Gender Issues and Prescription Medication Abuse
The April 2010 issue of the Journal of Pain highlights a Harvard Study that states gender appears to play a role in the risk of abuse of prescription pain drugs. The researchers say that predictors of such abuse are different in men and women, and knowing this could help doctors adopt treatment plans that are less likely to cause misuse of opioid medications.
As I read this report titled, Gender Differences in Risk Factors for Aberrant Prescription Opioid Use, I was very interested to note that this validated some of the conclusions I've developed in working with prescription pain medication addicted men and women the past twenty-seven years. I'm posting some of the excerpts from that report below. You can review the abstract in the April 2010 issue of the Journal of Pain posted by the American Pain Society.
There are distinct sex differences underlying the risks for abuse of prescription pain drugs, according to a Harvard study published in The Journal of Pain.
For the research, 662 chronic non-cancer pain patients who take opioid pain medications were surveyed with standard pain assessment questionnaires to examine rates and characteristics of problematic opioid use, profiles of risk factors for potential misuse, and predictive associations between risk factors and subsequent misuse behavior. The researchers assumed that predictors of misuse would be different in men and women, with misuse among women more strongly related to psychological distress.
The results of the study showed that men and women have similar frequencies of aberrant drug behavior, but sex differences were found in risk factors for misuse of opioid medications.
The authors indicate that their analysis showed that drug misuse by women is motivated by emotional issues and psychological distress while in men this behavior usually stems from behavioral problems that lead to substance abuse.
The study recommended that for women being treated with opioids for chronic non-cancer pain with evidence of significant affective stress, clinicians should treat the mood disorder and counsel on the dangers of relying on opioids to reduce stress and improve sleep. For men, closer monitoring of known or suspected behavioral problems, urine screens, pill counts and compliance monitoring are recommended to help reduce risks for drug misuse.
One other factor that may play a role is gender differences in pain perception. Here is an excerpt from a posting on Medscape.com titled White Cancer Patients' Perception of Gender and Ethnic Differences in Pain Experience. You can read the entire post in the
Cancer Nursing Journal (2006; 29(6):441-450).
Recently, gender and ethnic differences in pain descriptions have begun to be reported. In studies of experimentally induced pain, men have been reported to have a higher pain tolerance and higher pain threshold than women. In such studies, women were able to discriminate among heat intensities better than men, indicating that gender-related variations in pain perception were probably due to physiological differences, rather than only psychological differences in willingness to report pain.
In another study, whose authors describe gender differences in responses toward electrical stimulation, women subjects reported more pain than men, particularly at higher levels of stimulation. In a recent study, gender differences in pain characteristics were also reported: when severity and type of cancer pain are controlled, men more often presented somatic pain, whereas visceral pain was more often reported among women.
Gender differences in functional status related to cancer pain have also been reported: men tend to have higher physical functions than women. Additionally, gender differences in help-seeking behaviors were reported: men were more likely to seek information; women were more likely to seek encouragement and support.
FDA Approves a New Formula of OxyContin: Is it Enough?
The Food and Drug Administration has approved a new Oxycodone formula that releases the drug more slowly into the system. OxyContin, as many people know, is sometimes used by drug abusers for its opioid pain killer properties by breaking it down through crushing or dissolving it.
The new formulation for Oxycodone hydrochloride is released over the course of a day to "discourage misuse and abuse of the medication" says the FDA in a news release. I've posted a couple of other key points from that release below.
"Although this new formulation of OxyContin may provide only an incremental advantage over the current version of the drug, it is still a step in the right direction," said Bob Rappaport, M.D., director of the Division of Anesthesia and Analgesia Products in the FDA's Center for Drug Evaluation and Research.
"As with all opioids, safety is an important consideration," he said. "Prescribers and patients need to know that its tamper-resistant properties are limited and need to carefully weigh the benefits and risks of using this medication to treat pain."
The FDA also warns that the drug can still be abused by taking larger quantities than recommended. For those legitimately using the drug for moderate to severe pain, it will still provide around-the-clock treatment.
I discovered information about the controversy on Join Together—a project of the Boston University School of Public Health and posted excerpts from two of their reports below.
The latest version of OxyContin approved by the U.S. Food and Drug Administration (FDA) has a time-released formula that drug maker Purdue Pharma said makes it harder for users to tamper with. Even the FDA, however, warned that the drug can still be abused, and other experts said that users may be able to heat the pills to get a higher dose even if the drug is now harder to cut, crush, chew, or dissolve.
"You are led to believe it is now going to be almost tamper-proof," said state Sen. Steven Tolman, chair of the Massachsuetts OxyContin and Heroin Commission. "It either is or it isn't. I hate to be negative but I didn't get a lot of comfort with this." w"It is a lot too little, too late," added Tolman. "It is difficult to establish trust against a company that has created such destruction."
"OxyContin should be taken off the market," said Mary D'Eramo, a member of the Abington Anti-Drug Coalition and the parents group Learn to Cope. "There are other drugs out there. OxyContin hurts far more people and costs far more lives than it has ever saved."
The new formulation is designed to prevent the time-released pills from being cut, broken, crushed or dissolved by users looking to get high on the drug. FDA officials described the change to the drug formula as incremental and acknowledged that it will not be foolproof.
"The new formulation may be an improvement that may result in less risk of overdose due to tampering, and will likely result in less abuse by snorting or injection; but it still can be abused or misused by simply ingesting larger doses than are recommended," the agency noted.
The FDA will require OxyContin maker Purdue Pharma to conduct a follow-up study to determine whether the new formula is effective in reducing misuse of the drug.
There are many people concerned that this new formulation is misleading and like the comments above, some suggest taking OxyContin off the market. I don't believe taking OxyContin off the market is a good solution; in fact I think it is a very shortsighted idea. For some people OxyContin is the difference between living in bed and suffering, to leading a more productive, higher quality of life.
There is really no such thing as a "Bad" medication; it's how it's used and who it's used with that can lead to positive or negative outcomes. Someone is always going to find a way to abuse anything, if they have a mind to. By the way, there are significantly more ER visits due to an over-the-counter medication—Tylenol/ acetaminophen—than for OxyContin. Let's be smart about education, prevention and intervention followed by effective treatment. I think that is a good starting place. At least it will now be a bit harder to abuse than before.
