FREQUENTLY ASKED QUESTIONS

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The therapeutic effects of shock waves on the musculoskeletal system (pain relief and healing) are based on a multitude of molecular and cellular mechanisms. Without going into detail, the main short term effects are depletion of presynaptic substance P in C nerve fibers (resulting in pain relief) and improved blood circulation in the treated area (forming the basis for healing). The main long term effects are blockade of neurogenic inflammation and improved tendons gliding ability (resulting in pain relief) and activation of mesenchymal stem cells as well as new bone formation (both essentially involved in healing).

Treatment over air-filled tissue (lung, gut), treatment of preruptured tendons, treatment of pregnant women, treatment of patients under the age of 18 (except for the treatment of Osgood-Schlatter disease), treatment of patients with blood-clotting disorders (including local thrombosis), treatment of patients treated with oral anticoagulants, treatment of tissue with local tumors or local bacterial and/or viral infections, treatment of patients treated with local cortisone injections (within the six-week period following the last local cortisone injection).

This can only be pain relief but not healing
It is fully correct that reduction of pain within a few days does not mean that healing took place in this short time. On the other hand, sustained and statistically significant pain relief even two years after treatment of chronic plantar fasciopathy with the Swiss DolorClast11 is a strong indicator of healing. The final proof of healing would require to take biopsies which, however, is not possible due to ethical reasons.

References:
11) Ibrahim MI, Donatelli RA, Hellman M, Hussein AZ, Furia JP, Schmitz C. Long-term results of radial extracorporeal shock wave treatment for chronic plantar fasciopathy: A prospective, randomized, placebo-controlled trial with two years follow-up. J Orthop Res Epub ahead of print on Aug 27, 2016.

In general this is possible. However, the following must be considered: (i) The Swiss DolorClast Method is not yet approved for the treatment of fresh injuries; related clinical research is ongoing. (ii) With regard to tendon pathology it is critical to note that there are no acute tendinopathies, only newly diagnosed ones. Safety and efficacy of the Swiss DolorClast Method for treating newly diagnosed tendinopathies was demonstrated in the international peer-review literature for plantar fasciopathy (Rompe et al., 201012), primary long bicipital tenosynovitis (Liu et al., 201213) and lateral or medial epicondylitis (Lee et al., 201214)

References:
12) Rompe JD, Cacchio A, Weil L Jr, Furia JP, Haist J, Reiners V, Schmitz C, Maffulli N. Plantar fascia-specific stretching versus radial shock-wave therapy as initial treatment of plantar fasciopathy. J Bone Joint Surg Am 2010;92:2514-2522.
13) Liu S, Zhai L, Shi Z, Jing R, Zhao B, Xing G. Radial extracorporeal pressure pulse therapy for the primary long bicipital tenosynovitis a prospective randomized controlled study. Ultrasound Med Biol 2012;38:727-735.
14) Lee SS, Kang S, Park NK, Lee CW, Song HS, Sohn MK, Cho KH, Kim JH. Effectiveness of initial extracorporeal shock wave therapy on the newly diagnosed lateral or medial epicondylitis. Ann Rehabil Med;36:681-687.

These conditions usually require great care and very gentle treatments. In particular, the handpiece of the Swiss DolorClast should not be pressed against the patient’s skin. Furthermore, the therapist should be aware that even the lowest settings of the Swiss DolorClast may be too much and the patient feel too much pain during treatment. In these cases the treatment should be stopped. Good patient’s compliance is usually achieved when explaining the patient before starting the treatment that it is worth a try but the treatment can be stopped at any time in case it is too painful.

Yes, this is possible. Loosening of implants or surgical osteosynthesis material (such as screws, plates, nails) after exposure to shock waves has not beed described in the literature. In any case, direct contact between the applicator of the Swiss DolorClast and implants or surgical osteosynthesis material should be avoided. Furthermore, shock waves should not be applied “through” implants or surgical osteosynthesis material in order to treat a pathology behind; the shock waves would not reach their target.

