Quell Device Relieves Variety of Pain Conditions

By Pat Anson, Editor

A new medical device that uses electrical nerve stimulation was effective in managing chronic pain in patients suffering from arthritis, neuropathy, fibromyalgia and other conditions, according to a small clinical study conducted by NeuroMetrix (NASDAQ: NURO), the device’s manufacturer.

Pain News Network recently featured the Quell Wearable Pain Relief device in a column by J.W. Kain, who reported that Quell “worked brilliantly” in relieving her chronic neck and back pain.

Eighty eight people were enrolled in a 60-day trial of Quell. All had chronic pain for at least year and nearly a quarter had more than 15 years of pain. Participants had “complex medical histories” with arthritis (61%), diabetic nerve pain (40%), sciatica (27%), and fibromyalgia (26%) as the most common conditions.

Over 80 percent of the participants said Quell 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

image courtesy of neurometrix

"We are pleased with these results. They represent the first formal evaluation of self-administered wearable intensive nerve stimulation. Quell provided substantial pain relief and improvement in quality of life measures,” said Shai N. Gozani, MD, President and CEO of NeuroMetrix.

“We were not surprised that two-thirds of the subjects reduced their use of pain medications, as we have consistently received this anecdotal feedback from Quell users over the past several months.”

Quell is available over-the-counter and does not require a prescription. It relieves pain by using electric stimulation to “mask” pain signals before they reach brain, much like a TENS unit.  The device, which costs $249, is lightweight and designed to be worn over the upper calf during the day or night.

The marketing of Quell for the treatment of chronic pain was approved by the Food and Drug Administration in 2014, but NeuroMatrix did not begin shipping the device to healthcare providers until this summer. It is also available through the company’s website.

A study abstract, “Treatment of Chronic Pain with a Novel Wearable Transcutaneous Electrical Nerve Stimulator,” has been accepted for poster presentation at the annual PAINWeek conference next month in Las Vegas.

Debate Grows over Spinal Injections

By Pat Anson, Editor

A controversial government funded study critical of epidural steroid injections has been republished in the Annals of Internal Medicine, fueling a growing debate over the effectiveness and safety of spinal injections.

A prominent pain specialist called the study’s publication in a peer-reviewed journal “an insult to thousands of physicians across the world."

In a systematic review of 30 placebo controlled trials, researchers found that epidural steroid injections (ESI’s) offer limited or no relief from radiculopathy and spinal stenosis, two conditions that cause low back pain. The study was funded by the Agency for Healthcare Research and Quality (AHRQ) and conducted at the request of the Centers for Medicare and Medicaid Services.

“Epidural corticosteroid injections for radiculopathy were associated with early improvements in some outcomes versus placebo interventions, but effects were small and unsustained, and epidural corticosteroid injections had no clear effects in patients with spinal stenosis,” wrote lead author Roger Chou, MD, a Professor at Oregon Health & Science University (OHSU) School of Medicine and a staff physician in the Internal Medicine Clinic at OHSU.

Epidural injections using analgesics have long been used to relieve pain during childbirth, but spinal injections with steroids are also widely used for back pain. Although the Food and Drug Administration has never approved the use of steroids to treat back pain, several million ESI’s are performed “off label” in the U.S. annually.

The shots have become a common and sometimes lucrative procedure at many hospitals and pain management clinics. Costs vary from a few hundred dollars to over $2,000 per injection.

“Evidence on the effects of using different approaches, corticosteroids, or doses on effectiveness of epidural corticosteroid injections was limited, but indicated no clear effects,” said Chou, who was the principal investigator and author of several other studies published in peer reviewed journals.

“It is a travesty that Chou et al continue to publish these types of manuscripts. It is an insult to thousands of physicians across the world who perform these procedures and millions of patients who have received relief from them,” said Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians.

Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky, conducted several of the studies reviewed by Chou and his colleagues.

