Study Finds ‘Nocebo Effect’ of Statins Cause Pain

By Pat Anson, Editor

An industry funded study is adding more fuel to a sometimes heated debate over statins – and whether the cholesterol-lowering drugs cause muscle pain and weakness.

Research involving nearly 10,000 patients published in The Lancet medical journal suggests that people taking Lipitor – the brand name for the statin atorvastatin -- are more likely to report muscle aches and other side effects, but only if they knew there were taking the drug.

This is what is called the “nocebo effect” – the opposite of the placebo effect – where people complain of side effects because they expect to have them.

"Just as the placebo effect can be very strong, so too can the nocebo effect. This is not a case of people making up symptoms, or that the symptoms are 'all in their heads'. Patients can experience very real pain as a result of the nocebo effect and the expectation that drugs will cause harm,” said lead author Peter Sever of the National Heart and Lung Institute at Imperial College London.

“What our study shows is that it's precisely the expectation of harm that is likely causing the increase in muscle pain and weakness, rather than the drugs themselves causing them."

Sever said complaints about the side effects overstate how common the problems are and discourage people from taking statins, resulting in "thousands of fatal and disabling heart attacks and strokes, which would otherwise have been avoided."

“These results will help assure both physicians and patients that most AEs (adverse effects) associated with statins are not causally related to use of the drug and should help counter the adverse effect on public health of exaggerated claims about statin-related side-effects,” he said.

The study was funded by Servier Research Group, Leo Laboratories and Pfizer – the maker of Lipitor. Five of the eight co-authors reported potential conflicts of interest, including payments from Pfizer and other drug makers that manufacture statins.  

Only about 2 percent of the patients taking Lipitor in The Lancet study reported having muscle pain, a finding that is substantially at odds with previous research.

For example, in a study at the Cleveland Clinic last year, 42 percent of patients taking Lipitor reported muscle pain and weakness. Other studies have found muscle pain in 5% to 29% of statin users.

The Food and Drug Administration considered the problem serious enough that in 2014 it required warning labels on statins, cautioning that some statins can cause a muscle injury called myopathy, which is characterized by muscle pain or weakness. In rare instances, the FDA says statins can also cause liver injury, diabetes and memory loss.

Another study this week, published in JAMA Internal Medicine, linked statin use to back pain conditions such as spondylosis and intervertebral disc disorders. The study involved over 13,000 military veterans and their families.

“To our knowledge, this study is the first to report greater odds of back disorders among statin users compared with the odds of nonusers in a population with equal access to and the same cost of health care,” said Una Makris, MD,  of the VA North Texas Health Care System in Dallas. “Our results provide additional motivation to further investigate the overall influence of statin therapy on musculoskeletal health, specifically if prescribed for primary prevention in physically active individuals.”

Warriors Coach in ‘Excruciating' Back Pain

By Pat Anson, Editor

Golden State Warriors coach Steve Kerr is in “excruciating pain” and may miss the rest of his team’s first round playoff series against the Portland Trail Blazers after his chronic back pain "took a turn for the worse." Kerr warned other back pain sufferers "to stay away from surgery."

Kerr was unable to attend Game 3 Saturday night and doesn't know when he’ll return. Sources told the San Jose Mercury News that Kerr was in so much pain he was barely able to walk, which “was scary because it wasn’t a feeling he’s had before.”

The team had only given vague reports that Kerr has an “illness” and is “not feeling well.”

"This past week, for whatever reason, things got worse and my symptoms got worse," Kerr said at a news conference Sunday.  "With things getting worse, I just made the decision that I couldn't coach. As of now, I'm consulting with my doctors. I'm hoping for some improvement. If I get some improvement, I'll get back on the sidelines. 

"I'm not going into details on the symptoms, it's just discomfort and pain. It's not fun. And I can tell you, if you're listening out there,  if you have a back problem, stay away from surgery. I can say that from the bottom of my heart."

In the past, Kerr has complained of headaches, nausea and neck pain.

Kerr missed the first 43 games of the 2015-16 NBA season due to complications from surgery for a ruptured spinal disk. The dura membrane that surrounds Kerr’s spinal cord was punctured during the operation, causing spinal fluid to leak. A second surgery was performed to stop the leak.

“It’s very rare, it does happen occasionally, but it happens when there’s an accidental nick of the dura that surrounds the spinal cord. But I lost spinal fluid, took about a month to figure out what was going on, a lot of headaches, some other symptoms,” Kerr said in October 2015.

Headaches, nausea, and burning, stinging or tingling pain in the back and legs are the classic symptoms of adhesive arachnoiditis, an inflammation that causes scar tissue to build around spinal nerves, causing them to adhere or stick together. The disease is progressive, incurable and difficult to treat.  Many patients developed arachnoiditis after surgeries or epidural steroid injections that permanently damaged their spines.

Neither Kerr or his doctors have said he has arachnoiditis.

There’s a great deal of debate in the medical community over the value of spinal injections, surgeries, spinal cord stimulators and other “interventional” procedures to treat back pain. About 9 million epidural steroid injections are performed annually in the United States, often as a substitute for opioid pain medication.

Chiropractic Therapy Gives ‘Modest’ Relief to Back Pain

By Pat Anson, Editor

When it comes to treating short-term back pain, spinal manipulation may not be all it’s cracked up to be.

In a review published in JAMA of over two dozen clinical trials involving over 1,700 patients, researchers said chiropractic adjustments provided only “modest” relief for acute low back pain – pain that lasts no more than 6 weeks.