A cardiac pacemaker is not a contraindication for the Swiss DolorClast Method. In any case, direct exposure of a pacemaker and related wires to shock waves must be avoided by all means. Accordingly, treating of the left shoulder should be performed with great care in case the patient weares a cardiac pacemaker


No, a mild thinning of a tendon is not a contraindication for careful and mild use of the Swiss DolorClast Method. On the other hand, treatment of preruptured tendons is a contraindication. As a rule of thumb, tendons with a tear of more than 50% of the cross-sectional area must not be treated with shock waves. This is because of the pain relief the tendon could rupture during augmented physical strain

The Swiss DolorClast has not yet been approved for the treatment of erectile dysfunction. This is due to the fact that the clinical proofs that are available are not yet sufficient to predict good treatment outcome with sufficient probability.

A real frozen shoulder cannot be successfully treated with shock waves; this indication requires manual mobilization (under general anesthesia). On the other hand, it should be carefully evaluated whether the patient really suffers from a frozen shoulder. In case only a partial immobilization is present treatment with the Swiss DolorClast Method can substantially improve the situation. Other women may experience pain during shoulder movements because of a beginning or manifest secondary lymphedema (due to the resection of regional lymph nodes as part of the mastectomy surgery). The Swiss DolorClast is approved for the treatment of primary and secondary lymphedema, and good results were reported by Prof. Sandro Michelini (Rome, Italy).

If the patient already has lymphedema would ESWT help? Does the treatment parameter depend on whether the patient has had full axillary lymph node dissection or just sentinel node removal?
Development of lymphedema due to shock wave treatment has never been reported. Efficacy and safety of treating lymphedema with the Swiss DolorClast Method has been reported in the literature15, and the Swiss DolorClast is approved for this indication. It does not matter whether the patient has had full axillary node clearance or just sentinel node removal; of relevance is the clinical picture (i.e., the development of a secondary lymphedema). As a rule of thumb, treatment results will be better the sooner the therapy is started.

References:
15) Michelini S, Failla A, Moneta G, et al.: Treatment of primary and secondary lymphedema with shockwave therapy. Eur J Lymphol 2008;19:10.


Cording/ (axillary web syndrome) is not a contraindication of ESWT. Whether ESWT is successful in this condition needs to be established. Corresponding data have not been reported.

After surgery some patients have to delay radiotherapy treatment as they are unable to lift their arm above their head for treatment positioning. Physiotherapy is a good first option, but wondered if there is little or no positive response to physiotherapy if ESWT would be a useful tool in conjunction with physiotherapy. There is no clear answer to this question. In any case, ESWT should not interfere with wound healing (although ESWT could improve would healing after surgery). On the other hand, ESWT can be applied on those parts of the shoulder and the arm that are not directly affected by the surgery itself (such as the deltoid and upper trapezius muscles).

There are no data available to answer this question. Because radiotherapy may considerably damage the tissue, no shock waves should be applied to the same tissue during the time course of radiotherapy. The time interval between the last radiotherapy session and the first ESWT session should be at least one week in order to prevent potential negative interference between ESWT and healing of radiotherapy-induced tissue damage.

This question cannot be answered without taking the status of the rotator cuff into account. Tendons with a tear of more than 50% of the cross-sectional area must not be treated with shock waves. Accordingly, ESWT after subacromial decompression or rotator cuff repair must be preceded by diligent diagnostic imaging (MRT). In case no signs of tendon tear of the supraspinatus tendon and the rotator cuff are found, ESWT is possible 8 weeks after subacromial decompression or rotator cuff repair.

According to Wikipedia, “vulvodynia is a chronic pain syndrome that affects the vulvar area and occurs without an identifiable cause. Symptoms typically include a feeling of burning or irritation. For the diagnosis to be made symptoms must last at least 3 months. The exact cause is unknown but is believed to involve a number of factors, including genetics, immunology, and possibly diet. Diagnosis is by ruling out other possible causes. This may or may not include a biopsy of the area. Treatment may involve a number of different measures; however, none is universally effective, and the evidence to support their effectiveness is often poor. Some of these measures include improved vulvar care, dietary changes, medications, counselling, and, if conservative treatment is not effective, surgery. It is estimated to affect up to 16% of women.” The Swiss DolorClast Method is not approved for this conditions, because no data demonstrating efficacy and safety when treating this condition are available.

