Regular Post

2 May

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 Pain; Courage Kenny Rehabilitation Institute; State Representatives Matt Dean, Dave Baker, Mike 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

Regular Post

26 Apr

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

Reducing Pain Talk

Carolina Pain Scrambler

Chronic Pain, Neuropathic Pain, News Calmare Pain Scrambler, Cancer Pain, Carolina Pain Scrambler, Chronic Pain, Reflex Sympathetic Dystrophy, Scrambler Therapy, Scrambler Treatment, Wellness

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

Regular Post

8 Mar

Back Pain Relief Nurse, Chronic Pain, Pain Relief, Greenville, South Carolina

Carolina Pain Scrambler Open House

Carolina Pain Scrambler

News Open House

Carolina Pain Scrambler would like to thank everyone that attended our Open House. We would also like to congratulate our Winners in our door prizes Michelle C who won our MGM Grand Swedish Massage and Brenda C who won the Carolina Olive Oil Gift Basket.

Check out some photos below from our Open House:

Carolina Pain Scrambler - Open House

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

Regular Post

19 Feb

Carolina Pain Scrambler – Open House

Carolina Pain Scrambler

Calmare Pain Scrambler, News Carolina Pain Scrambler, Health, Open House, Wellness

OPEN HOUSE for CAROLINA PAIN SCRAMBLER

Be sure to attend the OPEN HOUSE in coming up in 2 days!!! All Visitors get 50% off treatment at: Carolina Pain Scrambler

Come join Carolina Pain Scrambler for our OPEN House
Date: Thursday, February 21, 2019
Time: 4:00 to 7:00 pm
Location: 103 S. Venture Dr, Greenville, SC

Food and drinks, Evaluations, Raffle Prizes and Shopping. Come learn about health, wellness and pain management.

Regular Post

4 Feb

Pain Relief, Nerve Pain Therapy, Greenville, South Carolina

Pain Scrambler MC-5A Scrambler Treatment

Carolina Pain Scrambler

Calmare Pain Scrambler, Chronic Pain, Neuropathic Pain, News, Therapy Chronic Pain, Pain Treatment, Scrambler Treatment

It is state-of-the-art pain treatment instrument accredited by US FDA(2009), EU CE(2008), and AMA(2011) that is effective to chronicle pain.

Characteristics of Pain Scrambler MC-5A Scrambler Treatment

Pain Scrambler MC-5A Scrambler Treatment is innovative pain treatment method especially for incurable chronicle pain treatment, besides neural pain and chronicle pain. is invented. Generally it applies to patients who are either dumb to all formal pain treatment and medicine treatment or careful of side effect of medicine, has no side effects, and can be expected to direct effective treatment effect.

In present it is used in Mayo Clinic, Johns Hopkins, MD Anderson Cancer Center, Walter Reed National Military Medical Center) and Navy Camp Hospital.

Effective objects of Pain Scrambler MC-5A Scrambler Treatment

Incurable chronicle pain despite of various conservative treatment
Continuous post-operative pain
Chronicle pain in neck, waist, and joint
Neural pain in hipbone, radiating pain
CRPS(Complex Regional Pain Syndrome)
Phantom pain of amputee
Peripheral neural disease caused by chemical treatment
Fibromyalgia Syndrome, etc

Principle of Pain Scrambler MC-5A Scrambler Treatment Pain Scrambler 2

It cures and controls pain through Max 5.5 mA electronic shock that generates artificial neuron to recover distorted pain recognition

Treatment Method of Pain Scrambler MC-5A Scrambler Treatment

Takes around 40 min for each treatment
practices treatment 10 times for everyday
Early regular treatment maximize effectiveness
Pain diminish and effect of painlessness continue for long duration after treatment
In case of disease with anatomical and structural problem, root cause treatment is mandatory.
In this case, you should utter to medical staffs before treatment.
-Patients with artificial cardiograph transplantation
-Medical history in cerebral aneurysm clip/coil surgery, arrhythmia, pregnancy, myocardial infarction

Cautions after treatment

Pain diminish stair in treatment duration.
Even if pain had disappeared, do not over-move right away. It has to increase motion gradually because disease causing pain take time to be recovered completely.
You might feel unrecognized remained pain after recovery of heavy pain. Remained pain due to primary pain arises so that continuous treatment is needed to accomplish effect.
Sometimes pain could be increased for some hours, however, it is treated in the process of Pain Scrambler MIC-SA Treatment.