The improvement in pain and function were considered “statistically significant,” but researchers said it was about the same as taking over-the-counter pain relievers. Over half of the patients also experienced side effects from having their spines manipulated, including increased pain, muscle stiffness and headache.

Although the study findings are mixed on the benefits of chiropractic treatment, the American Chiropractic Association (ACA) said it “adds to a growing body of recent research supporting the use of spinal manipulative therapy.”

“As the nation struggles to overcome the opioid crisis, research supporting non-drug treatments for pain should give patients and health care providers confidence that there are options that help avoid the risks and dependency associated with prescription medications,” said ACA President David Herd, DC.

Last month the ACA approved a resolution supporting new guidelines by the American College of Physicians (ACP), which recommend spinal manipulation, massage, heating pads and other non-drug therapies as first line treatments for chronic low back pain.

“By identifying and adopting guidelines that ACA believes reflect best practices based on the best available scientific evidence on low back pain, we hope not only to enhance outcomes but also to create greater consensus regarding patient care among chiropractors, other health care providers, payers and policy makers,” said Herd.

But the ACP guidelines are hardly a ringing endorsement of spinal manipulation. The overall evidence was considered low quality that chiropractic adjustments can “have a small effect on function” and that they provide “no difference in pain relief.”

In fact, the best treatment for acute low back pain may be none at all.

"Physicians should reassure their patients that acute and subacute low back pain usually improves over time regardless of treatment," said ACP President Nitin Damle, MD.

One in four adults will experience low back pain in the next three months, making it one of the most common reasons for Americans to visit a doctor. According to a 2016 Gallup survey, more than 35 million people visit a chiropractor annually.

Wear, Tear & Care: The SpineGym

By Jennifer Kilgore, Columnist

You’ve got to hand it to SpineGym’s marketing team -- when one of your device’s signature moves is visually hilarious, you could try to hide it... or you could own it.

They decided to own it.

The video was what intrigued me many months ago. I mean, it’s incredible.

I have Google Alerts set to notify me about new medical technology, and those are the types of emails sent to me by crowdfunding websites like Kickstarter and IndieGogo. The SpineGym device, which is designed to develop your back and abdominal muscles, was 928% funded nearly a year ago.

My core has as much strength as a trash bag filled with mashed potatoes. I’ve been desperate for something to help me focus on those important muscles, but I was concerned that it would be too intense for my spine at T-11 and T-12, as a facet joint in that area never healed correctly.

Upon watching the exercise video, however, it didn’t seem too physically strenuous. I reached out to SpineGym USA to ask for a test unit, and they were gracious enough to offer me one. I’ve been using the device for a couple months now. Each session is intended to be less than five minutes, a few times a week.

Surprisingly, that’s all I can physically manage.

What is the SpineGym?

The SpineGym has two parallel poles set into a floorplate that go back and forth. There is a black band between the poles that you lean back or forward on. There are also loops on the base plate where you can hook plastic bands as an alternative workout for your arms.

The machine bases a workout’s pace on the user’s strength and capabilities, because the force working against the machine is what sets the tone. The moves themselves range from simple isometrics to a variation of crunches that work the abdominal and back stabilizer muscles.

With the positioning of the machine’s arms, it changes the moves entirely. I felt my muscles in a way I never had on a yoga mat, and they engaged from my low back all the way up to the base of my neck. When you watch the video it doesn’t look hard, but it’s surprisingly difficult when you actually try it.

SPINEGYM PHOTO

I wondered if this was because I have absolutely no core strength, so I asked my husband to try it. Here are a few key demographic differences between the two of us: He’s 6’, an ultra-marathon runner and exercises for approximately three hours a day. (Yes, I am aware of the irony.) He did agree with my assessment, however, and said that the SpineGym engaged his midsection in a way that crunches definitely do not.

SpineGym’s Data

When 20 sedentary workers aged 35-60 were given SpineGyms to use for two weeks, they were instructed to exercise for only five minutes a day. The following results were based on EMG measurements after two weeks:

• an average 80% improvement in activation of back muscles
• an average 141% improvement in activation of abdominal muscles
• significant postural improvements
• significant improvements in abdominal muscle strength
• approximately 90% of users found the training method to be efficient or very efficient.

A second test was performed on users aged 70-90 and included three SpineGym sessions a week for two months. Each session lasted four to five minutes.

• Standing balance improvement of 74%
• Muscle strength and coordination: improvement of 58%
• Walking speed improvement of 41%

Most of this improvement was reached by participants already after the first month of exercise.

How It Worked for Me

My lower back has been hurting much more recently in that “coming-back-from-the-dead” way. If I overdo it with the SpineGym -- meaning if I use it more often than once every few days -- I go into spasm and have a flare. This is when a session lasts about five minutes. It targets that specific area that needs the most work, so I am very excited about this unit.

People larger than 6’ might find it a bit flimsy for their size, as the poles are quite tall, set into a base plate that fits your shoes side by side, and is made of carbon fiber. It’s a bit of a balancing act. However, as long as your feet are firmly planted and your core is engaged, the platform should not move. Plus, there’s an anti-slip pad underneath.

The other great things? It’s relatively small and light for medical equipment (11.2 pounds or 5.1 kg). It sets up and breaks down easily and stores flat in a T-shirt-shaped bag, though I don’t ever put it away. It doesn’t take up much space, so why bother?

When I’ve been working all day and desperately need to stretch my lower and mid back, the SpineGym hits the muscles that need releasing the most. The unit targets the discomfort better than an upward-facing dog pose on the yoga mat. I just have to remind myself not to use the SpineGym too often, or I’ll be my own worst enemy in terms of progress.

