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.

The Patient

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. 

References

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.


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