Worldwide attention from media oversea

Pain Scrambler 3 WSA UTAH State TV KSL-TV 5 News(2011.03.16)

“I gave up myself to live depend on crutches due to pain for my whole life. Till now nothing has been existed besides medicine. How incredible! It’s miraculous.”

Pain Scrambler 4 NBC-TV 10 News USA Rhode Island State TV(2012.03.13)

“Till now I cured hundreds of patients and above 80% of them achieved effectiveness. I was tortured for pain but all got cured after cancer treatment. It’s unbelievable.”

Pain Scrambler 5 SBS News – TV

SBS Washington correspondent release “Pain treatment without medicine”

Article Provided by Wooridul Hospital

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

Regular Post

4 Feb

Scrambler Therapy: New, Drug-Free Treatment For Chronic Neuropathic, Cancer Pain

Carolina Pain Scrambler

Calmare Pain Scrambler, Chronic Pain, Neuropathic Pain Chronic Pain, Neuropathy

A new pain management therapy plays games with your nerve fibers: It sends non-pain information via electrodes placed on the skin to nerve fibers that have been receiving pain messages, blocking the transmission of pain signals.

That’s how scrambler therapy works, using a machine by Calmare Therapeutics Inc. — no drugs and not invasive — for outpatient treatment of chronic pain.

Dr. Ricardo Taboada, an anesthesiologist specializing in pain management at the Hartford Hospital Pain Treatment Center, talks about nerve pain treatment on WFSB.

Beth Garrison, a physician’s assistant at the Hartford Hospital Pain Treatment Center, explains how the scrambler therapy works.

Q: What type of conditions can you effectively treat using scrambler therapy?
A: We can treat chemotherapy induced peripheral neuropathy and generalized neuropathies such as diabetic Complex Regional Pain Syndrome, and pain caused by damaged nerves.

Q: How does this therapy work to actually re-program pain?
A: Nerves pathways are how the body and the brain communicate. Calmare/Scrambler therapy actually reprograms transmission of the body’s pain signal through the nerve pathway so that the brain perceives it as reduced or no pain with the repetition of approximately 10 treatments.

The Calmare pain therapy device.

Q: Is this a one-time treatment or will it require a series of treatments?
A: If the patient responds to the initial treatment, and continues to have increased relief of pain by the third treatment, a series of 10 consecutive treatments is recommended with each treatment lasting 45-60 minutes.

Article Provided by Health Hub News

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

video Post

19 Oct

ON HEALTH WATCH – Scrambler Therapy: ‘Future of Chronic Pain’ Relief

Carolina Pain Scrambler

Calmare Pain Scrambler, Chronic Pain, News Carolina Pain Scrambler, Chronic Pain, Scrambler Therapy

On Health Watch News: Scrambler Therapy technology was cleared by the FDA in 2009

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

Regular Post

19 Oct

Scrambler Therapy for the Management of Chronic Pain

Carolina Pain Scrambler

Chronic Pain Carolina Pain Scrambler, Chronic Pain, Scrambler Therapy

Purpose

Chronic pain is a widespread and debilitating condition, encountered by physicians in a variety of practice settings. Although many pharmacologic and behavioral strategies exist for the management of this condition, treatment is often unsatisfactory. Scrambler Therapy is a novel, non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of pain fibers with the intent of re-organizing maladaptive signaling pathways. This review was conducted to further evaluate what is known regarding the mechanisms and mechanics of Scrambler Therapy and to investigate the preliminary data pertaining to the efficacy of this treatment modality.

