Latest news with #chroniclowbackpain
Associated Press
18-06-2025
- Business
- Associated Press
ReGelTec Announces First Patient Treated in U.S. IDE Clinical Trial for HYDRAFIL System to Treat Chronic Low Back Pain
BALTIMORE--(BUSINESS WIRE)--Jun 18, 2025-- ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL ® System for disc augmentation. The patient was enrolled by Kas Amirdelfan, M.D., an interventional pain physician and founding member of Boomerang Healthcare, Inc. in Walnut Creek, Calif. The HYDRAFIL System is an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain and improve daily function without the need for an invasive surgery. The launch of the HYDRAFIL-D U.S. study follows the company's receipt of CE Mark for the HYDRAFIL System based on promising results of clinical studies performed outside the United States on 75 patients. The studies showed that patients treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability, with more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit. 'An overwhelming majority of my chronic low back pain patients either do not want or are not good candidates for invasive spine surgeries, yet they continue to feel debilitated, without many treatment options,' said Dr. Amirdelfan. 'The early data on HYDRAFIL is compelling and promising for our subjects. I am excited to be working with ReGelTec and the other principal investigators to enroll the HYDRAFIL-D Study and evaluate the impact of HYDRAFIL on patients with degenerative disc disease.' The HYDRAFIL-D study is a 225-patient, multicenter, single-blinded, randomized, controlled trial evaluating the safety and effectiveness of the HYDRAFIL System to support FDA approval. The study will measure improvements in pain and disability, reliance on opioid medications, and the need for invasive medical procedures in patients with chronic low back pain due to degenerative disc disease. The protocol includes an interim safety analysis when the first sixty patients complete their six-month follow-up visit. There are nine study sites currently enrolling patients in Birmingham, Ala.; Walnut Creek, Calif.; Greenwood Village, Colo.; Jasper, Ga.; Shreveport, La.; Edmond, Okla.; Tyler, Texas; Richmond, Virginia; and Calgary, Canada, with additional sites being added. More than one in 10 U.S. adults suffer from chronic low back pain. 1 About 42% of this population, or more than 10 million Americans, has degenerative disc disease 2, a condition that is the largest contributor to chronic low back pain where intervertebral discs in the spine deteriorate and lose their height and volume. Degenerating discs cause vertebrae to move abnormally and inflame surrounding spinal structures, muscles, joints and nerves, resulting in pain in the back and sometimes the leg. Performed in an outpatient procedure under local anesthesia, ReGelTec's HYDRAFIL System delivers a permanent hydrogel into a degenerated disc via a needle to fill cracks and fissures and recruit water into the disc to restore natural biomechanics and provide pain relief. When the hydrogel implant solidifies in the disc, it distributes the load and strain felt in that intervertebral segment to improve function and reduce the pain signaling to the brain. 'I have been working with doctors and scientists for more than twenty years to develop a treatment for chronic low back pain, and in HYDRAFIL, we believe we've built a low-risk, effective option to fill a major market need,' said Tony Lowman, the inventor of HYDRAFIL and founder of ReGelTec. 'We look forward to fully enrolling the trial and securing FDA approval for the HYDRAFIL System so that patients in the United States with degenerative disc disease can benefit from this innovative, minimally invasive treatment option.' Patients interested in learning more about the HYDRAFIL-D Study can visit ABOUT REGELTEC, INC. ReGelTec is a clinical-stage privately held biomedical company dedicated to developing and commercializing a percutaneous hydrogel implant for the treatment of chronic low back pain due to degenerative disc disease. ReGelTec's HYDRAFIL System is an outpatient disc augmentation procedure where a permanent hydrogel is delivered into a degenerated disc via a needle to fill cracks and fissures and recruit water into the disc to restore natural biomechanics and provide pain relief. For more information, please visit 1 Shmagel A, Foley R, Ibrahim H. Epidemiology of Chronic Low Back Pain in US Adults: Data From the 2009-2010 National Health and Nutrition Examination Survey. Arthritis Care Res (Hoboken). 2016 Nov;68(11):1688-1694. doi: 10.1002/acr.22890. PMID: 26991822; PMCID: PMC5027174. 2 Michael J. DePalma, Jessica M. Ketchum, Thomas Saullo, What Is the Source of Chronic Low Back Pain and Does Age Play a Role?, Pain Medicine, Volume 12, Issue 2, February 2011, Pages 224–233, View source version on CONTACT: MEDIA CONTACT: Sam Choinski Pazanga Health Communications (860) 301-5058 [email protected] KEYWORD: UNITED STATES NORTH AMERICA MARYLAND INDUSTRY KEYWORD: RESEARCH SURGERY MEDICAL DEVICES FDA HOSPITALS CLINICAL TRIALS HEALTH TECHNOLOGY HEALTH SCIENCE SOURCE: ReGelTec Inc. Copyright Business Wire 2025. PUB: 06/18/2025 07:05 AM/DISC: 06/18/2025 07:04 AM
The Independent
13-06-2025
- Health
- The Independent
Your walking distance may be more important than speed to fix chronic back pain
