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DEA Proposes Change in Production Quota of Controlled Substances


Study Shows Yoga Has Modest Benefits in Treating Chronic Nonspecific Low Back Pain

TUESDAY, June 14, 2017 (Pain Medicine News) — A new Cochrane Database of Systematic Reviews analysis on the effects of yoga on treating chronic nonspecific low back pain has found “modest” positive outcomes with regard to improved function and reduced pain, according to University of Maryland researchers and other investigators.

While the positive effects seen with yoga were too small to be clinically important, the findings suggest with low to moderate certainty that yoga, compared with nonexercise, resulted in small to moderate improvements in back-related function and pain at three and six months. It is uncertain whether yoga and other back-related exercise have differing effects on function and pain.

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FDA Clears Cold Therapy System for Knee OA Pain

TUESDAY, May 23, 2017 (Pain Medicine News) — The FDA has cleared myoscience Inc.’s iovera° device for the relief of pain and symptoms associated with osteoarthritis of the knee for up to 90 days. The ioveraº technology is a nonopioid and nonsystemic treatment for blocking pain signals from peripheral nerves.

The FDA clearance was based on a recent prospective, multicenter, sham-controlled, randomized, double-blind study of 180 patients The study population included individuals with chronic knee pain related to knee osteoarthritis (age range, 35-75 years).

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HHS Awards State Grants to Combat Opioid Crisis

FRIDAY, April 21, 2017 (Pain Management News) — Health and Human Services (HHS) Secretary Tom Price, MD, announced that HHS will soon provide $485 million in grants to help states and territories combat opioid addiction. The funding, which is the first of two rounds provided for in the 21st Century Cures Act, will be provided through the State Targeted Response to the Opioid Crisis Grants administered by the Substance Abuse and Mental Health Services Administration.

The funding will be issued to all 50 states, the District of Columbia, four U.S. territories and the free associated states of Palau and Micronesia. Funding will support a comprehensive array of prevention, treatment and recovery services depending on the needs of recipients. States and territories were awarded funds based on rates of overdose deaths and unmet need for opioid addiction treatment.

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The Outlook for Pain Medicine: 2017 and Beyond

SUNDAY, April 16, 2017 (Pain Management News) — Moving Past Opioids. Opioids have rightfully been the focus of many states’ attention over the past several years. The move away from opioids as the primary treatment for chronic pain conditions should continue. High-dose opioids will and should face tighter scrutiny. Both state guidelines and the CDC opioid guidelines will continue to emphasize the diagnosis of an objective pain generator before initiating opioids. Alternative modalities must be tried first, including psychological therapies, physical therapy, occupational therapy, neuromodulation and precision injections. Alternative treatments such as acupuncture, massage and chiropractic therapy also are possible modalities in the nonopioid treatment of pain. The goal must be to utilize opioid-sparing treatments.

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Spinal Cord Stimulation Study Shows High Rate Of Infection

THURSDAY, April 13, 2017 (Pain Management News) — An analysis of two U.S. payor databases has found a 3.11% infection rate for spinal cord stimulation (SCS) implants, with age, peripheral vascular disease and history of infection identified as risk factors.

According to the study’s authors, when compared with rates of infection for total joint replacement and pacemaker surgeries, the data reflect a need for improvement of infection control practices.

“The approximate 3% infection rate within one year of SCS implant further emphasizes the need for enhancement in SCS infection control practices,” said David A. Provenzano, MD, a pain medicine specialist at Pain Diagnostics and Interventional Care, in Pittsburgh. “Based on these data, research is warranted on methods to limit SCS infection rates in patients with a history of prior infection.”

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Patients Report Worse Outcomes With Higher Opioid Doses

MONDAY, April 10, 2017 (Pain Management News) — Concerns with the safety and adverse effects of opioids have grown with increases in prescribing and dose, and higher doses have been associated with worse patient-reported outcomes in a study by researchers at Veterans Affairs (VA) and Kaiser Permanente health systems.

Benjamin Morasco, PhD, and his colleagues at the VA Portland Health Care System and the Kaiser Permanente Northwest Center for Health Research, in Portland, Ore., administered a battery of self-report measures to over 500 patients with chronic musculoskeletal pain treated with long-term opioid therapy. Their findings were published online on Dec. 17, 2016, in the Journal of Pain.

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Study Links Failed Back Surgery Syndrome to Fibromyalgia

TUESDAY, April 5, 2017 (Pain Management News) — San Diego — A new study shows that one in four patients with failed back surgery syndrome (FBSS) also has a diagnosis of fibromyalgia. According to the retrospective analysis, patients with FBSS and fibromyalgia also had more surgeries than patients with FBSS alone.

The association between fibromyalgia and FBSS is significant, the authors noted, with 25% of FBSS patients having a diagnosis of fibromyalgia compared with 1.75% in the general population.

“The impact of FBSS is tremendous, with direct costs ranging between $30,000 and $40,000 per patient, and high incidence of disability, decreased quality of living and unemployment,” said Esther Caballero-Manrique, MD, an anesthesiology resident at the University of Vermont Medical Center, in Burlington. “Given increasing rates of lumbar surgeries and high rates of failure, it is critical to identify patients with fibromyalgia prior to surgery and educate them regarding worsening symptoms and realistic expectations.”