“Consumers need to understand that the design of their systematic review is flawed and that significant bias exists in the reporting of the results,” Manchikanti wrote in an email to Pain News Network. “It is like eating 2 bananas from different countries and saying both are equally sweet, so neither is sweet. They also are looking for the differences in improvement between both groups rather than how a patient has improved from before the treatment to after the treatment."

Chou’s study also came under fire when it was released by the AHRQ. The Multisociety Pain Workgroup (MPW), a coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors, sent a lengthy letter to the AHRQ, calling the report's analysis on the effectiveness of ESI's "flawed” and “absurd.”  .

"I don't think its surprising that people who do these injections might disagree or not be happy with the results. Some of the comments seem to demonstrate a poor understanding of how to look at interventions in scientific research," Chou told Pain News Network. "I think people are afraid that they're not going to get paid for doing these types of things. It's not surprising, when people's pocketbooks are threatened, this how they respond."

Chou and his colleagues found the only significant benefit of ESI’s was temporary relief from back pain that usually lasts for only a few days. He attributes much of the pain relief to a placebo effect.

"It's clear that interventions for back pain have a very high placebo effect. We've known that for decades and its been demonstrated over and over again," said Chou.

Manchikanti says most of his patients get pain relief that lasts for several weeks.

“Each patient should be selected individually. They should understand the risks and the off-label nature of these drugs in the epidural space,” he said. “Epidural corticosteroids have been shown to be risky, come with a warning from the FDA, and are an off-label use of these powerful anti-inflammatories.

“For a patient, if they choose to have the procedures done with local anesthetic alone, or with local anesthetic and steroids, they should measure their progress. If they do not improve with the first procedure, they should carefully think about the second procedure; however, there is no reason to have any more than 2 procedures if they do not improve.”

The Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce or eliminate unnecessary medical procedures, also recommends that doctors do not to repeat the injection if a patient shows no sign of improvement.

A number of prominent pain doctors have told Pain News Network the shots are overused, with some patients getting dozens of injections.  

Terri Anderson says repeated shots gave her temporary pain relief from a bulging disc in her back.

“I did receive immediate and short-term benefits over a 3 year time frame. However, I am here to tell you that the injections did not save me from surgery as the disc ultimately failed,” she said.

Anderson now suffers from arachnoiditis, a chronic and painful inflammation of the spinal column that has left her permanently disabled. The Hamilton, Montana woman believes the condition was brought on by too many injections.

“If I had the opportunity to go back in time, I would have stayed away from intervention and lived with the pain I had which was chronic, but it was manageable,” Anderson said.

“The government and professional medical societies have been keeping chemically induced adhesive arachnoiditis hidden from public awareness. Why is that? There is too much profit at stake for hospitals and pain clinics throughout the country. If a physician were to provide their patients with true informed consent (and explain the horrors of arachnoiditis), then no one in their right mind would undergo an epidural steroid injection.”

Experts Say Epidural Steroid Injections Overused

By Pat Anson, Editor

Epidural steroid injections are being used too often to treat back pain, in part because of an insurance compensation system that encourages doctors to generate more income by using the procedure, several leading experts in pain management have told Pain News Network.

An estimated 9 million epidural steroid injections (ESI’s) are performed annually in the U.S. Epidural shots with an analgesic have long been used to relieve pain during child birth, but in recent years injections of a corticosteroid into the epidural space around the spinal cord have become an increasingly common procedure to treat back pain.

Critics say epidural injections are overused and patients risk permanent damage to their spinal cords if they get the shots too often.

“Have they been overused? Yes. And I’ve seen the complications. They happen when people have done far too many. I’ve seen people who’ve had two to three dozen epidurals in a given year,” said Forest Tennant, MD, a prominent pain management specialist in West Covina, California.

“It’s like a cumulative trauma. You just can’t keep doing epidurals on somebody or you’re going to get damage to the outer layer of the spinal cord. It’s amazing to me the number of people who’ve had epidurals and they can’t count how many they’ve had. I’ve had patients who say, ‘I’ve had a hundred.’ I mean, are you kidding me?”