While walking is beneficial for reducing the risk of lingering chronic low back pain, experts say that it is how you walk that really matters. Walking more is a bigger factor than how fast you walk, Norwegian researchers said on Friday. 'Our findings suggest that daily walking volume is more important than mean walking intensity in reducing the risk of chronic lower back pain,' they wrote in a study published in the journal JAMA Network Open. The authors also found that walking for more than 100 minutes a day -- or an hour and forty minutes -- was associated with a 23 percent lower risk of chronic low back pain compared with walking fewer than 78 minutes a day. Walking 125 minutes or more daily also lowered the risk by 24 percent. The study included data from more than 11,000 patients aged 20 years and older, who were a part of the Trøndelag Health Study. Their health was first assessed during the years from 2017 to 2019. The authors later followed up from 2021 to 2023. Participants did not have chronic low back pain at the start of the study. To measure their walking, they wore accelerometers. Following just over four years, 1,659 participants reported experiencing chronic low back pain. They noted that participants with a higher walking volume tended to exercise more often and that the reduction in risk of chronic low back pain leveled off beyond walking for 100 minutes a day. Still, they urged that these findings could inform policy related to the costly condition going forward. The findings come after previous research that also identified being active as a way to alleviate chronic low back pain. Back pain affects more than a quarter of Americans. Another study last year found that people with chronic low back pain who walked 30 minutes a day for five days a week went twice as long without a recurrence as those who did not walk, according to UCLA Health. Approximately 70 percent of individuals experience a recurrence of low back pain within 12 months following recovery from an episode, Australian researchers found. Walking can help to strengthen the muscles that support the spine, and increase circulation and joint mobilization, according to Healthline. It is the sixth-most costly condition in the U.S. and can be incredibly debilitating, making even standing up or sitting at work a struggle. 'If confirmed by future research, these results could inform public health strategies aimed at preventing chronic low back pain, as well as complementing current guidelines that solely report on physical activity as a secondary prevention tool,' they said.
Medscape
11-06-2025
- Health
- Medscape
Nonsurgical Options Show Modest Benefit in Chronic Back Pain
In people with nonspecific chronic low back pain, nonsurgical interventions like cognitive-behavioral therapy and mindfulness possibly showed small-to-moderate long-term benefits in reducing pain intensity and disability. However, the evidence was mostly of low-to-moderate certainty. METHODOLOGY: Researchers conducted a systematic review and meta-analysis of 75 randomized or cluster randomized controlled trials involving 15,395 participants aged 16 years or older (mean age, 45.7 years; median percentage of women, 61%) with chronic low back pain lasting at least 12 weeks. They assessed the effectiveness of nonsurgical interventions for chronic low back pain (including 91% trials on nonspecific chronic low back pain) with a focus on long-term (1-2 years) and very long-term (≥ 2 years) outcomes. Psychological, physical, and combination nonsurgical interventions, including cognitive-behavioral therapy, mindfulness, and multidisciplinary care, were assessed, with exercise being the most frequently assessed intervention. Interventions were compared with placebo or sham, adjuvant interventions, no intervention, or usual care. Pain intensity and disability were assessed using scales like the Numerical Pain Rating Scale and Oswestry Disability Index, respectively, along with other measures, and the certainty of evidence was assessed. TAKEAWAY: At long-term follow-up, small-to-moderate reductions in pain intensity and disability were possibly seen with cognitive-behavioral therapy (mean differences, -7.2 and -5.7, respectively) and mindfulness (mean differences, -10.0 and -9.3, respectively) in individuals with nonspecific chronic low back pain. The evidence was of moderate certainty. Goal setting and needling interventions probably resulted in small reductions in disability, with mean differences of -8.3 and -4.8, respectively. Multicomponent biopsychosocial care and behavioral therapy might have led to moderate and small reductions, respectively, in pain intensity in those with nonspecific chronic low back pain (mean differences, -10.2 and -7.4, respectively; low-certainty evidence). Multidisciplinary care could have led to small reductions in disability (mean difference, -8.3). At very long-term follow-up, multidisciplinary care may have led to a moderate reduction in pain intensity (mean difference, -10.1), whereas exercise may have resulted in a moderate decrease in disability (mean difference, -10.2) in those with nonspecific chronic low back pain. The evidence was mostly of low certainty. IN PRACTICE: 'Although we identified some interventions with long-term effects for people with chronic low back pain, the clinical importance of the effects is uncertain,' the study authors wrote. 'Greater attention is needed on developing and testing interventions with long-term effects for chronic low back pain.' SOURCE: The study was led by Hazel J. Jenkins, PhD, Macquarie University, Sydney, Australia. It was published online on May 28, 2025, in The Lancet Rheumatology . LIMITATIONS: The certainty of the evidence was reduced for most comparisons because of the quality of the studies and inconsistencies in the results. DISCLOSURES: The study reported receiving no specific funding. Some authors reported receiving grants, support for attending meetings, research fellowships, and serving as members of the executive board of the network and/or as members of associations outside the submitted work.
