Monday, November 21, 2016
New Treatment for Back Pain Using an Ipod and Neurotransmitter
Opioid addiction cost the U.S. 79 billion dollars in 2013. (Silverman, 2016) This article reviews an alternative treatment for lower back pain, besides prescription opioids. In a review of all emergency admissions between 2004 and 2008, two million people in the United States were found to have sought treatment for lower back pain each year. Back pain is also the second most common cause of workplace absenteeism and disability. (Waterman BR, 2012) A 1992 North Carolina survey of chronic lower back pain, defined as those who have experienced this problem for three months or longer, found that 3.9% of survey respondents reported debilitating back pain. The survey was repeated in 2006 and the incidence of lower back pain had increased across all sectors and had risen to 10.2% of the population. (Janet K. Freburger, 2009) The treatments for this health curse can be invasive and ineffective, often leading to prescription drug addiction to opioids, but new technologies have created a minimally invasive pain treatment for the millions of people suffering from lower back pain. This article highlights what a determined Oregon resident, is doing to treat her lower back pain, through participation in a high tech clinical trial using an Ipod and a neuro transmission device for pain control.
Fran had experienced years of back problems and was diagnosed with scoliosis and spinal stenosis. Spinal stenosis is the most common reason for back surgery for adults over the age of 65. Her back problem became much more pronounced on a European vacation, where she found herself racked with pain and struggled to regain movement of her left leg. In 2009, she tried steroid treatment and found the first injection was effective, but the second one failed to ease her pain. She also tried physical therapy but it did nothing to relieve her pain. However, when the pain returned, she even tried other medications like Lyrica and Gabapentin for a while, but found it had adverse side-affects. She finally had some surgery which opened areas of her spine that inhibited the nerves. After surgery her pain had virtually disappeared. Three years later the pain returned, like a poker in her left buttocks radiating down her left leg and ultimately down her right leg as well. After another MRI was performed it was determined that the constrictions were beginning again. Ultimately, she returned to her back specialist, who suggested she enroll in a clinical trial for lower back pain treatment to see if it might help relieve some of the pain. Her orthopedic specialist indicated the next surgery would be a difficult one as two discs would need to be replaced.
The Clinical Trial
In August 2016, Fran became a participant in a clinical trial called medical neuro trans stimulation, which has been approved by the Centers for Medicare and Medicaid, and is now eligible for insurance reimbursement. This clinical trial is run through St. Jude’s Medical Neuro Transtimulation program and it consists of a portable pain controller, operated with a pain management Ipod app, wireless data transmission, and electrodes implanted adjacent to the participant’s spine. The sensors are portable generators which transmit signals to the neuro system through the spine. (St. Jude Medical, n.d.) Fran’s sensors were installed by a board certified orthopedic spine surgeon in the Portland Oregon area. (Oregon Spine Care, 2016) Fran’s bionic machine is run by an Ipod and an electrical stimulation device, which responds to implanted metal sensors. The electrical stimulation generator is implanted in her waist area and is programmable by a medical specialist and reset by a magnet called a patient controller. The Ipod allows her to choose from pre-selected programs, or a continuous feed, and various levels of intensity for pain management. The programmable levels of pain management are determined by the St. Jude clinical trial procedures for each patient participating in the study.
Reducing Opioid Dependence
Neurotransmitters work by stimulating the electrical impulses between cells, which provide information to the brain and interpret sensations, such as pain or pleasure. During the early phases of opioid drug use, the neuro transmission normalizes as the drug wears off, but over time, when the addiction starts, the cellular material changes creating permanent abnormalities in cell communication. (Sherman, 2007) Thus, addiction is born from exposure, continuous use, and cellular damage from the invading drug.
With the access to individual pain monitoring programs through portable electronic devices, like Ipods, patients can use reduced amounts of the highly addictive opioids, such as OxyContin. According to the Centers for Disease Control and Prevention, 78 people die daily from opioid overdoses and 60% of these are from prescription medicine, not called pain killers by accident. (Centers for Disease Control and Prevention, 2016) Imagine losing your entire family in a day, that is the scourge of this epidemic, which claims 30,000 lives each year. Given the highly addictive nature of the manufactured opioid drugs, the use of the TENS treatment could have lifesaving implications for chronic pain sufferers.
