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Pain Management, Chronic Pain, Nerve Pain Therapy, CRPS, South Carolina

New Payment Model for Pain Rehab Programs

Minnesota Leads Nation in Developing New Payment Model for Pain Rehab Programs

This past summer, Minnesota Governor Mark Dayton signed into law an omnibus health and human services budget bill and in so doing he marked a significant milestone in the recent history of chronic pain management. The bill contained language, introduced by State Representative Deb Kiel and State Senator Jim Abler, authorizing the trial of a new payment arrangement through Medical Assistance, which makes it possible for state recipients of the public health insurance to receive care within an interdisciplinary chronic pain rehabilitation program.

The increasingly pressing need for effective alternatives to prescription opioid medications for the management of pain fueled the passage of the provision.

In over a three year effort, a number of additional organizations and individuals pooled resources to ensure passage of the bill, including: the Minnesota Department of Human Services’ Health Services Advisory Council, led by Jeff Schiff, MD, and Ellie Garret, JD, which authorized the state to seek to increase use of non-pharmacological, non-invasive pain therapies among Medical Assistance recipients; the Institute for Chronic PainCourage Kenny Rehabilitation Institute; State Representatives Matt DeanDave BakerMike Freiberg, and State Senator Chris Eaton. To our knowledge, with the passage of the bill, Minnesota became the first state in the nation in recent history to pay for an interdisciplinary chronic pain rehabilitation program in a viable manner through Medical Assistance.

The problem until now

Interdisciplinary chronic pain rehabilitation programsare a traditional, empirically-supported treatment for people with chronic pain conditions. The focus of the care is to assist patients in acquiring the abilities to successfully self-manage pain without the use of opioid medications and return to work or other meaningful, regular activity. Multiple physical and psychological therapies performed on a daily basis for three to four weeks constitute typical chronic pain rehabilitation programs. An interdisciplinary staff of pain physicians, pain psychologists, physical therapists, nurses, social workers and others deliver the different therapies. Research over the last four decades has shown that such programs are highly effective (Gatchel & Okifuji, 2006). Indeed, in 2014, the American Academy of Pain Medicine dubbed such programs the “gold standard” of care for those with chronic pain.

Despite the long-standing research base supporting its effectiveness, interdisciplinary chronic pain rehabilitation programs have historically faced obstacles to obtain adequate insurance reimbursement (Gatchel, McGreary, McGreary, & Lippe, 2014). Component therapies within such programs, when billed on a per therapy basis, are commonly reimbursed at below cost or not reimbursed at all. These low rates of reimbursement make it unviable for chronic pain rehabilitation programs to survive if they accept such reimbursement.

Historically, chronic pain rehabilitation programs have gotten around this problem by repetitively proving their superior outcomes through research and using this research to negotiate “bundled” payment arrangements with individual insurers within each state. The bundled payment is typically one fee for all the services delivered over an agreed upon time frame (usually, as indicated, for three to four weeks). Worker’s compensation and most commercial insurers pay for chronic pain rehabilitation programs in this manner.

State Medical Assistance programs over the last few decades have refrained from negotiating such bundled payment arrangements, due to lack of legislative authority to provide such arrangements. As a result, they’ve pursued more customary reimbursement practices. As indicated, though, such customary reimbursement effectively makes accepting the public health insurance unviable for interdisciplinary chronic pain rehabilitation programs. As a result, recipients of Medical Assistance were cut off from being able to receive this effective form of chronic pain management for many years.

During this time, society has also witnessed the onset of alarming epidemics of opioid-related addiction and death (CDC, 2017; SAMHSA, 2016). It is generally accepted that the impetus for these epidemics has been the large-scale adoption of the practice of prescribing opioid medications for acute and chronic, benign pain that began late last century and continues to this day.

These epidemics have led to increasing societal demand for safe, effective non-opioid options for the management of pain.

With the passage of the Minnesota bill, patients who have state-funded Medical Assistance insurance within Minnesota can now obtain chronic pain management that effectively helps them eliminate the need for opioid medications and return to work or other valued life activities, such as returning to school, job re-training or volunteering.

Not just a local problem

The importance of Minnesota’s legislative action to develop and trial a new payment arrangement for an interdisciplinary chronic pain rehabilitation program is highlighted by the fact that it’s a solution to a problem that is long-standing and widespread. This problem is not isolated, in other words, to the time and place of Minnesota in the year 2017. In other states throughout the nation, chronic pain rehabilitation programs face the problem of telling patients who would benefit that their insurance will not cover the cost of the program and as such would have to pay out of pocket if they attend. To be sure, most patients in this predicament choose to forego the therapy and resort to continuing their use of opioid medications for the management of their pain.

State-funded Medical Assistance programs are not the only insurer that has failed to cover interdisciplinary chronic pain rehabilitation programs. Medicare and some large commercial plans in the nation either do not cover such programs or only do so in a cost prohibitive way. As such, chronic pain rehabilitation programs and many would-be patients face the dilemma of being unable to access a therapy that could go a long way to resolving the epidemics of addiction and death associated with the opioid management of pain.

This problematic insurance reimbursement for interdisciplinary chronic pain rehabilitation programs has had significant consequences for the availability of such programs nation-wide. Because different insurers over the years have not covered chronic pain rehabilitation in a viable manner, many programs have struggled to remain open. While estimates vary, the number of interdisciplinary chronic pain rehabilitation programs in operation has dropped precipitously over the last two decades (Gatchel, McGreary, McGreary, & Lippe, 2014; Schatman, 2012).

This problem of reimbursement is both ironic and tragic at the same time. For the last two decades, we as a society have had a safe and effective alternative to the use of opioids for chronic pain and yet many people cannot access them because state-funded Medical Assistance programs, or Medicare, or some commercial insurance do not reimburse for them. All these insurers readily pay for opioid medication management, with all its adverse consequences, but not for chronic pain rehabilitation programs that show patients how to manage pain without the use of opioids. This irony becomes all the more tragic considering how many lives could have been saved from addiction and accidental death had people been allowed to access chronic pain rehabilitation programs as a substitute to opioid management.