Stem Cell Therapy for Chronic Pain Management
The emerging field of Regenerative Medicine has many definitions; however the National Institute of Health's definition, "A treatment in which stem cells are induced to differentiate into the specific cell type required to repair damaged or destroyed cell populations or tissues" is one that provides a basis for further discussion of stem cell therapies and their role in daily practice. Regenerative medicine was originally focused on tissue engineering and in vitro growth of replacement organs for transplant. However it has expanded to include other uses including the management of pain and chronic disease.
Interestingly, hematopoietic stem cell therapy has been widely used in human medicine since the 1960's in the form of bone marrow transplant. It is bone marrow and adipose derived mesenchymal stem cells (MSC) which are of current interest to the clinician for the management of pain and orthopedic injury in veterinary medicine.
The use of MSCs for the management of veterinary orthopedic disease was first commercially successful for tendon injuries in horses. They have since been increasingly used for the treatment of osteoarthritis in canine and equine patients.
Bone marrow derived mesenchymal stem cells are also being investigated for use in many diseases in veterinary species. The autologous stem cells (cells derived or transferred from the same individual's body) used for treatment of these conditions are of mesenchymal origin (usually adipose or body fat tissue) and seem to be effective by modifying injury healing and altering the local cytokine environment rather than by simply replacing diseased tissue and reversing the anatomy of degenerative tissue with pristine tissue.
The United States is behind some other areas of world in stem cell research due to political and religious controversy and many misunderstandings about the topic. The most controversial stem cell type used for research has been embryonic stem cells. Originally it was believed that embryo's would be the only source of stem cells but further research demonstrated there are numerous sources of viable stem cells including bone marrow, blood vessels, muscle, and adipose tissue.
One exciting breakthrough just released May 6, 2010 is from the University of Bristol where researchers have reported efforts to treat multiple sclerosis (MS) with stem cell therapy that has shown exciting benefits for those suffering from this condition. The ground-breaking trial to test bone marrow stem cell therapy has shown in several studies to have beneficial effects in disease models of MS.
The research team, led by Neil Scolding, Burden Professor of Clinical Neurosciences for the University of Bristol and North Bristol NHS Trust, have now completed a small trial in patients with MS. They are now working towards taking the procedures into further clinical trials later this year, and are excited by the results provided so far.
Another news report from Europe where clinical trials are about to start in humans - and researchers there say it could be the first cure for disc-related back pain. A global clinical trial for repair of degenerative disc disease is expected to start shortly.
Patients on the trial will be those with severe lower back pain and potential candidates for back surgery. A six-month trial will be carried out in the U.S. and Australia. If successful, a larger trial will include hospitals in Britain and Europe.
The trial will use mesenchymal cells, testing two doses of cells against a control group. After the damaged disc has been identified, doctors will inject these adult stem cells, grown in the lab, into the damaged disc under local anesthetic. Once in place, it is hoped they will stimulate local cells over several months to regenerate the damaged disc tissue.
The news of the study has been welcomed by Jane Tadman, from Arthritis research UK, which is carrying out its own research into using stem cells from bone marrow to repair worn discs in the spine. But she warned patients against raising their expectations of immediate treatment.
Stem cells have enormous future potential to treat knee osteoarthritis and degenerated discs in the spine without the need for surgery. "But this technique is still at an experimental stage," Ms. Tadman says. "It could be a few years before this procedure can be performed as an alternative to spinal surgery."
Cannabis for Chronic Pain Management
In 2002 I published a controversial article on medical marijuana. Last year I published an update on my thinking regarding the use of marijuana as a legitimate, effective medication because of the recent quality research that has been done on some its components.
With over $100 Billion dollars a year spent on chronic pain conditions, including the $20 Billion the pain management industry in this country has spent, at least one pharmaceutical company is positioning itself to introduce medical cannabis into the mix. Here is an excerpt from a recent Wall Street Journal Market Watch press release. The entire release can be found on the Market Watch website.
Mar 4, 2010 (GlobeNewswire via COMTEX) ? Cannabis Science, Inc., a pharmaceutical cannabis company in the U.S., announced today that it has set its second FDA drug target on the $20 Billion "Chronic Pain" market targeting the huge need for safe, non-addictive, non-lethal cannabis based medications. Its first step is to launch a new survey of cannabis use by chronic pain patients, which will compile additional first hand information from all chronic pain suffers for additional data.
Dr. Robert Melamede, PhD. Cannabis Science President and CEO explained, "We know that chronic pain patients are the largest single cohort of medical marijuana users; however, our survey is designed to help us better understand the needs of this very large and diverse group of chronic pain sufferers world-wide. We were very encouraged by what we learned from the survey of those with Post Traumatic Stress Disorder, which we just completed. This latest survey will be another example of what we mean when we say that we are a 'patient oriented company.' We should understand that cannabis is actually much safer than over-the-counter pain medications, which kill thousands of people every year, whereas cannabis does not. Also, chronic pain patients report that they use fewer opiates when they have access to cannabis. Also, there are no really good drugs for treating neuropathic pain other than cannabis medicines."
Dr. Melamede concluded, "The under-treatment of chronic pain is a national disgrace, especially when one considers that cannabis is thousands of times less lethal than even Aspirin. Millions of people are suffering needlessly because they cannot get access to medical cannabis. We want to provide them with FDA approved cannabis medicines that are both safer and in many cases more effective than those currently available."
I have two big concerns with the current use of medical marijuana; first is the dangerous delivery system?the issue of smoking it, second is the inability to regulate the dosage. Although marijuana smoke delivers THC and other cannabinoids to the body, it also delivers harmful substances, including most of those found in tobacco smoke, which is hazardous especially in the immuno-compromised patient. No other medication we have is administered this way because of the potential dangers. In addition, plants contain a variable mixture of biologically-active compounds and cannot be expected to provide a precisely defined drug effect. As to my second concern, the level of THC varies so greatly in the marijuana currently available, that it?s difficult to regulate a therapeutic dose. The delivery system and dosage problems need to be resolved before I would feel comfortable endorsing the use of medicinal marijuana for any of my chronic pain patients.