Indications of the Swis DolorClast Method are the following: tendinopathies, muscle aches and pain, ostheoartritis, fracture nonunions, spasticity, cellulite, acute and chronic soft tissue wounds and lymphedema.

The overall warranty of the products is 2 years. Only the maintenance kits in the handpiece have a lifetime limitation: 1 million for the Evo Blue handpiece and 600’000 for the Power+ handpiece.

Compressor: the level of liquid in the bottle needs to be checked every month by the user. The filters of the compressor need to be checked every year by the user.
Device: the device needs to be cleaned regularly.
Handpiece: O’rings should be replaced every 200’000 impulses, maintenance kit see question above.

The Swiss DolorClast Method is the most clinically proven shock wave technology, combined with education to provide end users with the best treatment outcomes.

It depends on 3 things:

  1. pathologies treated and their anatomical location within the human body: if a practitioner treats mostly tendinopathies, muscle pain, skin indications and ostheoarthritis, she/he will get excellent results with a Swiss DolorClast device. If the practitioner wants to treat mostly pseudoarthrosis or is a shoulder specialist, she/he should go for a Swiss PiezoClast.
  2. habit in the country: mostly because of the influence of the ISMST and DIGEST, in some countries it is difficult to push radial for orthopedists. So, I would recommend to go with a focused device.
  3. money to be spent: usually a focused device cost 2 times the price of a radial (in Europe around 20K for a focused device compared to approximately 10K for a radial device)

The Swiss DolorClast Classic is FDA approved as a “Generator, Shock Wave, For Pain Relief” device, Class III. It is the only radial device FDA approved as a shock waves one.
All our competitors have registered their radial devices with FDA as Electric Therapeutic Massagers (Class I). They are not allowed to use the terminology shock waves device. Furthermore, doctors in the USA must not bill treatments performed with these devices according to any Current Procedural Terminology (CPT) code. Electric Therapeutic Massagers are intended for minor muscle aiches and pain.

These terms are used by certain companies without providing technical and/or scientific details. It is reasonable to hypothesize that the term “defocused” should imply that there is no second focus point or no focus point at all, irrespective of whether the waves are convergent/concentrated, planar or radial. Furthermore, the term “planar” most probably means that the waves are linear and, thus, neither convergent/focused nor divergent/radial.

Whether defocused and planar shock waves show any scientific/medical advantage over radial waves has not been demonstrated in the literature.

Most of the clinical studies proved the efficacy of the Swiss DolorClast Method in 3 sessions. Nevertheless, there is no contraindication to apply more sessions as long as you see improvement in the patient’s condition. In most of the cases you should not go over 8 to 10 sessions.

We recommend keeping a week interval between two treatments to let the inflammation caused by shock wave treatment decrease. Nevertheless, if a patient is feeling well after 3-4 days without inflammatory signs such as redness or swelling, the next treatment can be done.

The higher the air pressure, the higher the energy density and cavitation level delivered to the patient (shown in Chitnis and Cleveland, 20061). Shock wave treatments are dose dependent. The air pressure should be set to the pain threshold of the patient.

References:
1) Chitnis PV, Cleveland RO. Acoustic and cavitation fields of shock wave therapy devices. In: Therapeutic Ultrasound. 5th International Symposium on Therapeutic Ultrasound (AIP Conference Proceedings Vol. 829). 1st edition. Edited by Clement GT, McDannold NJ, Hynynen K. College Park: American Institute of Physics; 2006:440-444.