You can purchase the SpineGym for $198 through Indiegogo.

Jennifer Kain Kilgore is an attorney editor for both Enjuris.com and the Association of International Law Firm Networks. She has chronic back and neck pain after two car accidents.

You can read more about Jennifer 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.

Study Finds Opioids Reduce Effectiveness of Massage

By Pat Anson, Editor

Massage therapy significantly improves chronic low back pain, but is not as effective when patients are taking opioid pain medication, according to a new study.

Nearly 100 patients with low back pain were given a series of 10 massages designed and provided by a massage therapist. Over half experienced clinically meaningful improvements in their low back pain.

"The study can give primary care providers the confidence to tell patients with chronic low back pain to try massage, if the patients can afford to do so," said lead author Niki Munk, an assistant professor of health sciences in the School of Health and Rehabilitation Sciences at Indiana University-Purdue University Indianapolis.

Most patients showed improvement in their pain and disability after 12 weeks, but the effectiveness of massage appeared to diminish after 24 weeks of therapy.

The study also identified several characteristics in patients that made them more or less likely to experience relief from massage:

• Adults older than 49 had better pain and disability outcomes than younger adults.
• Patients who were taking opioids were two times less likely to experience clinically meaningful change compared to those who were not taking opioids.
• Obese patients experienced significant improvements, but those improvements were not sustained over time.

"The fact of the matter is that chronic lower back pain is very complex and often requires a maintenance-type approach versus a short-term intervention option," said Munk.

Another inhibiting factor is cost. Patients in the study were given free massages, but in the real world massage therapy is often not covered by insurance, Medicaid and Medicare. Researchers say more studies are needed to determine just how cost-effective massage is compared to other treatments,

"Massage is an out-of-pocket cost," Munk said. "Generally, people wonder if it is worth it. Will it pay to provide massage to people for an extended period of time? Will it help avoid back surgeries, for example, that may or may not have great outcomes? These are the types of analyses that we hope will result from this study."

The study was published in the journal Pain Medicine. 

Lower back pain is the world's leading cause of disability. Over 80 percent of adults have low back pain at some point in their lives.

Lyrica Fails in Sciatica Pain Study

By Pat Anson, Editor

A small study in Australia has found that pregabalin – a drug more widely known under the brand name Lyrica -- works no better than a placebo at relieving leg pain caused by sciatica.

Researchers enrolled 209 sciatica patients in the study and assigned them to groups that received either pregabalin or placebo for a year. The findings, published in the New England Journal of Medicine, not only showed that pregabalin was no more effective than a placebo, but that it caused unwanted side effects such as dizziness.    

“Treatment with pregabalin did not significantly reduce the intensity of leg pain associated with sciatica and did not significantly improve other outcomes, as compared with placebo, over the course of 8 weeks. The incidence of adverse events was significantly higher in the pregabalin group than in the placebo group,” researchers concluded.

In all, 227 side effects were reported by the 108 patients who received pregabalin.

"Until now there has been no high quality evidence to help patients and doctors know whether pregabalin works for treating sciatica. Our results have shown pregabalin treatment did not relieve pain, but did cause side effects such as dizziness," said lead author Dr. Christine Lin, an associate professor at the George Institute for Global Health and the University of Sydney Medical School.

The placebo effect appeared to play a strong role in the study. Participants started out with an average score of about 6 on a zero to 10 pain scale. After one year, the pain levels dropped to 3.4 for those taking pregabalin and 3.0 for those taking placebo.

“It seems people associate a drop in pain being due to taking a capsule, rather than something which would happen naturally over time,” said Lin. "Unfortunately there are no drugs proven to work for people with sciatica and even epidural injections only provide a small benefit in the short term. What we do know is that most people with sciatica do eventually recover with time. It's also important to avoid bed rest and to stay as active as possible."

Sciatica originates in the lower back and travels down the sciatic nerve to each leg, causing pain, tingling and numbness. 

Pregabalin was originally developed as a treatment for epilepsy, but drug maker Pfizer was very successful in turning Lyrica into a multi-purpose pain drug that generates worldwide sales of $5 billion a year.

The U.S. Food and Drug Administration has approved Lyrica to treat chronic nerve pain caused by diabetes, fibromyalgia, epilepsy, spinal cord injury and post-herpetic neuralgia caused by shingles. The drug is also prescribed “off label” to treat a variety of other conditions, including sciatica and spinal stenosis.

According to ClinicalTrials.gov, dozens of studies are underway to test the effectiveness of pregabalin on conditions such as cirrhosis of the liver, anxiety, chronic cough, post-operative pain, pediatric seizures, and neuropathic pain caused by chemotherapy.

Common side effects of Lyrica are dizziness, blurred vision, nausea, headache, weight gain and fatigue.  Lyrica may cause suicidal thoughts in about 1 in 500 patients who use it. Pfizer also warns patients to talk to their doctor before they stop taking Lyrica. Suddenly stopping the medication may result in withdrawal symptoms such as headaches, nausea, diarrhea, trouble sleeping, increased sweating, and anxiety.

Steroid Injections Provide Little Relief for Back Pain

By Pat Anson, Editor

Steroid injections provide only short term relief for patients suffering from chronic low back pain, according to a new study funded by the French Ministry of Health that was published in the Annals of Internal Medicine.

Researchers evaluated 135 patients with discopathy – degenerative disc disease -- who were being treated at three different clinics in France. Half the patients were assigned to a control group and the rest received a single glucocorticoid (steroid) injection into their lower back.

