PAIN TREATMENTS THROUGH THE AGES

Through the ages, the search for pain relief has taken on many variations – some bizarre and some worthy of further investigation. This timeline summarizes how the desire to relieve pain has existed since the time of earliest civilizations, and that the application of electrical stimulation to nerves has evolved into innovations that make living with pain easier.

Thousands of years B.C. Opium was used by the Sumerian and Assyrian civilizations, and is mentioned in Egyptian medical scrolls dating back to 1500 B.C. Medical practitioners in ancient Greece discovered that electrical impulses emitted from electric eels in clinical foot baths relieved pain and improved blood circulation. Producing up to 600 volts in a single discharge, electric eel therapy was particularly popular for treating arthritis.

500–1500 A.D. Leeches were a mainstay in conventional treatment of pain and inflammatory diseases in the Middle Ages. Dioscorides reported that the torpedo fish could be applied to the skin to relieve headaches.

1745 The Leyden jar was invented. This was the first device able to store static electricity and was used, among other things, to treat pain.

1750s Benjamin Franklin and others began to experiment with the earliest creations of batteries. The batteries sent electrical stimulation through the skin to the painful area.

Early 1800s Morphine was first separated from opium by European chemists, and was found soon after in the United States, where it began to take the place of opium in patented pain medicines.

1831 British scientist Michael Farady discovered that an electric current can produce a magnetic field and that the reverse was also true. This observation served as the basis for neurostimulation.

1874 The cannabis plant, from which marijuana is made, became a well-regarded headache remedy by prominent physicians.

1882 The “Faradic Electrifier,” an early treatment with electricity, was advertised in the Boston Globe as one of the “Most Marvelous Inventions of the Century! All cases of Rheumatism, Diseases of the Liver, Stomach and Kidneys, Lung Complaints, Paralysis, Lost Vitality, Nervous Disability, Female Complaints are cured with the Electrifier!”

1898 Heroin, the newest opium derivative, was first produced commercially by Germany’s Bayer Company. It was widely advertised as being at least 10 times as potent a painkiller as morphine with “none of the addicting properties.” St. Jude Medical, Inc. Global Headquarters One Lillehei Plaza St. Paul, MN 55117 sjm.com Media Contacts Denise Landry Tel: 972-309-8000 dlandry@sjm.com Guy Davis Tel: 972-309-8000 gdavis@sjm.com Late 1800s Hot spring bathhouses were erected in England and the United States to relieve pain, heal injuries and prevent diseases. French scientist G. Gaiffe constructed an electrical nerve stimulating device called the Gaiffe TENS unit, which had all of the basic components of a modern neurostimulation device. However, its low electrical output (estimated to be about 3 milliamperes) made it ineffective for neurostimulation.

1900 More than 200,000 people in the United States were estimated to be addicted to opium, which was used as a main ingredient in patented pain medicines. The U.S. Congress passed a law in 1909 prohibiting the manufacture and sale of opium.

1915–1951 The Violet Ray Generator was introduced and tens of thousands were sold for home use over a 35-year period. Marketing literature claimed the device cured a wide variety of ailments including paralysis, wry neck and writer’s cramp. In 1951, the FDA banned the manufacturer from claiming it provided medical cures.

1919 The Electreat, a TENS device, was patented by Charles Willie Kent and manufactured in Peoria, Illinois. An estimated 250,000 Electreats were sold during the following 25 years. The device operated on two “D” cell batteries and a mechanical inductorium. A roller was built in at the top to be applied to the skin, and plug-in sponge pad electrodes were supplied. The Electreat was one of the very first high-output, battery-operated TENS units manufactured.

1939 Methadone was first synthesized in Germany in research efforts aimed at developing a new painkilling medication.

1944–1948 The first clinics devoted to the treatment of pain were established. They were often known as nerve block clinics.

1965 Psychologist Ronald Melzack and physiologist Patrick Wall published a landmark paper on their gate-control theory of pain. They theorized that the body has gating mechanisms within the spinal cord that close in response to normal stimulation and open with intense or painful stimulation, allowing the signal to reach the brain.