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FDA Clears 'Painless' Blood Draw

Push-button device collects 100 μL of blood from upper arm

TUESDAY, February 27, 2017 (Medpage Today) — WASHINGTON — A push-button blood collection device billed as "virtually painless" received initial FDA 510(k) clearance late last week.

The device, called TAP and sold by Seventh Sense Biosystems, is cleared for use by healthcare workers for testing HbA1c levels in patients with diabetes and prediabetes. However, a company official said that, in practice, it could be used for other types of tests.

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New Prescribing Information Released for Hundreds of FDA-Approved Opioids

THURSDAY, January 12, 2017 (Pain Medicine News) — Throughout 2016, we at the FDA have announced requirements for manufacturers to create new product labeling information for a variety of opioid medications.

These safety labeling changes are all effective as of Dec. 16, 2016.

A wide range of products, across virtually all opioids, will have some form of new labeling information. Here are the highlights of the new requirements.

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A Cautionary Tale of Geriatric Opioid Addiction

FRIDAY, January 6, 2017 (Pain Medicine News) — (Dallas) The older man’s addiction could be traced back to an opioid prescription after hip replacement surgery, according to Micah Sobota, PharmD, BCSP, a clinical pharmacist at Coleman Behavioral Health, in Lima, Ohio. When providers refused to keep renewing his prescription, the man, then in his early 60s, started buying from drug dealers.

“Then he had to switch to heroin, which was a heck of a lot cheaper,” said Dr. Sobota, recounting the story of his client, now in recovery, during a session on opioids at the 2016 annual meeting of the American Society of Consultant Pharmacists (ASCP). Eventually, the man’s habit cost $120 daily. “He was eating through his savings, eating through his retirement. He had to go back to work, just to feed his addiction.”

Dr. Sobota is one of many clinicians wrestling with opioid-related challenges in baby boomers. Whether it’s aging physiology that renders them more sensitive to the medications, or outright dependence, these patients present unique management challenges. Moreover, the latest statistics are not encouraging: In 2015, 30% of Medicare patients were taking at least one commonly abused opioid, and those seniors averaged five such prescriptions, according to a June 2016 report from the Office of Inspector General. With advancing age, experts note, controlled substances can be metabolized differently, might interact with other drugs, or can exacerbate medical conditions or age-related vulnerabilities, such as the risk for falling.

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$35K Grants Available for Better Pain Management

FRIDAY, January 6, 2017 (Pain Medicine News) — Through Generation Rx grant funding, the Cardinal Health Foundation with The Ohio State University College of Pharmacy are offering grants of up to $35,000 to hospitals and health care providers that can help reduce the number of opioids prescribed while producing better patient outcomes and improving pain management.

There is a critical need for better pain management, Cardinal said: In 2015, more than 15,000 people died from overdoses involving prescription opioids, according to the CDC.

Proposals for the grants must be submitted online by Feb. 27, 2017, 11:59 p.m. EST. Specified topics for the grants are Best Practices in Pain Medication Use and Patient Engagement. The proposal should seek to achieve one goal: to engage patients and their health care providers in reducing the number of opioids prescribed for pain management, while producing better patient outcomes and better pain management.

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Researchers: Cannabinoids Provide Modest Analgesic Benefit for Central Neuropathic Pain

THURSDAY, January 5, 2017 (Pain Medicine News) — (San Diego) Those touting the panacea-like properties of cannabinoids may be disappointed by a recent study from Canada. The systematic review and meta-analysis of trials for chronic neuropathic pain has shown that cannabinoids provide only a modest analgesic benefit compared with conventional management or placebo.

According to the study’s authors, the moderate quality of evidence suggested that cannabinoids are effective in reducing central but not peripheral neuropathic pain.

“Based on these data, we can say cannabinoids have a statistically significant but clinically modest effect on chronic neuropathic pain,” said Howard Meng, MD, a resident in the Department of Anesthesia and Pain Management at Toronto Western Hospital, University of Toronto. “With this moderate quality of evidence, we can make a weak recommendation for the use of cannabinoids for treating neuropathic pain as a pain adjunct, not as a sole agent, and specifically for central neuropathic pain.”

Click here to view the video and read more. 


Beyond Opioids: Surgeons Explore New Approaches To Pain Control

MONDAY, Decmber 19, 2016 (Pain Medicine News) — Two weeks before they undergo surgery for breast cancer, women at a Stanford University breast clinic watch a 90-minute online video about pain and management of pain.

The video, called “My Surgical Success,” educates women about pain, distress and how to manage both using techniques like deep diaphragmatic breathing for relaxation. It emphasizes the benefits of self-care for pain control and healing, and includes a downloadable relaxation audio file that patients are encouraged to use daily. The video makes the point that pain is real and that distress exacerbates pain.

The researchers behind the intervention hope that if women can cope with distress effectively, they also will manage their pain more effectively. 

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Incidence of Spontaneous Resorption of Lumbar Disc Herniation: A Meta-Analysis

Lumbar disc herniation (LDH) is the most common type of degenerative discogenic disease. It is mainly treated surgically or with conservative measures (1-3). Studies of acute LDH have found that 2 and 5 years after diagnosis there was little difference between patients who underwent surgery and those who did not (4-5). The literature has shown that conservative treatment of LDH has unique advantages, with the clinical symptoms of most patients diminished or even completely gone within a few weeks (6).