Centers for Medicare and Medicaid Approved TENS Treatment
In 2012, the Centers for Medicare and Medicaid (CMS) approved Transcutaneous Electrical Nerve Stimulation (TENS) for treatment of chronic low back pain for participants in clinical trials. In 2015, CMS approved insurance reimbursement for the TENS treatment for patients participating in clinical trials. This treatment is the use of electrical impulses, stimulated through a hand held electronic device, to send signals to the brain's neuro pain center. CMS will provide reimbursement for this type of treatment if it is shown to provide a meaningful reduction in chronic lower back pain or an improvement in function for these patients. In order to participate in the clinical trial, the patient must have had persistent chronic lower back pain for at least three months. CMS also stipulated that the study group and the control group must each receive the same concurrent treatments to validate the results and control for bias. (Centers for Medicare and Medicaid, 2015) Clinical Trials for Transcutaneous Electrical Nerve Stimulation are now being conducted at medical centers throughout the United States to assess real world effectiveness for patients. The initial investigative trial in 2008, which was to scientifically determine if transcutaneous electrical nerve stimulation worked, included eight scientific study sites throughout the country. (Center Watch, 2008)
Impact on National Population
Back surgeries are one of the selected procedures for higher scrutiny under the Centers for Medicare and Medicaid and the deployment of the neuro electrical stimulators and attendant handheld devices have the potential to save Medicare millions of dollars annually in unnecessary and ineffective back surgeries. This of course would drive treatment patterns for private sector insurance reimbursement as well. CMS has identified lower back pain as a diagnosis to monitor and it will begin paying physicians for clinical performance via value-based payments starting this year. (Baird, 2016)Technical expert panels were chosen in March of 2016 to review current treatment for lower back pain and make recommendations for treatment protocols based on improvements in patient health. (Centers for Medicare and Medicaid, 2016)
Are trans neurotransmitters effective? A 2008 peer reviewed study, published by Health and Human Services found that electrical stimulation through neurotransmitters was effective for treating joint pain for Rheumatoid Arthritis. This noninvasive non-addictive pain treatment requires adequate dosing and intensity for effectiveness. (Josimari M. DeSantana, 2008) Ongoing research for other applications for TENS therapy continues, but not all procedures are approved for reimbursement by the CMS. This intersection of technology and science appears to have a tremendous upside in lives saved, overall improvement in patient health, and reduction of ineffective surgeries. Instead of hearing, “Mom, you forgot your medicine, now it is Mom, you forgot your pain pad.”
This article was written by Roberta E. Winter and may be widely distributed with appropriate attribution of course.This article in no way provides medical advice and is intended for educational purposes only.
Roberta E. Winter is an independent healthcare analyst and writer and the author of Unraveling U.S. Healthcare-A Personal Guide, Rowman & Littlefield, 2013.
Baird, C. (2016). Top Healthcare Stories for 2016-Pay for Performance. Committee for Economic Development.org. Committee for Economic Development.org. Retrieved October 19, 2016, from https://www.ced.org/blog/entry/top-healthcare-stories-for-2016-pay-for-performance
Center Watch. (2008). Clinical Trial Details-Transcutaneous Electrical Nerve Stimulation. Boston: Center Watch. Retrieved September 2016, 28, from http://www.centerwatch.com/clinical-trials/listings/external-studydetails.aspx?StudyID=NCT00709748
Centers for Disease Control and Prevention. (2016, October 25). Understanding the Epidemic: Drug Overdose Deaths Hit Record Numbers in 2014. Retrieved from Centers for Disease Control and Prevention : https://www.cdc.gov/drugoverdose/epidemic/
Centers for Medicare and Medicaid. (2015). Transcutaneous Electrical Nerve Stimulation for Chronic Lower Back Pain. Coverage With Evidence Development Decision Memo, U.S. Department of Health & Human Services, Centers for Medicare and Medicaid. Retrieved September 28, 2016, from https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=256
Centers for Medicare and Medicaid. (2016, October 19). Technical Expert Panels-2016. Retrieved from Centers for Medicare and Medicaid (CMS).gov: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/TechnicalExpertPanels.html
Janet K. Freburger, P. P. (2009, February). The Rising Pravalence of Chronic Low Back Pain. Arch Internal Medicine, 169(3)(February 9, 2015), 251-258. doi:https://dx.doi.org/10.1001%2Farchinternmed.2008.543
Josimari M. DeSantana, P. P. (2008). Effectiveness of Transcutaneous Electrical Nerve Stimulation for Treatment of Hyperalgesia and Pain. Current Rheumatology Report. doi:PMC2746624
Oregon Spine Care. (2016, October 5). Oregon Spine Care. Retrieved from http://www.oregonspinecare.org/our-team/robert-tatsumi-md
Sherman, C. (2007). Impact of Drugs on Neurotransmission. National Institute of Drug Abuse. Retrieved October 3, 2016, from https://www.drugabuse.gov/news-events/nida-notes/2007/10/impacts-drugs-neurotransmission
Silverman, R. E. (2016, November 16). Employers Tackle Abuse of Painkillers. The Wall Street Journal, pp. B-5.
