New Stimulator Delivers Back Pain Relief

By Pat Anson, Editor

A new type of spinal cord stimulator (SCS) provides significantly more relief from chronic back and leg pain than traditional SCS therapy, according to the results of a new study published in the journal Anesthesiology.

The Senza spinal cord stimulator, which recently won approval from the U.S. Food and Drug Administration, uses high frequency pulses of 10,000 Hz to mask a patient’s perception of pain. Traditional SCS therapies use frequencies of 40 to 60 Hz.

"This is the first long-term study to compare the safety and effectiveness of high frequency and traditional SCS therapy for back and leg pain," said lead author Leonardo Kapural, MD, professor of anesthesiology at Wake Forest University School of Medicine and clinical director at the Carolinas Pain Institute.

"Chronic back and leg pain have long been considered difficult to treat and current pain relief options such as opioids have limited effectiveness and commonly known side effects. Given the prevalence of chronic pain, high frequency SCS is an exciting advance for our patients."

image courtesy of nevro

In a study of 171 patients with implanted SCS devices, 85 percent of those with back pain and 83 percent with leg pain using the Senza HF10 stimulator had a 50% reduction in pain or greater after three months.

Only about half the patients implanted with a traditional SCS device (44% with back pain and 56% with leg pain) experienced that kind of pain relief.

None of the patients in the HF10 therapy group experienced paresthesia – a tingling or buzzing sensation often felt with lower frequency stimulators. They were also more likely to be “very satisfied” with their pain relief (55% versus 32%).

Lower back pain affects about a quarter of the world’s adult population and is the leading cause of disability. Back pain is usually treated with physical therapy or pain relievers.

For chronic back pain, spinal cord stimulators are often the treatment of last resort because the devices have to be surgically placed near the spine and connected to batteries implanted under the skin. The devices send electrical impulses into the spine to mask pain.

The Senza SCS system is made by Nevro (NYSE: NVRO), a medical device company based in Menlo Park, California. Senza has been available in Europe and Australia for the last five years. In May, Senza won approval from the FDA for use in the United States.

MarketsandMarkets, a market research firm based in Dallas, estimates the global market for spinal cord stimulators and other neuromodulation devices could reach $6.8 billion by 2017.

Stem Cell Study for Back Pain Begins

By Pat Anson, Editor

Enrollment has begun in a clinical study of an experimental stem cell therapy that could – if proven successful – revolutionize the treatment of low back pain caused by degenerative disc disease.

About 330 adults with chronic low back pain who have not responded to conventional therapy will be enrolled in the Phase III “Cascade” study at over two dozen medical centers in the United States. Participants will be injected in the lumbar disc with millions of Mesenchymal Precursor Cells (MPCs) – adult stem cells derived from donated bone marrow.

An earlier Phase II study showed that a single injection of a 6 million cell dose of MPCs reduced low back pain and improved function for at least 12 months. Participants also used fewer opioids for pain relief and required less treatment.

“If you look at the study as a whole, people who received the 6 million stem cell injection into the disc, 70 percent of them had a reduction of their pain of 50% or greater. These were clinically relevant changes,” said J. Scott Bainbridge, MD, lead investigator at Denver Back Pain Specialists, one of the clinics participating in the Cascade study.

"The clinical program is the first of its kind in the United States and we are very excited by the potential of these adult stem cells to provide a novel therapeutic approach."

Bainbridge says the stem cell injection takes up to two months to stop the pain and inflammation triggered by degenerative disc disease.

“It takes time for the stems cells to normalize the inflammatory condition,” Bainbridge told Pain News Network. “You’re taking a disc that is on a degenerative cascade or path. The stem cells regulate that, they change it from an inflammatory stage to an anti-inflammatory, homeostatic state. It turns on the engine, if you will, to start building and producing some of the things that will help the disc become hydrated and build back some of its structural integrity.”    

Degenerative disc disease is the most common cause of low back pain, which develops with the gradual loss of proteoglycan, a substance that cushions the bones of the spine and enables normal motion.

Conventional treatment includes pain medication, physical therapy or surgical intervention such as a spinal fusion. Bainbridge says stem cell injections have the potential to become a frontline treatment, to be used before a riskier treatment such as surgery.

The Cascade study is sponsored by Mesoblast Limited, an Australian company focused on cell-based regenerative medicine. Mesoblast is also developing stem cell treatments for rheumatoid arthritis and diabetic neuropathy, using “off-the-shelf” stem cells from healthy adult donors that do not require tissue matching.

“(There) is compelling evidence that Mesoblast’s stem cell technology has the potential to change the treatment of spinal disease from focusing on surgical reconstruction to biologic regeneration. Physicians and patients are seeking access to a new modality to treat patients with this highly debilitating disease for whom there are limited options,” said Hyun Bae, MD, Medical Director at the Cedars-Sinai Spine Center in Los Angeles, which participated in the Phase II study.