Since 1990 magnetic resonance imaging (MRI) and computed tomography (CT) have provided evidence that conservative treatment allows resorption of the herniated disc (7-8). Although there have been numerous reports on this phenomenon, and researchers dedicated to determining how the resorption takes place, there has been little if any research on its incidence.

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Treatment Outcomes for Patients with Failed Back Surgery

Failed back surgery syndrome (FBSS) is a frequently encountered disease entity following lumbar spinal surgery. It has also been named “post lumbar surgery syndrome” and has been widely researched to date. If patients show chronic back pain or leg pain after successfully performed lumbar surgery, and there are no specific reasons for the pain, such as compressive lesions, infection, or others, then the diagnosis could be made. Although many plausible reasons have been investigated, the exact pathophysiology remains unknown. Residual lateral recess stenosis or foraminal stenosis, epidural fibrosis, recurrence of herniated nucleus pulposus, disc degeneration, adhesive arachnoiditis, or neuropathic pain have been suggested as etiologies of FBSS (1-4). In addition, many psychological risk factors, such as depression or worker’s compensation, have also been suggested as possible etiologies of FBSS (5,6). However, as many patients who have persistent symptoms following successfully performed spinal surgery, there was a problem using the term, “failed back surgery.” Because the term, “failed back surgery syndrome” has been suggested to be an inappropriateand illogical term, some authors have proposed using other terms, such as “postoperative persistent syndrome” (7) or “post lumbar surgery syndrome” (8-10).

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Topical Analgesics Result in Decreased Use of Other Pain Medications

TUESDAY, November 7, 2016 (Pain Medicine News) — Patients who were treated for at least five months with topical analgesics used less oral medication, including opioids, nonsteroidal anti-inflammatory drugs (NSAIDs) and over-the-counter (OTC) agents, according to an ongoing observational survey study presented at PAINWeek 2016 (abstract 47).

The OPERA (Optimizing Patient Experience and Response to Topical Analgesics) study is sponsored by Annie’s Apothecary in Boerne, Texas, and is being conducted by the clinical research organization Clarity Science. The researchers wanted to determine whether there were any differences between topical analgesics and other types of available treatments.

Patients ranged from 18 to 64 years of age, experienced chronic neuropathic or musculoskeletal pain, and had been prescribed one of the following topical analgesics: diclofenac, ketoprofen, flurbiprofen, amitriptyline, magnesium chloride, gabapentin, bupivacaine or other pain-relieving topical cream.


The good doctor: How Tulane's Mordecai Potash is fighting against the opioid epidemic

FRIDAY, October 28, 2016 (www.nola.com) — When Michelle O'Brien's car was rear-ended at a Covington intersection in 1999, doctors diagnosed her with whiplash. But a few months later, she lost the ability to hold her head up for more than a few seconds. Years would pass before she could do so long enough to read the chapter of a book.

During that time, a failed cervical disk replacement damaged nerves in her neck and arms, forcing her to quit her job as the director of a Montessori school. Unable to brush her hair or take a bath without excruciating pain, she tried every form of treatment she could find, from opioids and epidurals to spinal cord stimulation and hypnotherapy. None of it worked for long.

"I got to the point where I didn't want to live in this body anymore," O'Brien, 48, said.

Then she met Dr. Mordecai Potash, a psychiatrist and pain management specialist at Tulane University Medical Center. At their first session in 2009, Potash and his nurse Pat Bridges interviewed O'Brien for more than two hours. Potash surprised her by covering her entire medical background and asking how pain had impacted her social life and mental health.

Click here to watch the video and read more...


FDA Expands Warning Labels on Opioids & Sedatives

WEDNESDAY, August 31, 2016 (Pain Network News) — The U.S. Food and Drug Administration is expanding the warning labels on all opioids and benzodiazepines – a class of anti-anxiety sedative that includes Xanax – because of the serious risk of overdose and death when the drugs are used together.

The FDA’s “black box” warning labels – the FDA's strongest warning – involve nearly 400 opioid analgesics, opioid-containing cough products, benzodiazepines and other central nervous system (CNS) depressants. The risks associated with using the drugs simultaneously are fairly well-established and include extreme sleepiness, respiratory depression, coma and death.

The agency said the move is one of a number of steps the FDA is taking as part of its Opioids Action Plan, which is focused on policies “aimed at reversing the prescription opioid abuse epidemic, while still providing patients in pain access to effective and appropriate pain management.”

"It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together," said FDA Commissioner Robert Califf, MD. "We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks."

In addition to benzodiazepines, other CNS depressants include sedatives, hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and alcohol.

The new warning labels caution physicians to prescribe benzodiazepines or other CNS depressants “at the lowest effective dose” if a patient is already taking an opioid.

The FDA said the number of patients who were prescribed both an opioid analgesic and benzodiazepine increased by 41 percent between 2002 and 2014, which translates to an increase of more than 2.5 million opioid analgesic patients receiving benzodiazepines.

From 2004 to 2011, the rate of emergency department visits involving non-medical use of both drug classes increased significantly, with overdose deaths involving the drugs nearly tripling.