Not yet a permanent solution

The bill, as passed, provides authorization of a two-year trial of a bundled payment arrangement for a chronic pain rehabilitation program within the state of Minnesota. Its intent is to provide demonstration of the effectiveness of both this type of treatment and its corresponding type of insurance reimbursement. In turn, this subsequent data will provide lawmakers with further justification to make it a permanent benefit within Medical Assistance. The long-term goal would be to bring Medical Assistance in Minnesota into alignment with the current reimbursement practices of most commercial and worker’s compensation insurers in the state.

Article Provided By: Institute for Chronic Pain

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

If you would like to discuss what Carolina Pain Scrambler do to help relieve your chronic pain symptoms or receive more information on our treatment process, please do not hesitate to call us at 864-520-5011 or you can email us at info@carolinapainscrambler.com

Pain Management, Pain Relief, Pain Therapy, Neuropathy Treatment, Chemotherapy

Reducing Pain Talk

Reducing Pain Talk: Coping with Pain Series

A common complaint among people with chronic pain is that their pain has come to occupy too much of everyone’s time, attention or energy. In other words, it can sometimes feel like their pain is the only thing anyone ever talks to them about – that they’ve become almost synonymous with their pain.

We call it pain talk. Pain talk is the persistent verbal focus of everyone’s attention on the pain of someone with persistent pain.

Most, but not every person* with persistent pain has experienced pain talk. They quickly and inevitably add that they appreciate, of course, the attention of their friends and loved ones, but it comes to get old.

Might the same be true of you?

Friends and family can develop over the years a tendency to make you and your chronic pain, its treatments, and your overall well-being the topic of conversation. For after all, it tends to be the socially appropriate thing to do. When people are sick or injured or otherwise unwell in some way, we are all supposed to ask about it, express condolences and offer help. Indeed, most people want to express their concern in these ways.

This normal behavior is all well and good. Most of us appreciate some attention when not feeling well or injured or what not. People bring over dinners and help out around the house. Maybe they bring your kids to piano lessons or sports practices for a few weeks following a surgery. Everyone, on both the receiving and giving ends, tend to appreciate these gestures.

It’s also common that after a while these kinds of overt offers of assistance tend to fall away. Life goes on for other people and it’s hard to keep up with such overt helping behaviors. However, the well-being of the sick or injured person tends to remain in the object of everyone’s attention when others do in fact come around. In other words, despite overt helping behaviors falling by the wayside, most people continue to talk to you about your well-being. Again, it’s thing that we are supposed to do.

While initially nice and helpful, when this state of affairs continues on a chronic basis, it can become increasingly problematic. There comes a point for many people where it’s preferable that you are no longer the focus of everyone’s attention. The attention, in the form of you being the object of everyone’s conversation, can become problematic in a few different ways.

It causes inner conflict for you

Suppose that your spouse when she comes home from work tends to ask, expectantly, “How’d you do today?” which implies that she’s hoping you’ll be better. You tell the truth, which you can see in her demeanor is disappointing, and so you feel bad for disappointing her that your pain is still as bad as it ever was. Suppose your four-year-old daughter comments that she wishes you could pick her up, but knows you can’t because it hurts your back. Out of the mouth of a babe, she means no ill will. It’s just an innocent yet accurate comment and yet you end up feeling terrible. Or perhaps, you see your cousin for the first time in a number of months and the first thing she asks about is the surgery that she had heard you had. You know she just had a baby and you want to be there for her, yet she’s trying to be there for you. The brief interaction immediately puts you on edge.

What lies at the heart of these interactions is what, in psychology, we call feeling conflicted. You end up feeling guilty or awkward or ashamed or irritable that you’re yet again the topic of conversation. At the same time, however, it’s not that you can get upset with them. They are expressing a sincere regard for your well-being! It would be socially inappropriate for you to express your displeasure with their attempts to care about you. It’s a no-win situation. You feel conflicted.

This recurrent sense of feeling conflicted is stressful. It wears on you and reduces your abilities to cope with pain. Stress, of course, also makes pain worse.

As a result, pain talk that was initially helpful and nice can become increasingly problematic once it continues on a chronic basis.

People tend to give you unsolicited advice

Suppose your neighbor sees you across the yard and asks, “How’s your back?” and then goes on to ask whether you’ve ever tried chiropractic. He continues for a few minutes on how much it helped so-and-so. Or suppose your friend at church or synagogue or mosque sees you and comes over to tell you about laser surgery that he saw advertised on TV last night. Your cousin insists that you absolutely must try some salve that he absolutely swears by.

You’ve heard it all before, but what do you say? Of course, you’ve considered those therapies or maybe you’ve even tried them. Nonetheless, you nod your head and politely let them finish their thought, but the whole experience makes you irritable.

People trigger bad emotional reactions

Sometimes, people trigger an emotional reaction that you’d rather not have. In fact, as an active coper, you try to stay out of either the victim perspective or the perspective of perceived injustice. Nonetheless, other people’s attitudes can put you into a bad emotional place. Suppose your brother-in-law exclaims, “If they can put a man on the moon, why can’t they fix your back?” Or suppose a friend comments on how unfair it is that nothing legally happened to the person who caused the motor vehicle accident that started your chronic pain. Or perhaps it was your sister who, getting mad that your disability claim was denied, expresses, “It’s so unfair that you can’t get disability – you paid into it for years!”

Such comments, while understandable and perhaps wholly accurate, put you in a bad emotional place. They stoke the resentment that occurs deep down inside you. They tap you into the long-held anger and powerlessness and lack of control that you feel. You try not to go there too often, because you find yourself too depressed when you do, but it is difficult to hear such comments without going there.

