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What is SoftWave Therapy?
SoftWave Therapy is non-focused, parallel shockwaves sent through the body with the use of the Orthogold 100 device, which is made in Germany. While this is still under the umbrella of Extracorporeal Shockwave Therapy, most research has been conducted with Focused Shockwave devices and Radial Pressure Wave devices. As this device is different than conventional devices that have a lot of data one would assume that it would have the same effects as more established devices.
Research on SoftWave Therapy
Because there is a placebo effect with any treatment, showing some improvement in a patient population with a specific condition is not enough. There must be a comparison as well as follow up after treatment, months later, to see if an effect is lasting.
Finding any research on SoftWave was very difficult. This study on bone density did not show any difference after one session using an unfocused, parallel shockwave device.
Another research article on mice used an Orthogold 100 device and was able to show improvements in nerve growth as well as myelin sheath cell proliferation or increase of the Schwann cells.
An article on Plantar Fasciitis showed significant improvement following unfocused shockwave treatment with an Orthogold 100.
It appears that the company is quoting or referencing studies that have been done with other devices, focused and radial. There are some studies that show that the Orthogold 100 shockwave can have positive effects on different inflammatory conditions and injuries.
SoftWave or unfocused shockwave devices should go through more research to show its effectiveness as it compares with focused and radial devices. It does appear though that it has similar effects to focused shockwave and radial pressure wave therapy.
Is SoftWave FDA Approved?
The SoftWave Therapy website makes a statement that it is an FDA cleared device. They did not have any links to corroborate this statement.
Reviewing the FDA 510K webpage showed that the SoftWave TRT company, or parent company Tissue Regenerative Technologies LLC, listed their device as a medical massager. Hmm. Also, the FDA report is a premarket notification stating that the company is wanting to sell the device in the US. When a company says their device is FDA cleared, my assumption is that it has data to support its claims. The FDA report is about a premarket notification to sell the device and that the company will comply with the provisions in the act on safety and production.
The SoftWave website seems to be designed primarily to market the sale of their machine and that is the primary focus. They did not include working links for their claims related to their device, such as FDA premarket notification. A little misleading but this should not prevent someone from getting Shockwave Therapy treatment.
Our recommendation is that if you try SoftWave Therapy and it does not work, don't give up, look for a clinic or practitioner that is using a Radial Pressure Wave Therapy device and providing hands on manual therapy treatments as well as coaching as part for your care. This combination is the best way to maximize your change of success.
COMBINE SHOCKWAVE THERAPY WITH MANUAL MEDICINE AND COACHING FOR BEST RESULTS
We recommend Radial Pressure Wave Therapy devices as they are more suited for orthopedic conditions that require a lower depth. For more on this subject, check out this link on an overview of Shockwave Therapy.
SoftWave Therapy not Working? Try Radial Pressure Wave Therapy
Other terms used are Extracorporeal Pulse Activation Therapy (EPAT) and StemWave Therapy. These are marketing terms in an attempt at branding. The devices shown on these websites appear to be an unfocused, parallel device similar to the SoftWave device, Orthogold 100. Other EPAT devices appeared to be a specific focused shockwave device with a different label on the device itself. We found one website that had re-branded a Storz model device with the company's name and casing.
BE AWARE OF MARKETING. LOOK FOR A RADIAL PRESSURE WAVE DEVICE.
At the end of the day, Extracorporeal Shockwave Therapy is a great treatment option. Especially when combined with a clinical evaluation and treatment by an orthopedic specialist such as a Physical Therapist.
A RADIAL DEVICE IS THE BEST DEVICE FOR ORTHOPEDIC CONDITIONS
Check out Tissue Regenerative Therapy as it combines Shockwave Therapy with a clinical evaluation including diagnostic ultrasound, manual therapy or hands-on treatment and manipulation, and coaching.