Methods

The PubMed/Medline, SCOPUS, EMBASE, and Google Scholar databases were searched for all articles published on Scrambler Therapy prior to November 2015. All case studies and clinical trials were evaluated and reported in a descriptive manner.

Results

To date, 20 reports, of varying scientific quality, have been published regarding this device; all but one small study, published only as an abstract, provided results that appear positive.

Conclusion

The positive findings from preliminary studies with Scrambler Therapy support that this device provides benefit for patients with refractory pain syndromes. Larger, randomized studies are required to further evaluate the efficacy of this approach.

Introduction

Chronic pain is estimated to affect 100 million people in the USA alone, resulting in up to $635 billion in medical expenses and lost productivity each year. It predisposes to psychiatric comorbidity, and its massive impact is highlighted by the fact that it is the most common cause of long-term disability in the USA.

In simplest terms, pain can be defined as a bodily sensation experienced during genuine, or perceived tissue injury. In the acute setting, this sensation can serve as a protective role by alerting an individual to avoid potentially harmful stimuli and to protect the body during healing. When pain fails to communicate biologically useful or accurate information, it is maladaptive and thereby becomes a disease state in its own right. It is generally agreed that pain becomes “chronic” when it persists beyond the expected period of tissue injury and healing. The specific duration of symptoms required to qualify for a diagnosis of chronic pain is debatable but generally is considered to be in the range of 3 to 6 months.

The perception of noxious stimuli originates from nociceptors of the peripheral nervous system. Nociceptors recognize stimuli in the form of thermal, mechanical, or chemical inputs. The stimulation leads to activation of primary sensory nerve fibers that transmit this information to the central nervous system, via a complex network of interneurons housed predominantly in the dorsal root ganglia, posterior horn of the spinal cord, brain stem, and thalamus. Ultimately, signals reach the forebrain for interpretation of the sensory experience. There are multiple mechanisms that underlie the dysregulation of this system in chronic pain. In the setting of injury, for example, inflammatory changes in the biochemical milieu surrounding peripheral nerves can result in hypersensitization of nociceptors, such that pain signals are communicated in the absence of appropriate stimuli. Neurons surrounding damaged tissue have even shown the ability to develop spontaneous discharges that communicate pain information in the absence of external input. Similarly, spinal cord neurons in the central nervous system exposed to repetitive pain stimuli may undergo changes that result in the transmission of action potentials with a reduced threshold of synaptic input.

Currently, several treatment modalities exist for the management of chronic pain, including physical therapy, pharmacologic therapy, behavioral medicine, neuromodulation, minimally-invasive interventions, and surgery. Unfortunately, the heterogeneous nature of chronic pain syndromes and the lack of a functional understanding of chronic pain contribute to the absence of a clearly identifiable, appropriate management strategy for many patients. Nonetheless, pharmacologic measures are commonly prescribed as a component of chronic pain management. With many medications available, such as non-steroidal anti-inflammatory agents, anticonvulsants, antidepressants, and opioids, it is exceedingly common for patients to use multiple agents to try to achieve reasonable pain control.

Recognizing the limitations and hazards of polypharmacy, increasing emphasis has been placed on the non-pharmacologic options for management of persistent pain. A strategy combining psychological and physical medicine approaches can provide significant benefit for many patients . Neuromodulatory techniques, particularly since the commercial availability of wearable transcutaneous electrical nerve stimulation (TENS) units in the mid-1970s, have gained popularity as an adjunct to both pharmacological and non-pharmacologic pain management. While promising in theory, the scientific data supporting such methods remain limited, without consistently-shown benefit, underscoring the need for novel therapeutic options.

The aim of this paper is to review what is known about the mechanism of a relatively new neuromodulatory approach, Scrambler Therapy, and discuss the trials and clinical experience, published to date, regarding its use.