It’s not anyone’s fault

Please notice that in observing these complicated interactions no one is blaming anyone or criticizing those who talk too much about your pain. It’s not anyone’s fault. Pain talk is normal and natural, while at the same time it isn’t helpful.

So, what do you do about it?

One long-standing recommendation in chronic pain rehabilitation is for patients to have a discussion with their friends and loved ones and ask them to stop talking about pain. The discussion might go something like the following:

“I’d like to talk to you about something that is important to me. It’s the fact that we talk about my pain a lot – how I’m doing, whether it’s a good pain day or a bad pain day, and how my therapies are going. I know that you ask about all these things because you care about me. I appreciate your caring – I want you to know that. However, I’m also trying to cope better with pain and to do that I need to focus on my pain less. I need to get involved in other things that also matter and preoccupy my time and energy with these things, not my persistent pain. So, one thing I’ve learned recently is that I should ask everyone in my life to stop talking or asking about my pain. This will free us up to talk about all the other things that matter in life. It will also serve to keep me focused on these things, and less on my pain. If we all agree, I’ll make you a deal in that I will update you on my pain if there is any significant change for the better or for the worse. But as long as my chronic pain remains chronic, let’s try to stay off the subject. OK?”

Reducing pain talk leads to improved coping

Pain has a natural capacity to command our attention. When it’s a bad pain day, it’s hard to focus on anything else. This relationship between pain and attention is reciprocal or self-reinforcing: the more pain we experience the more we focus on it, but the more we focus on it the more pain we experience.

It is possible to counteract this natural tendency for focusing on pain. It involves a learning process over time and it takes repetitive practice, but it is possible. It’s a process of recognizing in the moment that your attention is focused on pain and making an intentional effort to change the focus of attention to something else – something that it is stimulating or interesting or pleasurable or meaningful in some way.

This process of repetitively recognizing and changing your focus of attention is helped along when others stop talking about your pain. Your interactions with them become focused on other things in life that are stimulating, interesting, pleasurable or meaningful.

When other things in life that matter start to compete for our attention, we can come to experience less pain. Pain gets relegated, as it were, to the background of our everyday lives. It’s a little bit like white noise. When a box fan gets turned on, it seems loud and it competes for our attention. But as we get involved in other activities, the stimulation remains, but we stop paying so much attention to it. We start to hear it less. We’ve all had the same experience with pain. When we get involved in other things that compete for our attention, we come to experience the pain less.

When we talk about pain less, life is less stressful. We don’t have to put up with feeling conflicted – knowing that others care about us but wishing they’d stop talking about pain so much. We also have a greater likelihood of staying out of bad emotional places, like experiencing the resentment that’s common when you have a chronic pain condition that you didn’t deserve or ask for.

Reducing pain talk also reminds you and everyone else that you are more than just your pain. You have endeavors and aspirations, activities about which you are passionate, and relationships that are meaningful. Reducing pain talk takes these issues off the back burner and puts them front and center. They can again come to define your identity.

Of course, when you see your healthcare providers, go ahead and talk about your pain. But in the course of your everyday life, it is best to repetitively practice staying off the subject.

*Such concerns are not always true of all people with chronic pain. Some people report basically the opposite experience. In their case, no one in their life asks about their pain anymore. They tend to feel alone and can understandably wish for someone to ask about their well-being once in a while. This state of affairs is also problematic. It deserves a discussion of its own and so we’ll save it for another post in the Coping with Pain Series. So, for now, let’s focus this post on how to cope when your pain occupies too much of everyone time, attention and energy.

Article Provided By: Institute for Chronic Pain

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

If you would like to discuss what Carolina Pain Scrambler do to help relieve your chronic pain symptoms or receive more information on our treatment process, please do not hesitate to call us at 864-520-5011 or you can email us at info@carolinapainscrambler.com

 

Back Pain Relief, Chronic Pain, Pain Therapy, Pain Relief, Calmare Scrambler Devices, Greenville, South Carolina

Breaking Away From Pain With the Help of ‘The Scrambler’

Participating in a clinical trial gave Karen Safranek a solution to her decade-long struggle with peripheral neuropathy 

Karen Safranek didn’t take a worry-free step for 10 years. Severe peripheral neuropathy — a side effect of breast cancer treatment she received in 2002 — left her with constant burning, tingling, numbness, and pain in both her feet.

Over time, Karen tried dozens of treatments to rid herself of the discomfort. Nothing worked. So in 2012 when she found out about a clinical research trial available at Mayo Clinic for people who had peripheral neuropathy after chemotherapy, she was interested, but not optimistic.

“I tried so many things. Anything a doctor recommended or heard about, or anything I heard about, I’d give it a try if I could,” Karen says. “But years past, and the pain didn’t get any better. By 2011, life was not good. I was analyzing my house to figure out where we could put a wheelchair ramp. At that time, I thought it wouldn’t be much longer before I couldn’t walk anymore.”

This new treatment was different. With MC-5A Calmare Therapy, often called “the scrambler” for short, Karen noticed improvement following the first session. After completing a series of treatments, she was pain-free for the first time in more than a decade. Through her participation in the clinical trial and occasional follow-up treatments at Mayo Clinic, Karen has been able to leave peripheral neuropathy behind and reclaim her life.

Battling pervasive pain

Karen began to notice symptoms of peripheral neuropathy shortly after she started receiving chemotherapy. By the end of her treatments, her breast cancer was gone, but she had constant shooting pain and numbness in her feet and legs that left her weak and unable to maintain her balance.

Peripheral neuropathy is a common side effect of some chemotherapy drugs. For many people, the condition fades away after treatment is over. But for some, like Karen, it can last long after other chemo side effects are gone and can have a significant impact on day-to-day life. The effect on Karen’s life was overwhelming.

“It hurt if I was sitting, walking or standing,” she says. “Blankets hurt my legs. I wasn’t getting a good night’s sleep. Going back to work wasn’t an option. In time, it got so bad that whenever I went somewhere, I would analyze where I had to park my car and how far it was to get to the building. If there wasn’t a spot close enough for me to walk the distance to and from my car, I would just go home.”