I also found a fairly new and promising cannabis product called Sativex. Here is some information about it from the free online encyclopedia, Wikipedia.
Sativex is an oromucosal (mouth) spray developed by the UK Company GW Pharmaceuticals for multiple sclerosis patients, who can use it to alleviate neuropathic pain, spasticity, overactive bladder, and other symptoms. Sativex is also being prescribed to alleviate pain due to cancer and has been researched in various models of peripheral and central neuropathic pain. Sativex is distinct from all other pharmaceutically produced cannabinoids currently available because it is derived from botanical material, rather than a solely synthetic process. Sativex is a pharmaceutical product standardized in composition, formulation, and dose. Its principal active cannabinoid components are the cannabinoids: tetrahydrocannabinol (THC) and cannabidiol (CBD). The product is formulated as an oromucosal spray which is administered by spraying into the mouth. Each spray of Sativex delivers a fixed dose of 2.7mg THC and 2.5mg CBD.
Approved by Health Canada under a license with conditions (NOC/c) for prescription use in April 2005, Sativex is the world's first pharmaceutical prescription medicine derived from the cannabis plant. The product is approved in Canada as adjunctive treatment for the symptomatic relief of neuropathic pain in multiple sclerosis, and more recently for pain due to cancer.
Sativex is available in a number of countries as an unlicensed medicine, which enables doctors to prescribe the product to individual patients who they consider may benefit. Most unlicensed prescriptions are currently written in the UK but the product has been exported from the UK to a total of 21 countries to date.
In the United States, Sativex is being studied in large randomized trials in cancer pain that has not been adequately relieved by opioids. Three early and six pivotal controlled studies in the United Kingdom demonstrated positive results treating chronic pain of various origins including neurologic pain, various symptoms of multiple sclerosis, rheumatoid arthritis, and cancer pain. Initial results show improvement in pain for more than one year despite lack of effectiveness of the opioids. Common adverse effects of Sativex have included complaints of bad taste, stinging, dry mouth, dizziness, nausea or fatigue.
Unfortunately, Sativex is not currently available for use in the United States except for ongoing FDA approved clinical trials. If someone brings it into the country?say from Canada?they could be arrested and charged with a felony. While cannabis-based medications may not be for everyone or every pain condition, we need all the help we can get in order to reduce the suffering for the millions of Americans who are not yet receiving adequate pain management.
More on Using Meditation for Chronic Pain Management
In response to stress the body mobilizes an extensive array of physiological and behavioral changes in a process of continual adaptation. This is an important part of the body's defenses with the goal of maintaining homeostasis and coping with stress. The body reacts to stress by secreting two types of chemical messengers – hormones in the blood and neurotransmitters in the brain. That is why stress management needs to be an integral part of an effective chronic pain management program.
It is important to understand the connection between stress levels and pain symptoms, as well as recognizing that stress management can decrease the perception of pain. Physically, chronic pain raises stress levels and drains physical energy, while psychologically affecting people's ability to think clearly, logically and rationally, as well as to effectively manage their feelings or emotions.
According to Herbert Benson, MD, of Harvard Medical School, meditation creates the exact opposite physiological state of what the human stress response produces. We know through use of biofeedback and other research testing that people who meditate experience decreased blood pressure, heart rate, respiratory rate, and oxygen consumption, along with increased intensity of alpha, theta, and delta brainwaves. This is why meditation can reduce the stress caused by chronic pain and can improve overall mood levels. In most cases when someone learns to lower their stress levels, they will also experience a decrease in their perception of pain.
Below is an abstract from a journal article titled Cortical Thickness and Pain Sensitivity in Zen Meditators by Grant JA, Courtemanche J, Duerden EG, Duncan GH, Rainville P. (Emotion. Vol 10(1), Feb 2010, 43-53).
Zen meditation has been associated with low sensitivity on both the affective and the sensory dimensions of pain. Given reports of gray matter differences in meditators, as well as between chronic pain patients and controls, the present study investigated whether differences in brain morphometry are associated with the low pain sensitivity observed in Zen practitioners. Structural MRI scans were performed and the temperature required to produce moderate pain was assessed in 17 meditators and 18 controls. Meditators had significantly lower pain sensitivity than controls. Assessed across all subjects, lower pain sensitivity was associated with thicker cortex in affective, pain-related brain regions including the anterior cingulate cortex, bilateral parahippocampal gyrus and anterior insula.
Comparing groups, meditators were found to have thicker cortex in the dorsal anterior cingulate and bilaterally in secondary somatosensory cortex. More years of meditation experience was associated with thicker gray matter in the anterior cingulate, and hours of experience predicted more gray matter bilaterally in the lower leg area of the primary somatosensory cortex as well as the hand area in the right hemisphere. Results generally suggest that pain sensitivity is related to cortical thickness in pain-related brain regions and that the lower sensitivity observed in meditators may be the product of alterations to brain morphometry from long-term practice.
Jon Kabat-Zinn, MD, who established the Stress Reduction Clinic at the University of Massachusetts in 1995, has conducted numerous programs for chronic pain patients that involved meditation, yoga, and relaxation. His findings indicate that four years after completing an eight-week meditation training course, practitioners were still able to reduce chronic pain by more than 50 percent.
Mindfulness-based stress reduction is one way of teaching meditation for chronic pain. "The first thing we do is get you lying down on the floor, because for patients in pain sitting can make things worse," explains Dr. Kabat-Zinn. "For the next 45 minutes, people do what's called a body scan focusing on their breathing and how their body feels in the present moment from the bottom of the foot up the leg, through the trunk, and up to the head," says Dr. Kabat-Zinn.
A 2007 study at the University of Basel Hospital, in Switzerland, found that mindfulness-based stress reduction helped fibromyalgia patients in several ways, including coping with pain, anxiety, and depression. A three-year follow-up found that patients who continued to use some form of mindfulness meditation kept seeing the benefits.
A study conducted by Patrick Randolph, Ph.D., at Texas Tech University, found that meditation in conjunction with traditional medicine enhances the effectiveness of Western conventional treatment. His stress-reduction program, combined with medical treatment, resulted in 85.5 percent of participants reporting an improvement in their ability to manage pain.
