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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

Chronic Pain Therapy, pain therapy, Neck Pain Relief, Greenville, South Carolina

Nerve Scrambler Therapy lessens pain for warfighters, Tricare patients

In reality, NST is one of the 79th Medical Wing’s most cutting edge methods for managing chronic and debilitative nerve pain that impacts warfighters’ job performance and long-term quality of life.

“Like many civilians, military patients sometimes experience nerve pain after they’ve healed from injuries or have been treated for diseases,” said Lt. Col. Candy Wilson, 779th Medical Group nurse scientist and NST practitioner. “NST has proven to be a viable alternative to opioids for reducing or eliminating this kind of pain.”

Nerve pain that indicates no underlying injury or disease, technically known as peripheral neuropathic pain, can affect patients who undergo chemotherapy or suffer from diabetic or sciatica pain, drug/toxin exposure, infections stemming from surgical complications or incidents of trauma.

“A common case we treat with NST is a condition found among some wounded warriors known as phantom limb pain,” said Wilson.
Phantom limb pain is a condition in which an amputee experiences pain sensation from the part of the body that was removed.

Wilson and her nursing colleagues at the 779th MDG’s Acupuncture and Integrative Medicine Center administer NST using a Calmare machine. Calmare is the name of the manufacturer and it means “to soothe” in Italian.

NST involves sending a low voltage current of electrical stimulation through two electrode pads placed on the skin of the patient. One pad is placed on a part of the body inches away from the source of a nerve pain; the other pad is placed on a part of the body not affected by pain.

According to the Calmare Therapeutics Company’s official website, the stimulation scrambles the pain nerve signals to the brain. A “no pain” signal to the brain replaces a pain signal. Cleared by the Food and Drug Administration, the Calmare machine has been used successfully in Europe for the past 15 years and in the U.S. for the past few years. The website reports the treatment is painless, non-invasive and patients experience no adverse side effects.

“In effect, NST means we’re able to re-train the brain for reducing or eliminating pain,” Wilson said. “Recurring treatments over a certain amount of time result in prolonged pain relief for the patient.”

Patients needing treatment at Acupuncture and Integrative Medicine Center require a referral from their primary care provider. Then, their treatment is determined by one of the Acupuncture and Integrative Medicine Center’s physician acupuncturists.

“Referrals are necessary to ensure we are providing the appropriate and most effective treatment for our warfighters and other patient beneficiaries,” said 1st Lt. Folake Niniola, 779th MDG registered nurse. “Because of our thorough screening process, we’ve been very successful with this therapy and there have been no known or reported side effects or injuries from the use of this machine.”

Because of the Nerve Scrambler Therapy’s ability to reduce patients’ pain without side effects, the 79th MDW exemplifies the Zero Harm tenet of Air Force Medical Service’s patient care philosophy.

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

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

Scrambler Therapy for Treating Neuropathic Pain

by Dr. Thomas Smith and Dr. Charles Loprinzi

What is neuropathic pain, from the non-expert oncologist’s point of view?

The way we think of it, pain is about the most protective instinct and impulse known to humans! If you touch a hot plate, you retract your hand even before you actually feel the pain. Then, the pain comes – very localized – such that you can plunge the hand into cold water. After that, usually the pain goes away and you can then blame your son-in-law for leaving the hot plate on. But sometimes, the pain signal gets stuck in the “on” position, even though your hand has healed. There has been some damage to the nerve endings, and they are continuing to send the “pain” impulse when it is not doing you any good. The pain pathways in the spinal cord and the brain actually get bigger and more active; neurologists call this “wind-up.”

Pain has come to the attention of most oncologists because we CAUSE it with chemotherapy agents; we call it chemotherapy induced peripheral neuropathy (CIPN).

For the unfortunate 40-70% of chemo patients who get CIPN, it can range from being a nuisance to being life-destroying. Our patients describe constant burning or pins-and-needles pain, with numbness and tingling. It starts in the longest nerves that go to the hands and feet first, then progresses upstream. For many people it is just an inconvenience, and goes away in between chemo cycles and abates after treatment. But for others it persists, for years.

Preventing or treating CIPN has been frustrating. We both were part of the American Society of Clinical Oncology panel that made national clinical practice guidelines for CIPN. There are no drugs proven to prevent it, and alpha-lipoic acid, Vitamin A, natural products, L-carnitine – things that help in other neuropathies – were no better than placebo. Only one drug is proven to help, duloxetine (Cymbalta), with a reduction in pain of about 1 point on a 10 point scale.

Of course, there are other neuropathic pains that oncologists know all too well. The pain from a pinched nerve leaving a collapsed or damaged vertebra, shooting down the leg. The pain after shingles, “post-herpetic neuropathy” that can last for years. The pain after chest surgery, or mastectomy, or radiation.

What is Scrambler Therapy, and How Does it Work?