One of Tennant’s patients compares epidurals to a game of Russian roulette.

“A doctor puts one bullet in the cylinder, gives it a spin, points it at your head, and pulls the trigger. Five of the six chambers are empty or ‘safe’ but the 6th chamber carries risk of a negative outcome that is so catastrophic that no one in his right mind would take the risks,” said Gary Snook, a Montana man who developed Arachnoiditis, a chronic and painful inflammation of the spinal cord, after getting a series of epidurals for back pain.

“These injections are expensive. Please take your limited health care dollars and spend them where they will do you some good. Join a gym, do pool exercises, swim, or learn and do Pilates. I know it is a lot of work, but you will not end up like me."

ESI’s can be a lucrative procedure for physicians, depending on insurance payments and where the epidurals are performed. Payments can vary widely, from a few hundred dollars to over $2,000 per injection.

The debate over the safety of ESI’s often pits surgeons and anesthesiologists, known as “interventionalists,” against traditional pain management doctors, who usually rely on opioids, physical therapy and other less invasive procedures to control pain.

“We have far too many interventionalists, compared to people who do medical management. I’m on the medical management side and I wish there were a lot more of us. I mean, I’m swamped,” Tennant told Pain News Network. “But on the other hand, you’ve got plenty of interventionalists who will do an epidural any day of the week. We have an imbalance of those people who want to do epidurals.

“Let’s face it. The money motive is there. And this money motive is not just the anesthesiologists. It’s the surgery centers, it’s the hospitals. And it has caused problems.”

Lobbying the Feds

Epidurals are drawing more scrutiny from federal agencies like the Food and Drug Administration, which has never approved the use of steroids in spinal injections. But steroids can still be used “off label” to treat back pain, which prompted the agency last year to warn that injectable steroids “may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death.”

That prompted an outcry from the Multisociety Pain Workgroup (MPW), a coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors. The group sent a letter to the FDA defending the use of epidurals and asked the agency to revise its warning.

“While complications with epidural steroid injections have been reported, and are likely underreported, serious complications are limited to isolated case reports,” the MPW letter states.

The FDA hasn’t changed its warning, but the MPW has stepped up its lobbying campaign with the federal government, recently asking the Agency for Healthcare Research and Quality (AHRQ), which is part of the Department of Health and Human Services, to tone down another report which said there was little evidence that ESI’s were effective in treating low back pain.

“We are fully cognizant of the issues of overutilization and inappropriate utilization,” the MPW said in a lengthy letter to the AHRQ, which called the report's analysis on the effectiveness of epidurals "flawed” and “absurd.”  The letter makes no mention of how to address the overuse of epidurals.

The MPW’s lobbying campaign has drawn criticism from Laxmaiah Manchikanti, MD, chairman and CEO of the American Society of Interventional Pain Physicians, which is not part of the MPW coalition.

DR. LAXMAIAH MANCHIKANTI

“There is no question that epidural steroid injections are over-utilized,” said Manchikanti, who is medical director of a pain clinic in Paducah, Kentucky.  “Unfortunately, MPW has been contributing to over-utilization of transforaminal epidural injections because of their own interest in this.”

Instead of addressing the overuse of epidurals, Manchikanti says the MPW is actually making the problem worse.

“They may be even promoting them. Multiple MPW signatories have numerous conflicts of interest of their own and each one is looking out for themselves,” he wrote in an email to Pain News Network.

Manchikanti has done some lobbying of his own, and is heading an effort to get the Centers for Medicare and Medicaid Services (CMS) to change its compensation system for epidural procedures.

Medicare currently pays about $132 to doctors who perform epidurals in their own offices, while physicians who do the same injections in a hospital, pain clinic or surgical center will get about $670. That “remarkable discrepancy,” according to Manchikanti, contributes to over-utilization by encouraging hospitals and other large facilities to do more epidurals.