Methods

Reports regarding Scrambler Therapy were identified by a combination of a database search, communication with investigators, and reviewing bibliographies of previously published manuscripts (Fig. 1). Several databases were utilized in the literature search, including PubMed/Medline, SCOPUS, EMBASE, and Google Scholar. Search terms including “Scrambler Therapy” and “Calmare” were used to identify all articles published prior to November 1, 2015. The search was refined with the use of Boolean terminology, specifically “Scrambler Therapy OR Calmare,” which yielded the largest number of articles. Results of these studies were reviewed and reported with an analytic intent that was primarily descriptive.

Chronic Pain, Scrambler Therapy Chart, Carolina Pain Scrambler, Greenville, South Carolina

Scrambler Therapy development and mechanisms

Giuseppe Marineo, a biophysicist who developed an interest in treating chronic pain, developed Scrambler Therapy and conducted basic and applied research related to its use. Marineo claims that chronic pain is the consequence of a phenomenon produced by the persistence in time of pain pathway activation, a typical condition of neuropathies. This process results in a loss of the linearity in the cause–effect relation that characterizes the physiological acute pain (which is protective) and creates a new type of nonlinear behavior of the pain system, that tends to self-sustain an anomalous response to painful and non-painful stimuli. Marineo proposes that the entire chronic pain process can be controlled by intervening on the afferent information aspects of pain, the variable that characterizes and mainly regulates every activity of the nervous system and represents its natural cybernetic expression. In short, Scrambler Therapy’s active principle is information control that manipulates the modulation or re-modulation of the pain system, and its physiological or pathological responses, in line with plastic properties of the nervous system. More specifically, a Scrambler Therapy unit is composed of five electrical stimulation channels that, through the surface receptors of C fibers, replace the endogenous pain information with a synthetic one of “non-pain” or “normal-self” that travels through the same pain pathways to the brain. Through plasticity within brain networks mediating the perception of pain, a series of treatments “retrain” the brain so that the area of concern is no longer considered painful. Marineo proposes that his functioning principle, like its neurophysiological target that uses receptors of C fibers, replaces the chronic pain information, rather than attempting to block its ascending path. An in-depth analysis of these differences are described in the International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317.

Scrambler Therapy has also drawn comparisons to spinal cord stimulation, which is another interventional technique that has been utilized in the treatment of refractory chronic pain. Spinal cord stimulation has been proven to be efficacious in a diverse array of pain syndromes, including refractory angina, failed back syndrome, and complex regional pain syndrome (CRPS), with the ability to reduce pain intensity in some cases by over 50 %. The drawback of this approach has largely been its invasiveness and cost.

What is the normal course of Scrambler Therapy?

Several authors of the present manuscript utilize Scrambler Therapy in clinical practice. Information in the following section is derived from their experience in treating hundreds of patients for a variety of pain syndromes. A patient treated with Scrambler Therapy has the area of pain identified and then has electrodes placed on the normal tissue around the painful site. The electrodes are not placed at the site of actual pain, but, instead, placed at a nearby location of preserved sensation. The dermatomal location is to feed this “non-pain” confusing information into the regular nervous circuit using peripheral nerves, rather than accessing the spinal cord. The intensity of stimulation is adjusted according to patient comfort and, if the placement is correct, the pain will usually be replaced by the Scrambler device sensation, which is often described as “pleasant, vibratory, and/or humming”. Up to the full set of five sets of electrodes can be used to treat the area(s) of pain. The device is allowed to run for a total of 30–45 min once the electrodes have been optimally positioned and stimulation intensity correctly regulated. After a session’s completion, patients may report a soothing sensation and note that the pain has been markedly reduced or has disappeared entirely.