Retraining the brain

Traditionally, chronic peripheral neuropathy has been challenging to successfully treat. Like many others who have this debilitating disorder, Karen tried everything she and her doctors could think of to relieve her pain. But still, she suffered. Then in December 2013, Karen learned of the clinical trial at Mayo Clinic that would change everything for her.

Peripheral neuropathy happens as a result of nerve damage. The damaged nerves send aberrant signals to the brain, causing pain and the other symptoms of peripheral neuropathy. During her treatment sessions as a participant in the research study, the damaged nerves in Karen’s feet were connected by electrodes to the scrambler. The device sent painless electrical signals to the damaged nerves, and the nerves relayed those signals to the brain. The new signals broke the pain cycle by retraining Karen’s brain to understand that it was not really experiencing pain.

Reclaiming her life

Although the scrambler does not ease symptoms of peripheral neuropathy in all cases, Karen’s response was dramatic.

“I was tremendously better after just one treatment,” she says. “My feet and legs felt light and pain-free. Previously, I had felt as though they were very heavy to lift and walking was comparable to wearing cement shoes. After the treatment, I could walk really fast. I could take the stairs. I could even run.”

After a total of 10 treatment sessions in January 2013, Karen no longer had any symptoms. The effects of the treatment were not permanent, however. She returned to Mayo Clinic for additional scrambler treatment nine months after her first sessions and again eight months after that.

Even though she knows she’ll likely need follow-up care over the long-term to keep peripheral neuropathy at bay, Karen is enthusiastic about the difference the treatment has made for her.

“Before this, I wasn’t able to do some of the smallest things. I couldn’t go grocery shopping alone. If I reached up to take an item off the shelf, I’d lose my balance and tip over. I couldn’t walk on uneven ground because I couldn’t feel my feet. I’d just fall down,” she says. “Being able to participate in this clinical trial at Mayo Clinic with the scrambler, it brought my life back to me. It’s a miracle. It really is.”

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

If you would like to discuss what Carolina Pain Scrambler do to help relieve your chronic pain symptoms or receive more information on our treatment process, please do not hesitate to call us at 864-520-5011 or you can email us at info@carolinapainscrambler.com

Calmare Scrambler, Neck Pain Relief, Chronic Pain, Pain Therapy, Carolina Pain Scrambler, Greenville SC

Optimizing Neuropathic Pain Relief With Scrambler Therapy

A review and retrospective study on the effectiveness of scrambler (stimulation) therapy to reduce noncancer-related neuropathic pain syndromes, with apparent, maximal pain relief achieved at 1 to 2 weeks.

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Minimizing the incidence of medication dependence in patients with chronic neuropathic pain (NP) poses significant difficulty for treating physicians. A recent increase in accidental deaths related to prescription opioid use has boosted the investigation of novel techniques for the treatment of chronic pain.1 In addition to the risk of opioid dependence, chronic pain patients suffer from a wide range of secondary medical conditions, including mental health difficulties and physical disabilities.2 Given the need for simultaneous treatment for chronic pain and associated comorbid conditions, pharmacological interventions alone are often inadequate when managing complex chronic NP syndromes.3

Scrambler therapy alleviates chronic pain relief with a novel, noninvasive stimulation. Photo credit: Edmond Boese, MD, Eagle, ID

Efforts to minimize risk of harm to chronic NP patients and their families prompted the development of noninvasive and nonpharmacological interventions.4 This trend toward more comprehensive and personalized standards of care will likely aid in appropriately relieving pain in patients suffering from NP syndromes, and will allow physicians to more directly address any associated medical conditions.

Among the novel alternative treatments for chronic NP syndromes is a patient-specific neurostimulative technique called scrambler therapy (ST). Scrambler therapy uses a noninvasive transcutaneous electrostimulation device that has shown promise for providers and patients seeking alternatives to traditional pharmacological pain relief techniques. Scrambler therapy works by introducing a pleasant sensation that acts as a distraction by sending a new message to nerve fibers that were used to receiving pain signals.

This retrospective review aims to shed light on the nature and extent of pain relief experienced during and across stimulation visits. The authors hypothesize that ST will reduce pain ratings for patients with a variety of chronic NP syndromes across and within stimulation visits.

Scrambler Therapy Promises Sustained Relief From Chronic Pain

Scrambler therapy was designed primarily as a method for treating cancer-related pain syndromes like chronic chemotherapy-induced peripheral neuropathy (CIPN).5Researchers explored the application of ST as a way of alleviating pain in cancer patients when metastases in the epidural space prevented use of nerve blocks and opioids from offering sufficient relief, and when adverse side effects prohibited achievement of adequate pain relief.

A preliminary case series reported findings of effective pain relief for 3 patients who were affected by severe cancer pain.6 In a separate pilot study of patients with CIPN, ST reduced pain scores by 53%, tingling by 44%, and numbness by 37%.7 This same study indicated that pain-relieving benefits of ST were sustained through 10 weeks of follow-up care. In another study, Coyne and colleagues measured changes in pain level on the Numerical Pain Rating Scale (NPRS)—a pain rating scale with 0 corresponding to “no pain” and 10 corresponding to “worst pain imaginable.” They found that when cancer patients were allowed to mark decimal points, pain ratings decreased from 6.6 before treatment to 4.6 over 3 months.8

Initial success in alleviating cancer-related NP syndromes allowed ST to emerge as a potentially successful treatment for a broader category of NP syndromes, including postherpetic neuralgia, low back pain, polyneuropathy, and peripheral neuropathy.4 Marineo et al aimed to directly compare ST to guideline-based drug therapy for patients grouped into a larger category of poly- or mono-radiculopathy.4 This randomized pilot study provided preliminary evidence that the neurostimulative technique may successfully alleviate pain better than pharmacology, reporting a mean rate of pain reduction of 91% in the first month of ST.As personalized noninvasive treatments develop, growing evidence has been presented in favor of these devices to successfully alleviate chronic pain over time.7,9