1967 Neurosurgeon C. Norman Shealy was the first surgeon to begin implanting neurostimulators in humans for pain relief. By 1970, six patients had undergone this treatment.

1972 Dorsal column neurostimulators were first marketed to neurosurgeons in the United States. These devices were later renamed spinal cord stimulators.

1976 Advances in cardiac pacemaker technology provided the basis for the development of the first totally implantable neurostimulator. St. Jude Medical, Inc. Global Headquarters One Lillehei Plaza St. Paul, MN 55117 sjm.com Media Contacts Denise Landry Tel: 972-309-8000 dlandry@sjm.com Guy Davis Tel: 972-309-8000 gdavis@sjm.com

1980s The use of opioids administered directly to the spinal column via epidurals emerged as a treatment for chronic pain.

1991 The first prototype of a radio-frequency (RF) spinal cord stimulation system is developed by Neuromed (now the neuromodulation division of St. Jude Medical) for the relief of chronic neuropathic pain.

1997 Intradiscal electrothermic therapy (IDET) was introduced as an investigative treatment for chronic low back pain. This procedure involves killing nerve fibers by heating a catheter positioned inside the spinal disc.

2002 The U.S. Department of Health & Human Services reported that narcotic analgesics were involved in 16% of total drug abuse-related emergency room visits for an estimated 108,320 visits in 2002. The 45 to 54 age group experienced the largest increase (298% since 1995).

2004–2005 The first rechargeable spinal cord stimulation systems became available in the United States. Using rechargeable technology similar to a cell phone, these devices represent the newest advancement in neuromodulation devices for the treatment of pain.

2008 St. Jude Medical introduces Eon Mini™, the world’s smallest, longest-lasting rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery.

PATIENT RESOURCES For more information on pain treatments and spinal cord stimulation, visit www.PowerOverYourPain.com.

SOURCES FOR STATISTICS AND INFORMATION Part of this timeline comes from the History of Neurostimulation, the Burton Report®

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WHAT IS CHRONIC PAIN?

In 1931, the French medical missionary, Dr. Albert Schweitzer wrote, “Pain is a more terrible lord of mankind than even death itself.” Today, pain has become a serious and costly public health issue, and it remains largely under-treated and misunderstood. According to the National Institutes of Health, 90 million people in the U.S. suffer from chronic pain. The American Pain Foundation estimates that chronic pain is the cause of $100 billion a year in lost work time and health care. The scope of individuals enduring some type of pain even eclipses cardiovascular disease, the nation’s number one killer of adults. By comparison, the American Heart Association reports that 71 million Americans suffer from cardiovascular disease. The National Pain Foundation (www.nationalpainfoundation.org), a health advocacy group for pain sufferers, notes that one in four people in the United States suffers from chronic pain and more than 40 million physician visits every year are related to pain. Yet, when individuals complain about pain, they are often given inadequate treatment or, out of strong fear of medications or aggressive therapies, they simply give up and decide to live with their pain.

TYPES OF CHRONIC PAIN

When pain lasts for a long time, it is considered to be chronic pain. Many physicians consider pain to be chronic when it has lasted for six months or longer. Others say that pain is chronic when it lasts one month longer than would generally be expected considering the injury, surgery, or disease that is causing it. To understand chronic pain, it can be helpful to categorize pain in general. Basically, there are two types of pain: nociceptive and neuropathic.

NOCICEPTIVE PAIN

Nociceptive pain is caused when special nerve endings—called nociceptors—are activated. This type of pain results from an injury to the body (such as a cut or burn), surgery, or a disease that is not a part of the nervous system (like arthritis or cancer). Pain from the activation of nociceptors depends on the parts of the body involved. It can be felt as a localized sharp, aching, or throbbing pain that is constant, or it can be a generalized deep, aching pain that comes and goes.

NEUROPATHIC PAIN

Neuropathic pain is caused by a malfunction of the nervous system due to injury, disease, or trauma. It can be sharp, intense, and constant, usually felt as a burning, shooting, or tingling pain; it can also be sporadic and felt as a dull, aching, and throbbing pain (for example, the chronic pain that people experience in their lower backs, upper backs, and legs is usually of this type). Neuropathic pain is divided into two categories: simple and complex. Simple neuropathic pain usually involves a single extremity such as an arm or leg, while complex neuropathic pain usually involves multiple extremities and has the possibility of spreading. Because chronic pain can arise spontaneously without a known cause and can vary widely in intensity, location, and response to therapy, treating it successfully can be a major challenge. Not treating it or under-treating it, however, can be devastating.

