Why Do Doctors Keep Pushing Invasive Procedures on Me?

By Mike Emelio, Guest Columnist 

I'm not a cynical person by nature, but I'm seeing a very clear pattern with interventional pain management doctors. Why is it that every doctor I've seen who is certified in interventional pain medicine (at least 8 of them already) demonize opioid medication and insist on pushing their non-FDA approved injections, radiofrequency ablations, pain pumps and spinal cord stimulators? 

This approach is even more absurd when you consider the fact that invasive procedures tend to have low rates of efficacy and are known to create scar tissue and nerve damage, both of which can cause more pain.  

As if this weren't ridiculous enough, in spite of explaining to these doctors how epidural steroid injections not only didn't work for me, but robbed me of my life by tripling my pain and making my condition much worse (see “Disabled by the War on Opioids”), every single one of the doctors I've seen still tries to push more of those injections on me.  

My head spins every time I hear them try to sell me on more injections. Are they deaf, insane, just trying to make their wallets fatter, or all three?

On what planet does it make sense to do more of what made a thing worse? 

Ever since my life was ruined by those injections 5 years ago, I've been desperately trying to find a doctor who truly cares about my well-being and wants to help me. My search has been fruitless so far.  

Sadly, it just keeps getting worse. The latest doctor I started seeing keeps pushing a pain pump on me. That is as absurd as it gets. Multiple doctors have told me that the reason those injections made my back pain worse is because they caused adhesive arachnoiditis or nerve damage – both of which can be made worse with invasive procedures.  

Why would any doctor push a pain pump on me? I could understand it for a patient with a history of drug abuse, but that is not the case with me. Not only do I have zero history of drug or alcohol abuse, but I have taken my pain meds responsibly for many years. Why should I submit to being put under anesthesia, cut open and have a device implanted in me, all which can have serious complications, when I can get the same medication in a pill that I took responsibly for many years? 

All of the surgeons say that my best option for improved quality of life is pain medication and staying as active and mobile as possible. Yet every interventional pain management doctor ignores their advice and pushes for injections, spinal cord stimulators or pain pumps. Why would they do that?  

It's simple.  According to my Medicare statements, a doctor makes about $75 per visit to write and maintain prescription medications. But with the injections, it's $1,000 and up!

Many times I've personally seen doctors perform unnecessary tests that pay them a lot of money and only for that reason. This is not just my opinion, as other doctors I've seen have confirmed this. Not all doctors are like this and I wouldn't even venture to say most, but the fact is there are plenty of them out there. 

I'm not saying any of this to bash doctors. I'm sharing this information in hopes that people take the time to get educated, be vigilant and be their own advocate when it comes to their healthcare. Doctors are only human. They're just as susceptible to flaws as anyone else. I can't impress enough on all of you to look out for yourselves and get second, third, fourth and even fifth opinions if needed.

If you think that sounds excessive, just think about what happened to me. They took away what was working for me and used a non-FDA approved procedure on me that wasn't even designed for what they were using it for. The end result was that it crippled me, robbed me of my ability to work, forced me into a life of poverty and disability, and took away my freedom, my dignity and my ability to properly care for myself. 

Simply put... It has devastated my life.

I don't post any this for sympathy. I am only trying to educate and inform people about what can happen if they put too much faith in doctors without doing some research. What happened to me is a prime example of just how essential it is that we patients be as proactive as possible, be our own advocates and protect ourselves. 

Michael Emelio lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Do You Really Need Spine Surgery?

By David Hanscom, MD, PNN Columnist

In today’s medical environment, big business is taking over in almost every realm. The focus is on productivity, instead of ensuring the highest quality of care. For spine surgeons like myself, the revenue generators are procedures and “interventions” – even though most of them have been shown to be ineffective.

New technology has made the situation worse instead of better. The interventions are larger, more expensive and much riskier. You, the patients, have become targets and opportunities.

The last five years of my practice became increasingly intolerable. I would see several patients a week who had surgery performed or recommended on spines that didn’t have a surgical problem. I hit a tipping point when I saw an athletic older gentleman who had his spine fused from his neck to his pelvis for muscular thoracic pain after lifting weights. He went from playing tennis and golf to being housebound, on high-dose opioids and had a psychotic break.

He was fused in a crooked position and could no longer see his feet.  He had to undergo a second 12-hour surgery just to stand him up straight again.

His case was a significant factor in my decision to retire from my practice as a complex spine surgeon in December of 2018 to pursue educating the public as to the nature and extent of the problem, as well as present viable solutions.

Fusions Have Low Success Rate

Spine surgery works wonderfully well when there is a distinct identifiable anatomical abnormality and pain is in the expected region of the body. However, surgery works poorly if the source of pain is unclear.

There is a widespread belief among patients and many physicians that when everything else has been tried and failed, then surgery is the next logical step. Nothing could be further from the truth.

Defining the correct anatomical problem to surgically treat is problematic. One of the most glaring examples of blindly proceeding with surgery in spite of the evidence is performing a fusion for low back pain (LBP).

It is well-documented that disc degeneration, bone spurs, arthritis, bulging discs, etc. are rarely the cause of LBP. Often, we really don’t know where the pain might be arising.

The success rate of fusions for LBP is less than 30%.  Most people expect a much better outcome and the resulting disappointment is problematic.