Recent guidelines by the Centers for Disease Control and Prevention also urge doctors to use caution when co-prescribing opioids and benzodiazepines.

The prescribing of opioid pain medication in the U.S. has actually been in decline for several years, but the number of overdoses blamed on opioids – both legal and illegal – continue to rise. One explanation for that is that the co-prescribing of opioids and sedatives has not changed.


Beyond oral opioids

Spinal cord stimulators, targeted drug delivery & the future of pain management

FRIDAY, August 12, 2016 (Becker's Spine Review) — In March the Centers for Disease Control and Prevention released guidelines for prescribing opioids for chronic pain. The guidelines outline appropriate opioid prescribing to avoid overuse and addiction among chronic pain patients.

In the wake of a prescription drug epidemic in the United States, implantable chronic pain technologies are a way to steer patients away from oral opioids while still controlling chronic pain. These technologies include spinal cord stimulation and targeted drug delivery, more specifically Medtronic's RestorSensor SureScan MRI Neurostimulator and the SynchroMed II Drug Pump.

Douglas Beall, MD, chief of radiology services at Clinical Radiology of Oklahoma in Oklahoma City, and Richard Vaglienti, MD, of WVU Medicine Pain Management Center in Morgantown discuss pain management going forward.

Q: How might the recent CDC and FDA announcements impact you, your patients and your practice?

Dr. Douglas Beall: They haven’t impacted my practice very much. I do primarily interventional pain which tends to focus on using narcotics but only in conjunction with other methods of treating patients. We see acute, subacute and chronic problems and treat them with the least invasive option available. We continue until the combination of the least invasive treatment that help the patient accomplish the goal of pain relief.

A lot of the practices this affects are using opioids for chronic pain patients over a long period of time. The maximum prescription affects a large amount of patients who have undergone chronic medication management with opioids.

Dr. Richard Vaglienti: My concern as a pain physician is related to the guidelines perhaps leading to physicians undertreating pain. I’m not advocating high-dose opioids for chronic non-cancer pain, but in certain individuals such as terminally ill patients they are necessary.

I am a little discouraged but not surprised that many physicians are giving up the treatment of chronic pain with opioids completely. It hasn’t impacted our practice much because we didn’t go in to the high dosage range very often; we used opioids as a late resort. Now they are a last resort.

Q: Will these guidelines have a significant impact on your business model?

RV: The treatment of chronic pain is an expensive venture no matter how you do it, but a worthwhile venture. That is going to be where our focus is from now on. We will apply opioid sparing therapies and gather data to prove they are as effective as we know they are.

DB: A lot of the impact has to do with the types of patients who arrive at my practice. People often come with acute sciatica and I can treat them with acute epidural injections. For spinal stenosis patients, you can try simple injections, physical therapy or other conservative management and maybe a minimally invasive decompression becomes necessary.

There are a category of patients who can’t be treated surgically but fail other non-surgical options; for those patients we employ pain blocks like stimulation or targeted drug delivery. These options are popular for patients who have undergone treatment with narcotics for a while but persist in having chronic pain.

Q: What other solutions are available for treating patients with chronic pain?

DB: There are options we have to relieve pain if all other less invasive methods fail, including electrical methods for targeting the spinal cord to replace their pain sensation with other types of stimulations.

Targeted drug delivery is another option to put in a catheter into the spinal fluid and slowly inject medication into the spinal fluid. That way the medication hits the pain receptors at their origin. Opioids like morphine taken by mouth over time creates a woozy feeling and alters the patient’s reflexes. It can cause memory loss. But if you take the same medication in the spinal fluid, you can cut back the dose and this may help reduce some of the side effects.

RV: At the University of West Virginia, we are in the process of redesigning our entire outpatient pain program, and there is going to be a huge psychological component. The base of the program is pain physicians that do interventions and manage non-opioid medications as needed. We’ll do implantable devices such as SCS as needed. But a large portion of our patient population also suffers from depression and anxiety, which makes the chronic pain more severe. These programs are expensive, but cost-effective.

Q: Do you believe there will be differences in how opioid pain treatments are prescribed?

DB: There has to be. Chronic oral opioids are a significant problem and the deaths from chronic use and opioid overdose have exceeded automobile accidents. Some patients take more than they should because the higher the dose you have been on, the more you need to elicit the desired effect.

There is less of a difference between the therapeutic dose and the threshold where the overdose is possible when you are taking such a high dose to feel pain relief.

RV: Some physicians have given up their DEA numbers and refuse to deal with it. Others are practicing in a poorly controlled fashion and they’ll get in trouble. Those in the middle will adapt to whatever we are allowed to do. Oral opioids will move down the treatment ladder and other therapies will move up.


New Treatment Shows Promise for Knee Arthritis

Small study found single shot of patient's own stem cells improved pain, mobility

FRIDAY, June 24, 2016 (HealthDay News) — For those who suffer debilitating arthritis in their knees, researchers report in a small study that just one injection of stem cells can reduce pain and inflammation.

The idea is experimental: Extract stem cells from a patient's own body fat -- cells known for their ability to differentiate and perform any number of regenerative functions -- and inject them directly into the damaged knee joint.

