Indications
The intended purpose of the DuoSonic, for which the conformity assessment procedure under the Medical Device Regulation (EU) 2017/745 (MDR) is under way, covers only the following four indications. This limitation matters to us: for a medical device, it is part of being credible.
Indication · ICD-10 M79.1
Pain originating in a muscle and its connective tissue sheath, often with tender, hardened areas (trigger points) whose pain radiates to other parts of the body. Typically found in the neck, shoulders and back.
Indication · ICD-10 M62.8
Persistently increased muscle tension, stiffness and restricted mobility, for example as a result of unbalanced strain, poor posture or stress.
Indication · ICD-10 M62.83
Involuntary, often painful muscle contractions, from an acute cramp to reflex protective muscle guarding.
Indication · ICD-10 M79.9
Complaints affecting muscles, tendons, ligaments and fascia that are not assigned to a more specific diagnosis.
In future, myofascial complaints associated with craniomandibular dysfunction (CMD) will be addressed by a dedicated device: the DuoSonic Dental, for treating the jaw joint and masticatory muscles in dental practices and practices specializing in CMD. It is currently in development.
Mechanism of action
The therapeutic effect is based on defined mechanical oscillations in the range of 10 to 150 hertz (Hz). Two mechanisms have the strongest clinical evidence in this frequency range, and they explain why the choice of frequency during treatment is a therapeutic decision.
Mechanical oscillation activates fast-conducting Aβ mechanoreceptors. According to gate control theory, these inhibit the transmission of pain signals at spinal cord level. The effect is most pronounced at around 100 Hz, which is why a 100 Hz phase can be added automatically at the end of a session.
Focal oscillation at around 50 to 100 Hz stimulates muscle spindles and Golgi tendon organs and modulates spinal reflex activity. This contributes to reducing muscle tension, which is why the lower frequency range is used here.
Supported by, among others, Melzack & Wall 1965 · Lundeberg 1984 (n=366 and n=267, over 18 months) · Staud et al. 2011 · Casale et al. 2014 (double-blind, 100 Hz, n=30). Full references are given in the instructions for use. Technical description and frequency comparison on the Technology & specs page.
The procedure
Active implants, acute thrombosis, hematomas, malignant processes, acute inflammation or open wounds in the treatment area rule out treatment (full overview).
The large applicator for larger areas and large muscle groups, the small one for hands, feet, face and small anatomical structures. Soft for sensitive and superficial regions, Deep for deep musculature.
Select the muscle on the body map and apply the stored starting values, or set them manually. Always start at a low intensity.
Directly on bare skin, without pressure, moving slowly along the course of the muscle or held on the trigger point. For small structures such as hands, feet and face, switch to the small applicator.
The device ends the treatment automatically. Optionally, it adds a final phase at 100 Hz for pain modulation.
Clean and disinfect after every treatment. No gel means no transducer head to wipe down and no residue on the treatment couch.
Programs for the most common musculoskeletal indications are already stored. The muscle and trigger point are selected on the body map on the touchscreen, and the device then suggests the matching parameters. Every value can be adjusted manually: the programs are a starting point, not a prescription.
This is why the treatment can be delegated. After product training, nobody needs to memorize frequencies, and two practitioners faced with the same findings arrive at the same settings.
For details of how the controls are organized, see Technology & specs.
Treatment time 10–15 minutes · 2 sessions per week · a course of around 3–6 sessions per patient.
Safety
The DuoSonic may only be used by trained medical professionals. This overview is a summary; only the instructions for use are binding.
Treatment must not be carried out in the presence of:
Treatment only with increased caution and, where appropriate, after consulting a physician:
During or after treatment, transient mild local skin redness, temporarily increased sensitivity in the treated area, a sensation similar to muscle soreness and mild discomfort during treatment may occur. These reactions are usually temporary and resolve on their own within a short time.
By specialty
The same technology, two different business models. Which one suits your practice?
Specialty 01
In specialist orthopedic practices, the DuoSonic reaches the highest concentration of patients with myofascial pain, muscle tension and soft tissue disorders, in an environment in which self-pay services have long been routine.
Delegation is what matters in practice: the treatment itself takes up no physician time. After product training, medical assistants or sports therapists carry out the session, while the physician’s contribution lies in the examination, establishing the indication and monitoring progress.
Specialty 02
Physiotherapy is the largest market for musculoskeletal treatment. The DuoSonic suits practices of any size, especially those with a high patient throughput and those that deliberately offer more than the standard range of services.
What makes the biggest difference here is not the technology but the fact that patients notice it: a treatment they can feel and hear makes immediate sense to them.
How you bill for the treatment in your practice is your decision, within the fee schedule that applies to you and in line with your practice model. We are happy to help with any questions: tell us how you work, and we will put together the relevant information for you.
Demonstration on site or online, including professional product training. Same-day response to your inquiry.