The benefit from Scrambler Therapy, after the first treatment, generally lasts for a relatively short period of time. When treatment is reinitiated the next day, the same process happens, but the benefit generally lasts longer, e.g., for a few hours. In most cases, if the treatment has been given properly, with each treatment session, the non-pain (or meaningful relief) timeframe is extended. The duration of posttreatment relief classically lengthens with continued treatments until, ideally, the benefit is maintained throughout the entire day. Usually, Scrambler Therapy is given for a total of ten treatment sessions on consecutive weekdays, if feasible, although some patients need fewer and some patients need more treatments. Pain relief can be expected to persist for weeks to months after treatment is stopped. When patients relapse, booster sessions can be administered. It may only take one or two booster sessions to re-establish the benefit that previously occurred, and this benefit may last for a substantial period of time (oftentimes months or longer).

Scrambler Therapy is an operator-dependent methodology. Treatment success is highly dependent on the ability of the operator to eliminate pain during each single treatment without any significant patient discomfort. Failure to completely resolve pain in a treated area (or have a Visual Analog Score < =1) during each treatment session may lead to less satisfactory results. Experience has confirmed that more expert operators can eliminate pain during Scrambler Therapy when less experienced ones have failed. This may explain, in part, why data coming from different publications are relatively heterogeneous.

Scrambler Therapy clinical trials

To date, 20 trials/reports of Scrambler Therapy are available for review (View Table). Eighteen have been published as manuscripts and two only as abstracts. One is a retrospective study, five deal with clinical practice experiences, 11 are prospective single-arm clinical trials, one is a randomized open-label controlled trial, and two are randomized, blinded, placebo-controlled trials.

View Table Here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4973603/table/T1/?report=objectonly

The first trial was authored by the Scrambler Therapy developer, Marineo, in 2003 and reported the results of the treatment of 11 patients with cancer-associated, drug-resistant, visceral pain. This manuscript noted that pain was quickly and markedly reduced in the studied patients, with 9 of 11 patients stopping the use of pharmacologic pain therapy altogether after the first five sessions, without any associated side effects. Pain scores were reported to have decreased from approximately 8.5 out of 10, at study initiation, to approximately 0.5 out of 10, after 10 treatments. No adverse effects were reported.

A second trial was published in 2005, with Marineo as a co-author. A total of 226 patients with neuropathic pain were treated, including patients with failed back surgery, brachial plexus neuropathy, and other chronic pain conditions. This trial, while also uncontrolled, was impressively large and reported that 80 % of subjects had at least a 50 % pain reduction and 10 % experienced a reduction of 25–49 %. Ten percent (10 %) had no appreciable response. No adverse effects were reported.

Additional groups became involved in the clinical evaluation of this therapy with the publication in 2010 of the first study that did not include Marineo as a co-author. This was a pilot trial in 16 evaluable patients with chronic chemotherapy-induced peripheral neuropathy, conducted at Virginia Commonwealth University. The findings from this study were in line with the success seen with the previously reported trials. After ten treatments, the average reported pain score dropped nearly 60 %, with four patients achieving complete resolution of pain. Patients with recurrent pain successfully retreated with 1–3 subsequent treatments.

The next trial, currently only available as an abstract, involved ten patients with failed back surgery treated by an anesthesiology-trained pain physician. While it only noted a 28 % mean pain reduction, there were patients on this trial who had substantial relief after multiple other therapies had failed to provide benefit. The author of this abstract, a coauthor on the present manuscript, notes that there are three reasons why his success rate might have been relatively low: (1) he had limited operator experience; (2) he included study subjects with multifactorial intractable pain despite intensive polypharmacy; and (3) treatment while adjuvant anticonvulsants were continued. Empiric observations have suggested less than optimal outcomes if these medications are not discontinued prior to treatment.

