SoftWave therapy is a type of shockwave treatment that sends acoustic pressure waves into injured or painful tissue to stimulate healing. It uses an electrohydraulic spark to generate unfocused shockwaves that spread across a broad treatment area, distinguishing it from the more targeted focused shockwave devices used in other medical settings. Sessions typically last 10 to 15 minutes, and the technology is FDA-cleared for specific wound-healing applications, though it’s most commonly marketed for musculoskeletal pain.
How the Technology Works
SoftWave devices create shockwaves using an electrohydraulic generator, which produces a spark gap that instantly generates a pressure wave. These waves rise from normal pressure to between 5 and 120 megapascals in just 5 nanoseconds, then drop to negative pressure values around -20 megapascals. The entire pulse lasts about 10 microseconds. That rapid pressure swing is what makes a shockwave different from ordinary ultrasound: it’s a brief, intense mechanical event rather than a continuous vibration.
When the positive pressure phase hits tissue, energy is absorbed, reflected, and transmitted through cells. This mechanical stress increases the permeability of cell membranes, essentially giving cells a physical nudge. During the negative pressure phase, tiny air bubbles form at tissue interfaces, a phenomenon called cavitation. Those bubbles then collapse at high speed, creating secondary micro-jets of fluid that deliver an additional wave of mechanical stimulation. The combined effect triggers cells to release ATP, the molecule your cells use as an energy currency, which then activates signaling cascades that promote cell proliferation and tissue repair.
What Happens Inside Your Body After Treatment
The mechanical stimulation from shockwaves kicks off a chain of biological responses. One of the most studied effects is the recruitment of mesenchymal stem cells, which are versatile cells your body uses to build and repair connective tissues like bone, cartilage, and tendon. Animal research has shown that a single shockwave session significantly increases total cell density in a defect area and boosts the proportion of cells actively differentiating into tissue-building types.
Shockwave treatment also increases the expression of two key growth signals. The first, TGF-beta 1, ramps up almost immediately after treatment and acts as a chemical beacon that draws stem cells toward the injury site. The second, VEGF (vascular endothelial growth factor), follows after a brief lag and promotes the formation of new blood vessels. Better blood supply means more oxygen and nutrients reaching damaged tissue, which is essential for healing. Together, these signals create a pro-regenerative environment: stem cells migrate in, new blood vessels form, and tissue rebuilding accelerates.
SoftWave vs. Other Shockwave Devices
Not all shockwave therapy is the same, and the differences matter. There are three main categories: focused shockwaves, radial (dispersive) shockwaves, and unfocused shockwaves like SoftWave. Each delivers energy differently.
- Focused shockwaves concentrate energy at a specific depth inside the body, typically 10 to 12 centimeters below the surface. The pressure wave rises and falls in about 10 nanoseconds, and the energy converges at a precise focal point. This is the same principle used in lithotripsy to break kidney stones. It’s powerful and targeted but treats a small area.
- Radial shockwaves have their maximum energy right at the device tip and disperse outward in all directions, losing strength quickly. They penetrate up to about 3.5 centimeters and have a slower pressure rise (5 to 10 microseconds). These are the most widely available shockwave devices in physical therapy clinics.
- Unfocused shockwaves (SoftWave) fall somewhere between the two. They spread energy over a larger treatment area than focused devices without concentrating it at a single point. This broader distribution is intended to treat wider regions of tissue in a single application.
The practical takeaway: radial devices are shallow and dispersive, focused devices are deep and precise, and SoftWave covers a middle ground with broader but less concentrated energy delivery.
What SoftWave Is FDA-Cleared For
The FDA has cleared the SoftWave device (marketed as the OW100S) for two specific indications. The first is chronic, full-thickness diabetic foot ulcers in adults 22 and older, specifically wounds no larger than 16 square centimeters that have been present for more than 30 days. These ulcers can extend through the skin, tendon, or joint capsule but must not expose bone. The second clearance covers superficial partial-thickness second-degree burns in adults, also 22 and older. In both cases, the device is cleared for use alongside standard wound care, not as a standalone treatment.
Many clinics market SoftWave for a much broader list of conditions: plantar fasciitis, knee arthritis, shoulder tendinopathy, back pain, and more. These are considered off-label uses. That doesn’t mean they’re ineffective, but it does mean the FDA hasn’t specifically reviewed evidence for those applications through the clearance process. Shockwave therapy in general has a substantial body of research supporting its use in musculoskeletal conditions, but the specific SoftWave device’s evidence base for those uses is less robust than the marketing sometimes suggests.
What a Treatment Session Looks Like
A typical SoftWave session lasts about 10 to 15 minutes. A provider applies gel to the skin (similar to an ultrasound exam) and moves the device’s applicator over the treatment area. You’ll feel pulsing sensations that can range from mild tapping to moderately uncomfortable depending on the area being treated and the energy level used. Pain is generally tolerable, and no anesthesia is needed.
Most treatment plans start with one session per week for three to six weeks. Progress is usually evaluated after the first three sessions to determine whether the therapy is producing results. Some providers extend treatment beyond six weeks or recommend periodic maintenance sessions, but the core protocol is relatively short. Many patients report some improvement within the first few sessions, though the biological healing processes triggered by the treatment continue working for weeks afterward.
Side Effects and Safety Concerns
SoftWave therapy is considered low-risk. The most common side effects are temporary skin redness, mild bruising, and soreness at the treatment site. These typically resolve within a day or two. Less common complications can include swelling, blood pooling under the skin, and nerve irritation. There is also a theoretical risk of tendon rupture, though this is rare and more of a concern with high-energy focused shockwave devices.
The treatment should not be used over areas containing a malignant tumor or over a developing fetus. Higher-energy shockwave protocols carry additional restrictions, including avoidance near lung tissue, the brain, the spine, growth plates in children, and in patients with severe blood clotting disorders. If you have a pacemaker or other implanted device, discuss this with your provider before treatment.
Cost and Insurance Coverage
SoftWave therapy typically costs between $150 and $250 per session. A full course of treatment (three to six sessions) runs roughly $450 to $1,500 out of pocket. Medicare and some Medicare Advantage plans currently cover the therapy, but Medicaid does not. Most private insurance plans do not cover SoftWave, though some may reimburse for specific approved conditions. It’s worth calling your insurer before starting treatment to check whether your particular diagnosis qualifies for any coverage. Many clinics offer package pricing or payment plans to offset the cost.