Genetics and Chronic Pain Management
According to the National Institute for Health (NIH) chronic pain states are common in the general population and genetic factors can explain a significant amount of the variability in the perception of pain. For instance, fibromyalgia syndrome (FMS) and related conditions are syndromes characterized by generalized pain sensitivity as well as a constellation of other symptoms. Family studies show a strong familial aggregation of FMS and related conditions, suggesting the importance of genetic factors in the development of these conditions.
Recent evidence suggests a role for polymorphisms of genes in the serotoninergic, dopaminergic and catecholaminergic systems in the development of FMS and related conditions. Environmental factors also may trigger the development of these disorders in genetically predisposed individuals. In the future, large well-designed studies will be needed to further clarify the role of genetic factors in FMS and related conditions. The knowledge of these gene polymorphisms may help to better sub-group FMS patients and to design a more specific treatment approach.
In other pain/genetic related news, researchers led by clinical geneticist Geoffrey Woods of the Cambridge Institute for Medical Research in the United Kingdom, examined the DNA of 578 people with the painful condition osteoarthritis. Woods and his colleagues searched for genetic variations that might be linked to how much pain a patient reported feeling — a subjective measure, Woods says, but currently the best researchers can do.
The team found that people who reported higher levels of pain were more likely to carry a particular DNA base, an A instead of a G, at a certain location in the gene SCN9A.The A version is found in an estimated 10 to 30 percent of people, Woods says, though its presence varies in populations of different ancestries. Visit Wired.com to read more.
In exploring this in more depth I discovered the Pain Genetics Lab at McGill University, headed by Dr. Jeffrey S. Mogil, is working towards explaining individual differences in the sensitivity to pain, pain inhibition by analgesic drugs, and susceptibility to chronic pain pathologies. His experiments are designed to identify and characterize both genetic and environmental contributions to such individual differences, and their interaction. Major sub-themes of the lab's activities include sex differences in and social modulation of pain processing, which we have found to interact with genetic background.
As I continued researching I came across information in the 2005 Journal of American Dental Association, Vol. 136, No 2, 148, which I've posted a portion of below, that stated some patients really do feel pain more keenly than others, and their sensitivity—or lack of it—probably can be traced to their genes. To see the entire article you can visit the JADA website.
Researchers studying pain perception and predisposition to chronic temporomandibular joint pain at the University of North Carolina at Chapel Hill have discovered a genetic explanation for why people feel pain differently and why some are more prone to chronic pain conditions.
A person's level of the enzyme catecholamine-O-methytransferase (COMT)—the enzyme that controls levels of adrenaline, noadrenalin and dopamine—is an indicator of how sensitive he or she is to painful stimulation, researchers theorize. Humans' genetic variants of COMT fall into one of three variations that give them high, average or low pain sensitivity.
Researchers from a variety of disciplines—including medicine, dentistry, physiology, epidemiology, molecular biology and genetics—studied 202 healthy, pain-free women 18 through 34 years of age for up to three years. All participants provided a blood sample for genotyping and underwent regular pressure and thermal pain perception assessments and head and neck examinations.
Study results showed that those with lower levels of COMT were more sensitive to pain and more likely to develop temporomandibular joint disorder. Researchers theorized that people with low levels of COMT also may be at greater risk of developing other chronic pain conditions such as fibromyalgia and irritable bowel syndrome, as well as other chronic sensory disorders. They also noted that testing for genetic variants can help tailor treatments for patients with chronic pain.
Finally according to the International Association for the Study of Pain, research on genes that mediate and control pain may lead to understanding how to better modulate the function of specific pain pathways. Other DNA sequences located between genes that comprise a large percentage of the human genome, may be converted into small RNAs that regulate the expression of pain genes. Optimal pain control may be achievable through understanding of molecular-genetic mechanisms, yielding individualized analgesic medications and dose regimens based upon each person's genetic endowment.
Risks and Benefits of Acetaminophen
To begin I want to reiterate my belief that there is no such thing as a "bad" medication. How it's used, what it's used for and who uses will determine either positive or negative outcomes. For most people, acetaminophen is something of a mystery as it appears in many combination cough and cold products, as well as prescription pain medications, such as Vicodin and Percocet. Since a wide variety of medications contain this ingredient, consumers may not realize that the multiple products they take all contain acetaminophen, an error that can cause significant liver damage in a very short time.
The maximum daily dosage of acetaminophen historically has been 4,000 mg which can cause dangerous side effects for someone with liver disease if taken in excessive dosages, or by a person who drinks large amounts of alcohol. This dosage was recommended for revision in June of 2009 by an FDA advisory panel who voted 21-16 to lower the maximum daily dose of nonprescription acetaminophen, currently equal to eight pills of a drug such as Extra Strength Tylenol.
In addition, the panel voted 24-13 to limit the maximum single dose of acetaminophen to 650 mg. The current single dose of Extra Strength Tylenol is 1,000 mg. The panel also voted 26-11 to make the 1,000-mg dose of acetaminophen available only by prescription. It should be noted that the FDA is not required to accept the panel's recommendations, but it typically does so.
Due to these and other concerns John Hopkins Medical center recommends that even though acetaminophen is the drug with the lowest overall risk of side effects, someone using acetaminophen on a regular basis should see their doctor periodically to be monitored for adverse effects.
However, there are many legitimate benefits for using acetaminophen. For example, a 2004 study that was presented at the 9th World Congress of the Osteoarthritis Research Society International (OARSI) in Chicago showed that the over-the-counter pain reliever acetaminophen, when used as directed, is a safe and effective treatment option for patients suffering from the pain of osteoarthritis of the hip or knee.
According to the results of this study, acetaminophen was found comparable in safety to placebo. There were no statistically significant differences in the number of serious or non-serious adverse events between patients treated with either dose of acetaminophen and placebo. The results of this study confirm that when used as directed, acetaminophen is an effective and safe choice for patients with osteoarthritis and reinforce the American College of Rheumatology guidelines that recommend acetaminophen as a first line therapy to relieve osteoarthritis pain.
Along with its other benefits, acetaminophen is less likely to interact with other medications or irritate the stomach. It is also considered safe for patients with conditions such as heart disease and diabetes.