Marineo and colleagues published the first randomized, controlled trial in 2011, which involved 52 patients with chronic neuropathic pain related to postsurgical causes, post-herpetic neuralgia, or spinal cord stenosis. Scrambler Therapy was compared to a control arm that utilized standard pharmacologic guideline-based recommendations, including frequent phone calls to modify analgesics. The pain reduction, after finishing 10 days of treatment, was 28 % in the control group (pain scores dropped from 8.0 to 5.8 out of 10) compared to a 91 % reduction with the Scrambler group (pain scores dropped from 8.1 to 0.7; p < 0.0001). Pain scores in the control arm were 5.7 and 5.9 at 2 and 3 months, respectively, as opposed to 1.4 and 2.0 in the Scrambler group (p < 0.0001). Analgesic consumption, including opioids, antidepressants, and anticonvulsants, decreased by 72 % in the Scrambler group. Allodynia also was reduced in the Scrambler patients, from 77 % at baseline to 15 % at 3 months. The benefit was obtained relatively equally amongst patients of all of the three diagnostic categories.

The sixth trial involved 82 (73 evaluable) prospectively-treated patients, about half of whom had cancer-related pain. Mean pain scores reduced from 6.2/10 before to 1.6/10 at the end of treatment and were 2.9/10 1 month after treatment was finished. Similar results were seen in patients with and without cancer. When patients were asked whether they would repeat this treatment, 97 % (71/73) responded affirmatively.

The seventh trial involved a cohort of eight patients treated with Scrambler Therapy for chronic low back pain. Patients were treated for six consecutive days; pain scores were recorded prior to initiation of treatment and after each session. The mean pain score was 8.12/10 at baseline, dropping to 6.93/10 after the first treatment. The mean pain score dropped to 3.63/10 in day 6. The group also recorded the Oswestry Disability Index (ODI) and found that mean score dropped from 49.88/100 to 18.44/100 by the end of the study, signifying an average drop from severe to minimal disability.

The eighth investigation was a prospective trial that reported on a series of 39 patients with cancer pain syndromes, including 33 with chemotherapy-induced peripheral neuropathy. Scrambler Therapy was associated with significant positive changes from baseline for a large number of outcomes, including degree of pain, interference with normal activities, and sensory neuropathy symptoms. The benefit persisted up to 3 months.

A small prospective trial published in 2013 involved 10 patients with post-herpetic neuralgia and included some data previously reported in another publication. The work reported a 95 % reduction in pain scores at 1 month, with sustained benefit observed at 2 and 3 month follow-up times.

In 2014, a prospective pilot trial experience was published, involving the treatment of 37 patients with chemotherapy-induced peripheral neuropathy, noting about a 50 % reduction in pain, tingling, and numbness. The increase in Scrambler benefit over the course of the trial suggested that, despite initial operator training in the administration of Scrambler Therapy, a learning curve was evident in this trial. The last 25 % of patients entered on this clinical trial did substantially better than did the first 25 % of patients, likely a reflection of improved technique afforded by greater experience.

The first attempt to compare Scrambler Therapy to a sham control was presented as an abstract at the 2013 Annual Meeting of the American Society of Clinical Oncology, involving 14 patients who were treated in a randomized, controlled, and double-blind manner. Results from this study have not been published as a manuscript. While the authors did note that the sham treatment from this particular trial was believable, in that the patients could not more often detect which of the two procedures was the true one, the authors did not observe any real improvements in neuropathy in the patients treated with the sham procedure versus Scrambler Therapy. This may well have been because this group had little experience with the technique prior to conducting their study. This finding fits with above-noted work that observed that there is a learning curve for the appropriate application of this therapy for treating chemotherapy neuropathy, which likely also applies to the treatment of other conditions. Additionally, the results of this trial support that there was not much of a placebo effect in this trial, as no benefit was noted in either trial arm. Paradoxically, this would support the argument that the positive results reported in other chemotherapy neuropathy Scrambler Therapy trials are not just ascribable to a placebo effect.

