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Calling for an Integrative Approach to Pain Management

This week, Real World Health Care continues our series on pain management with an interview with Bob Twillman, PhD, FAPM, Executive Director of the Academy of Integrative Pain Management. Dr. Twillman is responsible for overseeing federal and state pain policy developments and advocating for those supporting an integrative approach to pain management. He also serves as chair of the Prescription Monitoring Program Advisory Committee for the Kansas Board of Pharmacy. Dr. Twillman previously served as a faculty member at the University of Kansas School of Medicine, where he founded and directed the inpatient pain management program and was a co-founder of the hospital’s Palliative Care Team.

Improving People’s Lives

Bob Twillman, PhD, Executive Director, Academy of Integrative Pain Management

Real World Health Care: Can you describe the mission of the Academy of Integrative Pain Management?

Bob Twillman: Our mission is to improve the lives of people with pain by advancing a person-centered, integrative model of pain care through evidence-guided education, credentialing, and advocacy. In essence, we want to promote an integrative, multimodal, multidisciplinary approach to pain management because we believe such an approach is more effective and more cost-effective in treating all types of pain, both chronic and acute. Our educational opportunities teach clinicians how to provide this kind of care, and our advocacy efforts — which are unparalleled in the pain management sphere — promote policies that encourage provisions of this type of care.

Clinician Training & Challenges

RWHC: Why is it important for clinicians to be well-versed in integrative pain management?

BT: The traditional biomedical approach to pain management doesn’t always work well for a good number of people with pain. We know — and it’s been confirmed by the Institute of Medicine and in the recently-issued National Pain Strategy — that pain is a complex biopsychosocial phenomenon, and that an integrative approach is the only safe and sane way to care for people with pain. The only way to achieve the best possible pain control for every person with pain is to use an integrative approach that addresses all aspects of this complex phenomenon, as they play out for each individual person. There is no cookbook for pain care, and one size doesn’t even fit most, so we need to use an integrative approach that permits maximum flexibility in providing care.

RWHC: What are some of the biggest challenges that clinicians face in dealing with patients’ pain management issues?

BT: Undoubtedly, access to all the treatments we need in order to provide integrative pain care is our biggest challenge. Access to integrative non-pharmacological treatments such as acupuncture, massage therapy, biofeedback and others has never been good because insurance reimbursement is poor, causing people with pain to have to pay out of pocket for these treatments — something many of them can’t do. Adjunctive treatments such as physical therapy and behavioral health care might be more readily available, but they also are subject to inadequate insurance coverage that makes true access less than optimal. And now, even the medications that have been so ubiquitous as primary treatments of pain are under fire and both insurers and policymakers are restricting access to those as well. It’s really challenging to provide the kind of care that even key governmental agencies like the CDC have been calling for.

RWHC: How is the Academy addressing these challenges?

BT: AIPM continues to advocate for appropriate access to all of the treatments we need in order to provide comprehensive integrative pain care. Often, that means we have to battle inappropriate restrictions on pain medications, but we also advocate extensively for policies that promote improved access to non-pharmacological pain treatments. Recently, we have been advocating for enhanced Medicare and Medicaid coverage of integrative pain treatments, while also advocating for more opportunities to carry out Medicaid demonstration projects that we believe will show how much can be gained if those treatments were covered. And of course, we continue to educate clinicians about ways they can provide integrative pain care even if they don’t have a large multi-disciplinary staff and insurance coverage for all the treatments they need.

Pain Management Therapies

RWHC: What are the most promising non-pharmaceutical approaches for pain management and why are they important?

BT: Consider what the pain management experts at the Department of Defense and the Department of Veterans Affairs have listed as the five evidence-based, non-pharmaceutical approaches they think every current and former service member with chronic pain should be able to access: chiropractic and osteopathic manipulations, acupuncture, massage therapy, biofeedback, and yoga. And it’s important to note here, in follow up to my previous comment on inadequate coverage, that only some types of chiropractic and osteopathic manipulation are covered by Medicare, and only for some diagnoses. None of the rest of this list of five are covered.

Additionally, we know that many people with pain benefit from physical and occupational therapy and from behavioral health interventions. If we had full access with adequate insurance coverage for these treatments, we would be delighted. Being able to get these treatments for people with pain would mean that more of them would have less pain, better functioning in a number of areas, improved quality of life, and increased likelihood of being able to work. Plus, we would spend less money achieving those improved outcomes.