A little over half of the patients who received the injection reported positive effects on back pain after one month. But the effect was only temporary and decreased over time, with no differences in back pain intensity after 12 months when compared to the control group.

“Given these findings, the researchers question the efficacy of glucocorticoid injections as a treatment for chronic low back pain,” the American College of Physicians said in a news release.

The French study adds to a growing body of evidence questioning the effectiveness and safety of steroid injections into the spinal area.

A 2015 report by the Agency for Healthcare Research and Quality (AHRQ) found little evidence that epidural steroid injections were effective in treating low back pain. Researchers said the injections often provide immediate improvements in pain and function, “but benefits were small and not sustained, and there was no effect on long-term risk of surgery.”

A 2014 study by the AHRQ also found that epidural injections did little to relieve pain in patients with spinal stenosis.  

Epidural injections, which have long been used to relieve pain during childbirth, are increasingly being used as an alternative to opioids in treating back pain. The shots have become a common and sometimes lucrative procedure at many pain management clinics, where costs vary from as little as $445 to $2,000 per injection.

The Food and Drug Administration has never approved the use of steroids to treat back pain, but several million epidural steroid injections are still performed “off label” in the U.S. annually.

The American College of Physicians (ACP) recently released new guidelines saying there was little evidence that steroid injections are effective as a treatment for low back pain.

“Moderate-quality evidence showed no differences in pain between systemic corticosteroids and placebo and no to small effect on function in patients with radicular low back pain,” the ACP said.

Lower back pain is the world's leading cause of disability. Over 80 percent of adults have low back pain at some point in their lives.

New Guidelines Offer Little Relief for Back Pain

By Pat Anson, Editor

“Take two aspirin and call me in the morning” doesn’t cut it anymore for low back pain. In fact, very little does.

One in four adults will experience low back pain in the next three months, making it one of the most common reasons for Americans to visit a doctor. But when it comes to treating low back pain, the American College of Physicians (ACP) says the evidence is weak for many pharmaceutical and non-drug therapies.

In fact, the best treatment for acute low back pain may be none at all.

"Physicians should reassure their patients that acute and subacute low back pain usually improves over time regardless of treatment," said Nitin Damle, MD, president of ACP. "Physicians should avoid prescribing unnecessary tests and costly and potentially harmful drugs, especially narcotics, for these patients."

An ACP review committee analyzed dozens of clinical studies to arrive at new guidelines for treating acute back pain (pain lasting less than 4 weeks), subacute back pain (pain lasting 4 to 12 weeks) and chronic back pain (pain lasting more than 12 weeks).  

The ACP recommends that doctors start with non-drug therapies, such as exercise and superficial heat with a heating pad, along with massage, acupuncture, spinal manipulation (chiropractic), tai chi, and yoga. The evidence for the effectiveness of exercise and superficial heat was considered moderate, while the evidence for the other non-drug treatments was considered low quality.

Only when non-drug treatments have failed does the ACP recommend medication for chronic low back pain, starting with non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and aspirin. Tramadol (a mild acting opioid) and duloxetine (Cymbalta) are recommended as second line therapies. The ACP says physicians should only consider stronger opioids as a third line therapy when all other treatments have failed.

The evidence for the effectiveness of NSAIDs and opioids was classified as moderate, while the evidence for acetaminophen, benzodiazepines and systemic steroids was considered low-quality.

"For the treatment of chronic low back pain, physicians should select therapies that have the fewest harms and costs, since there were no clear comparative advantages for most treatments compared to one another," Damle said.

The ACP guidelines say surprisingly little about the documented risks associated with NSAIDs, such as cardiovascular and gastrointestinal problems. The guidelines refer only vaguely to “moderate quality evidence” that NSAIDs have “adverse effects.”

Short-term use of opioids for low back pain was linked to increased nausea, dizziness, constipation, vomiting, somnolence and dry mouth. Interestingly, addiction and overdose were not listed as potential risks because they were not studied.

“Studies assessing opioids for the treatment of chronic low back pain did not address the risk for addiction, abuse, or overdose, although observational studies have shown a dose-dependent relationship between opioid use for chronic pain and serious harms,” the guideline states.

The ACP guidelines were released one week after Australian researchers released their own evaluation of NSAIDs in treating back pain. Their study found that NSAIDs reduced pain and disability somewhat better than a placebo, but the results were not statistically important (see “Ibuprofen No Better Than Placebo for Back Pain”).

The ACP calls itself the largest medical specialty organization in the United States. ACP members include 148,000 internal medicine physicians (internists), related sub-specialists and medical students.

The new guidelines are published in the Annals of Internal Medicine.

Ibuprofen No Better Than Placebo for Back Pain

By Pat Anson, Editor

When it comes to treating back pain, anti-inflammatory drugs such as ibuprofen work no better than a placebo, according to new Australian study.

Researchers at the University of Sydney conducted a meta-analysis (a study of studies) of 35 clinical trials involving over 6,000 people with back pain, and found that non-steroidal anti-inflammatory drugs (NSAIDs) provide little benefit. The study was published in the Annals of the Rheumatic Diseases.

“NSAIDs are effective for spinal pain, but the magnitude of the difference in outcomes between the intervention and placebo groups is not clinically important. At present, there are no simple analgesics that provide clinically important effects for spinal pain over placebo,” wrote lead author Gustavo Machado, PhD, of The George Institute for Global Health. “There is an urgent need to develop new drug therapies for this condition.”