In 2015, a single-blind, sham-controlled, randomized clinical trial involving 30 patients with low back pain was reported from Virginia Commonwealth University. These authors noted significant decreases in the Brief Pain Inventory (BPI) back pain scores and pain interference scores (P ≤ 0.05). They also noted improvements in pain sensitivity, as measured by participants’ thresholds for pain in the initially painful area. Of note, the group randomizedtoScramblerTherapyhadsubstantialdecreasesin10 serum messenger RNAs (mRNAs) associated with nerve pain such as nerve growth factor (NGF) and glial derived nerve factor (GDNF), compared to no decreases in the sham group, understanding that these mRNAs have not yet been established as correlates for pain.

More recently, two subsequent single-arm prospective trials have been published which support therapeutic benefit. A pilot study was reported from an Italian hospital, evaluating outcomes of Scrambler Therapy in 25 patients with pain related to bony and visceral metastases. Each patient was scheduled for 10 daily sessions of treatment, and pain outcomes were measured by the use of a numeric pain scale. All patients were reported to have experienced at least a 50 % decrease in pain scores, with a mean pain score of 8.4 at baseline dropping to 2.9 after completion of the treatment course. The average duration of “pain control” (defined as >50 % reduction from baseline pain score) was 7.7 +/− 5.3 weeks. Sleep performance was also noted to improve significantly for the cohort. In Korea, Lee et al. performed an open-label, single-arm, exploratory study involving 20 patients with CIPN, metastatic bone pain, and postsurgical neuropathic pain. Pain scores decreased significantly, as did consumption of rescue opioid medication.

Clinical Practice Experiences

Two case series, published in 2013, each included three patients with cancer pain or post-herpetic pain. Both of these reports came from different authors and both reported positive benefits in the patients who were treated.

Sparadeo et al. reported their clinical practice experience regarding 91 of their initial 173 patients, representing all of those for whom they had collected data. These patients had a variety of pain syndromes, including CRPS, spine pain, neuralgias (such as post-herpetic or post-chemotherapy), and multi-focal pain problems. As part of their practice, with these 91 patients, they collected visual pain scores before and after each treatment for all of them and BPI questionnaires, in a subset of them, prior to treatment initiation and at 3- and 6-month follow-up times. The mean pain score prior to the first treatment was 7.2/10; it was 3.0/10 on the 10th day, prior to that day’s treatment. Relatively similar results were seen for the different pain syndromes. BPI scores at 3 to 6 months of follow-up were reported to be improved by more than 50 %.

In a second manuscript, Sparadeo and D’Amato analyzed the pre- and posttreatment data of 95 individuals (some of whom had been reported in the previous publication) entering their Scrambler Therapy program for treatment of chronic neuropathic pain, divided into two groups: CRPS and chronic spine-based pain. All patients were weaned from opioids and anticonvulsants being used for pain control. The data analysis revealed that 70 % of the entire sample was still reporting significant improvement 3 to 6 months following treatment. The two studied groups had similar levels of pain and degrees of lifestyle impact. Additionally, the 3–6-month successes were similar in the two treatment groups.

Another clinical practice experience report involved 147 patients treated at two United States military sites and one South Korean site. They noted that 38 % of patients had at least a 50 % pain reduction that lasted for more than a month.

Retrospective Study

Lastly, one retrospective report on Scrambler Therapy, involving 201 patients across multiple centers, was recently reported. Patients were treated for a variety of chronic pain syndromes; the most common indications included post-herpetic neuralgia, chronic low back pain, and polyneuropathy/ peripheral neuropathy. Patients were treated for a mean number of 10 sessions, with 39 patients experiencing complete resolution of pain symptoms sooner than this. The mean pain scores were 7.41 prior to treatment and 1.6 following treatment (P < 0.0001). Achieving a pain score of 0 during treatment was observed to associate with the durability of pain control, prompting the authors to advocate for a complete response as a target of therapy sessions.

Does Scrambler Therapy actually work?