Below is information from the manufacturer of TYLENOL® (active ingredient acetaminophen) that they posted on their website for people who want—or need—to take it, so they can do so in a responsible and safe manner.
Importantly, you can confidently continue to take TYLENOL® according to the directions currently on the package and can prevent inappropriate use by:
- Reading the label before each use and always following the directions
- Never taking more than the recommended dose
- Never using two products containing acetaminophen at the same time
- Keeping medicine out of the reach of children
- Consulting a healthcare professional with questions
The safety and efficacy of acetaminophen has been established through more than 50 years of clinical use and scientific investigation and it is safe when used as directed.
Any decisions about taking medications should be made with the advice and consultation of an appropriate healthcare provider. I believe that learning as much as we can and then educating our patients is one of the most important components of an effective chronic pain management plan.
Spinal Cord Stimulation for Chronic Pain Management
With all the concerns about the high toll prescription drug abuse and addiction takes, it is exciting to see recent research on a non-pharmacological medical approach to help alleviate back pain and increase quality of life. Electrical stimulation has been used in many different ways for decades, but there is now a newer procedure that is showing even better results.
As an intervention for chronic back and/or leg pain, spinal cord stimulation can be an effective alternative or adjunct treatment to other interventions that have failed to manage pain on their own. Spinal cord stimulation alleviates pain by electrically activating pain-inhibiting neuronal circuits in the dorsal horn and inducing a tingling sensation (paresthesia) that masks the sensations of pain.
Exciting new research on a Minimally Invasive Spine Surgery and Spinal Cord Stimulation procedure was presented at the American Academy of Pain Medicine's (AAPM) 26th Annual Conference held on February 3 - 6, 2010 in San Antonio, Texas. Below are excerpts from a PR NewsWire press release dated February 4, 2010.
In the first study, Daniel Bennett, MD, DABPM, from Integrative Treatment Centers in Denver, Colorado performed the minimally invasive facet arthrodesis procedure on 102 spinal joints in patients with recurrent facet-mediated (joint) low back pain... The goal of studying facet arthrodesis was to see if this treatment method could reduce pain, increase function, and reduce the use of medicines for a longer – hopefully permanent – duration...
Following the procedure, subjects were placed in a rigid lumbar brace for 16 weeks. At the one year follow-up, pain was reduced from 79 to 23 on a Visual Analog Scale (VAS) and function was improved from 33.46 to 8.32 on an Oswetry Disability Index (ODI). Both VAS and ODI are commonly used measurement tools to assess pain. In addition, 92 percent of the patients reported discontinuing use of narcotic medications. Only four patients' grafts dislodged, but only one of these patients reported continued pain.
"This is an impressive technique which had a profound positive effect on the patients in this pilot study," said Dr. Bennett. "It has the potential to be a long-term solution to intractable back pain due to joint disease."
Another study looked at the addition of spinal cord stimulation (SCS) to conventional medical management (CMM). Following a lumbosacral spinal surgery to alleviate pain, some patients continue to experience persistent or recurrent chronic pain – also called Failed Back Surgery Syndrome (FBSS). They report persistent pain, disability, reduced health-related quality of life, and incur high Medicare costs.
To evaluate the addition of SCS to known surgical CMM, a trial of the effectiveness of SCS was conducted. One hundred patients suffering from FBSS from twelve centers in different parts of the world were randomized into two equal groups. One group received SCS, while the other received CMM.
At the end of six months, 48 percent of the SCS group experienced greater than 50 percent pain relief as compared to 9 percent in the CMM group.
Thirty-eight percent of the SCS group also achieved greater than 30 percent back pain relief in comparison to 14 percent in the CMM group.
Additionally, at the six month point, participants who were not satisfied with the group to which they were randomized were allowed to cross over. Thirty patients of the CMM group crossed over to the SCS group while only 4 patients from the SCS group crossed to the CMM group.
Using Psychotherapeutic Approaches for Chronic Pain Management
Since 1996 I have been advocating the use of a multidisciplinary approach to chronic pain management, especially when accompanied with coexisting psychological disorders, including addiction. For many years I have encouraged participants at my trainings to include the use of a variety of non-medication based approaches for any chronic pain management condition, with pain focused psychotherapy topping the list.
When people are undergoing chronic pain management they are impacted in three major areas. Physically there is damage, injury or disease to a part of the body and the pain receptors in that area send a signal to the brain. Psychologically the brain interprets that ascending pain signal and sends a message to the cognitive section or the brain as well as the limbic system that controls emotions. Finally there is a social and cultural context in which to experience the pain in a way that reduces suffering.
Given this biopsychosocial nature of chronic pain management it is imperative to utilize a multidisciplinary treatment team approach. True multidisciplinary pain management involves interventions such as physical therapy, massage, medication management, counseling or therapy, biofeedback, occupational therapy, exercise physiology, an anesthesiologist or pharmacologist, as well as a case manager. It may also involve some type of movement therapy such as Tai Chi, spiritual wellness classes, yoga or meditation.
In our era of reducing resources, and limited access to a multidisciplinary team approach, many people are not getting the help they need and deserve for effective chronic pain management. I've said many times that knowledge is power, but especially so for people living with chronic pain. I've recently subscribed to a website that shares my premise; PainEDU.org.
This site published a report on January 5, 2010 titled "Use of Psychotherapeutic Co-interventions for Pain" that I found especially validating. In fact, it covers much of the same ground as my Addiction-Free Pain Management® system regarding the use of psychotherapy for more effective chronic pain management. I've posted some highlights from PainEDU.org which has the entire post if you want to read it.
The Importance of a Multidisciplinary Team
Chronic pain involves a complex interaction of physiological and psychosocial factors, and successful intervention requires the coordinated effort of a treatment team with expertise in a variety of therapeutic disciplines. Although some clinics offer a single treatment approach, most pain programs use a blend of medical, psychological, vocational, and educational techniques. Treatment modalities for chronic pain generally include medical assessment, medication management, pain-reduction treatments, didactic instruction, relaxation training, biofeedback, physical therapy, psychotherapy, and vocational counseling.