Another major problem is that when a surgical procedure is performed in a person with chronic pain in any part of the body, he or she may experience chronic pain at the new surgical site between 40 and 60% of the time. Five to ten percent of the time, the pain is permanent.

Many patients have told me undergoing spine surgery was one of the worst decisions of their life: “If I just knew how bad this could be, I never would have done it.”

Consider what happens when you go to the dentist with a painful cavity that may require a root canal, crown or extraction. There is a defined problem, and the pain will usually disappear once the problem is solved.

But what if you had gum disease or jaw pain, and a tooth doesn’t appear to be the source? Would you let your dentist randomly work on different teeth to see if it might help?

Making an accurate diagnosis of the problem is always the first step in solving it. 

Understanding the Whole Picture

Chronic pain is a complex problem that requires time and a multi-pronged approach to treatment. Current neuroscience research has unlocked the puzzle of chronic pain and it’s a solvable problem using the correct paradigm. But in the current medical climate, surgeons are being asked (and pushed) to move too quickly, and not factor in all of the variables that affect pain and surgical outcomes.

One 2014 research paper reported that only 10% of orthopedic spine surgeons and neurosurgeons are addressing and treating the well-documented variables in patients that predict poor outcomes. For example, one common problem for patients is lack of sleep. A large four-year study out of Israel demonstrated that insomnia induces low back pain. If a patient is sleep-deprived for just one night, his or her pain tolerance drops dramatically.

There are two sets of variables to consider when deciding whether to undergo spine surgery.

1) Your anatomy:  Has your doctor used an MRI or diagnostic test to identify the anatomical problem? If there isn’t a clearly identifiable source of pain, then surgery isn’t an option, regardless of how much pain you are experiencing.

2) Your nervous system and body chemistry:  Are you calm? Or are you stressed and hyper-vigilant? If your nervous system is on “high alert” for any reason, the outcomes of surgery are predictably poor, especially if you can’t identify the anatomical problem.  

If you are stressed, there are simple, consistently effective measures that can calm your nervous system and help you become pain free, often without surgery.

We already have the knowledge and technology to offer superb care and much of the data is being ignored. Whatever you decide to do or what resources you might use, don’t jump into spine surgery until you understand the whole picture. It may be the biggest decision of your life. 

Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in Control, Hanscom shares the latest developments in neuroscience research and his own personal history with pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Oregon Drops Opioid Tapering Plan

By Pat Anson, PNN Editor

An Oregon health panel has tabled a controversial plan that would have forced tens of thousands of Medicaid patients with neck and back pain to stop taking opioid medication. The Health Evidence Review Commission (HERC) voted unanimously to wait for additional studies to be completed later this year, which effectively delays any change in medical coverage under the Oregon Health Plan until 2022.

The forced tapering plan drew nationwide criticism from pain sufferers, patient advocates and pain management experts, who said it would “exacerbate suffering for thousands of patients.”

"Pain is complicated and different for everyone," said HERC chairman Kevin Olson, MD, in a statement. "We heard loud and clear that pain treatment and opioid tapering should be individualized based on the patient-clinician relationship. I am pleased that we were able to align the neck and back coverage with these principles."

If a patient with any chronic pain condition is not doing well with an opioid taper, HERC said the tapering should stop without consequence to the prescriber or patient.

But patient advocates say some doctors have already implemented HERC’s forced tapering proposal without waiting for it to be finalized.

“Many patients across Oregon have already suffered tapering from their opiate pain management or have been dropped by their physician as a result of this policy. Those patients who have already been affected deserve proper treatment for their medical conditions and must have their previous pain management regiments and care reinstated,” said Amanda Siebe, a pain patient and disabled activist who recently announced she was running for Congress in Oregon’s 1st congressional district.

“It's time HERC made up for the damage they've done to this community over the last 2 years, and give us the proper care and coverage we deserve to maintain functionality and quality of life. This fight won't be over for us until all patients are able to receive the pain management, care, and coverage they need and deserve.”

The HERC also voted unanimously to continue not covering treatment for five common chronic pain conditions, citing a lack of evidence on the effectiveness of any therapy, including opioids. The five conditions are chronic pain caused by trauma, post-surgical chronic pain, chronic pain syndrome, fibromyalgia and “other chronic pain.”

Patients advocates had supported a plan to cover those condition, not only with opioid therapy, but with alternative treatments such as physical therapy, acupuncture and yoga.

“The conditions being discussed are valid conditions, and I think they’re in need of medical treatment options. I think that opioids should be a part of those options,” Wendy Sinclair, a pain patient and co-founder of the Oregon Pain Action Group told the Bend Bulletin. “Doctors and patients need to work together and have those options available.”

HERC’s decision to reverse course on tapering was a significant and rare victory for the pain community, which rarely gets a set at the table or is listened to when political and regulatory decisions are made about opioid medication.

Last year over a hundred pain management experts signed a letter to HERC warning that its tapering plan would have been the most restrictive in the U.S. and was unsupported by treatment guidelines. That warning was recently echoed by the Food and Drug Administration, which said rapid tapering and forced discontinuation of opioids was causing “serious harm” to patients, including withdrawal, uncontrolled pain, psychological distress and suicide.

New Safety Concerns for Osteoarthritis Drug

By Pat Anson, PNN Editor

Disappointing results from a Phase 3 clinical study are raising new safety concerns about an experimental class of pain-relieving drugs once considered a promising alternative to opioids.

