“Ultrasound device shows promise for treating chronic pain.”

Diadem

University of Utah engineers developed Diadem, a noninvasive device that stimulates deep brain regions to potentially disrupt faulty signals causing chronic pain. (Credit: University of Utah)

Pain is a necessary biological signal, but a variety of conditions can cause those signals to go awry. For people with chronic engineers at the University of Utah have developed Diadem, a noninvasive device that can stimulate deep brain regions to potentially disrupt faulty signals causing chronic pain. Chronic pain often arises from faulty signals deep within the brain, which can persist even after the original injury has healed or a limb has been amputated. The University of Utah’s new device, Diadem, has shown promising results in providing relief to participants after just one treatment session. The device uses ultrasound to noninvasively stimulate deep brain regions, potentially disrupting the faulty signals that lead to chronic pain

.A recent clinical trial published in the journal Pain showed that 60% of the participants who received real treatment reported a significant reduction in symptoms one day and one week after the treatment. This unexpected rapid onset of pain symptom improvements and their sustained nature open doors for applying these noninvasive treatments to many patients who are resistant to current treatments.

Diadem’s approach is based on neuromodulation, a therapeutic technique that directly regulates the activity of certain brain circuits. Unlike other neuromodulation approaches, Diadem’s ultrasound stimulation can selectively reach the specific brain structure known as the anterior cingulate cortex, which was the focus of the researchers’ recent trial. The team is now preparing for a Phase 3 clinical trial, the final step before seeking approval from the Food and Drug Administration to use Diadem as a treatment for the general public. They are actively looking to recruit participants for the upcoming trial, and they believe that with more help, chronic pain can be effectively silenced, potentially offering new treatment options to tackle the opioid crisis as well. If you or your relatives suffer from chronic pain that does not respond to current treatments, the research team encourages reaching out to them for potential participation in the trials.

Patients suffering from life-altering pain are constantly seeking new treatment options. A new device developed by the University of Utah may finally provide a practical, long-awaited solution.

At the core of this research is Diadem, a new biomedical device that uses ultrasound to noninvasively stimulate deep brain regions, potentially disrupting the faulty signals that lead to chronic pain.

The study was conducted by Jan Kubanek, a professor in Price’s Department of Biomedical Engineering, and Thomas Riis, a postdoctoral researcher in his lab. They collaborated with Akiko Okifuji, professor of Anesthesiology in the School of Medicine, as well as Daniel Feldman, a graduate student in the departments of Biomedical Engineering and Psychiatry, and Adam Losser, a laboratory technician.

“We did not anticipate such potent and immediate effects from just one treatment,” stated Riis.

“The rapid onset of the pain symptom improvements as well as their sustained nature is interesting, and opens doors for applying these non-invasive treatments to the many patients who are resistant to current treatments,” Kubanek added.

Please take note of the following text: Diadem’s approach is founded on neuromodulation, which is a therapeutic technique aiming to directly regulate the activity of specific brain circuits. While other neuromodulation methods rely on electric currents and magnetic fields, they are unable to selectively target the brain structure examined in the researchers’ recent trial: the anterior cingulate cortex.

Following an initial functional MRI scan to map the target region, the researchers adjusted Diadem’s ultrasound emitters to account for the way the waves deflect off the skull and other brain structures. This procedure was published in Nature Communications Engineering.

“If you or your relatives suffer from chronic pain that does not respond to treatments, please reach out to us. We need to recruit many participants so that these treatments can be approved for the general public,” Kubanek said. “With your help, we believe chronic pain can be effectively managed. Additionally, with new pain treatment options, we can help address the opioid crisis as well.”

Ultralaser treatment for fibromyalgia yields 75 percent pain reduction when applied to the hands




A new device that combines low-intensity laser light and therapeutic ultrasound considerably reduces the pain experienced by patients with fibromyalgia.

A scientific study has shown that application to the palms instead of to tender points on different parts of the body has better analgesic and anti-inflammatory effects. As a result of pain reduction, patients also sleep better and are able to perform daily tasks with less discomfort. Their overall quality of life also improves.