Back pain is the world’s leading cause of disability, with about 80 percent of adults experiencing back pain at some point in their lives.

Opioids are usually not prescribed for simple back pain, leaving patients little alternative but over-the-counter pain relievers such as NSAIDs, a class of drugs that includes both aspirin and ibuprofen. NSAIDs are known to raise the risk of gastrointestinal and cardiovascular problems.

The Australian study found that NSAIDs reduced pain and disability somewhat better than a placebo or dummy medication, but the results were not statistically important.

"NSAIDs do not provide a clinically important effect on spinal pain, and six patients must be treated with NSAIDs for one patient to achieve a clinically important benefit in the short-term," wrote Machado. “When this result is taken together with those from recent reviews on paracetamol (acetaminophen) and opioids, it is now clear that the three most widely used, and guideline-recommended medicines for spinal pain do not provide clinically important effects over placebo.”

The study did not evaluate non-pharmacological treatments for back pain, such as exercise, physical therapy or chiropractic care.

NSAIDs are widely used to treat everything from fever and headache to low back pain and arthritis. They are found in so many different products -- such as ibuprofen, Advil and Motrin -- that many consumers may not be aware how often they use NSAIDs. 

Spinal Cord Stimulators Reduce Opioid Use

By Pat Anson, Editor

Most patients who have a spinal cord stimulator significantly reduce their use of opioid pain medication one year after their implant, according to new industry-funded research.

In an analysis of private and Medicare insurance claims from 5,476 patients who received a spinal cord stimulator (SCS), opioid use declined or stabilized in 70 percent of the patients. Opioid use was higher among patients who had the stimulator removed.

The study, presented at the annual meeting of the North American Neuromodulation Society (NANS), was sponsored by Abbott (NYSE: ABT), a manufacturer of SCS systems and other medical devices.

"Given the epidemic of opioid addiction and abuse, these findings are important and confirm that spinal cord stimulation therapy can offer strong benefits for patients struggling with chronic pain," said Ashwini Sharan, MD, president of NANS and director of Functional and Epilepsy Surgery at Vickie and Jack Farber Institute for Neuroscience.

"Based on these results, we concluded it may be possible to improve outcomes by offering our patients spinal cord stimulation earlier, before opioid dependence and addiction can occur."

Spinal cord stimulators have long been considered the treatment of last resort for chronic back and leg pain, because the devices have to be surgically implanted near the spine and connected to batteries placed under the skin. The implants send electrical impulses into the spine to mask pain.

Some patients find the stimulators ineffective and have them removed. According to one study, only about half of patients who received a traditional SCS device have a 50 percent reduction in their back and leg pain.

New technologies have been developed to make the devices more effective, easier to recharge and to reduce complications such as paresthesia – a tingling or buzzing sensation.

And with government regulators and insurers discouraging the use of opioid pain medication, the medical device industry is urging patients and doctors to take another look at SCS devices.

X-RAY OF PATIENT WITH MEDTRONIC SCS DEVICE

"As our society has been seeking ways to stem opioid abuse and addition, our company offers treatment options that can reduce their exposure to opioid medication," said Allen Burton, MD, medical director of neuromodulation at Abbott in a news release. "Data like these are critical to helping us demonstrate that spinal cord stimulation can reduce exposure to opioids while giving patients comprehensive pain relief."

Abbot recently purchased St. Jude Medical, giving the medical device maker its first exposure to the SCS and neuromodulation market, which has an estimated value of $5.3 billion.

"Non-medical pain relief is a focus with attention on the dangers of pain medication and the need to find alternatives to reduce chronic pain," said Bruce Carlson, Publisher of Kalorama Information, a research firm that tracks the neuromodulation market. "Abbott builds on its cardiovascular device properties with this deal, and that is a big focus of press coverage.  St. Jude's impressive spinal cord offering should not be obscured in this transaction."

Experts Say Weather’s Not to Blame for Your Pain

By Pat Anson, Editor

The age old debate over weather’s impact on pain is heating up again with new research indicating that cold, rainy weather has no impact on symptoms associated with back pain or osteoarthritis.

Researchers at The George Institute for Global Health in Australia say damp weather makes people more aware of their pain, but the symptoms disappear as soon as the sun comes out – suggesting there’s a psychological cause.

“Human beings are very susceptible so it’s easy to see why we might only take note of pain on the days when it’s cold and rainy outside, but discount the days when they have symptoms but the weather is mild and sunny,” said Professor Chris Maher, director of the George Institute’s Musculoskeletal Division.  

“The belief that pain and inclement weather are linked dates back to Roman times. But our research suggests this belief may be based on the fact that people recall events that confirm their pre-existing views.”

Maher and his colleagues conducted two studies involving nearly 1,000 Australians with back pain and 345 people with osteoarthritis.

Using weather data from the Australian Bureau of Meteorology, researchers compared the weather at the time patients first noticed pain with weather conditions one week and one month before the onset of pain as a control measure. 

Results showed no association between back pain and temperature, humidity, air pressure, wind direction or precipitation. Warmer temperatures did slightly increase the chances of lower back pain, but the amount of the increase was not clinically important. 

A previous study on back pain and weather at The George Institute had similar findings, but received widespread criticism from the public.

“People were adamant that adverse weather conditions worsened their symptoms so we decided to go ahead with a new study based on data from new patients with both lower back pain and osteoarthritis. The results though were almost exactly the same – there is absolutely no link between pain and the weather in these conditions,” said Maher.

