ISMST Recommendations
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Naples, Italy, October 12th, 2016
Consensus Statement on
ESWT Indications and Contraindications
The members of the managing board, the Advisory board and the Senators of the International Society for Medical Shockwave Treatment (ISMST), have decided at the managing board meeting in Naples, Italy held on October 13th, 2016, to publish a set of clinical recommendations for using therapeutic shockwaves in clinical practice.
The recommendations were assembled based on an assessment of the current published scientific and clinical information and accepted approaches to treatment.
The recommendations are meant to aid the clinician in the use of shockwave medicine. In particular, the Guidelines are intended to clarify the indications and contraindications to treatment.
The recommendations are not intended to be a fixed protocol, as some patients may require more or less treatment depending on the clinical scenario. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances.
On behalf of the ISMST Managing Board,
Dr. José Eid
General Secretary of the ISMST
A. Introduction and prerequisites and minimal standards of performing ESWT
In order to prevent improper treatment, the following list contents the minimum
prerequisites and standard examinations performing ESWT:
1. Clinical examination
2. Radiological imaging
3. Neurological and/or laboratory-diagnostic tests and/or other investigations may be necessary to corroborate the diagnosis.
Only a qualified physician (certified by National or International Societies) may use focused shockwave therapy to treat pathologies, which have been determined by diagnostic testing.
For the treatment on bones, a high-energy, focused shockwave with positioning technology has to be used.
In accordance with most scientific evidence ISMST recommends to use focused generators and high energy levels to treat calcifications.
To treat superficial soft tissue conditions, devices with or without focusing technology may be utilized; close attention must be paid to the depth of penetration of the shockwave source when treating deep tissue structures.
B. INDICATIONS
1. Approved standard indications
1.1.Chronic Tendinopathies
1.1.1. Calcifying tendinopathy of the shoulder
1.1.2. Lateral epicondylopathy of the elbow (tennis elbow)
1.1.3. Greater trochanter pain syndrome
1.1.4. Patellar tendinopathy
1.1.5. Achilles tendinopathy
1.1.6. Plantar fasciitis, with or without heel spur
1.2.Bone Pathologies
1.2.1. Delayed bone healing
1.2.2. Bone Non-Union (pseudarthroses)
1.2.3. Stress fracture
1.2.4. Avascular bone necrosis without articular derangement
1.2.5. Osteochondritis Dissecans (OCD) without articular derangement
1.3.Skin Pathologies
1.3.1. Delayed or non-healing wounds
1.3.2. Skin ulcers
1.3.3. Non-circumferential burn wounds
2. Common empirically-tested clinical uses
2.1.Tendinopathies
2.1.1. Rotator cuff tendinopathy without calcification
2.1.2. Medial epicondylopathy of the elbow
2.1.3. Adductor tendinopathy syndrome
2.1.4. Pes-Anserinus tendinopathy syndrome
2.1.5. Peroneal tendinopathy
2.1.6. Foot and ankle tendinopathies
2.2.Bone Pathologies
2.2.1. Bone marrow edema
2.2.2. Osgood Schlatter disease: Apophysitis of the anterior tibial tubercle
2.2.3. Tibial stress syndrome (shin splint)
2.3.Muscle Pathologies
2.3.1. Myofascial Syndrome
2.3.2. Muscle sprain without discontinuity
2.4.Skin Pathologies
2.4.1. Cellulite
3. Exceptional indications – expert indications
3.1.Musculoskeletal pathologies
3.1.1. Osteoarthritis
3.1.2. Dupuytren disease
3.1.3. Plantar fibromatosis (Ledderhose disease)
3.1.4. De Quervain disease
3.1.5. Trigger finger
3.2.Neurological pathologies
3.2.1. Spasticity
3.2.2. Polyneuropathy
3.2.3. Carpal Tunnel Syndrome
3.3.Urologic pathologies
3.3.1. Pelvic chronic pain syndrome (abacterial prostatitis)
3.3.2. Erectile dysfunction
3.3.3. Peyronie disease
3.4.Others
3.4.1. Lymphedema
4. Experimental Indications
4.1.Heart Muscle Ischemia
4.2.Peripheral nerve lesions
ISMST – International Society for Medical Shockwave Treatment
File: ISMST consensus statement on indications and contraindications 20161012 final 4 / 4
4.3.Pathologies of the spinal cord and brain
4.4.Skin calcinosis
4.5.Periodontal disease
4.6.Jawbone pathologies
4.7.Complex Regional Pain Syndrome (CRPS)
4.8.Osteoporosis
C. CONTRAINDICATIONS
1. Radial and focused waves with low energy
1.1.Malignant tumor in the treatment area (not as underlying disease)
1.2.Fetus in the treatment area
2. High energy focused waves
2.1.Lung tissue in the treatment area
2.2.Malignant tumor in the treatment area (not as underlying disease)
2.3.Epiphyseal plate in the treatment area
2.4.Brain or Spine in the treatment area
2.5.Severe coagulopathy
2.6.Fetus in the treatment are
San Sebastian, Spain, June 20th 2017
ISMST consensus statement Terms and Definitions
The Managing Board of the ISMST (International Society for Medical Shockwave Treatment) has decided to update and publish the following statement regarding the following terms.