Unfortunately, it could take years for the therapy to win approval from the U.S. Food and Drug Administration. The Cascade study alone is expected to take about three years. For further information about the study and a list of the 25 clinics that are recruiting participants, click here.

Wear, Tear & Care: The Quell Pain Relief Device

By Jennifer Kain Kilgore, Columnist

When presented with the Quell pain relief device, people make one of two assumptions about me: 1.) I injured my knee, or 2.) I am a paroled felon wearing a very forgiving Velcro GPS.

As I said in my recent guest column, I have made it my mission to test as many pain relief products and therapies as possible. Some of them might be familiar to you; others will be of the “new and bizarre” variety. Whatever they are, I will be your Friendly Neighborhood Guinea Pig and review them for your convenience. I only draw the line at “Made for TV” products that are out to swindle the desperate consumer.

Pain patients are certainly desperate. We have a constant refrain humming through our bodies that plays a different tune for each person. Doctors are the musicians taught to hear those tunes -- but how can they possibly learn all the music? How can they hear your specific song and have the knowledge necessary to fix it?

The problem is that sometimes they cannot. They are deaf to your pain, just like that one whale who sings higher than every other whale -- none of them can hear her.

Thus far, doctors have been unable to hear the song that thrills along my nerve endings. This leaves me with no choice but to fend for myself. I could take the route at which they have hinted: find some street drugs and wait for the undertow to take me (not that this is the problem the media makes it out to be). Or I could travel a different road and at the same time realize that this life of mine includes pain. If I can’t get rid of it, I can at least muffle it.

image courtesy of neurometrix

As I said recently in my blog -- Wear, Tear, & Care -- I have been trying the Quell pain relief device, which is made in the great state of Massachusetts (i.e., my backyard). I have been using it every day for more than a month. Here are my findings:

• It absolutely works. I have been wearing it for 35 days. I assume there was some psychosomatic effect at first because I was so excited to try the device after months of hype. Once the initial thrill wore off, I was left with the knowledge that, yes, I have reduced my number of Motrin from 16 a day to four, give or take. I am still on Cymbalta and Lyrica for pain control and situational depression, though I can now contemplate reducing the Lyrica entirely. Before, that was not even a possibility.
• Wearing any kind of medical device during the summer is difficult. I can make the Stride of Pride and show if off with a skirt or shorts; otherwise I have to find pants under which the device can comfortably fit. This means that a good portion of my wardrobe (leggings, skinny jeans, etc.) is not compatible with the Quell. This is a minor concern.
• The Quell is $249.00. Replacement electrodes cost $30 and last for two weeks. I have worn mine for longer than that because A.) I can, and B.) I’m cheap. The electrodes break down quickly, but as a whole they are more durable than traditional electrodes and do not irritate my skin. With the EMPI device, the electrodes left blisters on my back.
• The iPhone app is quite lovely. It has a countdown clock so you can see how long the therapy has lasted or how far away it is. I have become adept at the internal calculation of 60 minutes on, 60 minutes off.
• Unlike other TENS devices I have tried, the stimulation is not distracting, so wearing it at the office is fine.

This is all well and good. But how does the Quell work?

According to their research paper presented to the FDA, the Quell works not unlike other devices that latch onto a dense cluster of nerves in the upper calf. Generally it is best for lower-body pain (sciatica and the like), diabetic neuropathy, and fibromyalgia. I myself have fibromyalgia-ish symptoms, since my pain radiates all over my body. However, I apparently do not actually have the inflammation that is fibro’s hallmark. Doctors will only commit to “chronic pain syndrome.” Since the device works for me, I can say confidently that it treats more than those three conditions.

The Quell is twice as strong as conventional TENS units, does not irritate the skin like traditional electrodes, is less conspicuous, has a mobile app, and can be worn at night. (They say it can be worn at night; I personally found the stimulation too distracting.) It activates endogenous opioids in the body (natural opioids, to say it in English), a different system than the one on which prescription opiates work.

It is, simply put, a wearable intensive nerve stimulator that follows the Pain Gate Theory: The impulses generated by the Quell block pain signals from reaching the brain. As it was cleared to be sold over-the-counter, it is currently not covered by insurance.

I know you pain patients out there loathe the numbers system (What is your pain on a scale of 1 to 10?). I also despise it; this is the only one that has come close to working for me. That’s why I have created a new system. Instead of assigning an arbitrary number to my pain, I am going to tell you what I can do now that I couldn’t do before.

1. I can cut down my daily over-the-counter medication.

2. I can walk for longer periods of time (36 days ago I could walk about 10 minutes before starting to limp; now I can make it almost 30 minutes).

3. I can sit for longer periods of time during the work day (prior to the Quell I’d last 10 minutes before having to get up and move around; now I can make it to 30 before movement becomes necessary).

