Ian Rawe Ph.D BioElectronic Corporation Frederick, MD
ActiPatch
PainRelief.com: What is the
background for this study?
Response: The aim of this study was to investigate the long-term effectiveness of a neuromodulation medical device (ActiPatch®) in relieving chronic pain. The device is topically applied, paresthesia-free and uses high-frequency electromagnetic fields to mitigate nerve sensitization and provide pain relief. Identified as Pulsed Short Wave Therapy (PSWT), this technology is available over-the counter in many countries, including the US, Canada, EU and Australia.
While existing randomized, placebo controlled clinical trials demonstrated PSWT treatment effectiveness over several weeks, data on long-term effectiveness was unavailable. In this study, a sample of 240 chronic pain subjects, who reported clinically significant pain relief (reduction ≥ 2 VAS points) following a 7-day trial of the medical device, agreed to participate in a six-month study to investigate treatment durability. These subjects indicated an average chronic pain duration of 6.5 years, in multiple locations and from a wide spectrum of causes (etiologies). Moreover, these subjects reported that their existing pain management regimen (often multimodal therapy) provided inadequate relief, and that they experienced severe to moderate pain (≥ VAS of 8/10), daily.
PainRelief.com: What is the background for this study? Would you explain how VM202 is unique?
Response: Diabetic peripheral neuropathy is one of the most common complications of diabetes and many of DPN patients suffer from severe pain that affects their daily activities and life quality. Though there are medications, both Rx and OTC drugs, used to ameliorate pains from diabetic peripheral neuropathy, many of them fall short of analgesic efficacy or often lead to not so trivial side effects.
Engensis (VM202) is plasmid DNA therapy, non-viral gene therapy, which encodes hepatocyte growth factor (HGF) gene that is designed to simultaneously express two isoforms of HGF protein at high levels. HGF is known to have angiogenic and neurotrophic effects and, when expressed in the human body, induces formation of new micro vessels and nerve regeneration through remyelination and axon outgrowth, resulting in improvement in peripheral neuropathy condition. Engensis does not integrate into the human genome.
Historically, our research first focused on therapeutic angiogenesis of HGF with a proof of concept research in critical limb ischemia, an extreme form of peripheral artery disease. In the process, we realized that Engensis would also be effective for peripheral neuropathy, and a coffee chat with the current PI, Dr. Kessler of Northwestern University, led to an idea of using Engensis in neurological diseases.
Throughout Phase 1 through 3 clinical trials for DPN in the US, Engensis has been observed safe and well-tolerated in patients, and, during the Phase 3 study, received RMAT (regenerative medicine advanced therapy) designation from the FDA.
Samannaaz Khoja, PT, PhD Research Assistant Professor Department of Physical Therapy University of Pittsburgh School of Health and Rehabilitation Sciences
Dr. Khoja
PainRelief.com: What is the background for this study?
Response: The purpose of this study was to describe and compare rates of physicians’ recommendation for physical therapy (PT), lifestyle-counseling, and pain medication for knee osteoarthritis (KOA) between 2007 and 2015. The study also aimed to identify patient, physician and practice-level factors associated with each treatment recommendation. We used survey data from the National Ambulatory Medical Care Survey, data from this survey is publicly available and is housed within the CDC. We identified 2297 knee OA related visits, which approximated to 67 (±4) million weighted physician visits between 2007 and 2015 (around 8 million visits/year).
PainRelief.com Interview with: Dr.-Ing. Marcus Komann IT-Coordinator Jena University Hospital Jena, Germany
PainRelief.com: What is the
background for this study?
Response: A lot of non-pharmacological methods (like relaxation, cold packs, prayer and so on) for post-operative pain relief are used in today’s hospitals. There is also some literature out there on this topic. However, the literature mostly concerns single methods and very specific patient groups. Further, for most methods, the literature is not clear on the pain soothing effects.
We looked at a real-life registry to study the effects of a large number of such methods on a big sample of patients.
Arani Vivekanantham,MBChB,
MPhil University of Warwick University Hospitals Coventry and Warwickshire
NHS Trust
Coventry, UK Centre for Epidemiology Versus Arthritis
University of Manchester, Manchester, UK
PainRelief.com: What is the
background for this study?
Response: Around one in five people have persistent low back pain and one in thirty have chronic headaches. People with low back pain are usually managed by musculoskeletal services whilst those with headaches are typically treated by primary care doctors and neurologists. There may be particular challenges in treating people with both disorders because of the risk of medication overuse headache in people taking regular pain killers for back pain.
PainRelief.com Interview
with: Roberta Agabio, M.D.
Dpt. Biomedical Sciences
University of Cagliari
Cittadella Universitaria Monserrato
Monserrato (CA) – ITALY
PainRelief.com: What is the
background for this study?
Response: Pain is the leading cause for seeking medical care
worldwide, and opioids are the most frequently prescribed drugs for pain relief.
Differences and similarities between men and women in both effectiveness and
side effects to opioids used for pain relief have been described. In addition,
individuals may respond differently to these medications for other reasons for
example: the intensity of pain experienced, amount and type of administration
of opioids (e.g. fixed doses established by physicians or flexible doses
decided by patients), mental condition, age, body weight, and use of alcohol,
tobacco and/or cannabis.