St.. Jude Medical. (n.d.). Neuromodulation products. Retrieved October 3, 2016, from https://professional.sjm.com/sitecore/content/professional/products/neuro/scs/paddle-leads
Waterman BR, B. P. (2012, January 12). Low back pain in the United States: incidence and risk factors for presentation in the emergency setting. Spine, 12(1), 63-70. doi:doi: 10.1016/j.spinee.2011.09.002. Epub 2011 Oct 5.
Wednesday, November 9, 2016
The Rise of Fascism in the United States
In the aftermath of the unruly election and the debacle of Trump’s ascendency to the highest office in the land, this represents the public repudiation of decency and respect for women. Throughout his campaign he referred to women in derogatory terms and physical evidence was presented about his sexual assaults on women. However, like a flashback to the nomination of Clarence Thomas to the Supreme Court, the victims of his sexual harassment, were treated as criminals.
As a child, I was acutely aware of my lower status as a girl, but I concentrated on being studious and working 20% harder than everyone else at every job, such was my desire to live an independent life. I was grabbed and groped in vocational agriculture class and the teacher did nothing, because he wished I wasn’t there. These humiliations and many others were something I endured because I knew no one would intervene on my behalf. I believed in women’s rights and the promise of equality. I went to “college night” in my rural high school alone, riding my bicycle 10 miles on rural roads. When I approached my parents about my desire to go to college, my father suggested I consider secretarial school. But I was undaunted, I used my own money (I started working and paying into the Social Security system at age 13) and bought a greyhound bus ticket into the twin cities and attended my college admissions interview alone. Of course, I was accepted, what higher education institution wouldn’t include someone who wanted an education so fiercely? When I was in college, I marched for the ill-fated Equal Rights Amendment, with a Spanish girl I was mentoring. Note to Phyllis Schlafly (RIP), your shared bathroom fear failed, as they are called family bathrooms and are wildly popular today.
I obtained my first full-time job for Prudential, because they were under court order to integrate their sales forces with women. Of course, I was paid less than the men, but this was a strategic error on their part, because I always made my goals, making it hard to get rid of me. I regularly received notes from the regional manager, Bill Friedman on my performance. This was in the face of a sexist division manager, Claude Cosseau, who refused to put my legal hyphenated name on my business cards. His boss, Albert Tarabini, insisted on treating all women as ciphers and all “decision makers” were deemed to be male. When I did not agree with the sales manager, Greg Freitag’s aggressive tactics in a client interview and suggested a better approach I was admonished with, “What is wrong with you-is it the wrong time of the month?” I do recall that the men of color were particularly supportive, especially Juan Barrios.
Later, when I began my career in the employee benefits field, I was the first female account executive for the firm, an atmosphere which included a level of inebriation at corporate events equaled only by the Russian landscape. In one particularly humiliating situation, one of the account executives told a graphic joke about fellatio in front of a senior executive and me. As the only female executive in the firm I had to grin and bear it. I was propositioned by married executives in the firm, but this was practically an everyday thing in the business world. So, I left this firm for another one, which paid better.
As I became more successful in my field and exerted leadership for business development, this gained attention, but for women this is always the double-edged sword. I was ultimately fired for questioning my male manager’s approach to the implementation of a customer management system. Still having plenty of moxie, I took the firm to court and was awarded a modest settlement for discriminatory practices and wrongful dismissal. I used that money to start my own firm, which I ran for nearly nine years, until I decided to work on healthcare reform.
As a single mom, I attended a top ten public university, one of the best schools in the world, to prepare myself for advocacy and healthcare improvement work. Subsequently, I have slaved away for over a decade, mostly for free, researching and providing unbiased useful healthcare information for everyday people, in the hopes this will inform better decision making. In my upbringing, I was taught that to pursue a higher calling, regardless of compensation was a good and just thing. However, it appears the tide has turned against the elevation of humanity and self-interest is the only currency that matters.
Though I would like to say that girls can be anything to which they aspire, this has been tempered by the election of a misogynist to the presidency and it would be wise to explain to your daughters, nieces, and sons what that word means, as women like me have lived it our entire lives. My son, raised by a single mother, like Presidents Clinton and Obama is all too aware of the hatred and opportunism toward women having witnessed it throughout his life. So, to those who think that it is only women who suffer from this bilious resentment, don’t forget their children. And this is the healthpolicymaven signing off with a heavy heart. Feel free to share this article with people who value civility and have not given up on the tattered democracy of the United States.