4. I can focus better on immediate tasks.

5. I have more energy during the daytime, which makes me more social. I have been hanging out with friends more. However, I still practice the chronic pain version of sundowning in the evenings (i.e., I crash).

6. I have been able to resume my almost-daily yoga practice. I even did a 55-minute video the other day (which was   Aroga Yoga’s yoga class for those with chronic illness).

7. I have been able to resume my aqua aerobics practice two to three times per week.

8. I wear my emergency back brace less frequently.

9. I have fewer flares.

FINAL DIAGNOSIS: The Quell device has worked brilliantly for me. While it doesn’t get rid of all the pain I feel, it dampens enough of it so that I can more fully live my life. I hope that it can bring others as much relief.

Jennifer Kain Kilgore is an attorney in the Greater Boston area who also works as a writer and editor in her spare time.  She has chronic back and neck pain after two car accidents. 

You can read more about J.W. on her blog, Wear, Tear, & Care.  

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.

A Pained Life: When Habits Hurt

By Carol Levy, Columnist

I am a creature of habits, some of them bad. Not the “I can't stop eating chocolate”  kind of bad,  but bad in that I don’t always follow my own advice.

For example, I have a bad neck and as a result lifting something heavy often leaves me with worse neck pain. Every time I lift something heavy, I hesitate and think, “You need to put on the neck brace first. You really need to do that.”

Then I get annoyed and tell myself putting on the neck brace would be too much trouble.

The fact that I leave the brace out on the dresser and it is easily accessible makes no difference. My neck is held together with clamps and screws. How can a neck held together with a bunch of metal not be able to pick up anything, no matter what it is?

The fallacy of that thought is proven each time I move something heavy. But I don't heed myself and I pick it up anyway. Bad habit #1.

Then comes bad habit #2. The neck brace is supposed to help hold up my neck. But even when I wear it, I fight it. A good example is what happens when I take out the trash

The containers are a little ways away from my apartment. I do not want to have to make a number of trips (there is always a minimum of 2 large bags and more often 3). At least one is filled with cat box litter and is always heavy. The extra weight turns me into a turtle. I automatically scrunch up my shoulders and lower my neck as I lift the bags, feeling that somehow makes me stronger.

It doesn't, of course. And once I am finished my neck hurts horribly and the pain exhausts me.

So why don't I learn my lesson? Why do I fight doing a really simple thing that will help me?

One reason is denial and the other is looking at the short term rather than the long. I have to make the decision to accept what I can and cannot do -- sometimes just out of sheer stubbornness -- if I want help myself and reduce the pain when and where I can.

It is a lesson so hard to learn because it comes out of an acceptance of our limitations. At the end of the day, it is not the physical things that I do or refuse to do that cause the pain. It is my refusal to accept. Then I’m not a turtle but an ostrich, keeping my head in the sand.

I wish they had a neck brace for that.

Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

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

Aleve & Other Pain Relievers Reduce Fertility in Women

By Pat Anson, Editor

Health experts have warned for years about the side effects of over-the-counter pain relievers – everything from liver failure to heart disease to hearing loss.

Now researchers are saying that Aleve and some other non-steroidal anti-inflammatory drugs (NSAIDs) reduce the fertility of women so significantly they could potentially be used as an emergency form of contraception.

The results of a small study presented at the European League Against Rheumatism Annual Congress show that three NSAIDs --  naproxen, diclofenac, and etoricoxib -- inhibited ovulation in women after just a few days of treatment.

Naproxen, diclofenac, and etoricoxib are the active ingredients in several brand name drugs sold around the world, including Aleve, Voltaren, and Arcoxia, respectively. Etoricoxib is not approved for use in the United States.

Thirty nine Iraqi women of childbearing age who suffered from back pain took part in the study; receiving diclofenac (100mg once daily), naproxen (500mg twice daily), etoricoxib (90mg once daily), or a placebo.

Treatment was given for 10 days from day 10 of the onset of their menstrual cycle, with their progesterone levels and follicle diameter analyzed via blood sample and sonography.

“After just ten days of treatment we saw a significant decrease in progesterone, a hormone essential for ovulation, across all treatment groups, as well as functional cysts in one third of patients,” said study investigator Professor Sami Salman, Department of Rheumatology, University of Baghdad.

“These findings show that even short-term use of these popular, over-the-counter drugs could have a significant impact on a woman's ability to have children. This needs to be better communicated to patients with rheumatic diseases, who may take these drugs on a regular basis with little awareness of the impact.”

Of the women receiving NSAIDs, only 6.3% taking diclofenac, 25% taking naproxen, and 27.3% taking etoricoxib ovulated, compared with 100% of the control group that was not taking a pain reliever.

The dominant follicle remained unruptured in 75% of the women taking diclofenac, 25% taking naproxen and 33% of the patients receiving etoricoxib. Rupturing of the dominant follicle and the subsequent release of an oocyte (unfertilized egg), is essential for ovulation to occur.