In a recent examination of ST, this method produced a reduction in chronic pain from a pretreatment score of 7.41 to 1.60 pain score (based on NPRS) following 10 sessions of treatment.9 This comprehensive study also divided patients into several broad categories of chronic pain, ultimately suggesting that the ST’s efficacy may be dependent on pain type. While promising, these pain rates and time frames for pain relief in patients with general chronic pain syndromes differed from those reported in the studies examining ST in a population of CIPN patients.7,8

Reports of inconsistent rates and time spans for achieving pain reduction reflected an urgent need for further research concerning the mechanism and efficacy of ST. Of particular interest to researchers was identifying the length of time necessary for ST to achieve consistent, maximal benefit. Additional considerations in pursuing this research included whether specific types of NP syndromes, pain locations, and severity levels were better suited to favorable treatment response with ST.

This retrospective review was conceived to bolster the current evidence basis by examining the efficacy of repeated ST treatments over time through a lens of specific NP conditions.

Pain Relief From ST Assessed Across Multiple Conditions

A retrospective chart review was conducted among 25 patients who received ST as administered by a neurologist between 2014 and 2015 at an outpatient pain management clinic in Hopewell, New Jersey.10 Basic demographic factors, including age and sex, were gathered. Pain-related data was also collected for pain diagnosis or classification, areas of pain, and descriptive characteristics of reported pain. Concomitant medications and pre- and post-stimulation blood pressure were noted.

Stimulation treatment details were gathered, including side effects, frequency (volume) of stimulation, location of treatment, dates of treatment, and number of treatments. Institutional review board approval was obtained for this chart review,10 which met compliance standards and ethical guidelines set by the participating institution.

Last updated on: February 14, 2017

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

If you would like to discuss what Carolina Pain Scrambler do to help relieve your chronic pain symptoms or receive more information on our treatment process, please do not hesitate to call us at 864-520-5011 or you can email us at info@carolinapainscrambler.com

Calmare Scrambler, Pain Therapy, Carolina Pain Scrambler, Greenville South Carolina

Chronic Pain Update

New device offers relief

Chronic pain is a common problem that can take a significant toll on your mental and physical health. There arc various of causes of chronic pain, and a variety of strategies may be employed to manage pain or treat the cause.

These methods can be effective for some, particularly when combined into a comprehensive pain rehabilitation plan. However, it’s clear that addition-al therapy options are sorely needed.

Thankfully, one new therapy can be added to the list — at least for neuro-pathic pain tha€s caused by faulty nerve signals. Called scrambler therapy, it’s a novel form of electrical stimulation ap-plied to the skin. It involves sending scrambled electrical signals along nerve pathways to the brain in an attempt to retrain the brain to perceive the area of pain as normal, not painful.

Retrain the brain

With many types of chronic pain, normal nerve signals go haywire. There are multiple ways this can occur. Nerve endings may become damaged. Sensa-tions of pain may continue to be trans-mitted by nerve endings even after healing ofnearby tissues. Or nerve end-ings or nerves in the spinal cord may become somehow sensitized so that

even normal sensations —

such as

touch — cause the feeling of pain.

With the pain scrambler, the goal is to hijack the nerve pathways sending pain signals, and override the pain sig-nals with normal, nonpain signals. It’s believed that this can retrain the brain to recognize the area of pain as normal, not painful.

Wires from the pain scrambler machine run to electrode pads attached to points on the skin that are near, but not on, the site of pain. The scrambler electrodes are turned on, and the in-

tensity of the electrical signal is gradu-ally increased to where you can feel sensations, but not pain. The treatment continues for about 30 to 45 minutes. When successful, the pain is at some point replaced by the scrambler device sensation, which is Often described as a buzzing sensation. It’s believed that best results occur when the pain is com-pletely replaced by the buzzing sensa-lion during every scrambler session.

If the treatment is successful, the pain is usually greatly diminished or gone when the machine is shut off. This benefit may only last a few minutes to a few hours after the first session. But the process is repeated daily, and the post-treatment period Of benefit usu-ally gets longer after each session until the pain relief lasts for a day or more.

Ten sessions is the standard number needed, but it can be more or less than 10, depending on how things go.

Pain relief can persist for weeks to months after treatment is stopped. When pain returns, sometimes as few as one or two booster sessions can restore the benefit, and that benefit may last months or longer.

Mayo Clinic doctors are optimistic about the pain scrambler. Based on re-search and their own experience treating people at Mayo Clinic with the device,

it appears that the scrambler therapy can have good to sometimes dramatic results in people with select types of chronic pain who have reached the end of the line in terms of options. Importantly, it’s

generally well-tolerated.

The device appears to work best for chronic pain that is fairly isolated to one area, and due to faulty nerve signals, For example, research has shown good re-sults for conditions such as nerve pain (peripheral neuropathy) caused by che-motherapy, pain after a bout of shingles (postherpetic neuralgia), cancer-related pain, low back pain and numerous other pain syndromes.

It’s less clear if any benefit could be derived for Other common causes of chronic pain, such as osteoarthritis, fi-bromyalgia, irritable bowel syndrome or headache.

The downsides

Although the pain scrambler appears to reduce pain in most people, not everyone will benefit, and some people see only a modest benefit. In addition, i€s not widely available in the U.S.

Another potential downside is that it

(lakes a skilled operator for best resultsD that learning curve may skew research results or make it difficult for the device to be more widely adopted. -71

Scrambler therapy is a form of electrical stimulation applied to the skin for neuropathic pain that’s caused by faulty nerve signals.

