By Dr. Dave Bourgouin, DC · Chiro858, Solana Beach
SoftWave is a brand of shockwave therapy. A handheld applicator sends acoustic pressure pulses through the skin into sore muscles, tendons, and connective tissue. There are no needles or medication, and a session is short.
Two fair questions come up. How does it work, and does it actually help? Here’s what we can tell you, including the parts of the research that are still unsettled.
How SoftWave works
Inside the applicator, a high-voltage spark fires in water. That spark creates acoustic waves that pass through a water-filled membrane and a layer of gel into the treatment area. The FDA’s device summary describes the result as “unfocused pressure pulses.” SoftWave calls them “broad-focused,” meaning the energy spreads across a wider area instead of concentrating at one point.
That’s different from the other main types of shockwave therapy:
- Focused shockwave concentrates its energy at a chosen depth under the skin.
- Radial shockwave is strongest at the skin surface and spreads out from there. Researchers describe radial waves as lower-intensity pressure waves made by an air-driven mechanism, so they aren’t true shockwaves in the technical sense.
Why does the type matter? Because most shockwave studies used focused or radial devices, not SoftWave’s. Results from one kind of machine don’t automatically carry over to another.
What FDA clearance covers
The FDA has cleared SoftWave’s devices through its 510(k) process. That means the FDA found them “substantially equivalent” to devices already on the market. It isn’t the same as the FDA reviewing proof that a device works for a particular condition.
For muscles and joints, the cleared uses are relief of minor muscle aches and pains, a temporary increase in local blood circulation, and activation of connective tissue. Separate clearances cover certain chronic diabetic foot ulcers and second-degree burns in adults.
None of the SoftWave clearances listed in the FDA’s database names a specific orthopedic condition like plantar fasciitis or tendinitis. We’d rather you hear that from us.
What the research shows, by condition
Shockwave therapy has been studied for many muscle and tendon problems, and the results depend a lot on the condition.
Heel pain (plantar fasciitis). This is one of the better-supported uses. A 2024 meta-analysis of 11 randomized trials concluded that it “seems to be an effective and tolerable treatment” for plantar heel pain. Older 2009 guidance from the UK’s National Institute for Health and Care Excellence (NICE) called the efficacy evidence inconsistent, so the picture isn’t unanimous.
Tennis elbow. A 2020 meta-analysis of 13 trials with 1,035 patients found better pain and grip-strength results with shockwave than with other treatments. The authors noted the studies were limited in quality and number. A 2005 Cochrane review found only minimal benefit compared with placebo.
Outer hip pain (greater trochanteric pain syndrome). A 2015 review found moderate evidence that shockwave did better than home exercise and cortisone injections. A more recent review of 18 hip and pelvis studies said it “may be safe and effective.” Side effects showed up in about 12 percent of patients.
Shoulder (rotator cuff, with or without calcium deposits). A 2020 Cochrane review of 32 trials found “very few clinically important benefits.” On a 0 to 10 pain scale, people treated with shockwave averaged less than 1 point better than placebo.
Achilles and patellar tendons. A 2023 meta-analysis rated the Achilles evidence as very low quality and inconclusive. A 2026 network meta-analysis found no significant benefit over placebo for patellar tendinopathy (jumper’s knee).
Low back pain. Two 2023 meta-analyses found modestly lower pain scores with shockwave. A 2011 review found the evidence didn’t support it. We’d call this area promising but early.
What a session is like
According to SoftWave, a session usually takes 5 to 10 minutes with no anesthesia. The company says a standard plan is one treatment a week for 3 to 5 weeks. A UK hospital’s patient guide for a different shockwave device describes something similar: 5 to 10 minute sessions, usually three of them a week apart.
You’ll feel the pulses, and it can be uncomfortable. Tell us, and we’ll adjust the intensity to what you can tolerate.
Side effects
Most side effects are minor. That same UK hospital guide lists mild discomfort, skin redness, and bruising. It also notes a very small risk of increased pain or a tendon rupture.
The 2020 Cochrane shoulder review found that side effects were more common with shockwave than placebo, about 26 in 100 people compared with 7 in 100. They were mostly treatment pain, bruising, and bleeding, and “generally minor and short-lived.”