“Office-based practices are increasingly being purchased by hospitals and in this well-documented circumstance, the ownership has the potential to change the payment dramatically,” Manchikanti wrote in a letter to the journal Pain Physician. “These patterns increase expenses by paying a much higher rate for HOPDs  (hospital outpatient services), even though they are just physician offices. This issue also favors inappropriate performance of the procedures with bundling." 

Repeated requests to the CMS for comment on this story went unanswered.

Solutions to Overuse

What can be done to reduce or eliminate the overuse of epidurals? One approach is to stop paying high reimbursement rates for the procedure.

“Site-neutral payment is the solution,” says Manchikanti. “We have been working on this issue where a hospital’s pay should be reduced to the level of ambulatory surgery centers (ASCs) or about 10% higher, and office reimbursement should be at least 60% of ASC payment.” 

“Probably everything that gets compensated well is over-utilized because it’s the compensation system. It’s a reimbursement system that pays more for treatment procedures than outcomes,” said Lynn Webster, MD, a prominent pain physician and past president of the American Academy of Pain Medicine, which is a part of the MPW coalition.

“I think our healthcare system is perverted and doesn’t really help us deliver better outcomes; but more procedures, more visits, and none of that’s tied to improving the quality of care.”

Like Manchikanti, Tennant and other physicians Pain News Network interviewed for this story, Webster says epidurals can be effective in managing back pain when used sparingly.

“I’ve performed many epidural steroids and as a result I was able to I think provide a great deal of relief for thousands of individuals and they didn’t have to be on any other medicines,” Webster said. “Because the epidural steroids could work for several months sometimes, I would do an epidural steroid injection once every year for some people.”

Tennant thinks the solution is limiting the number of epidurals, regardless of where they are performed.

“There’s got to be a balance here. Epidurals have a place," Tennant said. "But I do think there needs to be some standards set based on the number of epidurals one can endure, in let’s say a year’s period of time.”

Wear, Tear & Care: The Biomat

By Jennifer Kain Kilgore, Columnist

Some pain relief modalities are unusual to the point that they’re out in the stratosphere. It’s also true that some products only work for some people. Just because a device doesn’t offer visible results the first, second, or even third time doesn’t mean it isn’t working.

That is why I have to keep an open mind and not make snap judgments based on concepts, websites, or promotional material.

Like, for instance, today’s topic: thermotherapy and the Amethyst Richway Biomat.

Amethysts?

Yes, amethysts -- February’s birthstone -- can also be beneficial in thermotherapy.

When speaking specifically about the Biomat, I should warn you that Richway’s website isn’t slick. The idea of amethysts being associated with anything health-related is out of most people’s comfort zone.

But hey, I’ve used the Biomat for upward of five years and fall onto it whenever I have sore muscles, which is constantly. It’s such a fixture in my life that at first I didn’t even think to discuss it. So here we go!

The Biomat. Behold:

This version is the full-body mat covered with a sheet. Underneath my head is the Biomat pillow. Each session can last for five minutes or twelve hours, depending on how much time you have available. The heat can reach temperatures of 158 F° degrees. Read on to find out why that number means absolutely nothing when it comes to treating pain.

The FDA has approved the marketing of the Biomat for a whole host of things: relaxation of muscles, improvement of circulation, temporary relief of muscle pain and/or spasms, and much more. There are specific range settings for certain medical conditions, though it is generally safe.

The science involved came to being when Drs. Erwin Neher and Bert Sakmann discovered how ions flow in and out of cells, which they called the “ion channel theory.” The two scientists revolutionized the field of cell biology and won the Nobel Prize in 1991 for their shared research.

If you’re like me, you have no idea what this means. However, this ion channel theory is put into play by the Biomat’s use of negative ions, which is then complemented by far infrared spectrum therapy (or thermotherapy, like what is found in saunas) and the amethysts embedded in the outer layer of the mat. These stones have been used for thousands of years for everything from fighting the evils of drunkenness to helping with meditation.

In modern times, researchers discovered that amethysts can carry an electrical charge. (Readers, are you still with me? Hang on, we’re almost there!) So, the infrared rays pass through the amethyst layer of the mat and then become “long wavelengths capable of safely penetrating the body as deeply as seven inches.” This heats up your core body temperature, encouraging your body to detoxify.