Opioid Addiction

RWHC: How is the rising opioid addiction issue in America changing how clinicians address and treat their patients’ pain?

BT: For much of the past two decades, pain treatment has been primarily associated with opioid prescribing. While I think increased opioid prescribing was a well-intended attempt by the medical profession to provide better pain care, it may have been misguided due to lack of evidence, lack of access to alternatives, and the influence of a number of market forces and cultural beliefs. Now that this increased prescribing has been implicated in the parallel and sharp increase in overdose deaths involving prescription opioids, policymakers are extraordinarily active in pushing legislation and regulation intended to reduce excessive prescribing. Unfortunately, this is happening in the context of the non-pharmaceutical treatment access problems I outlined previously, without concomitant attempt to improve that access. All of that leaves primary care clinicians, who deliver the majority of pain care in this country, struggling to figure out what to do.

We are hearing from people with pain that some clinicians are responding by either setting an arbitrary dose limit for opioids, or by establishing policies that they will not prescribe opioids, regardless of the circumstances. That may be harming people who benefit from those medications, in service of benefitting those who use opioids inappropriately and in a harmful manner. I think it’s going to be a while before all of this shakes out and we can arrive at a balanced approach that maximizes the benefits and minimizes the harms for everyone.

Pharmaceutical Industry Efforts

RWHC: What should be the role of the pharmaceutical industry in addressing the rising opioid addiction issue in America? How can they work with clinicians and groups like the Academy?

BT: The pharmaceutical industry has been engaged in efforts to make their products safer, by developing abuse-deterrent opioids. These medications make it much harder to abuse prescription opioids by means of altering them to permit snorting or injecting the opioid medication. This is an important step, because it will protect people who misuse these medications — the vast majority of whom are not people with pain. If we are able to do that, then perhaps we won’t see as much of a reactionary backlash that causes people with a legitimate medical need for prescription opioids to have their prescriptions denied or taken away.

The industry can also help us by increasing funding for our education and advocacy efforts. We have so many needs for education — both for new clinicians who are now in school and for experienced clinicians who are in practice — that meeting the need is an enormous and extremely expensive task. Due to mandates for Risk Evaluation and Mitigation Strategies (REMS) education imposed by FDA, much of this funding has been redirected away from organizations like ours that can provide integrative pain management education — and without discernible benefit. We desperately need FDA to revise the REMS program blueprints so we can teach clinicians about more than just the pharmacology of opioids and so we can teach about non-pharmacological approaches to pain care. It’s really challenging for the industry to adhere to FDA mandates and to go beyond those, but we need to find a way to encourage that to happen.

Assessing Chronic Pain

Our series on Pain Management continues this week with insight on how clinicians assess chronic pain. We spoke with Bryan Jensen, PhD, a clinical health psychology postdoctoral fellow at the VA Salt Lake City Health Care System, where he treats inpatients and outpatients with chronic pain as well as facilitates primary care chronic pain recovery groups. Dr. Jensen recently graduated with his doctorate in clinical psychology from Virginia Commonwealth University, where he focused his clinical and research work serving patients with chronic disease in both inpatient and primary care populations, most notably underserved patient populations and those with high levels of co-morbidities.

Bryan Jensen, PhD, VA Salt Lake City Health Care System

We asked him about his recent Translational Behavioral Medicine article on chronic pain assessment within a translational framework and the challenges facing researchers and clinicians who are studying and treating chronic pain.

Real World Health Care: Can you provide a summary of your recent article in Translational Behavioral Medicine?

How Chronic Pain is Assessed

Bryan Jensen: As researchers and clinicians seek to treat pain, we first need to understand if we are assessing pain accurately. The article is a review of how pain is assessed across the translational continuum. It starts by exploring the basic science of animal models of pain and the types of methods used in that setting to assess pain. Clearly, these methods are not the same methods we use in clinical practice — a rat is not the same as a human — but they must translate. We are starting to understand that older models of pain assessment may no longer be adequate, so we are looking at newer models and seeking to determine a more accurate definition of pain across clinical and research settings. Other translational issues are outlined with a focus on how providers are using pain assessment tools and how they can implement newer evidence-based tools for more evidence based assessment.