However, the role of these factors in influencing sex differences and similarities in the response to opioids used for pain control has not been thoroughly investigated.
PainRelief.comInterview with: Jason ChingMD Department of Neurology George Washington University School of Medicine Washington, DC
PainRelief.com: What is the background for this study? What are the main findings?
Response: The clinical course of chronic migraine patients who respond positively to serial botulinum toxin A (BotoxA) injection therapy and eventually discontinue treatment has not been well-studied. Optimizing the duration of treatment would be beneficial from both a cost and safety perspective.
In our study, we found that over 80% of our chronic migraine patients who achieved our stipulated stopping rule experienced no clinical worsening or associated need to resume prophylactic therapy for at least 6 months following discontinuation of BotoxA.
A greater number of BotoxA treatments required to achieve the stopping rule and the presence of baseline chronic daily headaches for over 6 months duration were factors correlated with clinical deterioration.
Professor, University of California, San Diego Skaggs School of Pharmacy & Pharmaceutical Sciences San Diego Supercomputer Center
PainRelief.com: What is the
background for this study? What are the
main findings?
Response: The background for this study was concern about unknown side effects of tramadol that became a popular treatment for chronic pain. With our informatics approach and access to millions of the FDA reports we were in a position to look for those adverse effects and we found that hyperglycemia (low blood sugar) is one of those concerns. There have been a few small-scale studies and case reports of tramadol use associated with hypoglycemia and hospitalizations related to it. The dramatic increase in tramadol prescription rates, especially in light of tighter control over hydocodone/acetaminophen (went from schedule III to II), warranted a larger scale postmarketing study of FDA FAERS reports.
As we compared the hypoglycemia side effect between different opioids we found that only one other drug, methadone (used to treat drug abuse and addiction), has a comparable association with hypoglycemia.
PainRelief.com: What should readers take away from your report?
Response:
Patients using tramadol should should be aware of
hypoglycemia symptoms such as shakiness, dizziness, sweating, hunger,
irritability, moodiness, anxiety/nervousness, and headache, or, in severe cases,
blurred vision, seizures or loss of consiousness. The same applies to
methadone, also known as Dolophine.
PainRelief.com: What recommendations do you have for future research as
a result of this work?
Response:
It may be beneficial to perform controlled studies to
confirm and understand this association. Our study looked at other drugs with
the known pharmacology of tramadol (mu-opioid agonism, serotonin/norepinephrine
re-uptake inhibition, and NMDAR antagonism), but did not find an association
with hypoglycemia with a specific class. Would be interesting to learn
more about additional/other pharmacology of tramadol and methadone behind the
etiology of hypoglycemia.
PainRelief.com: Is there anything else you would like to add?
Response:
We think that studies of this nature are beneficial since
rare side effects often go unnoticed in clinical trials due to a limited number
of participants. Additionally, hypoglycemia effects may often be attributed to
other medications and medical conditions, while tramadol or methadone were
unlikely to cause suspicion.
Any disclosures?
Non of the authors have any financial or non-financial conflicts
of interest to disclose.
Citation:
Tigran Makunts, Andrew U, Rabia S. Atayee, Ruben Abagyan. Retrospective analysis reveals significant
association of hypoglycemia with tramadol and methadone in contrast to other
opioids. Scientific Reports, 2019; 9 (1) DOI: 10.1038/s41598-019-48955-y
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PainRelief.com Interview with: Fanrong Liang MD and Ling Zhao PhD
Acupuncture and Tuina School Chengdu University of Traditional Chinese Medicine Chengdu, Sichuan, China
PainRelief.com: What is the background for this study?
Response: Chronic stable angina (CSA) is the cardinal symptom of myocardial ischemia and is associated with an increased risk of major cardiovascular events and sudden cardiac death. CSA affects with an average of 3.4 million people over 40 years of age each year. The most recent survey reported a CSA prevalence of 9.6% in China, making it a considerable burden on healthcare and medical costs, considering China’s large population base. Because of limited medical resources and lack of obvious improvement with percutaneous coronary intervention, Chinese clinicians choose traditional Chinese medicine (TCM) and acupuncture in addition to antianginal treatment for CSA. In China, acupuncture has been used as nonpharmacological treatment for several decades, especially to relieve myocardial ischemia symptoms, improve cardiac function, and prevent recurrence.
MedicalResearch.com: What is the
background for this study?
Response: The findings of this study are based on a systematic review of 25 randomized clinical trials evaluating surgical type interventions (open surgeries, arthroscopic, endoscopic, laparoscopic, heart catheterization, radiofrequency, laser, and other interventions) for chronic back and knee pain. In each study, researchers had also performed sham procedures on a control group where they replicated the invasive procedure by omitting the step believed to be therapeutically necessary. The purpose of this it to determine how much of the effects are due to the placebo response.
The information on PainRelief.com is provided for educational purposes only, and is in no way intended to diagnose, endorese, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website. None of the content on PainRelief.com is warranted by the editors or owners of PainRelief.com or Eminent Domains Inc.
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