Opinion vs. Evidence on Long Acting Opioids

Do you believe that long acting opioids should be used routinely when patients are taking round the clock meds?  A recently published study http://bit.ly/18y6RXL concluded that long acting but not short acting opioids were associated with hypogonadism in men.  Boxed warnings on long acting opioids now read that if short acting opioids are effective they should continue to be used rather than switching to long acting.

Without large studies to prove a concept and insure the absence of unwanted effects, the standard of care has been that more expensive long acting opioids were preferable because they were assumed to be less likely to lead to abuse and addiction. I experienced this opinion as a mandate when a mail- in pharmacy my patient was using, said that if I didn’t write for long acting opioids they would no longer dispense meds to him. Opinion based guidelines, rather than evidence based guidelines, unfortunately is driving much of the practice of pain medicine.

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I have heard from a number of group members who have been diagnosed with spinal stenosis. The diagnosis is often made based on what is found on a CT scan or MRI without the expected corresponding signs and symptoms. It is important to understand what any diagnosis means in relationship to your back or leg pain.

Spinal stenosis is a narrowing of the space formed by the bony segments that together make up the vertebra (the bones of the spine). The space in each vertebra is connected to the vertebra above and below to form the spinal canal, through which the spinal cord passes. Narrowing of the canal in the lumbar region, called lumbar spinal stenosis, could squeeze the spinal cord. When you are standing up, the curve in the spine makes the narrowing worse and may cause pain radiating to the leg. Many patients found to have narrowing don’t have the signs and symptoms that would indicate that their back and leg pain was caused by the narrowing. Bending over when you walk, having more pain if you straighten up, and having to wait a few minutes when you sit down for the pain to go away, are all symptoms that suggest the spinal stenosis was truly the cause of the pain; just finding narrowing with imaging isn’t enough.

Other imaging diagnoses such as degenerative disc disease, degenerative osteoarthritis, bulging or herniated disc, and facet arthropathy, may also be misleading. Just because there is an anatomic finding on an image doesn’t mean it is the cause of the pain. If some form of exercise relieved the pain, the most reasonable explanation would be that much of the pain was related to soft tissue, such as muscle and tendon and not to the imaging diagnoses.

 

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The importance of a multi-disciplinary approach to persistent pain

An example of the importance of a multi-disciplinary approach to persistent pain is the patient with Kinesiophobia (fear of movement associated with anxiety related to an injury).  Just as stress and anxiety can make pain worse, kinesiophobia can prevent a patient from recovering to their full extent and achieving relief from muscle pain.

An example….

Consider the case of a 50-year-old woman who was visiting the Norman Marcus Pain Institute for the treatment of her foot and ankle pain. The pain started two weeks after a fall, and had plagued her for five months. Because she felt that she was unable to walk without support, she used a walker or a cane. She complained of pain in her heel and ankle and in her Achilles tendon.  Her foot was cold and clammy. Attempting to move her foot up and down and applying pressure to the painful areas caused the pain to become much worse.

She was overwhelmed with her pain and fearful that she would never get better. With her continued pain, tenderness, stiffness, and cold and clammy feet, her doctor told her she had RSD and needed to see a pain doctor for medications and possibly nerve block injections.

When she came in to consult with Dr. Marcus, he wanted to see if he could help increase the range of motion in her ankle. He used Ethyl Chloride spray to briefly make the area cold and numb. She moved her ankle and her pain was gone! Once she felt relief from her original pain, Dr. Marcus asked her to stand. However, she couldn’t because she was too weak. Five months without walking had weakened her muscles and made her unable to walk. She needed strengthening exercises, so she was referred to a physical therapist that helped her re-learn her walking technique while strengthening her muscles. She is now without pain because she no longer holds her ankle stiffly.

Kinesiophobia created more problems than necessary

Her fear of pain and her belief that not walking or moving her ankle would protect her caused her to become disabled, relying on her walker or cane. This could have easily been mistaken for RSD and lead to unnecessary, expensive and painful treatments. She had kinesiophobia, or fear of movement. This is an important factor when a patient is trying to overcome the effects of a painful injury.

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The emphasis on procedures vs. cognitive and non-interventional approaches is a driving force in producing unsustainable costs of care in all areas of American Medicine. A recent study in JAMA Internal Medicine revealed that some procedures are reimbursed 3-5X more than cognitive services.  The insurance industry appears to have inadvertently affected the delivery of care for patients in pain by incentivizing expensive interventional procedures and shortchanging all others.

