Monday, November 21, 2016
Reducing Opioid Use And Back Pain With Ipod And Neurotransmitter
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.