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Women who have had a mastectomy, with or without axillary node clearance often develop a frozen shoulder - either fairly soon after surgery or a few months to a year later. Would ESWT help in this situation?

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).

Is there a risk of lymphedema from ESWT treatment if there is no lymphedema in the first place? 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 the sentinel nodes removal?

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.

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

Is cording a contraindication or does the treatment help in this case?

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.

How soon after surgery can ESWT treatment be performed? After surgery, some patients have to delay radiotherapy treatment as they are unable to lift their arm above their head for treatment. Physiotherapy is a good first option but if there is little or no positive response to physiotherapy, is ESWT 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 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).

Does radiotherapy play any part in the treatment parameters?  What is the timing between radiotherapy and the start of ESWT?

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.

The patient is 8 weeks post-op after a subacromial decompression or rotator cuff repair. Is it OK to have RSWT?

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.

Is the Swiss DolorClast the only radial shock wave device that is FDA approved?

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.

What is the difference between defocused and planar?

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.

Number of sessions: all your protocols mention 3 sessions. Can there be more sessions?

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.

Can I use it more often than once a week?

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.