Most of the clinical studies were designed with a fixed pressure (often above 3 bar) to be reproducible. But they do not take into account the patient feedback. According to a systematic analysis of more than 100 published randomized controlled trials on ESWT by Schmitz et al. (2015)1 ahock wave treatments are dose dependent: the higher the pressure, the better. A good practice during treatment is to ask for the biofeedback (pain level) of the patient and increase the pressure until you reach the pain threshold of the patient. You can do this at the beginning of the treatment, after 500 impulses and after around 1200 impulses.

Most of clinical studies were conducted with a frequency ranging from 6 to 10 Hz. The recent ones are now done with a frequency ranging from 10 to 15Hz. The influence of the frequency has not yet been clinically assessed except for its influence on the treatment time.
The trend is to treat tendinopathies with a frequency ranging between 10 and 12Hz, enthesiopathies with a frequency ranging between 12 and 15Hz, and muscle with a frequency ranging between 12 and 20Hz, depending on the skin surface above the indication and number of impulses.

Schmitz et al. (20152) showed that a good protocol is 2000 impulses for a treatment. Nevertheless, this is given a high energy per pulse and sticking to the painful point. The modern way of shock wave treatments tends to increase the number of impulses to 2500-4000 depending on the skin surface above the indication to be treated, thereby moving around the painful spot.

References:
2) Schmitz C, Császár NB, Milz S, Schieker M, Maffulli N, Rompe JD, Furia JP. Efficacy and safety of extracorporeal shock wave therapy for orthopedic conditions: a systematic review on studies listed in the PEDro database. Br Med Bull 2015;116:115-138.

The diameter of the applicator and thus, its weight influence the energy flux density and the cavitation field delivered. As a rule of thumb, the smaller the diameter, the higher the intensity and the smaller the cavitation field. Keep in mind that the maximum energy density is at the tip of the applicator.

It is also called the second pressure setting. By gently compressing the spring, you get closer to the pathology spot and thus deliver more energy to the targeted tissue. On top of that it absorbs part of the refracted wave. Only BTL and EMS have this feature.

Most of the clinical studies do not test this parameter keeping the applicator static on the spot. In terms of energy delivered it is efficient but not that much in terms of patient satisfaction. A good practice is to start away from the maximum painful spot, and gently move into the maximum painful spot.

In the early days of ESWT shock waves were considered a “Tier 2” or even “Tear 3” treatment, i.e., indicated only after application of other conservative treatments without success (for a very prominent example see the “Plantar Heel Pain Treatment Ladder” by Thomas et al., 20103) (Fig. 4 therein). The main reasons for this recommendations were (i) the belief that approximately 80% of all tendinopathies heal within one year without any treatment; (ii) the relatively high costs of ESWT compared to other treatment modalities; (iii) the fact that unlike ESWT, certain treatment modalities (such as cortison injections) were reimbursed in those countries where research on ESWT was performed; and (iv) the possibility to charge the same patient several times for inefficient treatments, that was not possible anymore after performing just a few ESWT sessions. However, more recent studies performed in countries with another reimbursement system (China, Korea) have shown that excellent results can be achieved with ESWT on newly diagnosed patients. Anyway, in case of acute pathologies it is recommended to wait 1 or 2 weeks in order not to be in the acute phase anymore of the pathology.

References:
3) Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, Weil LS Sr, Zlotoff HJ, Bouché R, Baker J; American College of Foot and Ankle Surgeons heel pain committee. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. 2010;49:S1-S19.

No it does not break bones or tendons because the energy density delivered is below 0.6 mJ/mm2 (even with the Power at 4 bar with the 15mm focus). Breaking of bones with shock waves was shown in experimental studies on dogs with energy flux densities of 5 mJ/mm2.

It should not hurt but should be discomfortable ((VAS score < 7)).

Yes, local anaesthetics can be used and does not harm. However, in case of chronic plantar fasciopathy it w shown in two independent studies that repetitive low-energy ESWT without local anaesthesia is more efficient than repetitive low-energy ESWT with local anesthesia (Labek et al., 20054; Rompe et al., 20055). The reason is that local anesthetics block peripheral nerve fibers including C nerve fibers. However, you cannot block C nerve fibers with local anesthetics and activate them with shock waves (Maier et al., 20036) at the same time. Furthermore, the application of local anesthetics limits and may even prevent biofeedback from the patient during the treatment.