Pfizer and Eli Lilly say 6.3% of osteoarthritis patients taking a 5 mg dose of tanezumab experienced rapidly progressive osteoarthritis in their joints. There was significant improvement in their pain and physical function, but the patients’ overall assessment of their condition was no better than those treated with non-steroidal anti-inflammatory drugs (NSAIDs).

Patients taking a lower 2.5 mg dose of tanezumab did not have any significant improvement in their pain, quality of life or overall condition. And 3.2% experienced rapidly progressive osteoarthritis.

“We are analyzing these findings in the context of the recent Phase 3 results as we assess potential next steps for tanezumab,” Ken Verburg, Pfizer Global Product Development, said in a statement. “We plan to review the totality of data from our clinical development program for tanezumab with regulatory authorities.”

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases as a result of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from reaching the brain.

Tanezumab was considered so promising a therapy that it was given fast track designation from the FDA in 2017, a process that speeds up the development of new therapies to treat serious conditions.

Ironically, it was the FDA that slowed the development of NGF inhibitors in 2010 because of concerns that tanezumab made osteoarthritis worse in some patients. Most clinical studies of tanezumab did not resume until 2015.

The reappearance of the same safety issue and the marginal pain relief provided by tanezumab could be the last straw for the drug, according to one analyst.

“It is hard for us to imagine how these results could have been much worse. Pfizer indicated that they ‘plan to review the totality of data’ with regulatory authorities, which suggests to us that the co-sponsors will try to find a way to resurrect the program for some subset or sub-population of patients, but recognizes that this result puts the drug’s entire future in doubt,” SVB Leerink research analyst Geoffrey Porges said in a note to clients.

A clinical study of fasinumab, another NGF inhibitor being developed by Teva and  Regeneron Pharmaceuticals, was stopped by the FDA in 2016 after a patient showed signs of severe joint disease. Regeneron and Teva are continuing to study fasinumab in patients with chronic low back pain.

Pfizer and Eli Lilly are also studying tanezumab as a treatment for low back pain, and reported promising results from a Phase 3 trial in February. Rapidly progressive osteoarthritis was also reported in a small number of patients involved in that study.

Epidural Steroid Injections Won’t Solve Your Back Pain

By David Hanscom, MD, PNN Columnist

A lawsuit was in the news recently about a Kentucky doctor who refused to give his patients pain medication unless they had epidural steroid injections.

Really? I have run across this scenario many times throughout my 32 years of performing complex spine surgery. It is a huge problem from several perspectives.

First of all, epidural steroid injections don’t provide lasting relief for any indication. This is particularly true when they are recommended for neck or back pain. There is not any research paper indicating a significant benefit. Yet they continue to be administered at a high rate.

I prescribed them sparingly for acute ruptured discs, where the natural history is for them to resolve without surgery most of the time. The steroids do knock down the inflammatory response that occurs around the disc material, so it buys some time and sanity while the body heals.

I also used them occasionally for spinal stenosis (constriction of the nerves). Pain in the arms and legs would usually improve for a short period of time.

What was unexpected was that many patients that I had on the schedule for surgery would cancel because their pain would disappear when they utilized other tools to calm down the body’s stress hormones. The more favorable hormone levels changed their pain threshold.

Epidural steroid injections as a stand-alone treatment might be of some benefit, but they aren’t going to definitively solve your chronic pain. Whatever benefit that a patient may feel probably comes from the systemic effects of the drug. Steroids make everything feel better, but it’s unfortunate that there are so many severe side effects.

Let me share what happened to one patient.

Ralph was one of my favorite patients. I worked with him for over 20 years. I haven’t met a more well-intentioned human being. By the time I first met him, he had undergone over ten surgeries and was fused from his neck to his pelvis. He never had relief from his chronic back pain. I had to perform a couple of major surgeries just to get him standing up straight.

I worked hard with Ralph on a structured rehab approach with some modest success. I lost track of the number of phone calls. He had a lot of stress at home and was helping to raise a grandchild. In spite of his pain, he kept moving forward.

Then he broke through and had a dramatic decrease in his pain and better function. Ralph wasn’t pain free and his function was permanently limited because his spine was fused. But he was stable on a relatively low dose of opioids. We were both pleased.

I didn’t hear from Ralph for many years until he called me from his local hospital. He was quite ill. His entire spine was severely infected. His primary care physician, who took care of his meds, had retired. No one else would take care of his needs and he was referred to a local pain clinic, which performed a high volume of spinal injections. They would only prescribe opioids if Ralph agreed to the injections.

Not only are injections ineffective for back pain, they really don’t work in the presence of 12 prior surgeries. Ralph’s back was a mass of scar tissue, rods and bone without much of a nerve supply. There is also less blood supply in scar tissue and a much higher chance of infection. Where would you even place a needle if the whole back is fused?

We admitted Ralph and had to open up his whole spine, which was infected with several hundred milliliters of gross pus. It took another two operations to wash him out and get the wound closed. He eventually did well, and we continue to stay in touch.

Ralph had to undergo a proven ineffective procedure in a high-risk setting in order to obtain pain medications that were effective. He became seriously ill, underwent three additional surgeries with the attendant pain and misery, and the cost to society was over a hundred thousand dollars. I rest my case. 

Dr. David Hanscom is a spinal surgeon who has helped hundreds of back pain sufferers by teaching them how to calm their central nervous systems without the use of drugs or surgery.