The article points to three main areas that hold promise to bridge current gaps. One is using computer adapted technologies to obtain self-reported measures of pain. Because we can’t take a “thermometer reading” of pain, we rely on patients’ assessments. But pain is multi-dimensional, and asking patients to go through a 100-question survey is daunting and time-consuming, so scientists have developed computer programs that evaluate how patients respond to clinicians’ questions and adapt those responses so clinicians can more efficiently and effectively get the information they need. The NIH has been rolling out these tools over the past decade.

The second promising area is lab-based, for example, using a blood draw to look for proxy measures of pain. This is more of a downstream method to assess the patient. These tools still require further research to understand how to directly translate into clinical practice.

The third promising area is observational. In animal models, we poke a rat and watch its response. With very few exceptions — such as needle prick tests for diabetic neuropathy — we’re not going to go poking human patients. But there are observation-based methods that allow clinicians to accurately measure pain and pain behaviors. For example, the University of Alabama at Birmingham developed a pain behavior scale. Unfortunately, it isn’t widely used, even though it has demonstrated excellent validity in terms of helping providers easily and quickly measure pain and pain behaviors like grimacing, holding one’s back, and limping. It really does an excellent job giving a complete picture of a patient’s experience.

Effective Pain Treatment

RWHC: What are some of the important implications for patients and for the field of pain management?

BJ: The whole point of accurate pain assessment is to allow for more effective treatment. If patients are more aware of various pain assessment methods, they can advocate for themselves and request clinicians to widen their scope of assessment. Informed patients always help the clinical process.

The goals are improved assessment and treatment, which would lead to better patient care, higher patient satisfaction, and a reduced burden on patients, their families, and our nation. Economically, the cost of chronic pain is over $600 billion a year. If we can chip away at that, we would be making a huge impact.

Challenges and Opportunities

RWHC: What are the biggest challenges facing researchers when it comes to studying pain assessment, and how can those challenges be overcome?

BJ: From a research perspective, there’s less emphasis on assessing pain than there is on treating pain. The main challenge is a financial one, with fewer research dollars dedicated to studying pain measurement. Another challenge is a theoretical one. There’s been some exciting, cutting-edge research on neurological measures, focused on neurosignatures that act as a thermometer to measure pain, but there’s been some discord in the field as to whether this is a useful pursuit. We also need better uniformity across the literature in terms of methods and measurement. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has been working for well over a decade to develop consensus and establish best practices for measuring pain in clinical trials, but these best practices aren’t always followed.

RWHC: What are the biggest challenges facing clinicians in assessing pain, and how can those challenges be overcome?

BJ: Making clinicians aware of the latest research is a big challenge. I hear lots of clinicians express that they don’t have the training to fully assess and treat pain — especially chronic pain. Many providers approach treating someone with chronic pain with some trepidation as we have seen political, societal, and clinical swings in the use of opiates and other pain medications. Many clinicians will opt to not treat chronic pain or to seek out clinics with non-opiate policies. This is problematic, because the fact is that some patients do benefit from opiates.

We need more focus on early medical training. Medical schools are just starting to employ an integrated approach to pain, by combining the fields of primary care, psychology, pharmacy and social work. Trainees and residents are now being exposed to a broad-based perspective on how to approach and treat chronic pain, but additional course work is needed.

Clinicians also have a practical challenge. Most cases of pain are managed in primary care practices, and these clinicians are time-strapped. They default to the model of assessing pain by asking patients what their pain is on a scale of one to ten without looking at how pain impacts a patient’s functionality and quality of life. Those quality of life measures, like being able to get back to work or play with your kids, are important goals for treatment.

RWHC: What initially attracted you to this field and what continues to inspire you?

BJ: I initially became interested in the field of pain assessment when my daughter was born. She had an early medical condition — which fortunately turned out to be benign— and I was struck by the integrated team at the Shriner’s hospital who cared for her and our family. Since then, I’ve had wonderful opportunities to do clinical work with chronic pain patients. I continue to be inspired by my patients and the impact pain has on their lives. It’s gratifying to help them go from being essentially disabled to the point where they can regain their lives and take part in meaningful activities.

 

A Big Pain

Editor’s Note: This article in our pain management series originally appeared in Biotech Primer Weekly. For more of the science behind the headlines, please subscribe.