To put all of this in English: The Biomat creates an environment in which the patient can safely enjoy negative ion therapy and infrared therapy.

What does this mean for the person actually flopped onto the mat? It means a yummy, delicious, low-grade heat. And low-grade does mean low-grade, even if it can reach 158 F° degrees.

One time, my husband wanted to use a heating pad on a strained muscle and cranked it all the way up to eleven: “Honey, I don’t think this is working. I’ve maxed it out and it’s still not warm enough.”

That’s because it doesn’t generate heat the same way a traditional heating pad does. It gets toasty, sure, but you couldn’t cook meat on top of it. At its price point, you certainly wouldn’t want to cook any sort of food on it.

I mean, look at the controls. It’s like the cockpit of an airplane.

For me, the Biomat doesn’t present a dramatic “Before and After” picture. It’s not like Tiny Tim could throw away his crutches after using this product. I can’t think of things I couldn’t do before that, with the Biomat, I can do afterward. Even so, I would never stop using it.

This product is just better than a heating pad. When you hurt all over, you want something that reaches all over. Those of us with chronic pain, we use a plethora of heating devices and creams and patches in order to soothe sore muscles. The Biomat, while extremely expensive, is a full-body restoration and relaxation device. Even the mini mat fits into a chair and covers a lot of real estate.

At the end of a long day, I look forward to sitting on the Biomat. I sleep better when I use it; in the summer, for instance, even a low-grade heat is too much for me, and I go to bed feeling stiffer and more rickety, like a broken marionette. Those are the days I truly notice a difference. Studies have been conducted regarding thermotherapy and resulted in pain decreasing significantly (concurrently with anger and depression). It has even been used to treat cancer.

So does one recline upon the Biomat and come forth as a new person? No, not after one session, two sessions, twelve sessions, or fifty sessions, but you absolutely do feel better. Your muscles are soothed. Your knots unwind, even just a little bit. Your pain is quieted for a time. And that’s enough for me.

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

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

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

Fed Report Sparks New Debate over Steroid Injections

By Pat Anson, Editor

A government report on epidural steroid injections is sparking a new debate on the safety and effectiveness of the procedure, which is used to treat back pain in millions of people.

A coalition of spine and pain management doctors is calling the report’s conclusion that steroid injections have little value  “fundamentally false.”

But critics of the procedure say the injections are risky, overused, and often a waste of money.

The report by the Agency for Healthcare Research and Quality (AHRQ), which is part of the Department of Health and Human Services, said there is little evidence that epidural steroid injections were effective in treating low back pain.

“Epidural corticosteroid injections for radiculopathy were associated with immediate improvements in pain and might be associated with immediate improvements in function, but benefits were small and not sustained, and there was no effect on long-term risk of surgery,” the report states.

Epidural injections have been used for many years to relieve pain during childbirth, but they are increasingly being used to treat back pain.

An estimated 9 million epidural steroid injections are performed in the U.S. annually, and the shots have become a common procedure at many pain management clinics. Costs vary from as little as $445 to $2,000 per injection.

A coalition of 14 different societies representing anesthesiologists, surgeons and pain management doctors is lobbying the AHRQ to tone down its report, saying it has raised “significant concerns for physicians who utilize injection procedures.”

“We are fully cognizant of the issues of overutilization and inappropriate utilization, and therefore also wish to bring into focus which interventions are effective when treating the various causes of back pain,” wrote Belinda Duszynski, senior director of Policy and Practice for the International Spine Society, in a lengthy letter to the AHRQ on behalf of the Multisociety Pain Workgroup.

Duszynski’s letter, which is also being sent to a number of medical journals, claims the authors of the AHRQ report used “flawed” and “absurd” analysis on the effectiveness of the injections. She warned the report “may lead to egregious denial of access to these procedures for many patients suffering from low back pain.”