In his book Back in Control, Hanscom shares the latest developments in neuroscience research and his own personal history with pain.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Are Sit-Stand Desks Overrated?

By Pat Anson, PNN Editor

You’ve probably seen commercials touting the health benefits of sit-stand desks. Experts say being able to stand occasionally – instead of sitting at an office desk all day -- helps prevent back pain, diabetes, high blood pressure, obesity and other chronic health conditions.

There may be some truth to that, but some of the health claims range from silly to the absurd.

“Sitting is more dangerous than smoking. We are sitting ourselves to death,” James Levine, MD, an endocrinologist at the Mayo Clinic, told the Los Angeles Times. “The chair is out to kill us.”

Is sitting really that dangerous? It is if you believe Australian researchers, who came to the eye-opening conclusion that sitting for one hour reduces life expectancy by 22 minutes. Their study was about people who watch a lot of television, but it is often cited by sit-stand desk manufacturers.

One desk manufacturer funded a study — which is mysteriously being promoted by the CDC — that looked into the psychological benefits of sit-stand desks. The study found that standing more often at work will not only relieve back pain, but make you feel healthier, happier and improve your self-esteem.

Minimal Health Benefits

Just how reliable is this industry-promoted research?

“There has been a great deal of scientific research about sit-stand desks in the past few years, but we have only scratched the surface of this topic,” says April Chambers, PhD, an assistant professor of bioengineering at the University of Pittsburgh’s Swanson School of Engineering. “I wanted to gather what we know so far and figure out the next steps for how can we use these desks to better benefit people in the workplace.”

Chambers and her colleagues reviewed 53 studies on sit-stand desks and published their findings in the journal Applied Ergonomics. Their research focused on the impact of the desks on behavior, physiology, psychology, work performance, discomfort and posture.

“The study found only minimal impacts on any of those areas, the strongest being changes in behavior and discomfort,” said co-author Nancy Baker, ScD, an associate professor of occupational therapy at Tufts University.

“There are health benefits to using sit-stand desks, such as a small decrease in blood pressure or low back pain relief, but people simply are not yet burning enough calories to lose weight with these devices,” added Chambers.

One of the biggest flaws in current studies is that most were done with young and healthy subjects who were asked to use the desk for a week or month at most. Researchers say it would be beneficial to perform longer studies with middle-aged or overweight workers to get a more accurate measure of the desks’ impact on cardiovascular health and weight loss.

Further study is also needed on desk height, monitor height, the amount of time standing, and the use of anti-fatigue floor mats to soften the blow of so much standing. 

“There are basic ergonomic concepts that seem to be overlooked,” said Chambers. “Many workers receive sit-stand desks and start using them without direction. I think proper usage will differ from person to person, and as we gather more research, we will be better able to suggest dosage for a variety of workers.”

Sit-stand desks range in price from inexpensive models for $179 to nearly $1,000 for motorized adjustable desks that come with settings for different users.

If you’re thinking of buying a sit-stand desk, a good place to start your research is online. In the YouTube video below, David Zhang rates some of desks he’s tried over the past year. David likes having a standing desk, but has doubts about their health benefits and says the desks do not replace the need for a good old-fashioned office chair.

Risky Combination: Opioids and Gabapentin

By Pat Anson, PNN Editor

Opioid medication significantly reduces low back pain, but opioids should not be used in combination with gabapentin (Neurontin) because of their limited effectiveness and potential for abuse, according to the authors of a small new study presented at the annual meeting of the American Academy of Pain Medicine.

"In these days, when we are focusing on reduction of opioids due to opioid crisis in the U.S., gabapentin could be an important part of multimodal non-opioid pain management," N. Nick Knezevic, MD, of the University of Illinois in Chicago told MedPage Today. "However, it should not be given to all patients since the effectiveness in chronic pain patients, particularly in those with low back pain, is limited."

KAISER HEALTH NEWS

In a retrospective study, Knezevic and his colleagues looked at 156 patients with low back pain; half of whom were treated with opioids alone and the other half with a combination of opioids and gabapentin.

“According to our study, the combination of gabapentin with opioids was not statistically superior in providing pain relief, in contrast to opioids alone, in patients with chronic pain. Our results are in line with recent guidelines for low back pain treatment that reflect the need to assess the recommendation of gabapentinoids for chronic pain in patients already taking opiods to mitigate risk factors of abuse and overdose,” researchers found.

Gabapentin is an anticonvulsant that was originally developed as a treatment for epilepsy, but is now widely prescribed for a variety of chronic pain conditions. Its use in primary care as a treatment for chronic back and neck pain has risen by 535% in the last decade, despite little evidence of its effectiveness.

"The fact that anticonvulsants are often advertised to be effective for 'nerve pain' may mislead the prescriber to assume efficacy for low back pain or sciatica," Oliver Enke, MD, of the University of Sydney, told MedPage.

A 2018 study by Australian researchers found that gabapentinoids did not reduce back pain or disability and often had side effects such as drowsiness, dizziness and nausea. Another recent study found that combining gabapentin with opioid medication significantly raises the risk of dying from an overdose than opioid use alone.

There have been increasing reports of gabapentin being abused by drug addicts, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances.

The CDC’s opioid prescribing guideline recommends gabapentin as a safer alternative to opioids, without saying a word about its potential for abuse or side effects.