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

If you would like to discuss what Carolina Pain Scrambler do to help relieve your chronic pain symptoms or receive more information on our treatment process, please do not hesitate to call us at 864-520-5011 or you can email us at info@carolinapainscrambler.com

Pain Management, Chronic Pain, Pain, Relief, Lower Back Pain Relief, Carolina Pain Scrambler, Greenville SC

Use of Calmare Therapy in treating Amplified Musculoskeletal Pain Syndrome (AMPS): A case report

Calmare therapy has been used to treat refractory neuropathic pain in cancer patients cause by chemotherapy. Calmare therapy works by sending no-pain signal via multiple skin electrodes applied near areas where patient is experiencing pain. The “no-pain” signals sent from the device overrides the pain signals thus providing relief. In this case study a previously healthy 12-year-old male started having episodes of fevers with arthralgias at age 10. He complained of abdominal and muscle pain along with weakness when exercising. He was presumptively treated for Lyme disease but he continued to have recurrent fevers with arthralgia. His symptoms were managed with antipyretic and non-steroidal anti-inflammatory drugs. He was seen by several subspecialties: infectious disease, rheumatology, hematology, cardiology, gastroenterology, neurology and underwent extensive tests including immunologic and genetic testing which were normal. He was given the diagnosis of amplified musculoskeletal pain syndromes (AMPS). When establishing care with pain clinic to be evaluated for Calmer Therapy he was scheduled to complete an inpatient program at children’s hospital of Philadelphia the following month for AMPS. On initial visit, he complained of left hip pain, subjective bilateral leg weakness and abdominal pain. After evaluation, patient agreed to proceed with 10 one-hour sessions of Calmare therapy. During each session, a total of ten electrodes were placed around both knees, near painful abdominal areas and right hip. After second session, he reported a decrease in his stomach pain by one point on VAS scale from 8 to 7. After the fifth session, his right knee pain and stomach pain were 1 and 2/10 (VAS). After his sixth session, he reported right hip pain was 1/10 (VAS). After completing all the sessions patient reported zero hip and knee pain. Calmare therapy may potentially be used to treat other forms of pain such as AMPS. (Moon JY1, Kurihara C, Beckles JP, Williams KE, Jamison DE, Cohen SP. Clin J Pain. 2015 Aug;31[8]:750-6)

 

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If you would like to discuss what Carolina Pain Scrambler do to help relieve your chronic pain symptoms or receive more information on our treatment process, please do not hesitate to call us at 864-520-5011 or you can email us at info@carolinapainscrambler.com

Chronic Pain, Back Pain, Foot Pain, Leg Pain, Calmare Scrambler, Greenvlle, South Carolina

Researcher Says Calmare ‘Scrambler’ Provides Pain Relief

Dr. Thomas Smith admits he had his doubts when he was first asked to investigate Scrambler therapy, a device that uses low doses of electricity to block pain signals without the use of drugs.

“I am a very skeptical Midwesterner,” says Smith, MD, a researcher at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine.

Dr. Thomas SmithDr. Thomas Smith

But after four years and several studies testing the Scrambler, Smith is now a believer.

“The evidence is pretty compelling, with most of the studies finding really a substantial reduction in pain with no toxicity,” Smith says.

“It’s simple, easy, relatively inexpensive, non-invasive, and easily testable on the individual patient. You put the electrodes on, move them around and you should be able to tell in three to five days whether it’s going to work at all or not for the patient.”

Smith’s latest study was published in the American Journal of Hospice & Palliative Medicine. Ten patients suffering from neuropathic pain after a bout with shingles achieved significant pain relief after 10 days of outpatient treatment.

Smith says the average pain score for the patients fell by 95 percent within one month. Relief continued over the next two to three months, long after Scrambler therapy ended.

Smith has had similar success treating patients with cancer induced peripheral neuropathy.  About 80 percent got substantial pain relief after using the Scrambler, which is similar to a spinal cord stimulator, but far less invasive. Spinal cord stimulators, which also use electricity to block pain, are surgically implanted next to the spine.

“We’re not talking about a 10 percent reduction in pain. We’re talking a 50 to 80 percent reduction in pain, which is exactly what one sees with spinal cord stimulation,” says Smith.

“It’s almost as if we’re getting the same ultimate end result as spinal cord stimulator, but without having to unroof the spinal cord, sew an electrode on and then have it permanently connect to an implantable pump that costs $50,000.”

A typical session on a Scrambler lasts 30 to 45 minutes, with the device sending low doses of electricity through electrodes placed on the skin of painful areas. The device “scrambles” or re-boots nerves left frayed and over-sensitized by chronic pain.

“You feed in artificial nerve impulses designed to confuse the nerves, scramble the pain information that they’re sending, and allow them to re-set,” says Smith.

Although the studies are promising, they’ve been small and haven’t made much of splash in the medical community. Originally developed by Giuseppe Marineo, an Italian scientist, about three dozen Scrambler devices are now in use at pain clinics in the United States, mostly on the east coast.

They are licensed to Competitive Technologies, Inc. (OTC: CTTC) a small technology company in Fairfield, Connecticut that distributes and leases the Scrambler under the name Calmare pain therapy. In Italian, the word “calmare” means “to ease” or “to soothe”.

“If this were a very rich company, it would invest $3 million and do a 60 patient sham controlled trial in a heartbeat. But the company doesn’t have that money,” says Smith.

Perhaps the biggest barrier to making the Calmare Scrambler more widely used is that the therapy is not usually covered by Medicare or private insurance companies. As a result, many patients pay in cash, usually about $150 to $200 per treatment. That can add up to thousands of dollars after a standard course of ten treatments.

“We are not what is called a ‘standard of care’ yet. And believe me, if we were, the number of people that could be treated with this would escalate dramatically,” said Johnnie Johnson, Competitive Technologies’ chief financial officer.

“When we go out to sell this device, my guess is out of ten calls that we make, we probably get two sales. If we got insurance reimbursement regularly for this, we’d probably get six.”

