Ultrasound: The Therapy of the Future Coming to a Clinic Near You!

Ultrasound is most commonly known for diagnostic imaging and image-guided interventions, but there is also the potential to harness its power for therapeutic benefits. The use of ultrasound as a therapy is growing, with more than 1,900 active clinical investigations underway. There are also avenues to get insurance reimbursement for the treatment of certain ailments with ultrasound therapy, including bone metastases, essential tremor, and prostate.

In order to help guide physicians that may become involved in the use of ultrasound therapies, the Bioeffects Committee of the American Institute of Ultrasound in Medicine (AIUM) has issued new and updated statements on the AIUM website. These statements help to identify what to consider when using ultrasound therapies, including what happens to the targeted tissue and safety. Some highlights from these statements include:

  • Although safe when used properly for imaging, ultrasound can cause biological effects associated with therapeutic benefits when administered at sufficient exposure levels. Ultrasound therapeutic biological effects occur through two known mechanisms: thermal and mechanical. Thermal effects occur as the result of absorption of ultrasound waves within tissue, resulting in heating. Mechanical effects, such as fluid streaming and radiation force, are initiated by the transfer of energy/momentum from the incident pulse to tissue or nearby biofluids. Indirect mechanical effects can also occur through interaction of the ultrasound pulse with microbubbles such as ultrasound contrast agents. Importantly, thermal and mechanical mechanisms can trigger biological responses that result in desired therapeutic endpoints.
  • The type of bioeffects generated by ultrasound depend on many factors, including the ultrasound source, exposure conditions, presence of cavitation nuclei, and tissue type. Different bioeffects will require different amounts of ultrasound, and thermal and mechanical mechanisms can occur simultaneously for some exposure conditions.
  • There is the possibility of adverse effects in therapeutic ultrasound for targeted and untargeted tissue. Practitioners using these modalities must be well trained on the safe and effective use of therapeutic devices, knowledgeable about potential adverse events, aware of contraindications, and diligent in performing safe procedures. Image guidance should be used to ensure accurate targeting and dosing to maximize the outcomes for patients.

The statements issued by the AIUM’s Bioeffects Committee are intended as baseline considerations when a new therapy device is being put into practice. As ultrasound therapies continue to be adopted into clinical use, the Bioeffects Committee will continue to monitor outcomes in order to inform and educate the community.

Interested in learning more about the bioeffects of ultrasound? Check out the following Official Statements from the American Institute of Ultrasound in Medicine (AIUM):

Dawning of Another Golden Age for Ultrasound

Diagnostic ultrasound is an essential clinician’s tool. And, although it often does not get the attention (such as Nobel Prizes) of its sibling imaging modalities, it is the most utilized imaging modality in the world, depending on the metric.

The reasons why ultrasound is an essential tool are likely obvious to most readers of this blog. Ultrasound is relatively inexpensive, portable, and provides real-time imaging. It can be brought to patients who might otherwise be unable to receive imaging, whether that is because of the condition of the patient or the condition of the world around them. The variety and depth of our communities of practice attest to the robustness of this imaging modality (as does this blog, in its relatively short history). Furthermore, ultrasound imaging is not a static field; new technologies and applications, such as the use of artificial intelligence for COVID-19 diagnosis, are being incorporated on a continual basis.

Kevin Haworth, PhD, Cardiovascular

The American Institute of Ultrasound in Medicine (AIUM) has played a central role in the history and promotion of ultrasound imaging due to its membership. I would argue one of its greatest strengths is that the AIUM provides a home for anyone involved in ultrasound: sonographers, physicians, scientists, academicians, students, private practice providers, and industrial partners. There are a number of other professional societies associated with ultrasound imaging, but none that cover the same breadth of topics and people.

The AIUM has done this, in part, by stepping up to the openings before it. The AIUM has embraced a variety of opportunities to make a difference in the lives of patients, including decades ago with the advent of the ‘modern’ array and continuing to more recent capabilities including bedside POCUS, telehealth, and artificial intelligence.

Is the AIUM ready to continue its role as the preeminent home for all areas of ultrasound? Is it ready to fully embrace the dawning of another golden age for ultrasound – therapeutic ultrasound?

The field of therapeutic ultrasound has a rich history stretching back decades. What separates the current era from the past is the combination of technological advancements made and the pairing of these technologies with dedicated clinicians. Furthermore, the field has been accelerating as it learns from past successes to create future ones. One of the most notable initial advances was the use of ultrasound thermal ablation of uterine fibroids, which has been available to women in the United States since 2004. A number of companies have subsequently obtained FDA clearance, the European CE mark, or other equivalent regulatory approval for their ultrasound thermal ablation devices, enabling the treatment of a wide range of conditions.

In the past decade, reimbursement has also become available for ultrasound treatment of bone metastases and essential tremor. Most importantly though, the pipeline is rich with dozens of potential applications and hundreds of clinical trials. Importantly, the mechanism of action by which ultrasound can have a therapeutic effect has grown beyond thermal ablation, with clinical trials in blood-brain barrier disruption, ultrasound-mediated drug delivery, and mechanical tissue ablation (just to name a few).