In an article published in the Journal of Novel Physiotherapies, researchers at the Optics and Photonics Research Center (CEPOF), one of the Research, Innovation and Dissemination Centers (RIDCs) supported by the São Paulo Research Foundation – FAPESP, describe the concomitant application of low-intensity laser light and therapeutic ultrasound for three minutes to the palms of the hands of patients diagnosed with fibromyalgia. The treatment consisted of ten twice-weekly sessions.




“The study describes two innovations: the device and the treatment protocol. By emitting laser light and ultrasound simultaneously, we succeeded in normalizing the patient’s pain threshold. Application to the palms differs from the focus on tender points found practically everywhere today in fibromyalgia care,” said Antônio Eduardo de Aquino Junior, a researcher at the University of São Paulo’s São Carlos Physics Institute (IFSC-USP) in Brazil and a coauthor of the article.

The research was also funded by the National Council for Scientific and Technological Development (CNPq) and the Brazilian Innovation Agency (FINEP).

The principal investigator for the project was Vanderlei Salvador Bagnato, Full Professor and Director of IFSC-USP.

In the study, 48 women aged 40-65 and diagnosed with fibromyalgia were divided into six groups of eight at the Clinical Research Unit run by IFSC-USP in partnership with the Santa Casa de Misericórdia hospital in São Carlos, São Paulo State.

Three groups received applications of laser or ultrasound separately or combined in the region of the trapezius muscle. The other three groups received applications only to the palms.

The results showed that treatment involving application to the palms was more effective regardless of the technique, but the laser-ultrasound combination significantly improved the patients’ condition. Assessments were performed using the Fibromyalgia Impact Questionnaire (FIQ) and the Visual Analogue Scale for Pain (VASP).

A comparison of the groups showed a difference of 57.72% in functionality improvement and of 63.31% in pain reduction for the ultrasound-laser group in the case of application to the trapezius. Ultrasound-laser application to the palms produced a 73.37% difference in pain reduction compared with application to the trapezius.

Tender points

The idea of testing the effects of the new device in application to the palms of the hands arose from a review of the scientific literature.

“Previous studies showed that patients with fibromyalgia had larger numbers of neuroreceptors near blood vessels in the hands. Some patients even had red points in this region. We therefore changed focus to test the direct action of the technique on these sensory cells in the hands rather than just so-called pain trigger points, such as the trapezius, which is typically very painful in fibromyalgia patients,” said Juliana da Silva Amaral Bruno, a physical therapist and first author of the study.

The study showed that application to the hands affects all pain points in the patient’s body. The same FAPESP-funded center group had previously published an article in the Journal of Novel Physiotherapies describing a case study in applying the device to pain points. Although the results of this first study were satisfactory, global pain reduction proved impossible.

“Combined application of ultrasound and laser to pain points such as the trapezius was highly effective but did not succeed in reaching the other main innervations affected by the disorder,” Bruno said. “Application to the palms of the hands had a global result, restoring the patient’s quality of life and eliminating her pain.”

According to the study, the optimization of peripheral and brain blood flow via the activation of sensitive areas of the hands during the sessions normalized the patient’s pain threshold.

“It’s important to bear in mind that this isn’t a cure but a form of treatment that doesn’t require the use of drugs,” Aquino said.

Fibromyalgia is a chronic disease that involves widespread nonarticular high-intensity pain lasting longer than three months. It affects 3% to 10% of the adult population, with a higher prevalence in women. Although patients experience pain in practically the entire body, they do not present with injuries, inflammation or tissue degeneration. Two other mysteries are associated with fibromyalgia: its cause is unknown, and no cure has been found so far.

The standard treatment comprises physical exercise, anti-inflammatory and analgesic medication, and psychotherapy, as patients typically complain of extreme fatigue, difficulty concentrating, dizziness, depression and anxiety.

According to Aquino, the new device that combines ultrasound and laser therapy should come to market in early 2019. It is currently being tested for other pathologies by researchers at the FAPESP RIDC.

“We’re testing it for osteoarthritis, knees, hands and feet, and the results have been interesting. Other projects are being designed for other diseases,” Aquino said.