Who should skip it or check first
Shockwave therapy isn’t recommended for everyone. Talk with your doctor first, and let us know, if you:
- are pregnant
- have a bleeding disorder or take blood thinners
- have cancer or a tumor in the area to be treated
- have a pacemaker or another implanted heart device
- have an infection in the area
- have a fully torn tendon
- had a cortisone injection in the area recently (one UK hospital waits 12 weeks)
In children and teens, it shouldn’t be applied over growth plates.
Cost and insurance
Many insurers treat most muscle and joint uses of shockwave as unproven. Aetna’s policy, for example, covers it only for certain calcific shoulder tendinitis and lists tennis elbow, low back pain, and Achilles problems as experimental. SoftWave itself says it’s “generally a cash-pay procedure” for musculoskeletal conditions. Ask our front desk about cost before you start, and see our financial options.
Is SoftWave a fit for you?
It depends on what’s causing your pain. Your first visit starts with a health history and an exam of your posture, movement patterns, and spinal alignment. We assess the patient as a whole. If SoftWave therapy makes sense for what we find, we’ll talk through what the research says for your condition and what a reasonable plan looks like.
Call us at (858) 481-2481 or request an appointment. We’re at 320 S Cedros Ave, Suite 320, in Solana Beach.
This article is general information and not a substitute for an in-person exam. If you have pain or a symptom that concerns you, talk with your doctor or call our office.
Sources
- U.S. Food and Drug Administration. 510(k) summary K213120, OW100S (SoftWave TRT). 2022.
- U.S. Food and Drug Administration. 510(k) summary K231710, OW100S (SoftWave TRT). 2023.
- SoftWave TRT. Frequently Asked Questions. Manufacturer information.
- SoftWave TRT. Shockwave Therapy Contraindication: When Not to Use It. Manufacturer information.
- National Institute for Health and Care Excellence. Extracorporeal shockwave therapy for calcific tendinopathy in the shoulder.
- De la Corte-Rodríguez H, et al. Extracorporeal shock wave therapy for the treatment of musculoskeletal pain: a narrative review. Healthcare, 2023.
- Lippi L, et al. Efficacy and tolerability of extracorporeal shock wave therapy in patients with plantar fasciopathy: a systematic review with meta-analysis and meta-regression. European Journal of Physical and Rehabilitation Medicine, 2024.
- National Institute for Health and Care Excellence. Extracorporeal shockwave therapy for refractory plantar fasciitis. 2009.
- Yao G, Chen J, Duan Y, Chen X. Efficacy of extracorporeal shock wave therapy for lateral epicondylitis: a systematic review and meta-analysis. BioMed Research International, 2020.
- Buchbinder R, et al. Shock wave therapy for lateral elbow pain. Cochrane Database of Systematic Reviews, 2005.
- Mani-Babu S, et al. The effectiveness of extracorporeal shock wave therapy in lower limb tendinopathy: a systematic review. American Journal of Sports Medicine, 2015.
- Rau OR, et al. Extracorporeal shockwave therapy for tendinopathies around the hip and pelvis: a systematic review. HSS Journal.
- Surace SJ, Deitch J, Johnston RV, Buchbinder R. Shock wave therapy for rotator cuff disease with or without calcification. Cochrane Database of Systematic Reviews, 2020.
- Stania M, Malá J, Chmielewska D. The efficacy of extracorporeal shock wave therapy as a monotherapy for Achilles tendinopathy: a systematic review and meta-analysis. Journal of Chiropractic Medicine, 2023.
- Guo NY, et al. The effect of extracorporeal shockwave therapy in tendinopathy: a systematic review and network meta-analysis of randomized controlled trials. Orthopaedic Surgery, 2026.
- Liu K, et al. Efficacy and safety of extracorporeal shockwave therapy in chronic low back pain: a systematic review and meta-analysis of 632 patients. Journal of Orthopaedic Surgery and Research, 2023.
- Wu Z, Zhou T, Ai S. Extracorporeal shock wave therapy for low back pain: a systematic review and meta-analysis. Medicine, 2023.
- Seco J, Kovacs FM, Urrutia G. The efficacy, safety, effectiveness, and cost-effectiveness of ultrasound and shock wave therapies for low back pain: a systematic review. The Spine Journal, 2011.
- Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust. Extracorporeal shockwave therapy (ESWT) patient information.
- Aetna. Extracorporeal shock-wave therapy for musculoskeletal indications and soft tissue injuries (CPB 0649).