A 2017 commentary in the The New England Journal of Medicine warned that gabapentinoids -- a class of nerve medication that includes both gabapentin and pregabalin (Lyrica) -- are being overprescribed.

"We believe… that gabapentinoids are being prescribed excessively — partly in response to the opioid epidemic,” wrote Christopher Goodman, MD, and Allan Brett, MD. “We suspect that clinicians who are desperate for alternatives to opioids have lowered their threshold for prescribing gabapentinoids to patients with various types of acute, subacute, and chronic noncancer pain."

Laser Spine Institute Shuts Down

By Pat Anson, PNN Editor

The Laser Spine Institute, which once ran a nationwide chain of surgery centers that specialized in “minimally invasive” spinal procedures, has abruptly ceased operations due to financial problems.

The company had four remaining surgery centers in St. Louis, Cincinnati, Scottsdale and Tampa, Florida, where it is headquartered. It recently closed three other surgery centers in an effort to control costs and restructure.

Despite “significant cost saving” in recent months, Laser Spine Institute said in a new release that it was “unable to attract the necessary financing” to continue operating while it sought Chapter 11 bankruptcy protection. About 600 employees are affected.

"My heart goes out to our great, dedicated staff who have stuck with us through all of our adversity and worked so tirelessly to help us right the ship," said Jake Brace, Laser Spine Institute's CEO, who was brought in last year to help restructure the company.

The company said it would contact patients slated for surgery and those in post-operative care and refer them to other medical facilities in their area.

Laser Spine Institute treated patients with neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, herniated discs, sciatica and other chronic conditions.

Although it claimed to have 98% patient satisfaction rate, the company was hit with dozens of malpractice lawsuits, including one by superstar wrestler Hulk Hogan, who claimed its treatments were ineffective and cost him $50 million in lost revenue. Hogan reportedly settled out of court for $10 million.

Last year the family of a Pennsylvania woman who died hours after being discharged from a Laser Spine Institute surgery center was awarded $20 million in a wrongful death lawsuit.

A competing surgery center also sued Laser Spine Institute for offering illegal incentives to patients, such as paying for their airfare and hotel expenses, which is prohibited under Medicare guidelines. Nine surgeons told Bloomberg Businessweek that the company was doing spinal surgeries that were often unnecessary or inappropriate.

New Non-Opioid Drug Effective in Treating Low Back Pain

By Pat Anson, PNN Editor

Pfizer and Eli Lilly have announced positive results from a large Phase 3 study evaluating an experimental non-opioid pain reliever as a treatment for chronic low back pain.

Patients receiving 10 mg injections of tanezumab showed statistically significant improvement in back pain at 16 weeks compared to placebo. A lower dose of tanezumab 5 mg was not as effective. Over 1,800 people with chronic low back pain in North America, Europe and Asia participated in the study.

Tanezumab is a humanized monoclonal antibody that targets nerve growth factor (NGF), a protein that increases in the body because of injury, inflammation or chronic pain. Tanezumab binds to NGF and inhibits pain signals from muscles, skin and organs from reaching the brain.

"This study demonstrates the potential of tanezumab to treat individuals suffering from moderate-to-severe chronic low back pain who have been unable to achieve relief with currently available medicines," said Ken Verburg, Pfizer’s tanezumab development team leader.

“This is one of the longest studies conducted to date in chronic low back pain. We look forward to further analyzing these results, and believe the data from this study will support our planned future global regulatory submissions in chronic low back pain."

Pizer and Eli Lilly have also reported positive findings in evaluating tanezumab for the treatment of osteoarthritis. The Food and Drug Administration granted “fast track” designation to tanezumab in 2017 to help speed its development.

Tanezumab has a history of safety concerns. Clinical studies were halted in 2010 after Pfizer reported some osteoarthritis patients receiving the drug had worse symptoms and needed joint replacement surgery. Another safety issue arose in 2012 when tanezumab caused adverse changes in the nervous system of animals.  Most clinical studies of tanezumab did not resume until 2015.

In the current study, rapidly progressive osteoarthritis (RPOA) was observed in 1.4 percent of patients receiving tanezumab and 0.1 percent of patients in the other treatment groups. Joint fractures and total joint replacements were experienced in 0.4 percent and 0.7 percent of tanezumab-treated patients, respectively, while none were observed in the other treatment groups.

In addition to back pain, the ongoing Phase 3 program for tanezumab includes studies in osteoarthritis pain and cancer pain due to bone metastases.

Spinal Fusions Ineffective for Osteoporosis Patients

By Pat Anson, PNN Editor

There is little evidence that two surgical procedures commonly used to treat spinal fractures caused by osteoporosis reduce pain for patients better than pharmaceutical drugs, according to a new report by an international task force of bone health experts published in the Journal of Bone and Mineral Research..

More than 10 million Americans suffer from osteoporosis, a loss of calcium and bone density that worsens over time and significantly raises the risk of bone fractures, especially among the elderly. About 750,000 spinal fractures occur each year in the United States alone.

The task force looked at two types of spinal fusions: vertebroplasty, where medical grade cement is injected into the broken vertebrae to fuse bone fragments together; and balloon kyphoplasty, where a balloon is inserted into the compressed area of the spine to lift it and allow the cement to be inserted. Metal plates, screws and rods can also be used in spinal fusions, but were not the focus of the study.