Focused or Defocused Extracorporeal Shockwaves
Generation: Piezoelectric, Electromagnetic, Electrohydraulic
Indications: See ISMST – website
Application: Trained Physicians
Radial Pressure Waves
Generation: Air pressure or Electromagnetic Coils
Indications: See ISMST – website
Application: Trained Physicians; after previous diagnosis of physician trained nurses or physiotherapist may perform ESWT
Dr. José Eid
ISMST General Secretary
Representing the Managing Board
Recommendation statement of the Conjoint Physics Working Group
of ISMST and DIGEST on ESWT study design and publication
| Edited by: | |
| Dr. Matias de la Fuente | RWTH Aachen University, Chairman of the Working Group |
| Dr. Vinzenz Auersperg | DIGEST and ISMST |
| Kristin Dietz-Laursonn, M.Sc. | RWTH Aachen University |
| Dr. Siegfried Ginter | Richard Wolf |
| Christian Dorfmüller | Nonvasiv |
| Dr. Whala Khaled | Dornier |
| Prof. Friedrich Ueberle | HAW Hamburg |
| Maxime Fournier | EMS |
| Dr. Rainer Pecha | RPacoustics |
| Peter Vallon | Likamed |
| Dr. Werner Schwarze | Jena MedTech |
| Ralph Reitmajer | MTS |
This statement is the final conclusion of the editors mentioned above as the result of a conjoined meeting of the Physics Working Group of ISMST and DIGEST, which was held at Berlin on October 21st, 2015.
The group has been called together under auspices of ISMST and DIGEST due to the ongoing discussion about the physical parameters used for the description of ESWT setup.
The editors conclude, that the use of currently established shockwave parameters to describe the physical conditions during in-vitro or clinical studies is insufficient as:
- We don‘t know yet the key effect of shock waves on tissue, the biological response is not clear as well as the best “shape” (spatial and temporal pressure distribution) of the shock
waves to be the most effective. - Therefore it is unclear, which shockwave parameters (as defined in IEC 61846) should be used to describe the clinical efficacy and to compare devices or if even new parameters need to be introduced.
- Currently only few parameters are used by the ESWT community, such as:
-
- Peak positive and negative acoustic pressure
- Derived pulse intensity integral (= ED)
- Total energy (-6dB)
- Focal extension in x-, y- and z-direction
- Number of pulses
- Pulse repetition rate (Hz)
But these usually don’t suffice to describe the sound field, because of the complex 3- dimensional distribution of the sound pressures and the influence of the tissue.
- We have to be cautious as one has to know how to read and interpret the parameters. Depending on the measurement setup and on the SW technology the meaning and significance of the parameters may vary a lot.
- Without further investigation, it cannot be expected in near future, that there will be a way to improve the comparability of different devices and techniques:
-
- Electrohydraulic applicators versus electromagnetic or piezoelectric ones: The
measurements at electrohydraulic devices are usually mean values because each
spark varies a little, so that each spark produces different shock waves - Radial and focusing applicators: The sound fields are very different and the
parameters are not defined in the same way, especially as most shockwave
parameters from IEC 61846 refer to the focal point.
- Electrohydraulic applicators versus electromagnetic or piezoelectric ones: The
- We need a rating and ranking of all measurable parameters
-
- Which parameters could be interesting (& should therefore be mandatory to be published in clinical studies)
- At the moment not enough parameters are mentioned at the publications
- It should be investigated, which additional parameters could be helpful to improve the physical description of what is used performing ESWT with all the different devices and their different techniques (focal, radial,planar, and defocused ESWT).
- Device approval is one reason for the problems:
-
- Currently, it is shown by “technical equivalence” or “substantial equivalence” based on few (unimportant?) technical parameters?
- But safety alone does not show clinical effectiveness.
- Clinical equivalence has to be shown.
The editors came to an agreement for the following recommendations:
- For clinical studies and in-vitro studies:
1.1. Get support from technicians of the device manufacturer from the beginning of the planning of the experimental study design until the interpretation of the outcome.
1.2. Clinicians should perform studies in conformance with „good clinical practice“ and describe every variable which might influence the clinical outcome
1.2.1. Description of indication
1.2.2. Description of the target to be treated
1.2.3. Measurement and documentation of the success including the definition of „success“
1.2.4. Documentation of all additional (non-shockwave) treatments (including anesthesia)
1.2.5. Number of sessions
1.2.6. Time between sessions
1.2.7. Number of pulses per session
1.2.8. Pulse repetition rate (my influence cavitation)
1.2.9. Navigation technique (how to find the target, e.g. Ultrasound, focused shockwave to find most painful spot, …)
1.3. Furthermore specify all parameters for the treatment settings of their devices which influence the sound field:.
1.3.1. Shockwave device
1.3.2. Shockwave head / applicator (name, model number, physical principle,
focused/radial/,…)
1.3.3. Intensity levels
1.3.4. All material interfaces the sound has to penetrate during in-vitro experiments
(geometries and materials between the transducer head and a few cm behind the focal point)
1.3.5. Coupling medium used and how it was applied
1.3.6. Penetration depth of focused device (skin to focal spot distance)
1.3.7. Treatment protocol (e.g. changes of device settings over time, movement of transducer…)
1.4. If not device settings but shockwave parameters (according to IEC 61846) are published, the origin of the data has to be referenced.
- For companies:
2.1.Provision of sound field parameters (as well as information concerning their
measurement) in a database, which will be created and published online by ISMST and DIGEST and support researches by interpretation of the parameters by direct contact.
2.2.Support of researchers in planning of in-vitro and in-vivo studies (setup, execution) and interpretation of the sound field data, especially when results are compared to other studies.
Berlin, October 21st, 2015
Dr.-Ing. Matias de la Fuente Klein
Chairman ISMST Physics Workinggroup
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