The back pain study was published in the journal Pain Medicine. The study on osteoarthritis was published in Osteoarthritis and Cartilage.

“People who suffer from either of these conditions should not focus on the weather as it does not have an important influence on your symptoms and it is outside your control,” said Associate Professor Manuela Ferreira.

The Greek philosopher Hippocrates in 400 B.C was one of the first to note that changes in the weather can affect pain levels. Although a large body of folklore has reinforced the belief that there is a link between weather and pain, the science behind it is mixed.

PNN readers say there’s little doubt in their minds that there’s a connection.

“I totally agree that rainy weather does affect pain. I have osteoarthritis and fibromyalgia, and pain is most severe when there is a change happening in the weather especially rain,” wrote Dee.

“It's been well established that the source of weather-related pain is a direct result from the variance in barometric pressure,” said Judith Bohr. “Changes in the intensity of that pressure is felt more acutely in the parts of the body where there are injuries, degenerative changes, surgeries, wherever there is an increased sensitivity because of inflammation.”

Others say they can predict the weather based on their pain levels.

“So many sunny days and I've said it’s going to rain. People thought I was crazy for a while, but now they know,” said Ashley. “My kids are always asking if it’s going to rain.”

A study currently underway in England suggests there is a connection between weather and pain. Over 9,000 people are participating in The University of Manchester’s Cloudy with a Chance of Pain project, using a special app on their smartphones to record their daily pain levels. The app also captures hourly weather conditions.

Preliminary results show that as the number of sunny days increase, the amount of time participants spend in severe pain decreases. When the weather turns rainy and cloudy, however, the amount of time people spent in severe pain increases.

Wear, Tear & Care: The Edge Desk

By Jennifer Kilgore, Columnist

Let’s talk about how much I hate sitting.

I have two neck fusions, a permanently messed-up thoracic spine, and bulging discs in the lumbar spine. All of these combined make it very difficult for me to sit for long periods of time. This was a large part of why I had to leave the traditional working world and work from home.

I am always looking for improvements to my physical work setup. I already have a kneeling chair that I’d used in my old office, and even that -- my best option -- is something I can only do for a limited period of time before my back flares.

It seemed that coupling a kneeling chair with a normal desk was sometimes an odd combination because the height difference could mean bending my wrists to type (bad) or adjusting my neck (also bad). For some reason, I couldn’t figure out the right height to put the kneeling chair to correlate with my computer monitor.

So the question became, is there a desk that’s made specifically to work with kneeling chairs?

Why yes! There is!

I backed the Edge Desk on Kickstarter in March 2016. Every square inch of my house is occupied by something and I have no extra space. I bought this desk without caring about that.

As of now the desk is sitting in the middle of my office, where it’s blocking the printer and two bookcases (it’s not a big office).

This thing came fully assembled in a huge box in the middle of December. Now I’ve had enough time to use it and gather my thoughts.

courtesy: edge desk

Thoughts on the Edge Desk

●       It’s ergonomic

There’s something about kneeling that makes you sit up straight. It’s not an uncomfortable sort of straight, though -- a lot of the pressure is taken by your shins and thighs. Most importantly, it doesn’t bother your shins or knees, or at least it shouldn’t. This ensures proper alignment of the spine. I actually also felt like it kept me alert and more awake at my desk in a way that normal chairs do not.

●       It’s compact and light

I am not a strong person. Let’s get this out of the way right now. I am basically an anthropomorphic noodle. However, I can manipulate this desk myself if I try. It’s still something I’d ask my husband to carry for me, were that option to arise -- it’s 25 lbs., though it folds down to an impressive 6 inches and can fit underneath a twin bed for storage. So, once I decide to move it from its current position in the middle of my office, it won’t take up too much room. 

●       Angle of the easel

The really cool thing about this desk is the connected tabletop. It can be flat, or it can tilt at an angle, like an artist’s easel. It can also tilt at a very sharp degree, like an architect’s table.

Most of my work is done on a computer, which this desk can still accommodate, but as some of my spine damage affects my hands, I’ve been trying to think of interesting new activities to work on my manual dexterity. I’ve tried knitting, and now I’m experimenting with calligraphy. This new desk is great for that purpose.

I’m perfectly okay with letting this desk float around my house until we can find a proper place for it. It’s very portable, so at least it won’t be difficult to move around!

courtesy: edge desk

All in all, I quite like the Edge Desk. It’s very good for people who require an ergonomic setup that is gentle on the spine, yet it’s sturdy enough to travel to an office if needed. And it’s a talking piece, because who else has anything like it?

You can purchase the Edge Desk for $350 through the company’s website.

Jennifer Kain Kilgore is an attorney editor for both Enjuris.com and the Association of International Law Firm Networks. She has chronic back and neck pain after two car accidents.

You can read more about Jennifer 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.

Quell Relieves Back Pain Without Medication

By Pat Anson, Editor

Like many people who suffer from chronic back pain, Greg Watson has tried a lot of different treatments, including physical therapy, soft tissue manipulation, chiropractic adjustments, trigger point injections and dry needling.

“I did trigger point injections with really big needles,” says Watson, whose back was broken in four places when his bike was hit by a car in 2011. “A lot of interesting ways of relieving pain by triggering an even bigger pain. Some of those things would work temporarily.”

Watson spent five days in the hospital after the accident, where he was “pumped full of morphine.” When he was finally released and sent home, the 45-year old Watson was determined to avoid taking more pain medication. That meant trying all of those alternative therapies, with little success, and living for years with intermittent pain that sometimes reached a 6 or 7 on the pain scale.