An interdisciplinary staff coordinates efforts to rehabilitate the pain patient and provides a comprehensive discharge and follow-up plan designed to meet the patient's short- and long-term needs. The patient's active participation in the treatment plan is strongly encouraged. Among the predictors of success in a multidisciplinary pain program are the patient's motivation to cope with pain and his or her external support systems.
Education
Most people with chronic pain have an inadequate understanding of the nature of their painful condition. It is important for them to be knowledgeable about their pain and the treatments designed for them. Information can be conveyed through patient manuals on chronic pain, video presentations, handouts, individual sessions, and interactive programs on the Internet. Topics for educational sessions may include:
- Physiology of pain
- Medication for chronic pain
- Exercise and pain
- Stress management
- Sleep disturbance
- Assertiveness training
- Posture and body mechanics
- Problem solving
- Weight management and nutrition
- Vocational rehabilitation
- Sexual issues
- Positive thinking
- Relapse prevention
In general, patients who understand their condition, and who have been exposed to relevant management techniques, maintain a perception of control over their pain and show higher rates of success in meeting their goals. Active learning techniques, including the completion of homework such as periodic surveys, checklists, diaries, or questionnaires are an important part of the educational approach.
Cognitive/Behavioral Therapy
Pain patients frequently show signs of emotional distress, with evidence of depression, anxiety, and irritability. Therapy with a cognitive/behavioral orientation helps patients gain control of the emotional reactions associated with chronic pain. Specific problem-solving strategies can be offered during therapy sessions, including:
- Identifying maladaptive and negative thoughts
- Disputing irrational thinking
- Constructing and repeating positive self-statements
- Learning distraction techniques
- Working to prevent future "catastrophizing
- Examining ways to increase social support.
Personal relationship issues can also be explored. The patient's strengths and positive coping mechanisms should be emphasized.
Chronic Pain Management Must Improve
The chronic pain problem continues to grow. Recent research in 2009 by Ohio State University Medical Center, US News & World Report the American Academy of Pain Management (2009) acknowledged that pain is a silent epidemic in the United States. An estimated 50 million Americans live with chronic pain caused by disease, disorder or accident. An additional 25 million people suffer acute pain resulting from surgery or accident. Many people undergoing chronic pain management are not receiving adequate treatment and are drifting into hopelessness, while others face medication abuse and even addiction due to mismanaged chronic pain. This must change.
Since 1996 I have been researching and developing the Addiction-Free Pain Management® System to help address this growing problem and have joined a number of pain management organizations in order to have better access to quality research. This month I wanted to revisit how serious this problem of undertreated or mismanaged chronic pain is becoming and review some ideas for improvement.
In my research I discovered The Mayday Fund that developed the Mayday Pain & Society Fellowship—A Media and Policy Initiative that trains physicians, nurses, pharmacists, social workers, scientists, and legal scholars in the pain management community to go beyond their own professional pursuits to become players in the pain field, and ultimately have real impact on the lives of people in pain. This is the fifth year of the program, which will run through 2009.
The Mayday Fund, a New York City-based foundation dedicated to alleviating the incidence, degree, and consequence of human physical pain, is interested in providing new leaders in the field with tools that will enable them to reach the broader public. The foundation established the fellowship to train six leaders a year, providing them with intensive training and five months of coaching in media, policy and leadership.
Here are the suggestions from a June 2009 meeting of the Mayday Fund that I welcome and believe are necessary. Please especially note their closing conclusion. To learn more, please check out the Mayday Fund's complete report
A Call to Revolutionize Chronic Pain Care in America: An Opportunity in Health Care Reform.
- Every American who suffers from chronic pain should have 24/7 access to access to a well-trained primary care provider who can offer—and coordinate—pain care that is high quality, equitable, and cost-effective.
- Every American with chronic pain who needs sophisticated or high-tech treatment, or whose pain has not responded to best practices in the primary care setting, should have access to evaluation and treatment by a pain medicine specialist.
- Every patient should expect to have pain managed in a manner that translates best evidence into appropriate treatments, and then coordinates these treatments into a plan that is likely to be effective in controlling symptoms and promoting function, while minimizing the risks associated with treatment. At the same time, such a plan should reduce the costs associated with duplicative and ineffective treatments.
- Government, health care payors, and health care providers should develop and utilize coordinated health information technology (IT) systems to track pain disorders, treatments, and outcomes as a mechanism to improve pain care. Quality indicators and performance measures should be developed and applied, and the public should gain access to information on the performance of hospitals, doctors and other health care providers.
- State medical and osteopathic boards, deans of medical and other health professional schools, directors of residency training programs in specialties and subspecialties that provide primary care, professional societies and other stakeholders should make sure that every trainee and health practitioner in the health professions has the skills to assess and treat pain effectively, including chronic pain. Licensing examinations should include assessment of clinical knowledge related to appropriate pain care.
- The Health Resources and Services Administration (HRSA) should expand funding for pain training programs that address competencies in pain assessment and management aimed at pediatric and adult primary care physicians, as well as other health professionals who manage pain, such as nurses, pharmacists, psychologists, physical therapists, social workers and other providers.
- The Department of Health and Human Services (HHS) should establish an independent commission to reform the reimbursement practices for chronic pain. At present, Medicare and Medicaid maintain fee for service systems that incentivize procedures and inadequately compensate professionals for the time required to assess, counsel and educate, and coordinate the care of chronic illnesses like persistent pain. This commission should explore outcome-based payments for a team approach for selected cases, revision of the disparity between non-procedural and procedural pain treatments, and parity for mental health services. Ongoing complex chronic pain management should be treated, when possible, with an interdisciplinary, rehabilitation-oriented, team approach with reimbursement for the team, rather than fee-for-service for specific individuals within the team.
- The National Institutes of Health (NIH) should increase funding for pain research to a level that is commensurate with the size of a public health problem that affects millions of people. The research should put an emphasis on emerging therapies and translational research, comparative effectiveness trials, bio-behavioral treatments, and health services research, as well as basic science. More research should focus on ways to prevent acute pain from developing into a chronic illness and to prevent childhood chronic pain from becoming a lifelong condition.
- The Agency for Healthcare Research and Quality (AHRQ) should expand funding for studies aimed at finding a set of best practices that could be used to treat specific types of chronic pain. Providers and policymakers could use such information to develop and promote high quality pain management models.