Johnson says Calmare therapy is more cost effective than prescription painkillers or other types of pain treatment that are reimbursed by insurance companies.

“A narcotic type drug or a very expensive drug could cost $400 to $1,200 a month. If you took half that money and applied it to Calmare, the payout on that is pretty quick,” says Johnson.

But Calmare therapy doesn’t work for everyone. Beth Stillitano, a North Carolina woman who suffers from a chronic pain condition called Reflex Sympathetic Dystrophy (RSD), had a very mixed experience with Calmare therapy. The first few treatments went well, leaving her pain free for the first time in 16 years.

womankneepain300“Within 15-20 minutes of starting the therapy, my RSD pain seemed to diminish,” Stillitano  wrote in her blog. “After treatment I went an hour and forty-five minutes with no RSD pain!!!!! It is so incredible to walk and not feel pain with every step.”

But a second course of therapy, held months later, did not go well. Stillitano stopped the treatment after just two sessions.

“I was in a lot of pain, and I could not even drive. My sister said watching me have an hour session of Calmare therapy was torture for her. That night, I went into complete flare-up,” Stillitano told National Pain Report.

Dr. Smith says more studies are needed to fully understand how the Calmare Scrambler works – and why it doesn’t for some patients.

“There are probably 20 percent of people who don’t respond to anything, but it seems like the other 80 percent get at least minimal, if not substantial relief. We’ve had people where you can actually see the redness and pain and inflammation diminish over a couple of days as the pain gets re-set,” Smith says.

“It could be that some of this is placebo. And I’m more than willing to accept that,” he adds.

Although it’s been used primarily to treat neuropathy, Calmare has been used with some success to treat other chronic pain conditions such as fibromyalgia, phantom limb pain, back pain, and Chronic Regional Pain Syndrome (also known as RSD).

This fall, Smith starts work on yet another study – this one on breast cancer patents – which is being funded by the Avon Foundation. The study will test the Scrambler’s effectiveness in relieving neuropathic pain cause by chemotherapy.

 

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

If you would like to discuss what Carolina Pain Scrambler do to help relieve your chronic pain symptoms or receive more information on our treatment process, please do not hesitate to call us at 864-520-5011 or you can email us at info@carolinapainscrambler.com

Nerve Pain Treatment, Pain Relief, Chronic Pain, Chronic Pain Therapy, Pain Therpy, Neuropathic Pain Therapy, Greenville SC

Mayo Clinic researchers test scrambler therapy for pain

Scrambler therapy is a pain management approach that uses a machine to block the transmission of pain signals by providing non-pain information to nerve fibers that have been receiving pain messages.

The first study on scrambler therapy was published in 2003 by a team of researchers led by Giuseppe Marineo, professor in delta research and development at University of Rome Tor Vergata in Italy. He and colleagues reported that scrambler therapy was effective at reducing pain symptoms in patients with severe, drug-resistant pain from terminal cancer.

Charles L. LoprinziCharles L. Loprinzi

The Calmare scrambler therapy device has since received FDA clearance in the United States for use in patients experiencing pain from cancer and chemotherapy, pain as a result of chronic diseases such as diabetes, multiple sclerosis and arthritis, back and neck pain, failed back surgery syndrome, and phantom limb pain among others.

HemOnc Today asked Charles L. Loprinzi, MD, Regis professor of breast cancer research at Mayo Clinic in Rochester, Minnesota, about the safety and efficacy of scrambler therapy, as well as his ongoing research efforts.

Question: Can you describe scrambler therapy and how it came about?

Answer: Scrambler therapy is an electro-cutaneous treatment. Although people may think of it as being similar to transcutaneous electrical nerve stimulation (TENS) therapy, scrambler therapy is felt to work through a different mechanism. TENS is thought to work through the gateway theory of pain relief, whereby normal touch sensations blocks pain sensations. Scrambler therapy, on the other hand, is proposed to provide normal-self, non-pain electrical information via nerves that have been transmitting chronic pain information. Through a process termed plasticity, this is able to retrain the brain so that it does not ascribe pain to the chronic pain area. Scrambler therapy consists of a machine, which looks somewhat like an electrocardiogram machine. Leads are placed on patients, around the areas of chronic pain. Scrambled electrical signals are then sent to the brain that perceives them as normal, non-pain signals. Via this process, the brain is retrained to think that there really is not pain in the area that is being treated.

Q: How and when did you become involved with this treatment approach?

A: I was introduced to scrambler therapy in 2010 by Thomas J. Smith, MD, now at Johns Hopkins University, who had heard about scrambler therapy and decided to try it in patients with chemotherapy-induced peripheral neuropathy (CIPN). He subsequently published a pilot trial that supported that scrambler therapy was an effective approach for treating established CIPN. After some internal debate as to whether I should look further into this treatment approach, which sounded quite strange to me, I did agree to study it. Having now treated more than 200 patients at Mayo, we published a paper on the use of this treatment for chemotherapy neuropathy, which concurred with Dr. Smith’s report, further supporting that this therapy was helpful for CIPN.

Q: What other published data support the value of scrambler therapy?

A: I am aware of 19 published reports regarding scrambler therapy, involving more than 800 patients. Seventeen of these are published manuscripts, whereas two are only published as meeting abstracts. These reports include clinical practice summaries, prospective non-randomized clinical trials and randomized controlled trials, including two trials that sought to double blind patients and investigators. The authors of 18 of the 19 reports concluded that scrambler therapy was a beneficial treatment approach, whereas one report — published only as a meeting abstract and only involving 14 patients — concluded that this was not an effective treatment. Of note, one relatively large randomized trial, with a non-blinded control arm consisting of optimizing medical management of pain, reported substantially more benefit from scrambler therapy than was observed in the control arm. Additionally, a relatively small placebo-controlled, patient-blinded trial reported a statistically significantly beneficial effect for scrambler therapy in a small number of patients with chronic low back pain. Thus, there are substantial data that support the value of scrambler therapy. Having said this, I readily admit that scrambler therapy has not yet been clearly proven to be beneficial.  Ideally, additional randomized clinical trials will be reported to provide for more substantial clinical data regarding the true value of scrambler therapy. Dr. Smith is conducting one trial at Johns Hopkins and we, at Mayo, are gearing up for another one. This all takes time, energy and funds.

