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The Swiss DolorClast® Method – Shockwave Therapy

Frequently Asked Questions

Learn more about The Swiss DolorClast Method – Shockwave Therapy by reading our frequently asked questions (FAQ).

Swiss DolorClast Shockwave System

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

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 have been published in the international peer-review literature. So far, 26 RCTs have been 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)

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

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 (which is the basis for healing). The main long-term effects are blockade of neurogenic inflammation and improved tendon gliding ability (resulting in pain relief) as well as activation of mesenchymal stem cells and new bone formation (both essentially involved in healing).

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

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.

The Swiss DolorClast Classic is FDA approved as a “Generator, Shock Wave, For Pain Relief” device, Class III. It is the only FDA approved shock wave radial device.

All our competitors have registered their radial devices with the FDA as Electric Therapeutic Massagers (Class I). They are not allowed to use the terminology shock wave device. Furthermore, doctors in the USA must not bill treatment performed with these devices according to any Current Procedural Terminology (CPT) code. Electric Therapeutic Massagers are intended for minor muscle aches and pain.

Swiss DolorClast Shockwave Operation

Most of the clinical studies do not test this parameter by keeping the applicator static on the spot. In terms of energy delivered it is efficient but no so good from the standpoint of patient satisfaction. A good approach is to start away from the most painful spot and gently move toward the most painful spot.

Yes, castor oil is better than standard contact gel according to Maier et al., 199910, “Castor oil decreases pain during extracorporeal shock wave application”. However, 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

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 treatment is 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 clinical studies have been conducted with a frequency ranging from 6 to 10 Hz. Recent studies now use a frequency ranging from 10 to 15Hz. The influence of the frequency has not yet been clinically assessed except for its influence on treatment duration.

The trend is to treat tendinopathies with a frequency in the range of 10 to 12Hz, enthesiopathies with a frequency in the range of 12 to 15Hz, and muscle with a frequency in the range of 12 to 20Hz, depending on the skin surface above the indication and the number of impulses.

Schmitz et al. (20152) showed that a good protocol is 2,000 impulses per treatment. Nevertheless, this is for a high energy per pulse, sticking to the painful point. The modern approach to shock wave treatment tends to increase the number of impulses to 2,500-4,000 depending on the skin surface above the indication to be treated, and 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 and therefore the weight of the applicator 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.

Most of the clinical studies were designed using 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 shock wave treatment is dose dependent: the higher the pressure, the better. A good practice during treatment is to ask for the patient’s biofeedback (pain level) and increase the pressure until you reach the patient’s pain threshold. You can do this at the beginning of treatment, after 500 impulses and after around 1200 impulses.

There are no data available to answer this question. Because radiotherapy can damage tissue considerably, no shock waves should be applied to the same tissue during a 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.

Swiss DolorClast Shockwave Treatment

The Swiss DolorClast method is suitable for the following indications: tendinopathies, muscle pain, ostheoartritis, non-union fractures, spasticity, cellulitis, acute and chronic soft tissue wounds and lymphedema.

The Swiss DolorClast has not yet been approved for the treatment of erectile dysfunction. This is because there is no sufficient clinical evidence to predict a good treatment outcome with a high enough probability.

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

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

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. If there is only partial immobilization, treatment with the Swiss DolorClast method can substantially improve the situation. Other women may experience pain during shoulder movements because of an incipient or existing secondary lymphedema (due to 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).

In the early days of ESWT shock waves were considered a “Line 2” or even “Line 3” treatment, i.e., indicated only after application of other conservative treatment protocols 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 these 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 cortisone injections) were reimbursed in countries where research on ESWT was performed; and (iv) the possibility to charge the same patient several times for inefficient types of treatment, which 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. However, in case the pathology is in the acute phase, it is recommended to wait 1 or 2 weeks in order not to be in the acute phase anymore.

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.

Development of lymphedema due to shock wave treatment has never been reported. The treatment of lymphedema with the Swiss DolorClast method has been reported to be efficient and safe in the literature15. The Swiss DolorClast is approved for this indication. It does not matter whether the patient has had full axillary node clearance or just the sentinel nodes removed; what is relevant is the clinical picture (i.e. the development of a secondary lymphedema). As a rule, the earlier the treatment is started, the better the outcome.

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.

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

There is no clear answer to this question. In any case, ESWT should not interfere with wound healing (although ESWT could improve wound healing after surgery). On the other hand, ESWT can be applied on those parts of the shoulder and arm that are not directly affected by the surgery itself (such as the deltoid and upper trapezius muscles).

We recommend keeping a one-week interval between two sessions 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 given.

It is absolutely correct that reduction of pain within a few days does not mean that healing has taken place in such a short time. On the other hand, sustained and statistically significant pain relief even two years after treatment of chronic plantar fasciopathy with the Swiss DolorClast method11 is a strong indicator of healing. The final proof of healing would require taking biopsies which is not possible for 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.

Yes, local anesthetics can be used and are not harmful. However, in case of chronic plantar fasciopathy it was shown in two independent studies that repetitive low-energy ESWT without local anesthesia 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 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.

In general, this is possible. However, the following points 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.

Yes, you can. In case of chronic midportion Achilles tendinopathy, it was shown that the combination of radial ESWT and eccentric loading resulted in a statistically significant improvement in clinical outcome compared to eccentric loading alone (Rompe et al., 20097), 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.

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). If there are no signs of tendon tear of the supraspinatus tendon and rotator cuff, ESWT is possible 8 weeks after subacromial decompression or rotator cuff repair.

These conditions usually require great care and very gentle treatment. 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 cause excessive pain during treatment. In these cases the treatment should be stopped. Good patient compliance is usually achieved when explaining to the patient that it is worth a try and that the treatment can be stopped at any time if it is too painful.

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

Yes, this is possible. Loosening of implants or surgical osteosynthesis material (such as screws, plates, nails) after exposure to shock waves has not been reported 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” an implant or surgical osteosynthesis material in order to treat a pathology located behind it; shock waves would not reach their target.

A cardiac pacemaker is not a contraindication for the Swiss DolorClast method. However, direct exposure of a pacemaker and its wires to shock waves must be avoided at all cost. Accordingly, treatment of the left shoulder should be performed with great care in case the patient has a cardiac pacemaker.

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 6,000 shocks in a single session is as effective as (or more effective than) the application of 2,000 shocks in three sessions.

Swiss DolorClast Shockwave Contraindications

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 tumours 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).

Cording (axillary web syndrome) is not a contraindication of ESWT. Whether ESWT is successful in this case needs to be established. No data have been reported on the subject so far.

No, 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 pre-ruptured tendons is a contraindication. As a general rule, tendons with a tear of more than 50% of the cross-sectional area must not be treated with shock waves. This is because due to pain relief, the tendon could rupture during augmented physical strain.

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The DolorClast® app is the reference in Radial Extracorporeal Shock Wave Therapy and features the Original Swiss DolorClast® Method invented by EMS Electro Medical Systems of Nyon, Switzerland.

Now available in 7 different languages – English, German, French, Spanish, Italian, Portuguese and Russian -, this app is an all-in-one educational and therapeutic guide.

The update includes a unique VAS pain scale measuring patients’ pain intensity. The app also provides medical descriptions, contraindications, treatment protocols, clinical reference studies and treatment videos for 17 conditions including chronic tendinopathies of the musculoskeletal system such as plantar fasciopathy or Achilles insertional tendinopathy.

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