A friend recommended that Watson try Quell, a battery powered medical device worn below the knee that uses electric nerve stimulation to relieve pain throughout the body -- a therapy known as neuromodulation.

“I felt it and noticed something right away,” says Watson. “It feels a little bit like pins and needles, and it kind of comes in little waves or pulses. Very low amounts of electricity coming into you.”

It took a couple of days for Watson to feel some pain relief. The biggest improvement he noticed was that he slept better.  

“I would go home and put it on for a few hours and then be able to get a full night’s sleep without having to wake up with leg discomfort in the middle of the night,” said Watson, a city planner in Boston who is an avid runner and bicyclist.

neurometrix image

On bad pain days, Watson will wear the Quell device while sleeping or at work. But mostly he just wears it for a few hours at a time. Watson has found that he’s often able the get through an entire day without even thinking about his pain. 

“There are some days I get a bigger uptick in the amount of pain that comes from that old injury site. But when that’s the case, I just up-ramp the use of it a little more.”

Quell is made by NeuroMetrix (NASDAQ: NURO), which recently won approval for the device to be sold in the Europe Union.

It’s been available in the U.S. since the summer of 2015 and is FDA approved for the treatment of chronic pain.

Quell can be purchased without a prescription, but is not covered by insurance and costs $249 through the company’s website or on Amazon. 

PNN columnist Jennifer Kain Kilgore says Quell “worked brilliantly” in relieving her chronic neck and back pain.

But readers have had mixed results with the device.

“Very expensive, wasn't covered under my Medicare insurance. I tried it for a couple of weeks and simply didn't receive ANY pain relief for my low back and neck. None. I am very disappointed,” wrote one woman.

“I have been using Quell for a month now. I use it mainly at night for the pain that I experience in my hips and legs that keeps me from sleeping,” wrote Pam. “It actually has helped me to ditch the sleeping pills. It helps me fall asleep. I am elated.”

“I am on day 18 of my Quell device. It has eliminated the pain in my knees. No more Bengay, Australian Dream or Blue Emu Cream needed. The pain in my feet and hips has diminished greatly,” said Beth Flood. “It is not perfect, it is not a complete answer, but for what it does and the relief it has offered, it is well worth buying.”

NeuroMetrix recently announced that it was conducting a small clinical study of Quell in 60 adults with chronic low back pain at the Brigham and Women’s Hospital Pain Management Center. The three month study will compare a group of patients using Quell to patients using their “treatment-as-usual.” Participants in both groups will use a smartphone app developed by the Pain Management Center to help them document and manage their pain.

“This study will analyze the potential for Quell to reduce pain and improve quality of life in people suffering from chronic low back pain. We look forward to learning a great deal from this study,” said Shai Gozani, MD, President and CEO of NeuroMetrix in a news release.

In previous small studies of Quell in patients with arthritis, diabetic neuropathy, sciatica or fibromyalgia, over 80 percent said the device relieved their chronic pain and improved their overall health. The largest measured changes were in pain relief, along with improved sleep, general activity and walking ability.

Over two-thirds of the patients said Quell also reduced the amount of pain medication they were taking. That’s an important consideration for Greg Watson.

“Especially if you’re looking to avoid medication. That’s the absolutely most appealing thing about it to me,” he says.

Living With Chronic Pain in an Opioid Hostile World

By Robert Hale, Guest Columnist

I am 50 years old and suffer from late-stage Ankylosing Spondylitis.  My entire spine has fused, along with my entire neck.  I cannot look left or right, nor up and down.  My shoulders are in the process of fusing.

I have a broken clavicle – broken in two places – that refuses to heal. I also suffer from peripheral neuropathy in my legs, which makes walking feel like treading on broken glass. 

My disease is degenerative, progressive and incurable. The only relief I can get is with opioids.  Taking long acting morphine and hydromorphone as a breakthrough medication, has literally saved my life.  I do not get any joy or “high” from these medications -- only relief from pain -- which is as close to a miracle as could be hoped for, for someone in my situation.

ROBert HALE

For the last 10 years, I have been seeing doctors, both in the field of palliative care and pain management. Early on, we managed to find a dose of opoid medication that was appropriate for me, and I began my life anew.

No longer bed-bound and useless, but able to function again, and become a productive member of my family and society.  I opened up a guitar shop and began working again – albeit at a gentle pace – and I really felt that my life was worth living again. 

I wasn’t happy to be taking pills every day to achieve this feeling of well-being, but it beat the alternative.  I asked my doctor, a wonderful, empathetic and kind doctor, how long I would have to be on these medications.  He told me, “Probably for the rest of your life”. 

Sadly, my awesome doctor left the palliative care clinic I was attending, and I was forced to move to a pain clinic in Overland Park, Kansas.  It is run by a highly respected pain management doctor, who took one look at me, asked me to walk down the hall and back, and knew immediately that I was a good candidate for the medications I had been taking.

For several years more, everything was fine – the doctors and nurses were great. Of course I had to sign a patient contract, agreeing to take my medications as prescribed (which I always do), not to take anything else, including illegal drugs, and not to share my medications with anyone.  I also was subjected to frequent urinalysis to prove that I was complying with my treatment plan. 

I never strayed from that plan, nor did I ever have a drug test showing anything but what it should.  I was, in the words of one of my nurse practitioners, the “perfect patient.”  I took the meds I was prescribed, exactly as they were meant to be used.