- The U.S. Surgeon General should make public education about pain, especially chronic pain, a high priority. Such a campaign could educate the public about the risks of untreated and undertreated pain in children and adults as well as promote preventive strategies that can enhance wellness and reduce the risk for the development of chronic pain.
- Health care providers, insurers and government should work to eliminate disparities in access to pain care related to race, ethnicity, gender, age (e.g. children and the elderly), and socioeconomic status so that chronic pain for all individuals in need is recognized and treated without delay.
- Federal, state and local agencies should publicly adopt a balanced approach to the regulation of controlled prescription drugs, particularly opioids. The clinical decisions of prescribers should not be inappropriately influenced by fear of regulatory scrutiny. Research has shown that state laws continue to harbor requirements that are outdated or reflect poor medical practice. A balance must be achieved between the legitimate need to protect public safety and public health through efforts to reduce drug abuse and diversion, and the imperative to address the public health problem of unrelieved pain. Policies and actions intended to reduce abuse or diversion must also include a comprehensive public analysis of these actions on access to quality and equitable pain care, including access to medications required for legitimate pain management.
Conclusion
Reducing the burden of uncontrolled chronic pain is a societal necessity, a medical challenge and an economic requirement. Chronic pain, if not recognized and treated as a chronic illness, takes an enormous personal toll on millions of patients and their families, and leads to increased health care costs. Chronic pain can also compromise the productivity of the U.S. workforce. Although the impact of pain on patients and on society is among the most serious of public health concerns, chronic pain has been largely left out of the current national debate on health reform. The nation must take the necessary steps to re-define chronic pain as a unique chronic illness and must immediately address this public health crisis.
Nerve Stimulation Therapy for Chronic Headache Pain
When it comes to the rate of chronic headaches in the United States, several studies have shown that roughly 45 million Americans suffer from them per year. There is an average of 20 million females in America that experience chronic headaches and an average of 25 million males. This represents a prevalence of chronic headaches that is roughly 1 out of every six people. Percentage-wise, 6.54 percent of all Americans experience the agony of a chronic headache condition.
This being said, most people seeking medical help are often prescribed medication. Below I have listed some of the different types of medications for chronic headache pain that was taken from the National Pain Foundation
website.
Medications are used in the following ways:
Analgesic, or pain relief. Such agents include over-the-counter (OTC) remedies, such as aspirin, acetaminophen, and non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, naprosyn, which are used to relieve headache symptoms. Some analgesics require prescriptions and include other NSAIDS, neuroleptics, and opioids.
Abortive. These agents are used to reverse, abort or reduce headaches once they start. They include such medications as ergotamine and the newest class of abortives, the triptans, including sumatripan, rizatriptan, and naratriptan. These medications are most appropriate when used no more than two days a week to avoid the risk of rebound headaches or when prophylactic, or preventive, medicines either aren't effective or can't be used.
Prophylactic, or preventive. These agents are prescribed when headaches occur more than twice a week and/or are extremely painful. They are also prescribed when other medications or remedies used to treat headache symptoms either don't work or cannot be used. Such agents include beta-blockers, calcium channel blockers and serotonin antagonists.
However, many people run into side effects and other problems such as dependency and even addiction with regular use of some opiate medications. I want to post some interesting research regarding a new nerve stimulation option that was reported in the November edition of Lancet Neurology. You can go to their website to see this latest report in its entirety. Here are some excerpts that I found interesting.
A novel therapy using a miniature nerve stimulator instead of medication for the treatment of profoundly disabling headache disorders improved the experience of pain by 80-95 percent, according to a new study from the University of California, San Francisco and the National Hospital for Neurology and Neurosurgery in London.
Up to 35 million Americans suffer migraine and other forms of headache, according to the American Academy of Neurology. "We need a range of treatments to offer patients whose lives are taken over by debilitating headaches," said Peter J. Goadsby, MD, PhD, lead author, neurologist and director of the UCSF Headache Center. "It's quite exciting to think about how technology will advance in the next five years to provide remarkable devices for the treatment of headache. Preventive approaches like these will completely change the landscape of headache treatment."
The device, called a bion, is a rechargeable battery-powered electrode, similar in size to a matchstick. When implanted near the occipital nerve in the back of the neck, it alleviates pain by generating pulses that the nerve receives. The bion can be turned on or off via an external wireless remote control. Previous versions of the bion have been used in pain management for osteoarthritis and in the treatment of dislocated joints for patients recovering from stroke.
The study measured the effectiveness of nerve stimulation in six patients aged 37 to 64 with hemicrania continua, a rare headache disorder defined by the International Headache Society as a form of chronic daily headache in which patients have 15 days or more of headache per month.
At long-term follow-up, four of the six patients reported substantial pain improvement at a level of 80 to 95 percent, one patient saw a 30 percent improvement, and one patient reported that his pain worsened by 20 percent.
Overall, the research team found that participants not only improved with the bion therapy, but their pain worsened when the bion was switched off during the fourth month. In addition, diary submissions revealed an overall reduction in the pain score of five to eight points.
"The treatment of migraine and other chronic headache pain can be a considerable challenge to physicians. Not all patients can tolerate the appropriate medicines, and the side effects leave patients and doctors in a difficult position," Goadsby said. "We have the opportunity to afford a huge change in quality of life for these patients. The bion was well tolerated, and neuromodulation is proving an effective and safe option, particularly in cases when patients have difficulty stomaching indomethacin."
How PTSD Impacts Chronic Pain Management
Over the past 27 years most of the chronic pain patients I have worked with had a moderate to severe history of unresolved trauma e.g., Post Traumatic Stress Disorder (PTSD). Even more significant is that 100 percent of my patients who were living with chronic pain and also developed a true addictive disorder had a moderate to severe trauma history. In addition to PTSD and addiction, depression is another very common coexisting psychological disorder for someone living with chronic pain.