But critics say "interventionalist" doctors are simply trying to preserve a lucrative part of their practice.

“These professional medical societies are worked up because this study basically states that epidural steroid injections have small benefit, the improvements in function are not sustained, and they do not prevent surgery,” said Terri Anderson, a Montana woman whose spine was permanently damaged after receiving about 20 steroid injections for a ruptured disc in her back.

Anderson now suffers from arachnoiditis, an inflammation in the spinal membrane that causes severe chronic pain and disability.

“From my personal perspective, these spinal injections are wasting billions of dollars on the front end, plus there is no estimate high enough to account for the human suffering that this industry has brought upon the American public,” Anderson wrote in an email to Pain News Network.  “When the injections go south and the steroids are misplaced in the spinal cord, this results in life-long disabilities and suffering that cannot be described.” 

The AHRQ report is not the first to raise questions about the safety and effectiveness of epidural steroid injections. Several recent studies have found the injections raise the risk of spinal fractures and do little to control back pain. Questions about their safety also led to an order from the Food and Drug Administration last year that requires drug makers to put warning labels on injectable steroids.

“Injection of corticosteroids into the epidural space of the spine may result in rare but serious adverse events, including loss of vision, stroke, paralysis, and death,” the FDA said in a statement.

The agency has never formally approved the use of steroid injections to treat back pain. However, the procedure can still be used “off label” to treat back pain.

Many patients who were injured by spinal injections say they were never warned about the risks involved.

“The fact of the matter remains that there is no solid evidence that these injections are of any lasting benefit,” said Dawn Gonzalez, who developed arachnoiditis after a botched epidural during childbirth. “There is just no sound supporting evidence of the efficacy of corticosteroid injections in the spine, and more evidence of the contrary. Epidural steroid injections are bad science.”

A study funded by the AHRQ and published last year in the New England Journal of Medicine found that epidural steroid injections do not relieve pain in patients with lumbar spinal stenosis, a common cause of lower back and leg pain.

The Choosing Wisely campaign of the ABIM Foundation, which seeks to reduce or eliminate unnecessary medical procedures, does not oppose the use of steroid injections for back pain. But it does urge doctors not to repeat the procedure if a patient shows no improvement from a previous injection. 

Lower back pain is the world's leading cause of disability, causing more health loss than diabetes, chronic obstructive pulmonary disease, and asthma combined. Over 80 percent of adults have low back pain at some point in their lives.

New Stimulator Delivers Back Pain Relief

By Pat Anson, Editor

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

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

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

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

image courtesy of nevro

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

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

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

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

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

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

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

Stem Cell Study for Back Pain Begins

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

Wear, Tear & Care: The Quell Pain Relief Device

By Jennifer Kain Kilgore, Columnist

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

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

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

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

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

image courtesy of neurometrix

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

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

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

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

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

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

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

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

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

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

4. I can focus better on immediate tasks.

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

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

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

8. I wear my emergency back brace less frequently.

9. I have fewer flares.

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

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

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

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

A Pained Life: When Habits Hurt

By Carol Levy, Columnist

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

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

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

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

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

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

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

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

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

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

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

I wish they had a neck brace for that.

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

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

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

Aleve & Other Pain Relievers Reduce Fertility in Women

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

Back Pain World's Leading Cause of Disability

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

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

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

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

Leading Causes of YLDs in 2013:

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

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

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

My Life with Spinal Stenosis

By Brandis Standridge

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

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

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

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

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

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

BRANDIS STANDRIDGE

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

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

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

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

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

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

Brandis Standridge lives in Idaho.

Pain News Network invites other readers to share their stories with us.

Send them to:  editor@PainNewsNetwork.org.

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

Better Sleep Means Less Pain

By Pat Anson, Editor

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

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

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

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

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

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

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

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

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

FDA Order Stops Production of Medtronic Pain Pump

By Pat Anson, Editor

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

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

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

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

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

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

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

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

When Drug Tests Go Wrong

By Pat Anson, Editor

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

It was only the beginning of her problems.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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