“These findings highlight the harmful effects NSAIDs may have on fertility, and could open the door for research into a new emergency contraception with a more favorable safety profile than those currently in use,” said Salman.

NSAIDs are among the most common pain relief medicines in the world. Every day more than 30 million Americans use them to relieve pain, lower fever and reduce inflammation.

Back Pain World's Leading Cause of Disability

By Pat Anson, Editor

Lower back pain remains the world's leading cause of disability, according to an extensive new study of health data that also warns that the number of people living in poor health is set to rise rapidly over coming decades.

Using a statistical analysis known as "years lived with disability" (YLD),  the Global Burden of Disease Study ranks lower back pain as the leading cause of disability worldwide, followed by major depression.  

Low back pain was the leading cause of YLDs in 86 countries and the second or third leading cause in 67 countries. It also caused more health loss than diabetes, chronic obstructive pulmonary disease, and asthma combined.

Several other painful conditions also ranked high, including neck pain (#4), migraine (#7),  musculoskeletal disorders (#10), osteoarthritis (#13) and medication overuse headache (#18).

The study, which is published online in The Lancet, is the first to examine the extent, pattern, and trends in disabilities worldwide. An international consortium of researchers led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington studied 301 diseases and injuries in 188 countries.

They found that while people around the world are living longer, they are spending more time in ill health as rates of diseases and injuries decline more slowly than death rates.

Just one in 20 people worldwide had no health problems in 2013, with a third of the world’s population -- 2.3 billion people -- experiencing more than five ailments. Of those, 81% were younger than 65 years old.

The disease burdens for low back pain and depression both increased more than 50% since 1990. There was also a startling increase in disability caused by diabetes (up 136%), Alzheimer’s disease (up 92%), medication overuse headache (up 120%), and osteoarthritis (up 75%).

"What ails you isn't necessarily what kills you," said IHME Director Dr. Christopher Murray. "As nonfatal illnesses and related ailments affect more people of all ages, countries must look closely at health policies and spending to target these conditions."

Between 1990 and 2013, YLDs increased from 537.6 million to 764.8 million for both sexes. The leading causes of YLD remained largely stable during this period, but they took an increased toll on health due to population growth and aging.

Musculoskeletal disorders, combined with fractures and soft tissue injuries, accounted for one-fifth of YLDs globally in 2013, ranging from a low of 11% for Mali's population to a high of 30% in South Korea.

"Many countries around the world have made great progress in addressing fatal diseases, but nonfatal illnesses pose the next major threat in terms of disease burden," said Professor Theo Vos of IHME, the study's lead author. "This need to meet the challenge of nonfatal diseases and injuries only becomes more urgent as the population increases and people live longer."

Leading Causes of YLDs in 2013:

1.  Low back pain
2.  Major depressive disorder
3.  Iron-deficiency anemia
4.  Neck pain
5.  Hearing loss
6.  Diabetes
7.  Migraine
8.  Chronic obstructive pulmonary disease
9.  Anxiety disorders
10.  Other musculoskeletal disorders

“Large, preventable causes of health loss, particularly serious musculoskeletal disorders and mental and behavioral disorders, have not received the attention that they deserve. Addressing these issues will require a shift in health priorities around the world, not just to keep people alive into old age, but also to keep them healthy,” said Vos.

This study was funded by the Bill & Melinda Gates Foundation.

My Life with Spinal Stenosis

By Brandis Standridge

I was a young, 16-year old track athlete the first time I experienced my back “going out.” The spasms, the pain and the sciatica were horrible. 

My family physician did everything right and I learned how to manage my symptoms for the next twenty years, although each time by back went out it was a little worse than the last.

At 37, my back went out again. I found out that I had severe spinal stenosis on multiple levels due to facet and ligament hypertrophy. Basically, osteoarthritis had overgrown the ligaments and joints in my spine so badly that it was crushing my spinal cord on 10 levels.

I was referred to several pain management specialists.  All of them were horrible.  I had to fill out lengthy questionnaires and they refused to give me pain medication unless I consented to their procedures.

They pushed for spinal injections and for fusion surgery, even while admitting the surgery had only a 50/50 success rate. I refused.

Never in my entire life have I felt as segregated, helpless, victimized, and scared as I have dealing with these specialized "professionals.” After the last one, I returned to my family physician in tears and told her I would rather live in agony than be forced into procedures and treated as if I were some local street addict before they even knew me.

BRANDIS STANDRIDGE

Two years ago I had to move.  My doctor gave me a letter of reference, medical and MRI records, and a report from my state pharmacy board. All of this was to help the new doctor with the vetting process to help get me treatment. But, it started all over again; the assumptions, ultimatums, and power plays: "If you don't do this, you won't get medication.”