Doing research for this month's News/Research posting led me to an article titled The Connection Between PTSD and Pain by Matthew Tull, PhD, that was posted on About.com and updated: October 29, 2008. About.com Health's Disease and Condition content is reviewed by the Medical Review Board. Here are some excerpts from that article:
PTSD and Pain
Studies have found that pain is one of the most regularly reported physical problem reported by people with PTSD — no matter what type of traumatic event was experienced (motor vehicle accident, physical assault or combat). People with PTSD are also more likely to report disability due to the experience of pain.
For example, one study of volunteer firefighters with PTSD found that approximately 50% were experiencing pain (mostly in the form of back pain) as compared with only about 20% of firefighters without PTSD. Two other studies found that 20 to 30% of patients with PTSD experience frequent and persistent pain symptoms.
It has also been found that many patients with chronic pain problems have PTSD. Anywhere between 10 to 50% of people getting treatment for chronic pain have PTSD. These rates of PTSD are higher than what is found among people in general.
Why Do PTSD and Pain Commonly Co-Occur?
First, many traumatic events may lead to the experience of pain. For example, a natural disaster, physical assault, sexual assault, motor vehicle accident or combat may all lead to serious injuries that could cause chronic pain. In addition, the more severe a traumatic event, the more likely it is that a person will experience some kind of physical injury as well as developing PTSD.
Second, certain symptoms of PTSD may lead to the experience of pain. For example, hyperarousal symptoms of PTSD may cause frequent muscle tension that could result in chronic pain.
Finally, other disorders that commonly co-occur with PTSD may also contribute to the development of pain. Depression, which frequently is experienced by people with PTSD, may cause a person to avoid or limit physical activities, resulting in disability and poorer health which eventually increases the likelihood of problems with pain.
Nowhere is this problem greater than in our military troops coming home from combat in the Middle East. This past year I have trained several people working with our returning Veterans and they shared with me the obstacles they are experiencing with some of the returning wounded warriors. Many of these men and women experienced major trauma while in combat. When they were wounded this trauma reaction seriously impacted their ongoing chronic pain management.
Here is a great resource from the Department of Veterans Affairs'— the Journal of Rehabilitation Research and Development (JRRD). Some excerpts from two different posts are below. First a 2003 posting Volume 40 Number 5, September/October 2003 Pages 397—406 titled An examination of the relationship between chronic pain and post-traumatic stress disorder. Go to their website to see this in its entirety.
While some chronic pain conditions may have an organic etiology and develop gradually over time, other conditions may develop because of an injury sustained in a traumatic event such as a motor vehicle accident (MVA), work-related injury, or participation in military combat. Most recently, there has been burgeoning interest in the relationship between pain and post-traumatic stress disorder (PTSD). Clinical practice and research indicate that the two disorders frequently co-occur and may interact in such a way as to negatively impact the course and outcome of treatment of either disorder.
Despite this recent interest, a review of the relevant literature indicates that neither empirical studies investigating theoretical models to explain the comorbidity of the two disorders nor well-controlled studies investigating the efficacy of tailoring treatments for individuals for which pain and PTSD co-occur have been done. The lack of controlled research in this area is unfortunate because such studies could significantly advance theory development and improve treatment efficacy.
This paper primarily provides a critical review and synthesis of the existing literature investigating the relationship between chronic pain and PTSD. The paper will begin with a presentation of the diagnostic criteria, prevalence, and theoretical models of chronic pain and PTSD. Research will then be presented that describes the co-occurrence of the two disorders, and several models will be highlighted that may explain the similar mechanisms by which these two disorders may be maintained. Finally, the paper will close with a call for continued research and refinements of the proposed models.
One area that has had a major increase in chronic pain and PTSD concerns the United States combat actions the past two decades. To show the scope of the problem please explore the second citation from the JRRD, which is more current and cites Volume 46 Number 5, 2009 Pages vii—xiii in a Guest Editorial by Heidi Golding, PhD; Elizabeth Bass, PhD; Allison Percy, PhD; and Matthew Goldberg, PhD titled Understanding recent estimates of PTSD and TBI from Operations Iraqi Freedom and Enduring Freedom. I've included some pertinent excerpts below and you can read the entire post at their website.
As of early summer 2009, some 5,000 U.S. troops had died and 34,000 had been wounded in action during Operation Iraqi Freedom (OIF) and Operation Enduring Freedom (OEF) in Afghanistan. The fraction of wounded troops who survive their injuries is higher than in previous conflicts, such as Vietnam. Enhanced survival is a desirable outcome; however, many policy makers and commentators have raised concerns about the ensuing healthcare needs of wounded service members and veterans.
In particular, much attention has recently focused on mild traumatic brain injuries (TBIs), posttraumatic stress disorder (PTSD), and other mental health conditions. Some 80 percent of TBI diagnoses stemming from OIF/OEF have been associated with closed (as opposed to penetrating) head injuries, suggesting that many more TBIs may have gone undiagnosed. Service members who survive gunshot wounds, explosions, or other kinetic events may suffer PTSD but so too may many others who do not receive physical injuries and, again, are not identified.
Although individuals who develop PTSD or sustain mild TBIs (concussions) often regain normal function without treatment, others recover only after medical intervention. To date, no definitive count is available of service members and veterans who were ever deployed to the conflicts in Iraq or Afghanistan and are impaired by PTSD or TBI. Nonetheless, the specter of large numbers of service members and veterans suffering—undiagnosed and requiring treatment—has been raised by a number of researchers and embraced by the popular press…
Understanding the scope of these problems helps decision makers effectively allocate scarce healthcare resources; conversely, reliance on incorrect prevalence rates can result in oversupply of medical personnel and equipment in some areas, while other medical services suffer from shortages and excessive waiting times. As recently indicated by Colonel Charles Hoge (Director of the Division of Psychiatry and Neuroscience at Walter Reed Army Institute of Research) and his colleagues, the presage of large numbers of service members with debilitating TBI and PTSD may fuel undesirable clinical and budgetary consequences: unproductive and time-consuming testing, inappropriate treatment and medication, and reinforcement of patients' and families' negative perceptions.
To learn more about how to developing a medication management plan please check out last month's article titled 12 Personal Action Steps for Chronic Pain & Medication Management that you can download for free on our Articles Page.
For more information and additional reading suggestions about pain management click here.
News & Research Archive — Here is a history of past Research for 2010 2009, 2008 or 2007
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