In the past 40 years the field of Pain Medicine has shifted dramatically. A Thermidorian Reaction has occurred in the pain treatment community. The failure of surgical interventions for many chronic pain problems was the foundation for the original mission of clinicians treating these patients. We were aware that focusing on a putative pain generator in the periphery or relying on opioids to minimize pain and suffering, often produced sub-optimal results.  We have reverted to the position against which we originally revolted. The platinum standard of care, the multi-disciplinary pain treatment center has been supplanted by high tech expensive interventions, often of questionable value (cost divided by effectiveness).

How can we take advantage of technological innovation in Medicine whilst at the same time continue to value what is simple and works well? This will require a shift in how we pay for medical services.  As we have seen when there is a large disparity between pay scales in different medical disciplines, human nature will oblige many new graduates to avoid the least reimbursed fields. Ultimately society suffers. If exercise can eliminate back pain in some patients who appear to have an operable lesion how can we improve the chances that it will be tried first? If we do not collectively come up with an effective solution, someone else will. What are your thoughts?

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One reason for the closing of many centers was the pull back by insurance carriers for payments for non-interventional pain treatment services. Doing a procedure seemed to be considered more valid and worthy of payment than a non-invasive service even if it was effective in reducing pain, improving function and lowering future cost of care. Today some of the best pain centers cannot survive by depending on insurance payments and are forced to charge their patients large out of pocket sums in order to remain in operation. Some of these insurance carriers that will not pay for comprehensive pain centers will routinely pay for procedures of questionable effectiveness. Although the number of CARF approved pain centers in the US halved, the number of outpatient pain centers mushroomed. The services provided however focused on two areas:

  1. Medication management
  2. Nerve blocks and other invasive procedures.

Some patients could be helped with one or both of these approaches, but many patients in need of physical therapy and psychological services that had been integrated in a comprehensive treatment plan, would no longer receive optimal treatment. Reimbursement would be the driver of care rather than the needs of the patient. Centers could not stay in business and provide care that insurance companies would not cover. The shift toward procedures became an accepted standard of care and new organizations of pain physicians were formed whose membership focused predominantly on invasive procedures.

The emphasis on medication management was in part fueled by the belief that most patients with persistent pain could be treated successfully and safely with strong pain medications, such as opioids like morphine and oxycodone. We have a better understanding now of problems encountered when we freely offered potent pain medications to too many patients. Strong pain medications not only treat pain but also affect mood. Many patients with or without pain have anxiety and/or depression. Pain medications can provide emotional relief and patients would take them consciously or inadvertently for psychological rather than pain relief. Prescribed pain medication have become more popular than street drugs such as heroin for people who were drug abusers and some patients feigned pain and sold the prescribed pills for a handsome profit.

The cost of services for the treatment of back and neck pain, now with many less comprehensive multi-disciplinary centers, has nonetheless continued to rise at an alarming rate. Next time let’s look at the phenomenon of unintended consequences.

 

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John Bonica, M.D. a world renowned anesthesiologist at the University of Washington in Seattle was the individual most responsible for the creation of a new specialty, Pain Medicine. In 1977 The American Pain Society was founded and became the United States national chapter in the International Association for the Study of Pain. Complicated difficult to treat pain patients were usually not successfully treated by a physician representing one medical discipline and thus the multi-disciplinary pain treatment model was created.

Clinicians observed that patients with persistent pain had misconceptions about their condition that inhibited their ability to recover. Patient would frequently say “ if I have pain it means I am harming myself “ resulting in the avoidance of activities that produce discomfort and eventually eliminating many important activities in their life with resulting deconditioning, depression, drug use, dollars spent, and ultimately disability. Pain becomes the focus of life and the more it is pondered the worse it feels. Multi-disciplinary teams composed of a pain management physician, psychiatrist, psychologist, social worker, occupational therapist, physical therapist and pain team nurses were created to address all of the factors associated with perpetuating the patient’s inability to function. Multidisciplinary pain centers provided weeks of intensive full day treatment programs with remarkable success in restoring function to patients disabled with persistent pain.