References:
4) Labek G, Auersperg V, Ziernhöld M, Poulios N, Böhler N. Einfluss von Lokalanasthesie und Energieflussdichte bei niederenergetischer extrakorporaler Stosswellentherapie der chronischen Plantaren Fasziitis – Eine prospektiv-randomisierte klinische Studie. [Influence of local anesthesia and energy level on the clinical outcome of extracorporeal shock wave-treatment of chronic plantar fasciitis] [Article in German]. Z Orthop Ihre Grenzgeb 2005;143:240-246.
5) Rompe JD, Meurer A, Nafe B, Hofmann A, Gerdesmeyer L. Repetitive low-energy shock wave application without local anesthesia is more efficient than repetitive low-energy shock wave application with local anesthesia in the treatment of chronic plantar fasciitis. J Orthop Res 2005;23:931-941.
6) Maier M, Averbeck B, Milz S, Refior HJ, Schmitz C. Substance P and prostaglandin E2 release after shock wave application to the rabbit femur. Clin Orthop Relat Res 2003;406:237-245.

Yes, you can. In case of chronic midportion Achilles tendinopathy it was shown that the combination of radial ESWT and eccentric loading resulted in statistically significantly better clinical outcome than eccentric loading alone (Rompe et al., 20097), with radial ESWT being as effective as eccentric loading for this indication (Rompe et al., 20078). The same was shown for the combination of radial ESWT and plantar fascia-specific stretching in case of chronic plantar fasciopathy (Rompe et al., 20159).

References:
7) Rompe JD, Furia JP, Maffulli N. Eccentric loading versus eccentric loading plus shock-wave treatment for midportion Achilles tendinopathy: a randomized controlled trial. Am J Sports Med 2009;37:463-470.
8) Rompe JD, Furia JP, Maffulli N. Eccentric loading compared with shock wave treatment for chronic insertional Achilles tendinopathy. A randomized, controlled trial. J Bone Joint Surg Am 2008;90:52-61.
9) Rompe JD, Furia J, Cacchio A, Schmitz C, Maffulli N. Radial shock wave treatment alone is less efficient than radial shock wave treatment combined with tissue-specific plantar fascia-stretching in patients with chronic plantar heel pain. Int J Surg 2015;24:135-142.

No clinical study has been done on the interaction Shock Waves + cryotherapy. However, Dr. Marc Rozenblat (Centre Coralis, Ozoir La Ferrière, France) reported at the 2008 ATRAD congress (Berlin, Germany) the successful combination of shock wave therapy using the Swiss DolorClast and neurocryostimulation in approximately 7000 cases.

Yes, being clinically proven is one of the pillars of the Swiss DolorClast Method. Many randomized controlled trials (RCTs) demonstrating efficacy and safety of the Swiss DolorClast Method on different indications were published in the international peer-review literature. So far, 26 RCTs were published on the Swiss DolorClast Method, 15 of which have been listed in the PEDro database (search for “radial shock wave” at www.pedro.org.au).

This has not been tested in a clinical study. With regard to focused shock waves, no study listed in the PEDro database has tested the hypothesis that the application of 6000 shocks in a single session is as effective as (or more effective than) the application of 2000 shocks in three sessions.

ESWT has been developed to be conducted on both normal patients and athletes. The vast majority of RCTs on the Swiss DolorClast Method was performed on normal patients.

Yes, castor oil is better than standard contact gel according to Maier et al., 199910, “Castor oil decreases pain during extracorporeal shock wave application”. But it is recommended to use the standard contact gel provided with the device.

References:
10) Maier M, Staupendahl D, Duerr HR, Refior HJ.: Castor oil decreases pain during extracorporeal shock wave application. Arch Orthop Trauma Surg 1999;119(7-8):423-427.

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