"While the goal of this small study was to evaluate the safety of using a patient's own stem cells to treat osteoarthritis of the knee, it also showed that one group of patients experienced improvements in pain and function," noted Dr. Anthony Atala, director of the Wake Forest Institute for Regenerative Medicine, in Winston-Salem, N.C. He was not involved in the study.

"In fact, most of the patients who had previously scheduled total knee replacement surgery decided to cancel the surgery," Atala noted.

"These results are encouraging, and it will be interesting to see if these improvements are seen in larger groups of study participants," he added.

Atala is editor-in-chief of STEM CELLS Translational Medicine, the journal that recently published the results of the 18-patient study.

The French and German researchers point out that osteoarthritis is the most common musculoskeletal disease among adults, a so-called "wear-and-tear" chronic condition that often affects the knee joint.

Typified by the ongoing breakdown of the cartilage that connect joints and bones, the progressively degenerative disorder ultimately gives rise to severe inflammation, significant pain and often crippling disability.

According to the Arthritis Foundation, osteoarthritis risk is driven by genetics; obesity; injury and joint overuse; other forms of arthritis; and metabolic disorders that can throw a person's iron or growth hormone levels out of whack.

No treatment can halt osteoarthritis' progress, and "no therapy is able to restore [damaged] cartilage tissue," noted study author Dr. Christian Jorgensen, head of the clinical unit for osteoarticular diseases at Lapeyronie University Hospital, in Montpellier, France.


Spinal Cord Stimulation for Chronic Pain

Publication of Two-Year SENZA-RCT Results in Neurosurgery Demonstrates Sustained Superiority of HF10™ Therapy over Traditional Spinal Cord Stimulation for Chronic Pain

REDWOOD CITY, Calif., Sept. 6, 2016 (PRNewswire) — Nevro Corp. (NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced the publication of long-term data for the treatment of chronic pain in Neurosurgery, the official Journal of the Congress of Neurological Surgeons. The SENZA-RCT is a groundbreaking pivotal study that was both the largest prospective randomized clinical trial ever conducted in SCS history and the first to evaluate comparative effectiveness of spinal cord stimulation (SCS) therapies.

The published two-year results demonstrate the sustained superiority of HF10 therapy versus traditional low-frequency SCS therapy across all primary and secondary endpoints. Significant findings from the SENZA-RCT study include:

  • Superior back pain responder rate with HF10 therapy: 76.5% versus 49.3%; P<0.001
  • Superior leg pain responder rate with HF10 therapy: 72.9% versus 49.3%; P=0.003
  • Superior and durable pain relief with HF10 therapy: average VAS scores for back and leg pain of 2.4 cm with HF10 therapy versus 4.5 cm and 3.9 cm with traditional SCS; P<0.001 and P=0.027
  • HF10 therapy delivered pain relief with no paresthesia or paresthesia-related discomfort
  • Consistent safety results with limited study-related serious adverse events in each treatment group at two years (5.0% for HF10 therapy, 7.2% for traditional SCS; P=0.56)

"Chronic pain is a significant public health problem that impacts an estimated 100 million American adults. More Americans are impacted by chronic pain than diabetes, heart disease and cancer combined and innovative, non-opioid treatments that work over a longer period of time are needed," said Leo Kapural, M.D., Ph.D, the Principal Investigator of the study. "By demonstrating a significant and durable decrease in back and leg pain over a two-year period, Nevro's HF10 therapy represents an important and evidence-based advance in pain medicine. As we read in the paper every day and hear mounting concern from regulatory agencies, treating chronic pain conditions with opioids is fraught with risks. HF10 therapy is a non-opioid, reversible therapy that may represent a compelling option for many of these suffering patients."

"Nevro is committed to delivering innovative, evidence-based therapies that significantly improve outcomes for patients living with chronic pain," said Rami Elghandour, President and CEO of Nevro. "HF10 therapy is now backed by two comprehensive prospective studies, each with robust two-year outcomes, representing a meaningful advance in the field of neuromodulation. We are honored to have this data published in the prestigious Neurosurgery journal, which has a rich history of publishing seminal SCS clinical trials including the Kumar (PROCESS, 2008) and North (2005) studies. This Level I RCT supports long-term positive outcomes for SCS and is critical for driving clinical and economic decision making among physicians, payers, and patients."

The Senza® SCS system received FDA approval in May of 2015. The 12-month results of the SENZA-RCT, first presented by Dr. Leonardo Kapural at the North American Neuromodulation Society meeting in December of 2014, provided the evidentiary basis for HF10 therapy's superiority labeling from FDA, a first in the SCS space. The two-year results of the SENZA-RCT were first presented by Dr. Todd Sitzman at the North American Neuromodulation Society meeting in December of 2015.

About the Senza System and HF10 Therapy

The Senza system is the only SCS system that delivers Nevro's proprietary HF10 therapy, an SCS therapy that provides electrical pulses to the spinal cord to alleviate pain. The electrical pulses are delivered by small electrodes on leads that are placed near the spinal cord and are connected to a compact, battery-powered pulse generator implanted under the skin. HF10 therapy is the only SCS therapy indicated to provide pain relief without paresthesia (a stimulation-induced sensation, such as tingling or buzzing, which is the basis of traditional SCS) and is also the first SCS therapy to demonstrate superiority to traditional SCS for back and leg pain in a comparative pivotal study. Nevro's innovations in SCS, including the Senza® system and HF10™ therapy, are covered by more than 100 issued U.S. and international patents.