Arguments against Scrambler Therapy certainly exist, with critics attributing much of the benefit to a placebo effect. Some of the positive endorsements in social media and on the Internet are only anecdotal. Additionally, the developer of Scrambler Therapy participated in the initial clinical trials, and this could be perceived as a potential conflict of interest even though it is scientifically desirable and logical to expect the device inventor to report the first set of results. Additionally, some of the reports claim that there is a phenomenal benefit that lasts for a long time, which sounds too good to be true. Lastly, there are no large, placebo-controlled, double-blinded clinical trials to estimate the effectiveness of Scrambler Therapy.

On the other hand, while some reports involved the inventor of the Scrambler device, these positive findings have been independently replicated by diverse groups in nearly all of the reported studies, involving over 900 patients in total. In some cases, the benefit achieved has been substantial, with some patients achieving complete pain resolution and substantially reduced dependence on pharmacologic therapy. There has been only one report of a negative experience. This was from one small, placebo-controlled trial in patients with chemotherapy-induced peripheral neuropathy. This was published only as an abstract, did not show much of a reduction in either study arm (arguing against a placebo effect), and was produced by a group that did not have much experience using Scrambler Therapy. This raises concerns regarding the validity of this trial, as data have supported that there is an extended learning curve with the provision of Scrambler Therapy, particularly for chemotherapy-induced neuropathy . At the same time, it must be noted that although this is the only negative trial published on Scrambler Therapy, the possibility of publication bias cannot be excluded. Negative experiences may not be put into publication form for various reasons, and so the currently available literature may be overestimating the positive experience with this technology.

The downsides of trying Scrambler Therapy

The downsides of trying Scrambler Therapy for chronic pain primarily relate to the time and expense associated with its administration, in addition to noting that many proposed treatments for chronic pain have not withstood the rigors of time and/or well conducted randomized trials. Additionally, the therapy is not yet widely available and some insurance companies will not pay for it due to lack of evidence or will reimburse it at very low rates. However, some insurance companies are covering this treatment as they have started to note the benefit of this therapy in allowing patients to return to work, with decreased use of medications and procedures. Scrambler Therapy relies on practitioner skill and familiarity with technique, which can influence outcomes, as has been noted in the literature. This might impede rapid integration into practice, especially in the absence of formalized training.

Additional Research

Additional work is needed to better understand the mechanism of Scrambler Therapy and to conduct larger randomized clinical trials investigating the efficacy of Scrambler Therapy in a number of chronic pain states. A large, multi-center, randomized, sham-controlled double-blinded trial, involving patients with a variety of chronic pain syndromes, would strengthen the conclusions from initial studies. The data compiled, to date, support the feasibility and value of such an undertaking. Multiple other research lines of investigation would be helpful for further defining the worth of Scrambler Therapy. Such work could better evaluate the types of patients who benefit, the best means for teaching operators, and the compatibility of this approach with other treatment approaches. For example, as indicated above, there are recommendations to titrate down and discontinue anticonvulsant medications prescribed for pain management prior to initiating Scrambler Therapy, based on the theory and empiric clinical experience that these agents may interfere with the therapeutic mechanisms involved. Whether this is truly necessary could be a focus of future research. To better define the mechanisms of action, studies of brain reactivity (functional MRI) and peripheral nerve function (changes in epidermal nerve fiber density or electrophysiological measures or quantitative sensory nerve testing) would be useful.

Article Provided by: NCBI

Carolina Pain Scrambler Logo, Chronic Pain, Greenville, SC

Regular Post

11 Sep

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’

Carolina Pain Scrambler

Calmare Pain Scrambler Calmare Pain Scrambler, Neuropathy

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

Regular Post

11 Sep

Optimizing Neuropathic Pain Relief With Scrambler Therapy

Carolina Pain Scrambler

Chronic Pain Calmare Pain Scrambler, Chronic Pain

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.

By Alexandra M. Lesenskyj, Christina R. Maxwell, PhD, MTR and Ricardo A. Cruciani, MD, PhD

Page 1 of 3

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.⁴As 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

1 … 20 21 22 23