Q: Can you briefly discuss the findings from the clinical study you reported regarding the use of scrambler therapy in patients with established CIPN?

A: When we received the scrambler therapy machine, we decided to treat patients on a clinical trial as opposed to just using it for routine clinical practice. For this, we developed an open-label clinical trial to document our results and to learn how to provide this therapy.  Prior to treating patients on this trial, we went to Rome for training. We then treated patients on this clinical trial, who had chronic pain or neuropathy with a pain and/or tingling score of at least 4 out of 10. In order to report data on a series of these patients, we took the first 37 patients who entered on this clinical trial who had CIPN as their designated clinical problem. We prospectively collected patient-reported outcome data on each of 10 days of treatment and then weekly for 10 weeks following that. Results, reported in Supportive Care in Cancer, illustrated that, during the treatment days, there was approximately a 50% reduction from baseline for pain, tingling and numbness scores. When we then followed the patients weekly, after the 10 days of therapy, the benefit, on the whole, persisted.

Q: Can you describe the treatment process and when beneficial results appear?

A: The area of pain/neuropathy is first defined and a set of leads is placed in normal sensation skin sites, close to the area of pain/neuropathy. The electrodes are then turned on with a gradual increase in intensity to a point where the patient is able to feel sensations, short of pain. When successful, the patient reports that the buzzing sensation has replaced an area of pain/neuropathy. This generally occurs within a minute or two. At times, electrodes need to be moved to obtain this sort of success. Sometimes, several sets of electrodes are needed to cover the area of discomfort. The scrambler machine stays on for about 30 minutes following successful electrode placements. The electricity is then turned off and the patient commonly reports that the pain/tingling is still markedly improved.  After one treatment, the benefit is often relatively short-lived, lasting for minutes to hours.  With repetitive days of treatment (standardly up to 10 treatments, although stopped earlier if the problem goes away completely and lasts overnight), the period of benefit increases until it lasts for a couple days.  The benefit largely persists for weeks to months. Some patients relapse and can be successfully retreated, oftentimes only needing an additional few doses.

Q: Is this therapy routinely offered at Mayo Clinic?

A: Mayo recently began offering scrambler therapy as part of clinical practice. As with many new practice approaches, there are many questions that arise: How effective is the therapy? Who should be treated and for which conditions? How well is this approach covered by different insurance carriers? Admittedly, we do not have ideal answers for these and many other questions, but we are cautiously proceeding forward. There is considerable demand for scrambler therapy along with concerns that efficacy has not been proven and that the reported results from it sound too good to be true. But, these concerns are not too surprising, as there is often a wariness when a new therapy is initiated.

Q: Is this therapy routinely offered at places other than Mayo Clinic?

A: Yes, it is available at other select places. I understand there are more than 30 institutions in Italy and even more institutions in South Korea that provide scrambler therapy as a part of clinical practice.  Multiple United States military institutions also offer scrambler therapy. In the United States, I estimate that there are between 15 and 30 sites that are actively offering this treatment. It should be noted that there is a learning curve in terms of making this therapy work. For example, in our paper where we looked at CIPN, even though we had reasonably good experience which included visiting the inventor in Rome and being trained by him, we did a whole lot better with the later patients we treated than we did the first 25% we treated.

Q: What type of feedback have you received on the therapy?

A: There are patient testimonials, which can be found on the Internet, whereby patients swear by this therapy. In line with this, I have seen some phenomenal results in patients. We have clinical trial data that asked patients, daily while they were receiving 2 weeks of outpatient therapy and then weekly for 10 weeks of follow-up, whether they would recommend this treatment to others.  Approximately 80% of the replies noted that they would recommend it, 1% said that they would not and the rest said that they were unsure.  There, admittedly, are some people who say this therapy did not work for them.

Q: How much of an issue is cost?

A: There are the issues regarding the cost of the machine, the cost of training and whether insurance companies cover this therapy. There are some insurance companies that cover the therapy, having realized that it is a lot cheaper than alternative therapies that might be employed for the same patient problem. This is certainly an evolving process. The cost can run anywhere between $200 and $500 per session, and up to 10 sessions may be recommended. This is less expensive than some other procedures and therapies employed for chronic pain, such as spinal cord stimulators. There are some patients who choose to pay for the treatments on their own, if not covered by insurance.

Q: Are there any side effects associated with this therapy? Do they outweigh the benefit, in your opinion?

A: There have not been many documented side effects with this therapy. People feel a buzzing sensation when the machine is working and sometimes this can be uncomfortable.  If pain happens during the procedure, the signal intensity should be turned down and/or off. At times the electrode leads can be moved to an alternative site, sometimes by just a couple centimeters. Occasionally, patients may develop some skin irritation or bruising under the sites of the leads. There have been some patients who report more pain in the day or days following the treatment, but it is not apparent that this is more than the normal process of a waxing and waning of the baseline pain. Overall, the reports in the literature have been largely free of side effects.

Q: Is there anything else you would like to add? 

A: Although if I consider myself to be a fairly conservative clinician and have not been shy about publishing negative results from many clinical trials, I do believe that scrambler therapy works. This contention is based on the knowledge that the majority of the reports in the literature are positive an also the personal experience I have observed in many patients, including seeing dramatic reductions of symptoms in some patients that did not derive similar benefit from previous treatment approaches. – by Jennifer Southall

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If you would like to discuss what Carolina Pain Scrambler do to help relieve your chronic pain symptoms or receive more information on our treatment process, please do not hesitate to call us at 864-520-5011 or you can email us at info@carolinapainscrambler.com

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