Interventional Pain Medicine

Epidural Steroid Injections May Reduce Spending for Patients With Low Back Pain

MONDAY, May 23, 2016 (Pain Medicine News) — (Palm Springs, Calif.) For patients who have low back pain, the up-front cost of epidural steroid injections (ESIs) may be worth it in the long run. A retrospective analysis of administrative claims data suggests that patients who receive ESIs have a greater reduction in health care spending than those who don’t receive them. According to the data, presented at the 2016 American Academy of Pain Medicine annual meeting, ESIs were associated with total health care spending decreases of 16.4%, 7.56% and 4.67% for radiculitis, sciatica and lumbago, respectively.

“The drop in spending is more pronounced in patients who undergo ESI compared to those who do not, in absolute and in percentage terms,” said Eric Sun, MD, PhD, instructor in the Department of Anesthesiology,,Stanford University School of Medicine, in Stanford, Calif. “This decrease was primarily due to decreases in outpatient spending; we observed no decreases in pharmacy or inpatient spending.”

As Dr. Sun reported, the economic burden of low back pain can be substantial, with one study estimating costs to be $100 to $200 billion annually (J Bone Joint Surg Am 2006;88[Suppl 2]:21-24). Despite the large sums of money that are spent to treat back pain, however, there is growing concern among policymakers and clinicians that these treatments have been, on the whole, largely ineffective, given the lack of population-level improvements in outcomes and disability rates.

“While a growing body of literature suggests that ESIs have the potential to improve clinical outcomes, whether ESIs reduce overall spending remains unclear,” said Dr. Sun.

Using MarketScan data of private insurance claims, the researchers collected Current Procedural Terminology and International Classification of Diseases, 9th Revision codes of patients (aged 18-64 years) who received a diagnosis of lumbago, sciatica or radiculitis between 2002 and 2011, and who were continuously enrolled for at least one year before and two years after their initial diagnosis date. Patients who received more than one of these diagnoses were excluded from the study, as were patients who received an ESI 90 days or more after their diagnosis date.

To reduce confounding between the ESI and non-ESI groups, the researchers used a difference-in-differences approach, in which each patient served as his or her own control. In addition, spending by non-ESI recipients was used to control for secular trends in medical spending. Analysis also included adjustment for age and an extensive set of medical comorbidities, Dr. Sun reported.

“Not surprisingly,” he said, “medical spending increased sharply among both groups in the first quarter following the initial diagnosis date, with a sharper increase among ESI recipients. However, spending largely returned to baseline levels in the subsequent quarters, 90 days or more after diagnosis.”

According to Dr. Sun, the reduction among ESI recipients was much larger—in percentage terms and absolute value—than that among non-ESI recipients, with decreases ranging from 4.67% for lumbago to 16.4% for radiculitis. Despite the precipitous drop following ESI, health care spending still failed to reach prediagnosis levels, a sign that ESI doesn’t work for everyone.

“For some patients,” Dr. Sun explained, “the pain becomes intractable, so population spending will be higher than it was before.”

He added, “If all you’re doing is comparing before and after, though, you’re going to underestimate the effect of ESI. Spending is higher, but that’s not to say it doesn’t work—it just doesn’t work for everyone.”


BOTOX® For Migraines

Wanting to alleviate those troublesome migraines?

TUESDAY, Apr. 12, 2016 (botoxchronicmigraine.com) — BOTOX®(onabotulinumtoxinA) is a prescription medicine that is injected to prevent headaches in adults with chronic migraine who have 15 or more days each month with headache lasting 4 or more hours each day in people 18 years or older.

It is not known whether BOTOX® is safe or effective to prevent headaches in patients with migraine who have 14 or fewer headache days each month (episodic migraine).

IMPORTANT SAFETY INFORMATION
BOTOX® may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX®:

  • Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months.
  • Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

Full-Endoscopic Procedures Versus Traditional Discectomy Surgery for Discectomy

A Systematic Review and Meta-analysis of Current Global Clinical Trials

MONDAY, Mar. 29, 2016 (PubMed.gov)

BACKGROUND:
Traditional discectomy surgery (TDS) provides good or excellent results in clinical surgical discectomy but may induce neural adhesion, spinal structural damage, instability, and other complications. The potential advantages of full-endoscopic (FE) procedures over standard TDS include less blood loss, less postoperative pain, shorter hospitalization, and an earlier return to work. However, more evidence is needed to support this new technology in clinical applications.

OBJECTIVE:
The aim of this systematic review and meta-analysis was to compare the safety and efficacy of FE and TDS.

STUDY DESIGN:
Comprehensive systematic review and meta-analysis of the literature.

METHODS:
Electronic databases, including PubMed, EMBASE, SinoMed, and Cochrane Library, were searched to identify clinical therapeutic trials comparing FE to TDS for discectomy.