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TREATING PAIN

Many Americans suffer from chronic pain. The U.S. Centers for Disease Control and Prevention (CDC) reports that one in 10 American adults surveyed said they have suffered pain that has lasted for a year or more.1 In a recent survey, the American Pain Foundation found that only 48 percent of Americans being treated for pain felt they were getting enough information about ways to manage their pain, and 51 percent of those surveyed felt they had little control over their pain.2

TREATMENTS FOR PAIN

People in pain often try several remedies looking for relief, beginning with over-the-counter pain medications, ice packs and heating pads. When pain persists, people usually go to primary care physicians, who may use diagnostic tools (such as an X-ray) to determine if there has been an injury. If specific causes for pain are not found, physicians may refer patients to a specialist for treatment, or they may prescribe non-steroidal anti-inflammatory drugs (NSAID). Patients might also be referred for physical therapy, transcutaneous electrical nerve stimulation (TENS) or pain counseling. Pain treatments often proceed in this manner until a remedy is found; however, the array of treatment options can be overwhelming, and patients with persistent pain may become discouraged and even depressed during this process.

PAIN MANAGEMENT SPECIALISTS

At any point in the treatment process, primary care physicians might refer patients to pain management specialists or to interventional pain physicians (a relatively new and growing specialty). In addition to a medical degree, these physicians have at least one year of medical training in pain management and are qualified to develop comprehensive pain management programs that employ a full range of chronic pain therapies.

PAIN TREATMENT REGIMEN

Physicians generally follow a treatment regimen when dealing with pain patients. Elliot Krames, M.D., a leading interventional pain physician, was one of the first to recognize that pain should be treated in a progressive order, similar to other diseases. Dr. Krames published an example of a recommended sequence of pain treatments in 1999.3 The order in which treatments are administered varies according to patients’ conditions and responses to previous therapies; more than one treatment can be given at a time. The diagram below exemplifies the types of treatments patients may receive:

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SPINAL CORD STIMULATION OVERVIEW

Spinal cord stimulation (SCS) devices are approved by the U.S. Food and Drug Administration (FDA) as a method of pain control for the treatment of chronic pain of the arms, legs and trunk, or pain resulting from failed back surgery. Although it is not a cure, SCS therapy can be successful in reducing pain that is the result of dysfunction or damage to the nervous system caused by injury, disease or localized trauma. Chronic pain is a largely under-treated and misunderstood disease that affects millions of people worldwide. It is defined as moderate to severe pain that persists for one or more months longer than would generally be expected for recovery to a specific disease, injury or surgery. According to the National Institutes of Health, 90 million people in the U.S. suffer from chronic pain. The American Pain Foundation estimates that chronic pain costs approximately $100 billion per year in lost work time and health care expenses. In their search for relief, patients often endure inadequate treatments and struggle with prescription painkillers. In a report issued by the U.S. Department of Health & Human Services, the number of narcotic, analgesic, drug abuse-related emergency room visits increased 20 percent over the course of one year, totaling 108,320 visits in 2002. The 45–54 age group experienced the largest increase (298 percent). Neurostimulation studies have shown that SCS systems can often reduce pain by 50 percent or greater. These patients are often able to reduce or eliminate their use of pain medications, such as analgesic opioids, which potentially have negative side effects, including dependency. By providing significant pain relief, SCS therapy enables many patients to increase their activity levels and improve their overall quality of life.

WHAT ARE SPINAL CORD STIMULATORS?

Spinal cord stimulators are implanted neurostimulation devices that are similar in function and appearance to cardiac pacemakers, except that the electrical pulses are sent to the spinal cord instead of the heart. These “pacemakers for pain” interrupt the pain signals’ pathways to the brain by delivering low intensity electrical pulses to trigger selective nerve fibers along the spinal cord. Researchers theorize that stimulating these nerve fibers diminishes or blocks the intensity of the pain message being transmitted to the brain, replacing feelings of pain with a more pleasant tingling sensation called paresthesia.