The researchers found little to no evidence that vertebroplasty or kyphoplasty relieve pain effectively. In five clinical studies, vertebroplasty provided no significant benefit in pain control over placebo or sham procedures. There were no placebo-controlled trials for balloon kyphoplasty, leaving doctors to rely on anecdotal, low-quality evidence.

"The message for doctors and their patients suffering from painful spinal fractures is that procedures to stabilize spinal fractures should not be a first choice for treatment," said lead author Peter Ebeling, MD, Head of the Department of Medicine in the School of Clinical Sciences at Monash University in Australia.

"While patients who had these surgeries may have had a short-term reduction in pain, we found that there was no significant benefit over the long-term in improving pain, back-related disability, and quality of life when compared with those who did not have the procedures."

The task force report comes as spine surgeons increasingly market vertebroplasty and kyphoplasty as “minimally invasive" procedures that offer immediate relief from back pain without the risks of opioid medication. But there are still risks of infection, cement leakage and complications associated with elderly patients undergoing anesthesia.

Some 300,000 Medicare patients underwent vertebral augmentation between 2006-2014, with most getting the more expensive balloon kyphoplasty. The procedures have become so common they are recognized as a standard of care. The video below calls them "the most effective pain relieving treatments for elderly patients.”

"These procedures are not a magic bullet," says Bart Clarke, MD, President of the American Society for Bone and Mineral Health and a Professor of Medicine at the Mayo Clinic. “Until now, doctors have been left to sift through the data on their own to determine whether these procedures can benefit their patients. This report coalesces all that information concisely and provides recommendations to guide them."

Clarke said Mayo Clinic doctors do not typically perform vertebral augmentation procedures unless a patient's pain is unmanageable for more than 4-6 weeks. "We've seen that with analgesics and other pain relief, our patients often get better within about 6 weeks," he said.

The task force also focused on the need for osteoporosis prevention. About 25% of older men and women who have a hip fracture will have a second fracture within one year, as will around 20% of older patients who have a spinal fracture. Breaking a bone in your spine or hip may be so traumatic – especially for the elderly -- that it often leads to disability and chronic widespread body pain.

Recent studies have shown that many patients at high risk of fractures are not being diagnosed or treated for osteoporosis, even though hormones and bisphosphonate drugs can help strengthen their bones. Bisphosphonates such as Fosamax have been found to be effective at slowing the loss of bone mass and reducing fractures, but concerns about side effects made some patients reluctant to take bisphosphonates and doctors less likely to prescribe them.  

"Overall, prevention is critical. and we need to get these high-risk patients on anti-osteoporosis drugs that have proven to reduce future fractures by as much as 70 percent," Clarke said.

Bad Posture During Computer Use Leads to Back Pain

By Pat Anson, PNN Editor

It's no secret that staring into a computer screen for too long can lead to a stiff neck or back pain. Many of us instinctively lean forward to get a closer look at laptop or tablet, without being fully aware of how bad our posture is or what it’s doing to our spines.

Researchers at San Francisco State University say this “head-forward position” compresses the neck and can lead to fatigue, headaches, poor concentration and muscle tension. And it takes less than a minute for the symptoms to start.

"When your posture is tall and erect, the muscles of your back can easily support the weight of your head and neck -- as much as 12 pounds," says Erik Peper, PhD, a Professor of Holistic Health at San Francisco State University.

"But when your head juts forward at a 45-degree angle, your neck acts like a fulcrum, like a long lever lifting a heavy object. Now the muscle weight of your head and neck is the equivalent of about 45 pounds. It is not surprising people get stiff necks and shoulder and back pain."

Peper and his colleagues tested the effects of head and neck position in a recent study published in the journal Biofeedback.

SAN FRANCISCO STATE UNIVERSITY

First, they asked 87 students to sit upright with their heads properly aligned on their necks and asked them to turn their heads. Then the students were asked to "scrunch" their necks and jut their heads forward. Ninety-two percent reported being able to turn their heads much farther when they were not scrunching.

In a second test, 125 students scrunched their necks for 30 seconds. Afterwards, 98 percent reported some level of pain in their head, neck or eyes.

“Most participants were totally surprised that 30 seconds of neck scrunching would rapidly increase symptoms and induce discomfort. It provided motivation to identify situations that evoked neck scrunching and avoid those situations or change the ergonomics,” Peper said.  

What can you do to prevent yourself from scrunching? Two easy solutions would be to increase the font size on your computer screen or get a pair of computer reading glasses. You can also make sure your computer screen is at eye level, which will reduce the temptation to lean forward.

If you suffer from headaches or neck and backaches from computer work, check your posture and make sure you are sitting upright, with your head aligned on top of your neck.

"You can do something about this poor posture very quickly," says Peper, who recommends people test themselves by scrunching forward and try rotating their head. Until they do that, many have no idea how bad posture contributes to back and neck pain.

"You can exaggerate the position and experience the symptoms. Then when you find yourself doing it, you can become aware and stop," he said.

A recent study by researchers at the University of Nevada Las Vegas found that 60 percent of students have persistent pain in their neck and shoulders -- often caused by slouching or bending to watch their iPads or tablets. Women were twice as likely as men to experience neck and shoulder pain during tablet use.

New Spinal Discs Grown from Stem Cells

By Steve Weakley

Scientists have moved a step closer to being able to replace degenerated spinal discs with new ones grown in a laboratory from a patient’s own stem cells.