There is an organization called Cochrane Collaborations that reviews commonly provided treatments for various medical conditions to determine if the treatment is effective, ineffective or undetermined. Almost all of the treatments for chronic back pain have been found to be neither ineffective or effective, meaning the evidence is inconclusive and more and better studies are needed- but multi-disciplinary pain centers have consistently been found to be effective for the treatment of chronic back pain. In the early 1990s there were more than a hundred pain centers certified by the Commission on Accreditation of Rehabilitation Facilities and despite their success, close to half of them are no longer operating. “So what’s up with that?”

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A number of my patients who have been struggling with pain management for more than a year may report that although their pain began in one specific spot, over time, it began to spread. Sometimes, over time, neck pain would involve the lower back pain as well. Many of these patients were thought to possibly have fibromyalgia syndrome and were given anticonvulsant or serotonin-norepinephrine reuptake inhibitors (SNRIs). The spread of pain may be from central sensitization (CS) (http://bit.ly/1aVsdg0, http://bit.ly/1bHgSDU). With some of these patients when the worst pain was treated and resolved from one area it could appear in another and muscles not recognized on the initial examination would now be found to be causing discomfort. This could be a function of diffuse noxious inhibitory control (DNIC) http://bit.ly/14Ac4GL,

These confounding problems appear to represent two opposing and confusing phenomenon: CS and DNIC [currently referred to as conditioned pain modulation (CPM)] (http://bit.ly/1aVuish). Do these issues enter into your evaluation and treatment protocols?

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The study published in JAMA today demonstrated that from 1999-2010 in 3 key areas, guidelines for the treatment of back pain are being ignored:

  1. Use of recommended NSAIDs and APAP as first line drugs decreased by ~35% whilst not recommended opioid use increased by ~50%.
  2. Not recommended referral from PCPs to specialists for back pain increased by ~106%.
  3. Not recommended use of imaging increased ~50% for MRI and CT and for x-ray remained the same.

Is this a problem? If so, how should it be addressed?

Read more: http://bit.ly/13touQu

 

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Spine surgery and exercise

I was interviewed, on Doctor Radio on Sirius XM. One of the callers told us that after she had spine fusion her pain was eliminated but if she didn’t do exercises at least every other day her muscles above and below the surgical site would tighten up and  pain would begin to return. Even when surgery is indicated for back pain, proper conditioning of the postural muscles is still important.

If she didn’t have a good physical therapist and she wasn’t motivated to doing her exercises her surgery might have been considered a failure, another Failed Back Syndrome. Too often the need to address muscle health is overlooked in the treatment of persistent pain problems. As I emphasize in End Back Pain Forever, exercise and physical conditioning should be taught in grade school and encouraged throughout our life.

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Many Back Surgeries Unnecessary

In the United States we are faced with the highest per capita health costs in the world. One would think that massive expenditures could provide the best care and treatment outcomes, but this is not the case. In many aspects the US is worse or no better than countries spending 50% of what we do on health care. One reason is that we often inappropriately provide costly evaluation and treatment interventions. We provide surgery too frequently on conditions that could be treated more cost-effectively. Having a step- care model (using the least invasive and potentially harmful, and most cost-effective approaches first) for various conditions would offer models of care for the majority of problems whilst still allowing for modifications in unusual circumstances. —Dr. Norman Marcus

 

By Ryan Sabalow

Some doctors estimate the national rates of unnecessary hysterectomies and back surgeries are even higher than the 25 percent cited by state health officials questioning the Redding area’s high rates of the procedures.

Dr. Ernst Bartsich, a clinical associate professor of obstetrics and gynecology at Weill Cornell Medical College in Manhattan, N.Y., said as many as one in three women in the U.S. has had her uterus removed by the time she’s 60. That number increases to one in two by 65.

Bartsich, an outspoken critic of what he calls the overuse of hysterectomies, said he believes that 85 percent of such procedures could have been avoided through less invasive methods, such as removing painful fibroid tumors from the uterine wall or through medication.
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How can we know what back pain treatments make sense?

If the cost of health care is to be reduced in the US, new methods should be established to pay clinicians, pharmaceutical companies and device manufacturers. If graduating medical students are so laden with debt that paying it off is more important than the possibility of ongoing study and academic pursuit, we must lower the cost to the student of medical education. If the cost of drug development is so high that huge prices must be charged for pills, we must find ways to reduce the cost of development of new pharmaceuticals. These fundamental issues in health care have an impact on the standard of care of back pain in the USA. Read the rest of this entry

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Bedside Manner and the power of suggestion in back pain

Prior to drawing blood, saying a word to patients that suggested pain increased the likelihood of them experiencing pain. You might think of this study as just another example of the importance of “Bedside manner”- the awareness of the importance of the behavior and speech of the physician or other care-takers, on the feeling of well-being of the patient. Eugene Bauer, M.D., a Viennese physician, said in 1931: “A word in the mouth of a physician is as important as the scalpel in the hands of a surgeon”. Words can cut, soothe, and rattle. How you are approached by a doctor is determined not only by their personality but also by the beliefs concerning your problem.