The Science Behind Opiods

Emily Burke, BiotechPrimer.com

The opioid addiction epidemic gained attention at the highest levels of U.S. policy circles this past year, as presidential candidates that disagreed on nearly everything else vowed to make fighting the problem a priority if elected. In July, the U.S. Senate overwhelmingly approved a bill to strengthen prevention, treatment, and recovery efforts. And no wonder – according to the Center for Disease Control, opioid overdose deaths are at an all-time high – a stark reality that highlights the dark side of a class of treatments serving a vital need. Opioid pain medications manage the severe short-term or chronic pain of millions of Americans. While these medications mitigate needless suffering, joining forces are the government, corporations, and medical community to battle against opioid abuse and addiction.

We wonder: what is the science behind the headlines? So, let’s talk about how pain medications work, the different types on the market, and the approaches to developing less addictive versions of opioid drugs.

Opiods vs. NSAIDS

There are two main categories of pain medications, opioids and non-steroidal anti-inflammatory drugs (NSAIDs). Although these two categories of drugs work differently, they do share one thing in common: both are derivatives of natural products. The NSAID Aspirin is a synthetic version of an extract from willow tree bark, and opioids are synthetic versions of opium and morphine, which come from poppy flowers.

Aspirin works by inhibiting an enzyme called cyclooxyrgenase 1 (COX-1). Once stopped, COX-1 is no longer able to produce signaling molecules, called prostaglandins and thromboxanes. Prostaglandins and thromboxanes have a wide variety of functions, including mediating aspects of inflammation (fever and swelling) as well as promoting neuronal response to pain. Other NSAIDs, such as ibuprofen and naproxen, also work by inhibiting COX-1 or its sister enzyme COX-2.

Opioid pain medications, such as Oxycontin and Percocet, work by binding to mu receptor proteins on the surface of cells in the central nervous system (CNS) —think brain and spinal cord. While the CNS is tasked with relaying pain signals, opioids decrease the excitability of nerve cells delivering the message, resulting in pain relief—along with a feeling of euphoria in some users. 

Lessening the Pain

Short term medical used of opioid pain killers rarely leads to addiction—when properly managed. Due to the euphoria-inducing effects of the drugs, long-term regular use, or use in the absence of pain, may lead to physical dependence and addiction. And because regular use increases drug tolerance, higher doses are required to achieve the same effect, leading abusers to consume pain pills in unsafe ways such as crushing and snorting or injecting the pills. According to the Centers for Disease Control, 44 Americans die every day due to prescription painkiller overdose. At the same time, chronic pain is also a serious problem, affecting approximately 100 million U.S. adults, while millions of others suffer acute pain due to injury or surgery. The medical need for these drugs is very real despite the dark side.

The answer to developing less addictive drugs may be found in a drug that blocks pain without inducing euphoria. These new drugs will need a different mechanism of action than traditional opioid drugs, which bind to the mu receptors of cells inside the CNS. Drugs under development include those that bind to a different type of opioid receptor, the kappa opioid receptor. These receptors are present on sensory nerves outside of the CNS.

Preclinical studies suggest that targeting these receptors could be effective at reducing pain without driving addictive behaviors. A lead candidate, CR845, is currently in Phase 3 clinical testing for post-operative pain and pruritus (severe itching), and in Phase 2 clinical testing for chronic pain. Also under development are compounds that selectively activate cannabinoid (CB) receptors outside of the CNS. CB receptors inside the CNS are linked to the psychoactive qualities of marijuana; those outside the brain are found on white blood cells and have been shown to be involved in decreasing pain and inflammation. A lead CB receptor activator, CR701, is in preclinical development.

Also under development are small molecule inhibitors of ion channels – proteins on the surface of nerve cells that help to transmit pain signals by allowing positively charged calcium ions to enter the nerve. This plays a critical role in sending the pain signal to the brain, yet because it works on nerves outside of the brain, it has less of a potential for addiction.  Phase 1 clinical studies are currently underway of HX-100 for the treatment of painful diabetic neuropathy.

Another development is a derivative of capsaicin, a naturally-occurring compound found in chili peppers. Capsaicin has pain relieving properties and has been used as a natural remedy. The lead candidate, CNTX-4975, is a highly potent, synthetic form of capsaicin designed to be administered via injection into the site of pain. CNTX-4975 targets the capsaicin receptor, an ion channel protein on the surface of nerve cells. When CNTX-4975 binds the capsaicin receptor, the influx of calcium ions results in desensitization of the nerves, making them unresponsive to other pain signals. This effect can last for months, and only affects nerves near the site of injection. CNTX-4975 is currently in Phase 2b clinical studies for knee osteoarthritis, and Phase 2 clinical studies for Morton’s neuroma, a sharp pain in the foot and toe caused from a thickening of the tissue around one of the nerves leading to the toes.