Scrambler Therapy (marketed as Calmare™ therapy in the United States) is a new type of pain relief that uses a rapidly changing electrical impulse to send a “non-pain” signal along the same pain fibers that are sending the “pain” stimulus. We got interested in Scrambler Therapy because we thought it MIGHT help CIPN patients, and Scrambler Therapy appeared to be non-toxic. It had been cleared for safety by the FDA in 2009.

We were skeptical, but we did a trial of Scrambler Therapy. We treated 16 patients with refractory CIPN (present for at least 6 months, and refractory to medications); the group had a 60% reduction in their CIPN pain – in 10 days of treatment. Of the 16 patients we treated, essentially all reported some benefit, including 4 whose pain resolved to “0.” Function improved in most patients including less interference with walking and sleeping, for at least 3 months.

The setup is simple as shown in Figure 1 (Tom Smith’s legs). EKG electrodes are used to transmit the electrical impulses from a colored electrode to a black one, back and forth. The treatment is given for 30-45 minutes for up to 10 days in a row (excluding weekends). Our patients report a feeling like being bitten by electrical ants, or bee-stings. If the treatment is working, the sensation will change to a “hum” in the nerve and go to the ends of the nerve. We have to start above the painful area – remember, we are trying to replace the pain with a “non-pain” stimulus, and sometimes can work progressively down the legs and arms as pain relief occurs.

Figure 1: A typical setup to treat “stocking and glove neuropathy”

Colleagues at Mayo Clinic were skeptical and repeated the study in a larger group of people with CIPN. Pachman, Loprinzi and colleagues at Mayo reported about a 50% reduction in pain, numbness and tingling lasting at least 3 months. Of note, there appeared to be a learning curve, with the later patients getting better and longer lasting pain relief.

We will be the first to note that Scrambler Therapy lacks the “Good Housekeeping Seal of Approval” of cancer treatments – the well-designed, large, high statistical power, randomized controlled trial. We are both doing randomized trials, comparing Scrambler Therapy to “sham” (electrodes in the wrong place” and to TENS (trans-cutaneous electrical stimulation).

That said, we are interested in treatments that might work and don’t cause side effects. A recent review of at least 20 scientific reports noted no harm in any trial, with most reporting a substantial relief of pain. The two randomized trials comparing “sham” to real Scrambler Therapy showed a 50% reduction in low back pain, and a 91% reduction in pain from failed back syndrome, post herpetic neuropathy, and spinal cord stenosis. In all the trials, pain relief – if it happened – was obvious in the first 3 days, continued to get better, and usually lasted several months. There are additional reports of Scrambler Therapy having success in cancer somatic pain including bone and visceral metastases, complex regional pain syndrome, pediatric cancer chest wall pain, and others (see list below). The US Military has 17 Scrambler Therapy machines for treating both wounded warriors and civilians.

Some types of pain for which Scrambler Therapy has been used

  • Pancreas and abdominal cancer pain
  • Chemotherapy induced peripheral neuropathy
  • Non cancer pain such as neuropathic back pain
  • Post-herpetic pain (shingles pain)
  • Bone metastases
  • Spinal cord stenosis
  • “Failed back syndrome” – after surgery, the back hurts worse
  • Complex regional pain syndrome
  • Post-mastectomy pain

Is Scrambler Therapy Related to Anything Similar?

Scrambler Therapy looks superficially likes TENS therapy. TENS applies similar electrodes on the skin and passes a pulse of electrical current between them. TENS is a completely different type of on-off current, and, classically, the effect wears off as soon as the electrodes are removed. When Scrambler Therapy works, it seems to reset or reboot the system for an extended period of time.

Spinal cord stimulation appears to have a same effect on pain that Scrambler Therapy appears to have. However, it involves putting electrodes on the spinal cord, and implantation of a pulse generator, similar to a pacemaker. It is also expensive – typically near $100,000 for a trial, then surgery and the equipment. It can last for years.

Is Scrambler Therapy Covered by Insurance?

Quick answer, no, not very well yet. They are waiting for more traditional evidence (unlike the U S Military!) Some places are doing it for free on the clinical trials listed on clinicaltrials.gov. There is a list of certified centers on the Calmare website. An increasing number of insurers are paying for Scrambler if the person and their doctor appeals with lots of evidence from the trials above.

The machines themselves are expensive ($105,000 was the last quote we got) but can be used for a new person each hour, and last for years. The electrodes cost $4-15 dollars per person for a course of treatment. A person with training can do the treatment supervised by a physician with knowledge of the nervous system.

What research needs to be done before Scrambler Therapy is proven effective, and reimbursed if it is?

We have been using Scrambler Therapy routinely at our centers, and believe there is benefit to some patients. At the same time, we are humbled by the many therapies that have shown promise in phase II trials only to be no better than placebo or sham in Phase III trials. We need bigger randomized trials, sponsored by the NIH or someone who is not trying to sell the machines.

Dr. Thomas Smith is the Director of Palliative Medicine, Harry J. Duffey Family Professor of Palliative Medicine, Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Dr. Charles Loprinzi is Regis Professor of Breast Cancer Research, Mayo Clinic

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

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

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