A spinal cord stimulation system includes:

• Neurostimulator or generator—a surgically implanted, battery-operated medical device that is like a pacemaker for pain

• Leads—one or more thin wires with several electrodes or contacts that carry mild electrical pulses from the neurostimulator to specific segments of the spinal cord

• Patient controller—a remote control device that turns the system on and off and allows patients to adjust stimulation within parameters set by physicians

• Programmer—a device that enables the doctor or clinician to adjust and fine-tune the stimulation programs

To have a spinal cord stimulator implanted, a patient undergoes a minor surgical procedure in which a lead or leads are placed in the epidural space next to the spine. Leads are positioned using a small needle or by making an incision and they are then connected to the generator, which serves as the power source. Once activated, the system’s programs are adjusted and fine-tuned to best control the patient’s pain. Patients use a controller that allows them to check the system’s battery, adjust the power level, select from pre-set programs, and turn the system power on and off. St. Jude Medical, Inc. Global Headquarters One Lillehei Plaza St. Paul, MN 55117 sjm.com Media Contacts Denise Landry Tel: 972-309-8000 dlandry@sjm.com Guy Davis Tel: 972-309-8000 gdavis@sjm.com The neuromodulation division of St. Jude Medical is a technology leader in implantable neurostimulation therapies with nearly 30 years of experience and numerous technology firsts. More than 45,000 people in approximately 35 countries have St. Jude Medical neuromodulation devices managing their chronic pain. To learn more, visit www.PowerOverYourPain.com.

PATIENT RESOURCES Patients should always be encouraged to talk with their physicians or seek out pain management practitioners if they believe they are suffering from chronic pain. Information on how to locate a physician who treats pain can be found at www.PowerOverYourPain.com. Indications for Use: Chronic, intractable pain of the trunk and limbs. Contraindications: Demand-type cardiac pacemakers, patients who are unable to operate the system or who fail to receive effective pain relief during trial stimulation. Warnings/Precautions: Diathermy therapy, cardioverter defibrillators, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted. Adverse Events: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). User’s guide must be reviewed prior to use for detailed disclosure. Caution: U.S. federal law restricts this device to sale and use by or on the order of a physician.

SOURCES FOR STATISTICS AND INFORMATION:

• www.PowerOverYourPain.com

• www.NationalPainFoundation.org

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SPINAL CORD STIMULATION FOR FAILED BACK SURGERY PAIN

The number of back surgeries in the United States increased dramatically between 1992 and 2003.1 Correspondingly, so has the number of patients experiencing failed back surgeries. Physicians refer to the chronic pain a patient suffers after undergoing unsuccessful surgery to relieve back pain as “failed back surgery syndrome” (FBSS), or post-laminectomy syndrome. The prevalence of FBSS in the United States is not exactly known, but it has been estimated to affect nearly 30 percent of spinal surgery patients2.

TREATING FAILED BACK SURGERY SYNDROME

For a patient with FBSS, treatment options usually are very limited. This is because more conservative and less invasive measures typically have been tried already, without success. After the failure of one back surgery, patients may have the option of another back surgery. Some patients also are given the choice of spinal cord stimulation (SCS), which has been available for several years with good results for many FBSS patients. In a study published in 2005, FBSS patients were randomly assigned either to have an SCS system implanted or to have a repeat back surgery. The study found that 47 percent of patients treated with SCS were satisfied with the therapy, experiencing at least a 50 percent reduction in pain; however, only 12 percent of patients with repeat surgery were satisfied. All of the patients were given the opportunity to try the treatment that they had not been originally assigned. Of those who had an additional procedure, 43 percent of the repeat-surgery patients who tried SCS were satisfied with SCS, but none of the SCS patients who tried repeat surgery were satisfied with the additional surgery.3 In a 2007 study, 74 percent of the patients studied said that SCS was beneficial. The authors concluded that SCS does decrease the low back pain associated with FBSS.4 Further, in a comprehensive review of medical literature by the department of neurosurgery at Wayne State University, it was reported that SCS was an effective treatment for FBSS pain, with 60 to 80 percent of patients achieving effective pain relief with SCS. Additionally, these patients had significant improvements in their quality of life and a much greater chance of returning to work than patients who did not undergo SCS.5