Once again I refused to be without choices or a voice of my own.

I am a former social worker.  I know how to advocate and refuse to be pushed into procedures that will more than likely hurt me more in the long and short term.  I refuse to let doctors push me into places where I have no voice, where I am not able to be a member of my medical treatment team.

I did eventually find a doctor. Our relationship is a bit tense at times but I am receiving the care that I choose.

We have a right to choose our medical procedures without fear of punishment. We have a right to be active in our treatment and to live as pain free as possible.

Never lose faith in yourself. Never stop having hope.  We are chronic pain warriors, not victims!

Brandis Standridge lives in Idaho.

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.

Better Sleep Means Less Pain

By Pat Anson, Editor

Getting a good night’s sleep plays a key role in determining how bad your pain levels are doing the day, according to a large new study by researchers in Norway.

The study included more than 10,400 adults from an ongoing Norwegian health study. Each participant underwent a standard test of pain sensitivity -- the cold pressor test -- in which they were asked to keep their hand submerged in a cold water bath for 106 seconds.

Only 32% of participants were able to keep their hand in cold water throughout the experiment. Those who suffered from insomnia were more likely to take their hand out early: 42% did so, compared with 31% of those without insomnia.

Pain sensitivity also increased depending on the frequency of insomnia. Those who had trouble sleeping at least once a week had a 52% lower pain tolerance, while those who reported insomnia once a month had a 24% lower tolerance for pain.

"While there is clearly a strong relationship between pain and sleep, such that insomnia increases both the likelihood and severity of clinical pain. It is not clear exactly why this is the case," wrote lead author Børge Sivertsen, PhD, of the Norwegian Institute of Public Health.

The study, which is published in the journal PAIN,  is the first to link insomnia and impaired sleep to reduced pain tolerance in a large, general population sample. The results suggest that psychological factors may contribute to the relationship between sleep problems and pain, but they do not fully explain it.

“We conclude that impaired sleep significantly increases the risk for reduced pain tolerance. As comorbid sleep problems and pain have been linked to elevated disability, the need to improve sleep among chronic pain patients, and vice versa, should be an important agenda for future research,” the study said.

A previous study in Norway found that women who have trouble sleeping are at greater risk of developing fibromyalgia – although it’s not clear if there’s a cause and effect relationship between the two symptoms.

Another study, recently published in PLoS One, found that insomnia – not surprisingly – made chronic pain patients less likely to exercise. Researchers followed 119 chronic pain patients, most of whom suffered low back pain, and found that quality of sleep was the best predictor of physical activity the next day – not mood or pain intensity.

FDA Order Stops Production of Medtronic Pain Pump

By Pat Anson, Editor

The U.S. Food and Drug Administration has filed a court order against medical device maker Medtronic ordering it to cease production and distribution of its SynchroMed II pain pumps.

Defects in the surgically implanted pumps, which are used to treat patients with chronic pain, cancer and severe muscle spasms, have been blamed for over a dozen deaths. The devices either lost power or inadvertently injected patients with too much or too little medication. The pump delivers analgesic drugs directly to the spinal fluid of pain patients.

Under the FDA's consent decree with Medtronic, the company will stop production of the SynchroMed II pump at its manufacturing plant in Columbia Heights, Minnesota. Medtronic will also retain a third-party expert to help develop and submit plans to the FDA to correct manufacturing and design problems. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions of the consent decree.

The FDA first approved the SynchroMed II pumps in 2004. Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s production facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying quality control problems, failure to document design changes, and failure to ensure that finished products meet design specifications.

“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Over 200,000 SynchroMed pumps have been implanted worldwide, according to Medtronic, but the devices are not being recalled. Patients who experience a sudden change in their pain levels or hear a device alarm are being urged to contact their physician immediately.

“The agreement does not require the retrieval of any Medtronic products. With this announcement there is no new information to share about the safety and performance of the SynchroMed drug infusion system. Patients with the SynchroMed drug infusion system do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement,” the company said in a statement.

"We are committed to the highest level of quality, and have pursued significant efforts in recent years to enhance the performance of the pump and to address the FDA`s expectations," said Tom Tefft, senior vice president and president of Neuromodulation, which is part of the Restorative Therapies Group at Medtronic.

When Drug Tests Go Wrong

By Pat Anson, Editor

Robin Haas was driving to Disneyworld with her husband and three children in 2008 when their vehicle was rear-ended by a truck on a Florida highway. The accident left Robin with chronic back pain, and she had 17 surgeries over the next 11 months to repair her damaged spine.

It was only the beginning of her problems.

Last year Robin was kicked out of a pain management practice after two office urine tests failed to find any trace of the fentanyl patch she was wearing for pain relief – a red flag for physicians that a patient may be diverting a drug.

Initially, Robin says her doctor didn’t seem too concerned.