The AIUM already has a number of our basic-scientist and clinician-scientist members making great contributions, particularly within the Basic Science & Instrumentation and Therapeutic Ultrasound Communities of Practice. However, to remain the preeminent home for all areas of ultrasound, we will need engagement from the entire broad and rich swath of expertise that our full membership community has to offer. There are important questions to answer, and I do not pretend to know the answers. I am confident, though, in the ability of our community to answer them. A few of the important questions for us to consider are:

  1. Just as there has been great opportunity in bringing together ultrasound imaging expertise across medical fields, do we see similar opportunity in being a home to bring together ultrasound therapy expertise across different medical fields?
  2. How do we make our society a welcoming place for therapeutic ultrasound clinicians who might not have the deep background in diagnostic ultrasound that is common of current AIUM members?
  3. How do we integrate our existing imaging expertise in helping to advance therapy, through treatment planning, guidance, and monitoring?
  4. How do we break down some of the silos between our existing communities, particularly the more discovery-oriented communities and the more practice-oriented communities?
  5. As we have played an important role in establishing standards, guidelines, and practice parameters in ultrasound imaging, should we do the same for therapeutic ultrasound?

The fundamental question, however, is: do we want to remain to be the American Institute of Ultrasound in Medicine, or do we want to be the American Institute of Ultrasound Imaging in Medicine?

Kevin Haworth (Twitter: @kevinhaworth) is an Associate Professor of Internal Medicine at the University of Cincinnati in Ohio.

Real-time Ultrasound in Physical Therapy

In the past 20 years, there are very few pieces of equipment I can say unequivocally changed how I practice as a physical therapist (PT); without question, real-time ultrasound (RTUS) is one. A sports/orthopedic colleague introduced RTUS to my practice 8 years ago. As a pelvic PT, I thought it would be a nice adjunct to my current practice with biofeedback, exercise, and manual techniques. I was wrong. It was a game changer. What initially started out as an exercise in interpreting black & white ink-blot-like images has evolved into so much more.Lisa-Damico-Portraits-Carrie-Pagliano-0413-LOW-RES

For those unfamiliar with pelvic floor physical therapy, typical pelvic floor assessment, without RTUS, includes an external assessment of the perineal region. Frequently, internal digital assessment is used to identify pelvic floor muscle strength, endurance, coordination, tender points, and presence of pelvic organ prolapse. Biofeedback assessment can give a general sense of local muscle activity, via either internal or external electrodes. Absent from this data collection, however, is the ability to assess function. What is the effect of pelvic floor activity on the bladder? What specific muscles in the pelvis and abdomen are activating and when? What do you do when a patient is unable to tolerate an internal assessment? RTUS addresses all of these questions. Via a transabdominal approach, I am able to assess the function of pelvic, abdominal, hip, and back musculature in the context of breath and movement. I am able to make an assessment without an internal approach, which may be threatening or uncomfortable for patients with pelvic pain. I am able to determine the function of the pelvic floor and its effect on the bladder and urethra as well.

My practice includes RTUS primarily for evaluation of movement of the pelvic floor, abdominals, hip, and spine. The primary goal is to find and address neuromuscular dysfunction in the context of urinary/fecal incontinence, pelvic pain, diastasis recti, and pelvic girdle pain. Beyond helping me identify inefficient movement strategies, coordination variances, and relevant dysfunction, RTUS has been an enormous help in educating my patients about their own bodies and how they function. I never anticipated how much a little black and white image would help patients make this connection! For example, many people have no idea where their pelvic floor is, much less what its relationship is to their bladder, pelvis, or breath. With just a quick look at the screen and a little orientation, RTUS can give patients a window into the simple yet complex connections within their own bodies.

The most striking patient activity with RTUS is using imaging to show the relationship between breath and the pelvic/abdominal region. Patients who are visual learners especially find this an invaluable tool. I use focused exhalation (cued blowing through a straw), vocalization, and varying volumes and octaves to get automatic activation of transverse abdominal and pelvic floor musculature. Patients see, in real time, the effect of their breathing (or breath-holding) strategies have on activation of muscles in the pelvic region. Patients no longer have to try to cognitively process how to turn these muscles on or off (which is laborious and practically impossible to be consistent), but rely on something as simple as breath to assist in activating or relaxing their muscles.

As you can see, RTUS provides both patients and clinicians a window into the pelvic region, providing additional insight into the patient’s function and dysfunction. Having AIUM recognize physical therapists in the AIUM Practice Parameter for the Performance of Selected Ultrasound-Guided Procedures is an outstanding step toward including PTs in this area of practice. I’ve been privileged to work alongside physical therapists working in the area of RTUS education, facilitated diagnostics and real-time needle tracking within our profession. I’m excited that the area of pelvic physical therapy is being included in using RTUS in progressive physical therapy practice. I am looking forward to more integration of RTUS in physical therapy patient care as well as physical therapy education! The more physical therapists have knowledge and skill using this unique tool, the more comprehensive care and outcomes PTs can provide!

Have you included real-time ultrasound in your physical therapy practice? If so, how has it impacted your practice? Comment below or let us know on Twitter: @AIUM_Ultrasound.

Carrie Pagliano, PT, DPT, MTC, is a Board Certified Women’s Health & Orthopaedic Clinical Specialist and is owner of Carrie Pagliano PT, LLC, in Arlington, VA.