COST OF THERAPY

In the United States, Medicare spending for inpatient back surgery more than doubled between 1992 and 2003. The biggest increase was in lumbar fusion surgery, which jumped from $75 million to $482 million, accounting for almost half of the more than $1 billion dollars spent on back surgeries in 2003.1 A 2004 review of medical literature revealed that SCS was cost effective for the treatment of chronic pain. The researchers concluded that SCS saved money in the long run by reducing patients’ demand for future healthcare.6 One study by British researchers also showed SCS to be less costly and more effective than conventional, non-surgical medical care over the course of a patient’s life.7 In an article published in Pain Practitioner in 2006, two European doctors wrote, “Studies consistently report that over time, SCS is potentially cost saving to the healthcare system. At present, SCS is considered a ‘last resort’ in the treatment of refractory neuropathic pain, yet evidence suggests that early intervention with SCS results in greater efficacy and, in the case of FBSS, should be considered before re-operation.”8

PATIENT RESOURCES

St. Jude Medical, Inc. Global Headquarters One Lillehei Plaza St. Paul, MN 55117 sjm.com Media Contacts Denise Landry Tel: 972-309-8000 dlandry@sjm.com Guy Davis Tel: 972-309-8000 gdavis@sjm.com People suffering from pain after back surgery should talk with a physician, such as an interventional pain physician, or other healthcare provider about their symptoms. More information about SCS is available at www.PowerOverYourPain.com.

SOURCES FOR STATISTICS AND INFORMATION:

• www.PowerOverYourPain.com

Sources:

1 Weinstein JN, Lurie JD, Olson PR, Bronner KK, Fisher ES. United States’ trends and regional variations in lumbar spine surgery: 1992-2003 [abstract]. Spine. 2006;31(23):2707-2714. Taken from: PubMed. Available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=1707 7740. Accessed April 30, 2007.

2 Javid MJ, Hadar EJ. Long term follow-up review of patients who underwent laminectomy for lumbar stenosis: a prospective study. J Neurosurg. 1998;89(1):1-7. Taken from: PubMed. Available at: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=9647165& ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum. Accessed June 8, 2007.

3 North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. Jan 2005;56(4):98-107.

4 De Andres J, et al. Patient satisfaction with spinal cord stimulation for failed back surgery syndrome [abstract]. Rev Esp Anestesiol Reanim. 2007 Jan;54(1):17-22. Taken from: PubMed. Available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids= 17319430&query_hl=2&itool=pubmed_docsum. Accessed April 25, 2007.

5 Lee AW, Pilitsis JG. Spinal cord stimulation: indications and outcomes [abstract]. Neurosurg Focus. 2006 Dec 15;21(6):E3. Taken from: PubMed. Available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids= 17341047&query_hl=2&itool=pubmed_docsum. Accessed April 25, 2007.

6 Taylor RS, et al. The cost effectiveness of spinal cord stimulation in the treatment of pain: a systematic review of the literature. Journal of Pain and Symptom Management. Apr 2004;27(4) 370-378. Taken from: ScienceDirect. Available at: http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T8R4C1C83CC&_user=10&_coverDate=04%2F30%2F2004&_rdoc=1&_fmt=&_orig=search&_sort=d&view=c&_acct=C 000050221&_version=1&_urlVersion=0&_userid=10&md5=a64adacf1044ee2fa755266cef07b45c

7 Taylor RJ, Taylor RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effectiveness analysis [abstract]. Int J Technol Assess Health Care. 2005 Summer;21(3):351358. Taken from: PubMed. Available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=16110715&dopt=Ab stract. Accessed April 26, 2007.

8 De Andres J, Van Buyten JP. Neural modulation by stimulation [abstract]. Pain Pract. 2006 Mar;6(1):3945. Taken from: PubMed. Available at: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids= 17309708&query_hl=2&itool=pubmed_docsum. Accessed April 25, 2007.

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