Spinal discs are soft tissues that cushion the vertebrae and enable our backs to conform and perform the tasks of everyday movement. Over time, the discs can wear out and cause the bones of the spine to rub together and pinch nerves. This disc degeneration is one of the leading causes of back pain.

University of Pennsylvania researchers reported in the journal Science Translational Medicine that they have successfully grown and implanted replacement discs made from the stem cells of goats. The cells were grown in a laboratory in a disc shaped form and then implanted into the necks of goats.

After 8 weeks, MRI’s showed that the replacement discs functioned just as well or better than the goats’ original cervical discs. The implanted discs were left in for 20 weeks and became part of the animals’ own tissue.

Researchers told Medical News Today that this was a major step forward from previous experiments in which they implanted discs into rat tails. Goat discs are more comparable to humans in size, structure and function.

"I think it's really exciting that we have come this far, from the rat tail all the way up to human-sized implants," said co-senior author Harvey Smith, MD, a professor of Orthopaedic Surgery at the Hospital of the University of Pennsylvania.  

"Using a true tissue-engineered motion-preserving replacement device is not something we have yet done in orthopaedics. I think it would be a paradigm shift for how we really treat these spinal diseases and how we approach motion sparing reconstruction of joints.”

Current treatments for degenerative discs include spinal fusion or artificial implants.  Both have limited benefits and usually cannot restore full functionality. Artificial implants also break down and have be replaced.

"The current standard of care does not actually restore the disc, so our hope with this engineered device is to replace it in a biological, functional way and regain full range of motion," said co-senior author Robert Mauck, PhD, a professor for Education and Research in Orthopaedic Surgery.

"This is a major step, to grow such a large disc in the lab, to get it into the disc space, and then to have it to start integrating with the surrounding native tissue. That's very promising."

The researchers say the next step is longer and more extensive tests on goats, before working on a bioengineered human model.  If those tests are successful, they eventually hope to test the implants in human trials.

"We have every reason to be optimistic, and if it works, we can change the way we think about treating some of these disc diseases," said Smith.

Many Alternative Therapies for Back Pain Not Covered

By Pat Anson, PNN Editor

A new study by the Johns Hopkins Bloomberg School of Public Health has confirmed what many back pain sufferers already know: Public and private health insurance plans often do not cover non-drug alternative pain therapies.

Bloomberg researchers looked at dozens of Medicaid, Medicare and commercial insurance coverage policies for chronic lower back pain and found that while most plans covered physical therapy and chiropractic care, there was little or no coverage for acupuncture, massage or counseling.

"This study reveals an important opportunity for insurers to broaden and standardize their coverage of non-drug pain treatments to encourage their use as safer alternatives to opioids," says senior author Caleb Alexander, MD, a professor of epidemiology at the Bloomberg School.  

Alexander and his colleagues examined 15 Medicaid, 15 Medicare Advantage and 15 major commercial insurer plans that were available in 16 states in 2017.

Most payers covered physical therapy (98%), occupational therapy (96%), and chiropractic care (89%), but coverage was inconsistent for many of the other therapies.

Acupuncture was covered by only five of the 45 insurance plans and only one plan covered therapeutic massage.

Nine of the Medicaid plans covered steroid injections, but only three covered psychological counseling.

"We were perplexed by the absence of coverage language on psychological interventions," Alexander says. "It's hard to imagine that insurers wouldn't cover that."  

Even for physical therapy, a well-established method for relieving lower back pain, insurance coverage was inconsistent.

"Some plans covered two visits, some six, some 12; some allowed you to refer yourself for treatment, while others required referral by a doctor," Alexander says. "That variation indicates a lack of consensus among insurers regarding what model coverage should be, or a lack of willingness to pay for it.”  

The Bloomberg study is being published online in the journal JAMA Network Open.  It was funded by the U.S. Department of Health and Human Services, National Institutes of Health and the Centers for Disease Control and Prevention.  

Lower back pain is the world’s leading cause of disability, but there is surprisingly little consensus on the best way to treat it. A recent series of reviews by an international team of experts in The Lancet medical journal found that low back pain is usually treated with bad advice, inappropriate tests, risky surgeries and painkillers.

“The majority of cases of low back pain respond to simple physical and psychological therapies that keep people active and enable them to stay at work,” said lead author Rachelle Buchbinder, PhD, a professor at Monash University in Australia. “Often, however, it is more aggressive treatments of dubious benefit that are promoted and reimbursed.”

The authors recommend counseling, exercise and cognitive behavioral therapy as first-line treatments for short-term low back pain, followed by spinal manipulation, massage, acupuncture, meditation and yoga as second line treatments. They found limited evidence to support the use of opioids for low back pain, and epidural steroid injections and acetaminophen (paracetamol) are not recommended at all.

Many Invasive Surgeries No Better Than Placebo

By Pat Anson, PNN Editor

In an age when doctors are urged not to prescribe opioids, many patients are being told to have surgery or other invasive procedures to treat their chronic pain.

But a systematic review of 25 clinical trials found little evidence that invasive surgeries are more effective than placebo or sham procedures in reducing low back and knee pain. The study was published in the journal Pain Medicine.

"Our findings raise several questions for clinicians, researchers, and policy-makers. First, can we justify widespread use of these procedures without rigorous testing?" said lead author Wayne Jonas, MD, a Professor of Family Medicine at Georgetown University School of Medicine.