I am not an addictive personality, so I never was tempted to use my medications to try to get high, nor do I think I am addicted to my pain medications. I do have a tolerance to them, which is unavoidable in my situation.  I have been on large doses of morphine and hydromorphone for over 10 years. I’ve learned to respect these powerful drugs, and to treat them with great care.

The "New Cruelty"

Unfortunately, ever since the CDC opioid prescribing guidelines were released, stating that the maximum dose for any one person should be no more than 90 mg of morphine equivalent opioids per day, my pain care has changed for the worst.

The guidelines clearly state that they are meant for general practitioners, not doctors who specialize in pain management. However every pain doctor I have contacted see the guidelines as rules, and they have begun a relentless campaign of reduced opioid prescribing.  All of the pain clinics in my area have followed suit.  My pain doctor even went so far as to sell his practice to one of his partners.  I suspect this is so he couldn’t be blamed for the “new cruelty,” as I like to put it. 

It is very disturbing to talk to him these days – it’s like he is a completely different person. Gone is the compassion, the empathetic “do no harm” doctor that I had gotten to know over the last several years.  He now claims that the reason he no longer prescribes the meds we need is because of the danger of overdose.

If a doctor like him can be swayed by this propaganda, there are at least a thousand more around the country acting the same way. 

Some chronic pain patients have it worse than me, although it is difficult for me to imagine that, as my increase in pain levels has literally left me all but crippled.  I have told the pain clinic this, but they just look at me and say, “Oh, I’m sorry.  You’ll get through this somehow.”  But they know better. 

I have already had my medications reduced drastically, to about a tenth of the dose I have been safely taking for years, and I am absolutely miserable.  My days are once again filled with unrelenting pain, and on top of that, I am suffering from opioid withdrawal. I constantly feel like I have the flu, and can only sleep 2 to 4 hours every night.  I am back to being bed-bound most of the time, and it is physical torture to do the simplest things like dressing and showering. 

I cannot help around the house, to help my father who is 77-years old.  He just lost his wife, and my mother, to Alzheimer’s disease, and he needs me.  And I need him.  I can no longer play with my dog, Aya.  This breaks my heart – she deserves so much better.  

The worst part is, I’ll be back in the pain clinic next month, to have my dosage cut down again, because I have not agreed to have an intrathecal morphine pump installed in my body – an option that is not available to me, due to the fusion of my spine.  Other doctors have warned me not to have this procedure done, so it’s back to the clinic to get my meds cut down again.  Pretty soon, I’m going to be at a level of pain that the tiny amount of morphine they will allow won’t even touch.  What am I to do?

Here is a link to an excellent article on PNN, headlined “Pain Care Shouldn’t Be Political Theater” by Dr. Richard Oberg, a man whose disease is in the same family as mine.  

“The current hysteria over opioid pain medication is, without a doubt, the most unbelievable and difficult situation for patients I've ever seen in my 30 years of practice,” Oberg wrote.

Something is going to have to change, and fast, or a large percentage of the chronic pain patients in this country are going to die by their own hands, or be forced to find their medicines through illegal means, or switch to drugs like heroin and become statistics themselves.  I am just one voice, but I speak for thousands. There are so many of us who are unable to even summon the energy needed to type a column such as this. 

I just read an article stating that since the CDC guidelines were put in place, the rate of suicides among pain patients may be rising. I’m not surprised at all.  I think about it all the time now. The only thing keeping me here is the fact that I have people who depend on me, and the fact that I think suicide is a sin. I don’t want to wind up having to learn all these life lessons again. 

Please, for the love of God, listen to my words: Most of us are too weak and too sick to even make a plea, so I’m doing this on behalf of all those who are too weak to even type a letter to their congressmen or the people who can make a difference.  Stop treating chronic pain patients like drug addicts! 

We don’t even like the damned pills, but without them, we are in a living hell – an evil downhill spiral that can only end in madness, addiction to illegal drugs, or death.

Robert Hale lives in Kansas City, MO. He was diagnosed with Ankylosing Spondylitis at the age of 27.

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.

Back Pain Raises Risk of Mental Health Problems

By Pat Anson, Editor

Back pain is the world’s leading cause of disability, but a new international study has documented the toll it also takes on mental health.

British researchers analyzed data for nearly 200,000 people in 43 countries and found that back pain sufferers were three times more likely to be depressed and over twice as likely to experience psychosis.

“Our data shows that both back pain and chronic back pain are associated with an increased likelihood of depression, psychosis, anxiety, stress and sleep disturbances,” said Dr. Brendon Stubbs of Anglia Ruskin University.

“This suggests that back pain has important mental health implications which may make recovery from back pain more challenging. The exact reasons for this are yet to be established.”

Stubbs and his colleagues say their findings, published in the journal General Hospital Psychiatry,  were broadly similar across all 43 countries. The research team studied data from the World Health Survey from 2002 to 2004.

About 80 percent of adults worldwide experience back pain at some point in their lives. A previous study also found that about one in five low back pain patients suffer from depression.

“Further research is required to find out more about the links between these problems, and to ensure effective treatments can be developed. It is also important that healthcare professionals are made aware of this link to refer patients to other services if necessary,” said Stubbs.

Although the association between back pain and mental health problems was similar around the world, the incidence of back pain itself varied widely – from 13.7% in China’s population to 57% in Nepal and 53% in Bangladesh.

A large 2015 study in the United States linked back pain to a wide variety of other health issues, including obesity, nicotine dependence and alcohol abuse.

People with chronic lower back pain are more likely to use illicit drugs -- including marijuana, cocaine, heroin and methamphetamine -- according to a recent study published in the journal Spine.