RESULTS:
Six trials comprising 730 patients were included, and the overall quality of the literature was moderate, including 4 Grade I levels of evidence (4 randomized controlled trials, [RCTs]) and 2 Grade II levels (2 non-RCTs). The pooled data revealed no difference in reoperation rates between FE and TDS (P = 0.94), but the complication rate was significantly lower in the FE group (3.86%) than in the TDS group (11.4%). Perioperative parameters (operation time, blood loss, hospitalization time, and return to work days) were significantly lower in the FE group (P < 0.05 for all groups using either score). Postoperative pain and neurology score assessments were conducted at 4 different time points at 3 months, 6 months, 12 months, and 24 months. Significant differences were detected in the following: lumbar North American Spine Society (NASS) pain at 6 months (P = 0.008); cervical NASS neurology at 6 months (P = 0.03); visual analog scale (VAS) score in leg at 3 months (P < 0.001); VAS score in arm at 24 months (P = 0.002); VAS score in neck at 3 months, 6 months, and 12 months after therapy (P = 0.003, P = 0.004, P = 0.01); and VAS score in neck at 3 months and 6 months (P = 0.01, P = 0.004). Moreover, the pooled data revealed no statistically significant differences in improvements in the Oswestry disability index (ODI), instability (X-ray), and Hilibrand criteria (P > 0.05 for all groups).

LIMITATIONS:
Only 6 studies were included, 4 of which had the same authors. Between-study heterogeneity due to differences in socioeconomic factors, nutrition, and matching criteria is difficult to avoid.

CONCLUSIONS:
Based on this meta-analysis of 24 months of clinical results, we conclude that the FE procedure is as effective as TDS but has the additional benefits of lower complication rates and superior perioperative parameters. In addition, patients may experience less pain with FE techniques due to a smaller incision and less operative injury. However, large-volume, well-designed RCTs with extensive follow-up are needed to confirm and update the findings of this analysis.

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Epidural Injections for Lumbar Radiculopathy and Spinal Stenosis

A Comparative Systematic Review and Meta-Analysis

WEDNESDAY, Mar. 23, 2016 (PubMed.gov)

BACKGROUND:
The prevalence of chronic low back pain and related disability is rapidly increasing as are the myriad treatments, including epidural injections. Even though epidural injections are one of the most commonly performed procedures in managing low back and lower extremity pain, starting in 1901 with local anesthetic alone, conflicting recommendations have been provided, despite the extensive literature. Recently Chou et al performed a technology assessment review for Agency for Healthcare Research and Quality (AHRQ) part of which was published in Annals of Internal Medicine showing lack of effectiveness of epidural steroid injections in managing lumbar radiculopathy and spinal stenosis. In contrast, multiple other publications have supported the efficacy and use of epidural injections.

PURPOSE:
To assess the efficacy of 3 categories of epidural injections for lumbar and spinal stenosis: performed with saline with steroids, local anesthetic alone, or steroids with local anesthetic and separate facts from opinions.

DATA SOURCES:
PubMed, Cochrane Library, US National Guideline Clearinghouse, prior systematic reviews, and reference lists. The literature search was performed through August 2015.

STUDY SELECTION:
Randomized trials, either placebo or active control, of epidural injections for lumbar radiculopathy and spinal stenosis.

DATA EXTRACTION:
Data extraction and methodological quality assessment were performed utilizing Cochrane review methodologic quality assessment and Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB). Evidence was summarized utilizing principles of best evidence synthesis.

DATA SYNTHESIS:
Thirty-nine randomized controlled trials met inclusion criteria. There were 9 placebo-controlled trials evaluating epidural corticosteroid injections, either with sodium chloride solution or bupivacaine, compared to placebo injections. There were 12 studies comparing local anesthetic alone to local anesthetic with steroid.

RESULTS:
A meta-analysis of 5 studies utilizing sodium chloride or bupivacaine with steroid showed a lack of efficacy.A comparison of lidocaine to lidocaine with steroids in 7 studies showed significant effectiveness from baseline to long-term follow-up periods. Meta-analysis showed a similar effectiveness for pain and function without non-inferiority of lidocaine compared to lidocaine with steroid at 3 months and 12 months.

LIMITATIONS:
The review was restricted to the data available with at least 3 months of follow-up, which excluded some studies. The inclusion criteria were restricted to English language studies.

CONCLUSION:
Epidural corticosteroid injections for radiculopathy or spinal stenosis with sodium chloride solution or bupivacaine were shown to be ineffective. Lidocaine alone or lidocaine in conjunction with steroids were significantly effective.

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FDA Adds Strongest Warning to Widely Used Painkillers

The warnings of painkillers 

TUESDAY, Mar. 22, 2016 (Associated Press) — Federal health regulators will bolster warning labels on the most widely used prescription painkillers, part a multi-pronged federal effort to reverse an epidemic of abuse and death tied to drugs like Vicodin and Percocet.

The Food and Drug Administration will add a boxed warning — the most serious type — to all immediate-release opioid painkillers, including combination pills containing oxycodone. Those drugs, sold as Vicodin and many generic brands, are consistently among the most prescribed drugs in the U.S.

The long-awaited move comes roughly three years after the FDA added the same warnings to long-acting opioid drugs like OxyContin, which slowly release their dose over 12 hours or more. The labeling switch means both drug types will now carry bold warnings about the risks of abuse, overdose and death.


Botox® May Help Knee Pain

Knee Pain. Man suffering from knee pain.

