder (4)

(the same recommendations apply for the subacromial pain syndrome)

  • 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)
slide14

Calcifying tendonitis of the shoulder (5)

(the same recommendations apply for the subacromial pain syndrome)

  • 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)
slide16

Tennis elbow (Epicondylitis humeri radialis) (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
  • 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.
slide18

Greater trochanteric pain syndrome (1)

Palpation of the painful region

slide19

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)
slide21

Patella tip syndrome (1)

Palpation of the painful region

slide22

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)
slide24

Osgood-Schlatter disease (1)

Palpation of the painful region

slide25

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.
slide27

Medial tibial stress syndrome (1)

Palpation of the painful region

slide28

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)
slide30

Insertional Achilles tendinopathy (1)

Palpation of the painful region

slide31

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)
slide33

Midportion Achilles tendinopathy (1)

Palpation of the painful region

slide34

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)
slide36

Plantar fasciopathy(1)

Palpation of the painful region

slide37

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)
slide38

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)
slide40

Myofascial pain syndrome / trigger point treatment (1)

(treatment of the piriformis muscle shown as example)

Palpation of the painful region

slide41

Myofascial pain syndrome / trigger point treatment (4)

(treatment of the piriformis muscle shown as example)

  • 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.
slide44

Idiopathic lower back pain / pseudoradicular 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: 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.
slide46

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., 2001Abstracts 19th World Congress on Endourology and SWL, Bangkok, Thailand, 2001.
slide48

Acute and chronic soft tissue wounds (1)

(treatment of diabetic foot ulcer shown as example)

Perform standard wound cleaning and debridement

slide49

Acute and chronic soft tissue wounds (2)

(treatment of diabetic foot ulcer shown as example)

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)

slide50

Acute and chronic soft tissue wounds (3)

(treatment of diabetic foot ulcer shown as example)

Apply sterile coupling gel to the film

slide51

Acute and chronic soft tissue wounds (4)

(treatment of diabetic foot ulcer shown as example)

  • 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
slide52

Acute and chronic soft tissue wounds (5)

  • 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
slide54

Primary and secondary lymphedema (1)

Application of coupling gel

(no need for palpation and labeling because the treatment area is visually identified)

slide55

Primary and secondary lymphedema (2)

  • 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
slide57

Cellulite (1)

Application of coupling gel

(no need for palpation and labeling because the treatment area is visually identified)

slide58

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

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.
slide62

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
slide64

Carpal tunnel syndrome(1)

Palpation of the painful region

slide65

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
focused shock waves ems swiss piezoclast

Shock wave focus

Cavitation bubbles

Secondary

shock waves

Focused shock waves (EMS Swiss PiezoClast®)

11 cm

physical characteristics of the focus
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)

requirements for the focus in orthopedics
Requirements for the focus in orthopedics
  • 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
summary of requirements for focused shock waves

Power

Size

Characteristics of the cigar

(„Powerful but small“)

Focus should be

as small as possible

in order to prevent

unwanted side effects

in adjacent, not affected

tissues

A certain energy

flux density

must be reached in order to achieve

treatment success*

Energy flux density

*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)

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“)

requirements for the size of the focus 1
Requirements for the size of the focus (1)

2 cm

5 cm

Calcifying tendinitis of the shoulder

requirements for the size of the focus 2
Requirements for the size of the focus (2)

10 µm

Trigger points

(Hong and Simons, 1998)

requirements for the size of the focus 4
Requirements for the size of the focus (4)

Avascular necrosis of the femoral head

characteristics of the ems swiss piezoclast
Characteristics of the EMS Swiss PiezoClast®

Sharp focusing (by special arrangement of the piezo crystals)

Sufficient maximum output

(P+ max = 82.2 MPa)

Power

Size

Characteristics of the cigar

(„Powerful but small“)

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

Necessary* energy

flux density

can be reached

(EFDmax = 0.40 mJ/mm2)

Energy flux density

*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)

characteristics of the
Characteristics of the...

Example of a big shock wave device

Huge maximum output

(P+ max = 120 MPa)

Focusing

Power

Size

Characteristics of the cigar

(„Powerful but small“)

Delivers energy flux densities that can become dangerous to the patient

(EFDmax = 1.50 mJ/mm2)

Focus ways too large for shoulder, trigger points etc.

(fx5MPa max = 34.0 mm)

Energy flux density

characteristics of the1
Characteristics of the...

Example of another table-top device

Low maximum output

(P+ max = 47.7 MPa)

Weak focusing

Power

Size

Characteristics of the cigar

(„Powerful but small“)

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)

Energy flux density

characteristics of the2
Characteristics of the...

Example of another combined radial / focused shock wave device

Less maximum output

(P+ max = 62.0 MPa)

(measured: 51.4 MPa)

Focusing

Power

Size

Characteristics of the cigar

(„Powerful but small“)

Necessary energy

flux density

can be reached

(EFDmax = 0.55 mJ/mm2)

(measured: 0.167 mJ/mm2)

Focus larger than the focus of the Piezoclast

(fx5MPa max > 40 mm)

Energy flux density

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