“When it happened the second time, he said ‘Don’t worry about it. It’s happened with several of my patients with the fentanyl patches,’” Robin said

About a week later, she was shocked to get a certified letter from the doctor discharging her.

“I don’t know what happened. I really don’t,” Robin told Pain News Network. “I was just mortified. I never did anything wrong in pain management. Ever.”

What happened to Robin is not uncommon. According to a recent study, immunoassay urine tests widely used by pain management doctors to screen patients for drug use are wrong about half the time – frequently giving false positive or false negative results.

“Clearly, people don’t know how to interpret these tests,” said Jeffrey Fudin, a pharmacist and patient advocate, who says most physicians have no idea how inaccurate immunoassay testing is.

“I’m positive that they don’t. I get probably 50 emails a week from all over the country from concerned physicians and nurse practitioners who want to make the right decision, but they’re not sure what to do,” said Fudin.

"The other problem is there are no standards. You can go to five different providers and be treated five different ways for the same results.”

Fudin says fentanyl may not show up on an opiate screen because it has a  different chemical structure compared to most commonly prescribed opioids. There can also be false negatives because an opioid is simply prescribed in too low of a dose to be detected.

Some medications can also trigger false positives for an illicit drug. Widely used pain relievers like naproxen and ibuprofen, for example, can trigger a false positive for marijuana. 

To help doctors correctly interpret immunoassay results, Fudin is developing an online app called Urintel that can help them decide whether to take a negative or positive drug screen seriously – and whether to order more reliable and more expensive confirmation testing in a laboratory.

“Basically, it’s educational and it’s not punitive to the patient,” said Fudin about his app.

“My goal is to make opioid therapy as safe as possible and to make it individualized for each patient. And also to be fair, not only to patients, but providers because it’s not their fault that they don’t have training in pharmacokinetics or biochemistry. It takes a lot of things to understand the complexity of this.”

Fudin’s app may be too late to help pain patients like Robin Haas. She just hopes more patients aren’t wrongly accused of diverting or abusing drugs because of a test that is so often wrong.

“I guarantee not one of my pills has ever hit the street,” says Robin.

The 43-year old Florida resident says the pain clinic told her that her urine samples were re-tested in a laboratory – at a cost of $18,000 – but the results came back the same. She’s still not sure what went wrong. The  clinic has refused to identify the laboratory it used or provide her with the lab results. She had to find a new doctor.

“It’s a horrible thing to happen to people. And when you’re having to deal with chronic pain to begin with, nobody should have to go through it,” she says.

Have you been wrongly accused of failing a drug test?

Tell us your story. Send an email to editor@PainNewsNetwork.org.

We respect your privacy.

Physical Therapy Lowers Healthcare Cost of Back Pain

By Pat Anson, Editor

Early physical therapy for low back pain significantly lowers healthcare costs by reducing the use of expensive treatments such as spinal surgery, injections, imaging and painkillers, according to a large new study published in the journal BMC Health Services Research.

About a quarter of Americans report an incidence of low back pain (LBP) within the previous three months and it is one of the most common reasons to visit a physician. Most LBP episodes resolve within 2 to 4 weeks, but about 25% of patients will experience recurring back pain for a year or more. 

Researchers analyzed health care records for over 122,000 patients in the U.S. Military Health System who went to a primary care physician for an initial episode of low back pain and received physical therapy within 90 days. 

Over 17,000 patients in the study received early physical therapy within 14 days – and it was this group that made significantly less use of advanced imaging, spinal injections, spine surgery and opioids than patients who started physical therapy later. 

Health care costs on average were 60% lower (about $1,200) over a two year period for patients who had early physical therapy compared to those who delayed therapy.

"Physical therapy as the starting point of care in your low back pain episode can have significant positive implications," said physical therapy researcher John Childs, PhD. "Receiving physical therapy treatment that adheres to practice guidelines even furthers than benefit."

Medical guidelines recommended for low back pain are to avoid opioids and advanced imaging as a first-line of treatment. However, recent research shows those guidelines are often ignored.

A large new study by pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Another study of older adults with low back pain found that spending thousands of dollars on advanced imaging such as CT scans or MRI’s within six weeks of visiting a primary care doctor was often a waste of money.  

“Early imaging was not associated with better one-year outcomes. The value of early diagnostic imaging in older adults for back pain without radiculopathy is uncertain,” said Jeffrey G. Jarvik, MD, a professor of radiology in the University of Washington School of Public Health, who studies the cost effectiveness of treatments for patients with low back pain.

Combined direct and indirect costs for low back pain in the U.S. are estimated to be between $85 billion and $238 billion a year.

"Given the enormous burden of excessive and unnecessary treatment for patients with low back pain, cost savings from physical therapy at the beginning of care has important implications for single-payer health care systems," said Paul Rockar, President of the American Physical Therapy Association.