Earlier this year, researchers at Tulane University published a paper that shows great promise for the development of effective yet non-addictive pain medications. They have developed a compound that is derived from the endogenous opioid endomorphin. Endogenous opioids are chemicals produced naturally by the body that bind to and activate the mu opioid receptors, resulting in pain relief and mild euphoria without the detrimental side effects associated with opioid drugs such depressed respiration, motor impairment, and addiction. Scientist have tried before to develop safer pain medications based on endogenous opioids, but have not been successful, due to the instability of these molecules. The Tulane team created a derivative of endomorphin that is stable and binds to the mu receptor in such a way that pain relief occurs, but not the negative side effects listed above. Clinical testing is expected to begin by the end of 2017.

An Antidote to an Overdose

Overdosing can be fatal since respiratory failure occurs at high blood concentration levels of opioids. If an overdose is suspected, the individual should be treated as quickly as possible with naloxone—a “competitive antagonist” of the mu opioid receptor. Simply put, a competitive antagonist binds the receptor without activating it. Since naloxone doesn’t activate the receptor, it doesn’t have any pain-relieving or euphoria-inducing qualities; rather, it prevents the opioid drugs from binding. It may also displace opioids that have already bound the mu receptor, aiding in the stoppage of an overdose.

Cocktail Fodder: Runner’s High

Some folks love to run; others avoid it at all costs. This might be explained by inherent differences in sensitivity to the natural opioids called endorphins that are released during exercise. Not everyone experiences the “runner’s high” — feelings of calm and mild euphoria – just like not everyone experiences euphoric feelings from pain medications. These differences may help to explain why some people enjoy exercise and others don’t, and why some people get addicted to opioids—while others can take them or leave them.

 

New Real World Health Care Series to Focus on Pain Management

I remember visiting my grandmother in the hospital in late 1989.  She was in the final stages of pancreatic cancer; her hospitalization was primarily meant to keep her comfortable until her passing.  She had a “button” that added morphine into her IV line.  Although the machine was programmed to deliver only so much morphine within a certain timeframe, she could push that button whenever she needed pain relief.  She never stopped pushing that button.

Krista Zodet, President, HealthWell Foundation

Over twenty-seven years later, the pain associated with and caused by cancer is still a challenge.  In fact, pain seems to accompany many of the diseases we help with at HealthWell and we certainly hear so from our patients.  Even in life outside of HealthWell, I hear from friends and family members stricken with chronic pain related to surgery or an injury and their struggles to manage it productively.

Their stories are powerful and many put into words a pain that I cannot fathom trying to cope with day in and day out.  From minor headaches and injuries, to the effects of major surgeries and chronic disease, pain is an unfortunate fact of life for millions of Americans. It affects more Americans than diabetes, heart disease and cancer combined, according to the American Academy of Pain Medicine.

In a 2011 report, the Institute of Medicine estimated that 100 million adult Americans experience chronic pain every year, costing the nation between $560 billion and $635 billion annually. Much of this pain is preventable or could be better managed, according to the committee that wrote the report, which called on health care providers, insurers and the public to have a greater understanding about pain: Although pain is universal, it is experienced uniquely by each person and care often requires a combination of therapies and coping techniques. It is more than a physical symptom and is not always resolved by curing the underlying condition.

We at the HealthWell Foundation agree with the authors of the IOM report in believing that successful treatment, management and prevention of pain requires an integrated approach that responds to all the factors that influence pain.

We also share the growing concern about the role of opioids in treating pain. In its Guideline for Prescribing Opioids for Chronic Pain, the CDC notes that opioid pain medication use presents serious risks, including overdose and opioid use disorder. CDC estimate that nearly 2 million Americans age 12 or older either abused or were dependent on prescription opioids in 2014.

Over the next couple of months, we will be focusing on the issue of pain management, including traditional pharmaceutical approaches and non-traditional alternative therapies. We’ll be interviewing top researchers in the field as well as leaders of clinical organizations dedicated to helping patients manage pain.

We invite you to check back to learn more about what’s working in the field of pain control and the challenges researchers and clinicians continue to face, especially in light of the growing issue of opioid addiction. You can also sign up to receive email alerts when new interviews are posted. Just enter your email address under the sign-up message to the right.