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Obesity, poverty, and community influence- back pain

Obesity is more prevalent in neighborhoods with a high incidence of poverty. A study in the New England Journal of Medicine showed that encouraging families to relocate to higher income neighborhoods could lower the rate of obesity and signs of diabetes. This finding may lead to a better understanding of how we can combat the obesity epidemic. Read the rest of this entry

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In the last part of Chapter 1 from End Back Pain Forever, we turn to the story of “Stephanie”. Please review this blog for the complete chapters 1 and 2 from my book.

“Doctor, My Back is Killing Me!”, Part 3

 

Take the case of a patient whom I shall call Stephanie. She is a married attorney who in 2004 began to experience stiffness whenever she she got up out of a chair. She also had problems straightening up if she bent over. This was bothersome, but it was nothing compared to her first attack of spasms in her low back, on the right side. The spasms were incapacitating. She couldn’t walk and had to lie in bed for four days, taking painkillers and muscle relaxants. When the spasms broke, she still felt an inkling of discomfort that would frequently and unexpectedly morph into repeat episodes of painful spasms.

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Here is Part 2 of Chapter 1 from my book, End Back Pain Forever.  Click here for Part 1.

Chapter 1

“Doctor, My Back is Killing Me!”, Part 2

“I can put you on strong medication to dull the pain,” says the doctor. “It may be that your spine is the problem.”

“Does that mean surgery?”

“It could. Surgeons do a million spinal operations a year.”

Surgery on your spine is the last thing you want to do, but your back pain is horrendous. And, of course, you want to get better. So you say, “Can’t we do an MRI or a CT scan to see if there’s anything wrong with the spine?” MRI, or Magnetic Resonance Imaging, is a picture generated by magnetic fields, while a CT (computed tomography) scan is a picture generated by X-rays.

When you are shown the test results, the doctor points out that the images of your spine show that you have, say, a herniated disc (in which the cushion between two bony vertebrae is either protruding or has ruptured) or spinal stenosis (narrowing of the spinal column that houses your spinal cord), or some other spinal anomaly–and that, apparently, is the cause of your pain.

But if it were true that the abnormality on the MRI or CT scan was indeed the cause of your pain, I wouldn’t have written this book–because almost no one has a “normal” MRI or CT scan of the lower spine, and what is read as abnormal is frequently not the cause of your pain.

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Where to begin? In the first two chapters of my book I explore a variety of issues related to the difficulties in evaluating and treating patients with back pain. I am posting these chapters as a means to share my perspective which developed over more than 40 years as a pain medicine physician in the US and the UK. I wrote End Back Pain Forever to open up a discussion on back pain and provide insights on effective treatments.

 

Chapter 1

“Doctor, My Back is Killing Me!”

You felt a twitch in your low back, then a heaviness and a sudden stab of pain. It struck without warning — when you were crossing the street, stacking the dishwasher, jogging, whacking a golf ball, lifting a baby, swatting a fly, carrying groceries, bending over, getting out of a car, or just turning on a faucet.

Now you’re afraid to move. You’re locked in place. You feel a belt of pain pulsing across your back from hip to hip. You wonder, what’s happening? What did I do to get this? You feel as though you’re cut in half as the pain seems to separate you from your legs. Will the pain go away? Will it stay? Gingerly you start to move, but the pain only strikes harder. No, it’s not going away, not at all. And if — this is a big “if” — the pain does not ease off in a few days or go away in a couple of weeks, without proper treatment it is certain to return because your back is a target waiting to get hit again.

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Newly published study showing positive muscle treatment results

Dr. Marcus and his colleagues just published a 2 part long-term muscle treatment outcome study of lower back pain patients who were originally diagnosed as having pain in the spine and nerves exiting the spine (i.e. herniated disc, facet arthropathy, spinal stenosis, lumbar radiculopathy). The first large group of patients had been treated unsuccessfully with one or more of the following: spine surgery, facet blocks, radiofrequency ablation, trigger point injections and prolotherapy. The second small group were scheduled for back surgery. Both groups responded to a muscle treatment protocol with significant reductions in pain intensity and improvements in level of activity.  Three of seven pre-surgery patients, identified with painful muscles, had their surgeries cancelled. Results were maintained at > 14 months follow-up. This second published study of his muscle evaluation and treatment protocol suggests that improved treatment and cost of care could result if muscles were routinely evaluated and treated in all patients with lower back pain. Click here to read the study document.