Study: One in Five Opioid Prescriptions for Low Back Pain

By Pat Anson, Editor

Doctors continue to prescribe opioids for low back pain, headaches and fibromyalgia – even though some medical guidelines recommend against their use for such common conditions, according to a large new study.

In an analysis of prescriptions filled for 12 million of its members between July 2013 and September 2014, pharmacy benefit manager Prime Therapeutics found that about one in five opioid prescriptions were written to treat low back pain.

"Our analysis found low back pain was the most common diagnosis among all members taking an opioid, even though medical guidelines suggest the risks are likely greater than the benefits for these individuals," said Catherine Starner, PharmD, lead health researcher for Prime Therapeutics.

Over 22% of those receiving long-acting opioids had been diagnosed with low back pain, nearly 5% had headache and about 2% were diagnosed with fibromyalgia.

In a position paper adopted last year, the American Academy of Neurology found there was “no substantial evidence” for long term use of opioids to treat low back pain, fibromyalgia and headache.

“Collectively, the data suggest that opioids do not improve function in low back pain and therefore should be avoided. While I am an advocate of minimizing opioids to every extent possible, I also believe that absolutes can be damaging," said Beth Darnall, PhD, a pain psychologist, clinical associate professor at Stanford University and author of Less Pain, Fewer Pills.

“In select individual cases, opioids may be one part of an effective pain management plan.  Even then, patients should be monitored closely and opioids used at the lowest dose for the shortest amount of time possible.  The opioid studies are based on large samples and there are always outliers; we must find ways of minimizing risks, protecting patients, and still leaving room for the reality that the medications may be effective for a minority of individuals.”

Nearly 9% of Prime Therapeutics’ members were prescribed at least one opioid during the study period. On average, the cost for those taking short-acting opioids was $72 per member, compared to $907 per member taking only long-acting opioids.

The company said a clinical program that assesses the appropriateness of long-acting opioids could help improve safety and reduce costs. A screening program could also identify members with a significant number of opioid claims in a short period, or those with diagnosed conditions that may not benefit from prolonged opioid use.

"Identifying these members and helping them find the most appropriate pain treatment for their condition could help reduce safety concerns," said Starner.

Darnall says an education program would also help – one that includes non-drug treatments.

“To reduce opioid prescriptions, patients must be given access to effective alternatives,” Darnall said in an email to Pain News Network. “Additionally, by providing patients with education regarding the limitations of opioids and associated risks clinicians may engage patients in their own care and motivate them to seek and try alternatives.  Such alternatives include psycho-behavioral interventions, self-management programs, graded exercise programs, rehabilitation approaches, and the like.”

Prime Therapeutics manages pharmacy claims for health insurers, employers, and government programs including Medicare and Medicaid. It is collectively owned by 13 Blue Cross and Blue Shield Plans, subsidiaries or affiliates.

Physical Therapy vs. Surgery for Spinal Stenosis

By Pat Anson, Editor

Physical therapy works just as well as surgery in relieving pain and other symptoms of lumbar spinal stenosis in older patients, according to researchers at the University of Pittsburgh.

Their two year-year study, published in the Annals of Internal Medicine, is believed to be the first that compares outcomes between surgery and physical therapy (PT) for spinal stenosis, a condition caused by narrowing of the spinal canal that causes pain, numbness and weakness in the lower back.  Decompression surgery to relieve pressure on spinal nerves has become a fast-growing intervention in today's older population.

"Probably the biggest point to put across to physicians, patients and practitioners is: Patients don't exhaust all of their non-surgical options before they consent to surgery. And physical therapy is one of their non-surgical options," said principal investigator Anthony Delitto, PhD, chair of the Department of Physical Therapy, University of Pittsburgh School of Health and Rehabilitation Sciences.

Delitto, a physical therapist, was puzzled why some patients responded well to physical therapy  and others to surgery.

In his study, 169 patients aged 50 and older with spinal stenosis agreed to be randomly assigned to two groups: Those who would have decompression surgery and those who would have two standardized physical therapy sessions each week for six weeks.

In his study, 169 patients aged 50 and older with spinal stenosis agreed to be randomly assigned to two groups: Those who would have decompression surgery and those who would have two standardized physical therapy sessions each week for six weeks.

After both groups were re-examined at intervals of six months, one year and two years, the patient outcomes appeared to be about equal. There were no detectable differences between the groups in how their pain abated and the degree to which function was restored in their backs, buttocks and legs.

"The idea we had was to really test the two approaches head to head," said Delitto. "Both groups improved, and they improved to the same degree. Now, embedded in that, there are patients who did well in surgery, and patients who failed in surgery. There are patients who did well in PT, and there are patients who failed with PT. But when we looked across the board at all of those groups, their success and failure rates were about the same."

The research project also revealed issues surrounding physical therapy and the cost of co-pay – which apparently discourage some patients from continuing their treatment.