Globe and Mail
20-05-2025
- Health
- Globe and Mail
Aclarion Announces Addition of Keck Medical Center of USC as CLARITY Trial Site
BROOMFIELD, Colo., May 20, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., ('Aclarion' or the 'Company') (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, today announced the addition of Keck Medical Center of USC as a CLARITY (C hronic L ow b A ck pain R andomized I ndependent T rial stud Y) trial site. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery. 'Keck Medicine of USC strives to offer patients access to new treatments and procedures, and tailored treatment options for all types of spine conditions – from simple to complex,' says Patrick Hsieh, MD, neurological spine surgeon with Keck Medicine of USC. 'The USC Spine Center's participation in the CLARITY trial demonstrates our commitment to deepening our understanding of spinal conditions to best serve patients' specific care needs.' Keck Medicine of USC is the latest CLARITY trial site, joining Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute and Texas Back Institute. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine. The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment of 1- or 2- level discogenic low back pain. The study will enroll 300 patients at multiple high-volume sites across the US and all patients will receive a Nociscan prior to surgery. The study will be randomized at a 1:1 ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to guide the surgical treatment (Fusion / TDR). The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected. 'The USC Spine Center has a long history of being at the forefront of innovation and research to advance patient care and we look forward to partnering with Dr. Hsieh and the USC Spine Center team on the CLARITY trial,' said Ryan Bond, Chief Strategy Officer at Aclarion. 'We anticipate the CLARITY trial to represent a turning point in how physicians are able to leverage Nociscan to understand and diagnose chronic low back pain for the millions of patients suffering from this debilitating condition.' Chronic low back pain is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. Aclarion's Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain and has the potential to drive better surgical outcomes. For more information about CLARITY, please visit: CLARITY Trial To find a Nociscan center, view our site map here. All organizations cited and/or quotes from individuals not part of Aclarion have reviewed and approved the contents herein. About Aclarion, Inc. Aclarion is a healthcare technology company that leverages Magnetic Resonance Spectroscopy ('MRS'), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The Company is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient's low back pain, giving physicians clarity to optimize treatment strategies. For more information, please visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company's current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as 'anticipates,' 'believes' and 'expects' or similar expressions, are forward-looking statements. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the Company's current plans and expectations, as well as future results of operations and financial condition. These and other risks and uncertainties are discussed more fully in our filings with the Securities and Exchange Commission. Readers are encouraged to review the section titled 'Risk Factors' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, as well as other disclosures contained in the Prospectus and subsequent filings made with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contacts: Kirin M. Smith PCG Advisory, Inc. ksmith@ Media Contacts:
Associated Press
12-05-2025
- Health
- Associated Press
Aclarion Announces Texas Back Institute as New CLARITY Trial Site
BROOMFIELD, Colo., May 12, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., ('Aclarion' or the 'Company') (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, today announced the addition of the Texas Back Institute (TBI) as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial site. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery. 'Texas Back Institute has a rich tradition of excellence in research. We remain focused on the relationship between diagnostic evaluations and treatment outcomes,' said Alexander Satin, MD, board certified orthopedic spine surgeon, Texas Back Institute. 'We have participated in numerous studies involving discography, MRI, minimally invasive procedures, and total disc replacement. The CLARITY trial is exciting, in part, because it builds on previously published evidence and aligns well with our patient population at Texas Back Institute. Our physicians and research leaders are pleased to participate in this important trial.' Texas Back Institute joins the growing roster of previously announced CLARITY trial sites, which includes Johns Hopkins Medicine, Northwestern Medicine and Advocate Aurora Research Institute. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine. The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment of 1- or 2- level discogenic low back pain. The study will enroll 300 patients at multiple high-volume sites across the US and all patients will receive a Nociscan prior to surgery. The study will be randomized at a 1:1 ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to guide the surgical treatment (Fusion / TDR). The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected. 'The Texas Back Institute's reputation for excellence in patient care, innovation and research is renowned,' said Ryan Bond, Chief Strategy Officer at Aclarion. 'It is common, at spine society meetings, that TBI physicians and research leaders are not only in attendance but actively presenting their extensive research to advance the spine industry. We are grateful to have this expert group of physicians and researchers participating in the CLARITY trial.' Chronic low back pain is a global healthcare problem with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain. Aclarion's Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain and has the potential to drive better surgical outcomes. For more information about CLARITY, please visit: CLARITY Trial To find a Nociscan center, view our site map here. For more information on Nociscan, please email: [email protected] All organizations cited and/or quotes from individuals not part of Aclarion have reviewed and approved the contents herein. About Aclarion, Inc. Aclarion is a healthcare technology company that leverages Magnetic Resonance Spectroscopy ('MRS'), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The Company is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient's low back pain, giving physicians clarity to optimize treatment strategies. For more information, please visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company's current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as 'anticipates,' 'believes' and 'expects' or similar expressions, are forward-looking statements. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the Company's current plans and expectations, as well as future results of operations and financial condition. These and other risks and uncertainties are discussed more fully in our filings with the Securities and Exchange Commission. Readers are encouraged to review the section titled 'Risk Factors' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, as well as other disclosures contained in the Prospectus and subsequent filings made with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contacts: Kirin M. Smith PCG Advisory, Inc. [email protected] Media Contacts: Jennie Kim SPRIG Consulting [email protected]
