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Scientists explore the efficacy of AT-04, a new portable device designed to alleviate pain, for the management of endometriosis-related pain and discomfort
Endometriosis is a chronic condition causing painful symptoms like menstrual cramps and pelvic pain, adversely impacting quality of life. Now, a prospective, phase III, sham device-controlled, double-blind study led by Associate Professor Hiroshi Ishikawa and Professor Kaori Koga investigates the effectiveness of the Angel Touch device (AT-04) — a new portable pain relief device, for managing endometriosis-related pain. Owing to its electromagnetic technology, AT-04 holds promise for alleviating pain without inhibiting ovulation, improving reproductive health and well-being.
Image title: Despite undergoing treatment, approximately one-third of women with endometriosis continue to experience endometriosis-related pain.
Image caption: Researchers from Chiba University test the effectiveness of a new portable device, AT-04, for the management of pain and discomfort in women with endometriosis. Their study focuses on assessing AT-04’s potential using its unique magnetic field technology, intending to improve pain management, reproductive health, and overall quality of life.
Image credit: quickspice from OpenVerse
Image Link: https://openverse.org/image/d3ddae03-b89c-43c0-8726-660c521a329c?q=period%20pain
Image license: CC BY 2.0
Endometriosis is a chronic condition affecting women, often resulting in painful symptoms such as menstrual cramps and pelvic pain. Pain caused by endometriosis significantly lowers the quality of life and reproductive health of affected women, with around one-third of women still experiencing pain and discomfort despite treatment. While hormonal therapies and surgeries are common treatments, they often do not result in complete alleviation of symptoms. Effectively managing pain is, therefore, crucial for managing the profound impact of the condition on daily life and work productivity, with challenges persisting even after treatment.
Now, in a recent study published in Reproductive Health on January 26, 2024, researchers investigate the effectiveness and safety of a new portable pain relief device known as the Angel Touch device (AT-04). The device, developed by Peace of Mind Co., Ltd. in Japan, emits a mix of magnetic fields that target pain in specific areas. Previous research on animals has shown that the device works by adjusting nerve growth factors, reducing inflammation, and activating the body’s natural pain relief mechanisms. Building upon this existing body of knowledge, Associate Professor Hiroshi Ishikawa and Professor Kaori Koga from Chiba University’s Graduate School of Medicine, along with their team, is now undertaking a study to investigate the potential of AT-04 in managing endometriosis-related pain by utilizing its unique combination of alternating magnetic fields.
“We focused our study on AT-04 since it is an exceptionally minimally invasive device suitable for premenopausal women, as it does not disrupt ovulation. Its method of pain management differs significantly from current treatments, indicating promising potential for effectively addressing endometriosis-related pain,” highlights Dr. Ishikawa, underscoring the efficacy of AT-04 in managing endometriosis-related pain.
Approved by the Clinical Study Review Board, this study involves premenopausal women above the age of 18 with moderate to severe endometriosis-related pain. Fifty participants will be randomly divided to either receive genuine electromagnetic wave treatment from AT-04 or use a placebo device for a “double-blind” period lasting 16 weeks. Following this, both groups will wear the AT-04 for an additional four weeks. The researchers then aim to measure changes in pain levels using a pain scale and also look at other factors such as pelvic pain, participants’ quality of life, and safety.
In addition to assessing pain levels using the Numeric Rating Scale (NRS), the study also evaluates the participants’ Health-Related Quality of Life (HRQoL) using the Endometriosis Health Profile-30 and the EuroQol 5-Dimension scoring systems. These tools can provide insights into various aspects of HRQoL, including pain, emotional well-being, and social support.
Despite the potential benefits of AT-04, the study still has several limitations which require further consideration. For instance, determining the device’s sole efficacy in treating endometriosis-related pain can be challenging since most participants would have already undergone treatment for the condition. Furthermore, hormonal fluctuations associated with the menstrual cycle can impact pain and HRQoL assessments during the research period. Additionally, the effectiveness of pain relief by AT-04 can vary among participants with moderate pain levels.
Despite these limitations, however, Dr. Ishikawa is optimistic about the future potential of this study. Elaborating further, he says, “Women experiencing persistent endometriosis-related pain often endure mental strain such as depression. This stress, alongside the condition itself, can exacerbate future fertility issues. By effectively managing long-term pain with minimal side effects using AT-04, the device is expected to enhance the quality of life for women with endometriosis-related pain and also to potentially safeguard against future declines in fertility.”
In summary, the potential of AT-04’s benefits offers hope for those enduring persistent endometriosis-related pain unresponsive to existing treatments. Promisingly, this study underscores physicians’ commitment to enhancing reproductive health and quality of life for women battling this condition.
About Associate Professor Hiroshi Ishikawa
Hiroshi Ishikawa is an Associate Professor at Chiba University’s Department of Obstetrics and Gynecology, Reproductive Medicine. Ishikawa graduated from the Kanazawa University School of Medicine in 1995 and earned his degree in 2007. With a specialization in reproductive medicine, he focuses on uterine fibroids’ pathophysiology, development of novel treatments for endometriosis, cesarean section sequelae, and oncofertility. Ishikawa has garnered significant attention, with over 9,966 publication views and 3,679 publication downloads. His expertise lies in exploring innovative approaches to reproductive health challenges, emphasizing understanding and addressing conditions like uterine fibroids and endometriosis, and advancing oncofertility research.
Funding:
This study is conducted with research grants obtained from the 2022 Growth-Oriented Small and Medium-Sized Enterprises Research and Development Support Project (Go-Tech Project) supported by the Ministry of Economy, Trade and Industry in Japan.
Reference:
Title of original paper: Efficacy and safety of a novel pain management device, AT-04, for endometriosis-related pain: study protocol for a phase III randomized controlled trial
Authors: Hiroshi Ishikawa1, 2*, Osamu Yoshino3, Fuminori Taniguchi4, Tasuku Harada4, Mikio Momoeda5, Yutaka Osuga6, Tamiki Hikake7, Youko Hattori8, Michiko Hanawa7, Yosuke Inaba7, Hideki Hanaoka7, Kaori Koga1,2
Affiliations:
- Department of Obstetrics and Gynecology, Graduate School of Medicine, Chiba University, Inohana 1-8-1, Chuo-Ku, Chiba, 260-8670, Japan. ishikawa@chiba-u.jp.
- Department of Obstetrics and Gynecology, Chiba University Hospital, Chiba, 260-8677, Japan. ishikawa@chiba-u.jp.
- Department of Obstetrics and Gynecology, University of Yamanashi Graduate School of Medicine, Yamanashi, 409-3898, Japan.
- Department of Obstetrics and Gynecology, Faculty of Medicine, Tottori University, Tottori, 683-8504, Japan.
- Department of Obstetrics and Gynecology, Aiiku Hospital, Tokyo, 105-8321, Japan.
- Department of Obstetrics and Gynecology, The University of Tokyo Graduate School of Medicine, Tokyo, 113-8655, Japan.
- Chiba University Clinical Research Center, Chiba University Hospital, Chiba, 260-8677, Japan.
- Data Center, Chiba University Hospital, Chiba, 260-8677, Japan.
Journal: Reproductive Health
DOI: 10.1186/s12978-024-01739-8
Contact: Hiroshi Ishikawa
Associate Professor, Chiba University
Email: ishikawa@chiba-u.jp
Public Relations Office, Chiba University
Address: 1-33 Yayoi, Inage, Chiba 263-8522 JAPAN
Email: koho-press@chiba-u.jp
Tel: +81-43-290-2018