“Given their high cost and safety concerns, more rigorous studies are required before invasive procedures are routinely used for patients with chronic pain.”

The invasive procedures that were analyzed include arthroscopic, endoscopic and laparoscopic surgeries, as well as radiofrequency ablations, laser treatments and other interventions.

In each study, researchers also performed sham or placebo procedures on a control group where they faked the invasive procedure. Patients did not know which intervention (real or sham) they received. Researchers then compared the patients’ pain intensity, disability, health-related quality of life, use of medication, adverse events, and other factors.

They found that reduction in disability did not differ between the two groups three months after the procedures or at six months. Seven of the studies on low back pain and three on knee osteoarthritis showed no difference in pain intensity at six months compared with the sham procedures.

“There is little evidence for the specific efficacy beyond sham for invasive procedures in chronic pain. A moderate amount of evidence does not support the use of invasive procedures as compared with sham procedures for patients with chronic back or knee pain,” said Jonas.

Invasive treatments are being increasingly used as an alternative to opioids. Americans spent an estimated $45 billion on surgery for chronic low back pain and $41 billion on arthroplasty for knee pain in 2014.

Several previous studies have also questioned the value of arthroplasty. Over 850,000 arthroscopic surgeries are performed every year to relieve knee pain in the UK and the United States. But a 2015 study published in the BMJ questioned the evidence behind the surgery and said it provides only “small inconsequential benefit.”

Disabled by the War on Opioids

By Michael Emelio, Guest Columnist

I am 53 years old and have severe disc degeneration spread throughout my spine and scoliosis in my lower back. As if that weren't enough, I've also been diagnosed with fibromyalgia.

I have been on opioid medication since 2001.  For over a decade the meds helped reduce the pain enough so that I could still work 40 hours a week, including some heavy lifting. But in 2013 the DEA shutdown the doctor I had been with for over 12 years, forcing me to find a new pain management doctor.

The new doctor not only refused to continue the meds that were working for me, but immediately cut my opioids by over 90% without tapering me down at all. My pain increased so much that I couldn't return to work, even for light duty.

When I asked the doctor why he wouldn't continue the prescriptions my previous doctor was giving me, he said and I quote, “Because of the crackdown on pain meds you're not going to find a doctor in this state will give you more than what I'm giving you now." 

Mind you, this was back in 2014, and was still less than the maximum 90mg morphine equivalent dose that the CDC started recommending in 2016. 

Little did I know that was only the beginning of my nightmare. Since back surgery wasn't an option, the doctor told me my only choice was to have epidural steroid injections.

MICHAEL EMELIO

I did some research and had legitimate reservations about the injections, but without being offered any other options and not wanting to be labeled a drug seeker, I reluctantly agreed. I couldn't afford to be out of work much longer.

The injections were administered a month apart. The first series did nothing for my pain and the second one actually increased the pain by over three-fold. This resulted in me becoming completely bedridden 24 hours a day and struggling to complete the most basic daily life functions. I'm not talking about doing laundry and cleaning house. I'm talking about just feeding myself.

This left me unable to do any kind of work whatsoever, let alone return to my regular job of over 7 years, where I was working towards retirement. When I asked the doctor what was I supposed to do now, his response was, “Have you considered applying for disability?"

Unless you've been here, you cannot fathom the level of shock and horror that I felt at that moment, yet alone the level of injustice and outrage. A word that comes to mind is appalled, but that doesn't even begin to describe it. I went from being an able-bodied worker to disabled and bedridden 24 hours a day.  And for no other reason than the War on Opioids!

To be perfectly clear, I didn't take illegal drugs and I never abused, gave away or sold my prescriptions. I passed all my drug tests, never had a record of drug problems, or even a DUI. I didn't even drink alcohol. I did NOTHING to give them any reason whatsoever to take my medications away.

My current doctor is currently weaning me off the last of my opioids, stripping me of the last tiny bit of medication that have any effect on my pain. What little quality of life I have left is about to be taken away completely.

The only thing I can do now is pray that I am able to hold on and not become another suicide statistic after being forced to live in agony day-in and day-out. All because of the barbarically handled, totally blind, and uncompassionate War on Opioids.

Don't get me wrong. I'm not against fighting drug abuse and addiction, I'm just against the way it's being fought. Taking these medications away from people who have proven they need and use them responsibly will fail to have any impact whatsoever on the addicts who are abusing them.  It only serves to punish the honest and innocent. Why should I be punished and forced to live a life of pain, misery and indignity when I have done nothing wrong?

With the help of opioids, I was still very active and happy, enjoying things like riding motorcycles, jet skiing, and even paragliding. Although recently becoming single, I had no reason not to hope for eventually finding the right woman and living happily ever after.

But I've been robbed of all of that now. I am bedridden and struggling to survive on nothing more than disability income. My pain has tripled thanks to the unnecessary and unwanted steroid injections, and for no other reason than the fear instilled in my doctor by the DEA and CDC.

And it's still not over. The only thing my doctor is offering now is more of the very same injections that put me here in the first place and robbed me of my life.

What keeps me fighting is the sheer anger and outrage that I have for the injustice of it all. If you are a doctor, DEA agent, politician, or anybody else who is not a chronic pain patient – then take a minute to realize that you are only one car accident, one slip, or one fall away from this happening to you.

STOP THIS MADNESS!

Michael Emelio lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.