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A discussion about back pain

Back PainWhere to begin? In the first two chapters of my book, End Back Pain Forever,  I explore a variety of issues related to the difficulties in evaluating and treating patients with back pain. I am posting these chapters as a means to share my perspective which developed over more than 40 years as a pain medicine physician in the US and the UK. I encourage the members of my LinkedIn Group, Let’s Talk About Pain to agree, disagree, or share your own experience as a patient, family member of a patient, or clinician.

_______________

The cost of evaluating and treating lower back pain and neck pain is rising. From 1997-2005 it went up from $54 to $86 billion/year. Unfortunately, advances in spine surgery techniques, nerve blocks, and pain medication have not translated into more successful treatment – from 1997-2005, 25% more patients reported difficulties functioning because of neck pain or back pain.

Although 70-80% of back pain is diagnosed as non-specific lower back pain, referring to sprains and strains of muscles, ligaments and tendons, the current guidelines do not mention muscle as a possible source of persistent back pain. This leads to an overemphasis on the spine and the nerves leaving the spine.

We need a treatment model (step-care) that addresses the most common reason for back pain first. Protocols that provide soft tissue treatments that are least costly with minimal chance of harm, should produce better, more cost-effective outcomes.

Spending more money to do the same kinds of treatment is not working. This discussion group will explore possible reasons for sub-optimal pain treatment outcomes. How can we change the way we evaluate and treat persistent pain to improve our results and lower the costs of care?

A search for back pain on the internet finds almost 600 million sites. With so many different ideas on how to address this problem, we will attempt to narrow the discussion to concepts that have been studied and published in scientific journals. One obvious issue is the absence of a muscle evaluation and treatment protocol.

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Epidural Steroids- Are they worth the downside risk?

The tragic occurrence of meningitis, stroke and death following use of infected steroids used for spine injections should make us more aware that this very common treatment for back pain may not be worth the risks. The use of epidural steroid injections (ESIs) to shrink an inflamed nerve thought to be causing back pain has not been shown to consistently reduce pain and even when it does the benefit is frequently short-lived. Aside from infection, other rare but serious side effects include bleeding that can cause  nerve damage with possble weakness and paralysis, and additional pain. Steroids themselves have been the cause of bone  (aseptic necrosis) and tendon  damage.

Multiple medical professional organizations have suggested that ESIs should not be used for long standing back or neck pain or for pain in the back or neck that does not radiate to the arms or legs. Despite the evidence that even when ESIs reduce or eliminate pain, at best they are useful for 3 months or less. Other countries i.e. Denmark, rarely use ESIs. 

As long as a thorough physical examination does not take place with all patients complaining of back or neck pain, with the purpose of determining if muscles are a source of pain, we will continue to rely on imaging studies that lead us to mistakenly believe that all back pain comes from the spine and the nerves leaving the spine. Continuing to provide unnecessary and ineffective treatments not only squanders our limited resources but could cause irreparable harm.

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Opioid misuse

“Thank you for treating me as someone struggling with pain and not as a former drug addict who could not be trusted with strong pain medication”  – a note I recently received from one of my patients.

A patient with a history of drug abuse may be fearful that their past will prevent adequate treatment for a serious painful condition. My patient imagined that I would not be respectful of his suffering and his commitment to sober living. He received the pain medication that allowed him to go through a series of medical and dental procedures without suffering. He was grateful.

Concerns about opioid misuse have made physicians wary of  prescribing potentially habit-forming pain medication. Illicit prescription drug use is a growing problem in the USA and is actually the preferred street drug aside from marijuana. However in treating patients in pain, two basic American traditions should be the guiding principles with patients who have a history, or who test positive on a written test to determine the risk, of drug abuse:

1. Innocent until proven guilty; and

2. in the words of Ronald Reagan, Trust but verify. Those patients who have problems properly using pain medication need extra attention, not condemnation. They may be more difficult to treat, but that is why there are specialists to deal with complex pain problems.

 

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