"One of the big things that we know held patients back from PT were co-payments," Dr. Delitto added. "Patients were on Medicare, and a lot of them were on fixed incomes. Some of those co-payments had to come out of pocket at $25, $30, $35 per visit. That adds up, and some of the patients just couldn't afford it."

Most patients didn't finish the PT regimen allowed under Medicare and one-third of the patients failed to complete even half of the regimen. About one in six didn't show for a single treatment, though they had agreed to consider physical therapy.

Acetaminophen Ineffective for Back Pain

By Pat Anson, Editor

The world’s most widely used over-the-counter pain reliever is ineffective in treating low back pain and provides little benefit to people with osteoarthritis, according to a new study published in the British Medical Journal.

In a systematic review of a dozen research reports (a study of studies), Australian researchers also questioned many of the conventional treatments for back pain and other musculoskeletal conditions.

Acetaminophen -- also known as paracetamol – is the active ingredient in Tylenol, Excedrin, and hundreds of other pain medications. It is often recommended by doctors worldwide for back pain and osteoarthritis.

"Clinicians should carefully weigh benefits and harms when making treatment decisions. Paracetamol is not efficacious and potentially harmful. In this context we cannot justify its continued use for these prevalent diseases,” said Professor David Hunter of the University of Sydney.

The researchers found “high quality” evidence showing that patients taking acetaminophen are at greater risk of liver toxicity and nearly four times more likely to have abnormal results from liver function tests.

"World-wide, paracetamol is the most widely used over-the counter medicine for musculoskeletal conditions so it is important to reconsider treatment recommendations given this new evidence," said lead author, Gustavo Machado of The George Institute and the University of Sydney.

Low back pain is the leading cause of disability worldwide, and osteoarthritis of the hip or knee is the 11th highest contributor to global disability.

"This latest research, the most comprehensive systematic review of its kind, reaffirms this with an even larger, global patient base, and has for the first time also established that the effects of paracetamol for knee and hip osteoarthritis are too small to be of clinical importance." said senior author Manuela Ferreira of the George Institute for Global Health and the University of Sydney.

"We urgently need to take stock of the evidence for common musculoskeletal conditions, a largely under-recognized health priority, and make sure people are receiving appropriate care."

Treatments known to be effective for low back pain include counseling, physical therapy, exercise and psychological therapies such as cognitive behavioral therapy.

Aerobic exercise, strengthening exercise, weight management and anti-inflammatory medicines have been shown to provide benefit for patients with lower limb osteoarthritis.

A recent study published in The Lancet found that acetaminophen had no effect on pain, disability, function, sleep quality, or quality of life for people with low back pain.

Over 50 million people in the U.S. use acetaminophen each week to treat pain and fever. The pain reliever has long been associated with liver injury and allergic reactions such as skin rash. In the U.S. over 50,000 emergency room visits each year are caused by acetaminophen, including 25,000 hospitalizations and 450 deaths.

Depression and Obesity Raise Risk of Low Back Pain

By Pat Anson, Editor

Depression, obesity, smoking, and alcohol use significantly raise the risk of having low back pain, according to a large new study presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

“The results were pretty surprising to us. We kind of expected to find a significant difference but not to that extent,” said lead study author and orthopedic surgeon Scott Shemory, MD.

Shemory and his colleagues at Summa Health and the Crystal Clinic Orthopedic Center in Akron, Ohio reviewed the health records of over 26 million patients from 13 health care systems in the U.S. Of those 26 million patients, 1.2 million were diagnosed with lower back pain.

Researchers then analyzed the records to see if the patients with low back pain had any of the four modifiable risk factors: obesity, depressive disorders, alcohol and tobacco use.

• 19.3% of low back pain patients were depressed
• 16.75% were obese with a body mass index (BMI) over 30
• 16.53% were nicotine dependent.
• 14.66% abused alcohol

The study did not address the “chicken and egg question” of which came first. Do depression and obesity cause low back pain, or does low back pain lead to depression, obesity and other risk factors?

“With our study there was no way to determine the cause and the effect or which came first because there was so much overlap,” Shemory told Pain News Network.

“Especially with alcohol abuse and depressive disorders. Anybody who’s got low back pain for years and years, I don’t think it would be surprising that they would have a higher chance of depression or alcohol abuse.”

Regardless of which came first, Shemory says patients should take steps to improve their health by eliminating risk factors that they can control.

“If a patient has any of these risk factors and has low back pain that doesn’t have a neurogenic cause, like a pinched nerve or something like that, I would be counseling them on trying to control these risk factors, not just for their general health but their back pain and livelihood as well,” he said.

According to the National Instituteof Neurological Disorders and Stroke, about 80 percent of adults experience low back pain at some point in their lives. It is the most common cause of job-related disability and a leading contributor to missed work days. One large survey found that over a quarter of adults reported having low back pain during the past 3 months.