TUESDAY, Mar. 15, 2016 (Health.com) — Pain in your knee? You might want to consider getting Botox®. No, really. A new study published in the American Journal of Sports Medicine looked at people who had a type of knee joint pain common in active people. The researchers found that when a Botox®-like substance was injected into the tensor fascia latae (TFL)—the muscle that runs along the side and front of the hip—and followed by three months of physiotherapy, 69 percent of subjects required no further medical intervention.

“The overlying problem is that the TFL is over active, and the back of the hip, the gluteus medius, is underactive, and that leads to a tight band on the outside of the thigh, rubbing on the knee, pulling of the knee cap over, and fat pad impingement,” explained one of the researchers, Dr. Sam Church, a knee surgeon at Fortius Clinic in London. “But it seems that while the hip muscles were turned off [due to the injection], the muscle they could use to keep steady, the gluteus medius, got stronger. And when the hip muscles came back on line, both muscles were parallel [in strength] rather than one being weak.”

So what does all of this mean? It means it’s time to beef up your backside—especially since people tend to be very weak in that area, and overactive elsewhere. (We are talking to you, runners and cyclist!) Also important, stretching out that iliotibial (IT) band, or thick tendon that runs from the hip to the knee, Church said.

Here’s why: Not only are IT band issues typically a result of weak glutes and hips, but when the IT band gets tight or inflamed, you’ll often feel pain in the knee.

See the connection there?

To help rev up that rear and relieve some of the pressure on the IT Band, we got Chicago-based physical therapist David Reavy, owner of React Physical Therapy, who has worked with such elite athletes as Matt Forte, Dwyane Wade, and Swin Cash, to recommend a few moves. Work these into your routine ASAP, and your butt, hip, knee—OK, your entire body—will thank you.


Many Chronic Pain Sufferers May Overuse Over-The-Counter Meds

They run risk of stomach bleeds, ulcers, liver damage from meds, doctors say

MONDAY, Jan. 25, 2016 (HealthDay News) — Many people with chronic pain ignore dosing instructions on over-the-counter pain medicines and put themselves at risk for an overdose, a new survey suggests.

An overdose of these medicines can result in serious side effects, such as stomach bleeding, ulcers, liver damage and even death, according to the American Gastroenterological Association (AGA).

The AGA-commissioned poll of more than 1,000 U.S. adults aged 30 and older and 251 gastroenterologists found that 43 percent of chronic pain sufferers said they knowingly have taken more than the recommended dose of an over-the-counter (OTC) pain medicine at some point.

Common types of OTC pain medicines include acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen (Advil, Motrin), naproxen (Aleve) and aspirin.

"Pain is incredibly personal, but taking more than the recommended dose of OTC pain medicine can cause significant stomach and intestinal damage, among other complications," Dr. Byron Cryer, councillor-at-large at the AGA Institute, said in an association news release. Cryer is also an associate dean at the University of Texas Southwestern Medical Center at Dallas.

The survey also found that 38 percent of respondents did not know that combining two or more NSAID pain relievers, or two or more acetaminophen pain relievers, increases the risk of serious health complications.

Many of the gastroenterologists in the poll said many of their chronic pain patients use OTC pain relievers at a higher dose and for longer than recommended. Those patients often don't make the connection between the pain medicines and overdose symptoms, the doctors added.

While 66 percent of those with chronic pain had been plagued by pain for two years or more, only 12 percent had been diagnosed with chronic pain, the survey also found.

People with chronic pain should never try to self-manage their pain with over-the-counter medicines, according to the news release.

If you have chronic pain, talk to your doctor about all the medicines you're taking, read and follow all medicine labels, and only take one type of pain medicine at a time, the association advised.


Weight Loss May Spare Knee Cartilage

Losing more than 10 percent of body weight was linked to slower degeneration of cushioning in joints

MONDAY, Nov. 30, 2015 (HealthDay News) — Losing a large amount of weight slows the loss of knee cartilage in obese people, a new study shows.

Obesity is a major risk factor for knee osteoarthritis, a degenerative joint disease that often leads to joint replacement surgery.

The new study included just over 500 overweight and obese Americans who either had mild to moderate osteoarthritis or risk factors for the disease. The study participants were randomly assigned to a control group that lost no weight, a group that lost a little weight, or a group that lost more than 10 percent of their body weight.

Four years of follow-up showed significant weight loss protected against cartilage degeneration and that larger amounts of weight loss provided more protection, according to the study to be presented Monday at the annual meeting of the Radiological Society of North America, in Chicago.

Research presented at meetings is considered preliminary until published in a peer-reviewed journal.

"Cartilage degenerated a lot slower in the group that lost more than 10 percent of their body weight, especially in the weight-bearing regions of the knee," study author Dr. Alexandra Gersing, from the department of radiology and biomedical imaging at the University of California, San Francisco, said in a society news release.

"However, those with 5 to 10 percent weight loss had almost no difference in cartilage degeneration compared to those who didn't lose weight," she added.

Significant weight loss not only slows the loss of knee joint cartilage, it also reduces the risk of osteoarthritis. Along with moderate exercise, weight loss is one of the best ways to prevent the disease, Gersing said.

"It's most helpful if these lifestyle interventions take place as early as possible," she said.

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