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gennaio 2015 – Research in Nursing & Health- Pubblicato studio in doppio cieco randomizzato e controllato su ST

gennaio 2015 -Research in Nursing & Health
Pubblicato studio in doppio cieco randomizzato e controllato:
Decreased Low Back Pain Intensity and Differential Gene Expression Following CalmareW: Results From a Double-Blinded Randomized Sham-Controlled Study
Angela R. Starkweather, Patrick Coyne, Debra E. Lyon, R. K. Elswick, Jr., Kyungeh An, Jamie Sturgill

Decreased Low Back Pain Intensity and differential gene expression following Calmare

3 settembre 2013 Testimonianza su utilizzo ed efficacia della Scrambler Therapy – Dr. Thomas Smith

Researcher Says Calmare ‘Scrambler’ Provides Pain Relief

September 3rd, 2013 by Pat Anson, Editor

Dr. Thomas Smith admits he had his doubts when he was first asked to investigate Scrambler therapy, a device that uses low doses of electricity to block pain signals without the use of drugs.
“I am a very skeptical Midwesterner,” says Smith, MD, a researcher at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University School of Medicine.
But after four years and several studies testing the Scrambler, Smith is now a believer.
“The evidence is pretty compelling, with most of the studies finding really a substantial reduction in pain with no toxicity,” Smith says.
“It’s simple, easy, relatively inexpensive, non-invasive, and easily testable on the individual patient. You put the electrodes on, move them around and you should be able to tell in three to five days whether it’s going to work at all or not for the patient.”
Smith’s latest study was published in the American Journal of Hospice & Palliative Medicine. Ten patients suffering from neuropathic pain after a bout with shingles achieved significant pain relief after 10 days of outpatient treatment.
Smith says the average pain score for the patients fell by 95 percent within one month. Relief continued over the next two to three months, long after Scrambler therapy ended.
Smith has had similar success treating patients with cancer induced peripheral neuropathy.  About 80 percent got substantial pain relief after using the Scrambler, which is similar to a spinal cord stimulator, but far less invasive. Spinal cord stimulators, which also use electricity to block pain, are surgically implanted next to the spine.
“We’re not talking about a 10 percent reduction in pain. We’re talking a 50 to 80 percent reduction in pain, which is exactly what one sees with spinal cord stimulation,” says Smith.
“It’s almost as if we’re getting the same ultimate end result as spinal cord stimulator, but without having to unroof the spinal cord, sew an electrode on and then have it permanently connect to an implantable pump that costs $50,000.”
A typical session on a Scrambler lasts 30 to 45 minutes, with the device sending low doses of electricity through electrodes placed on the skin of painful areas. The device “scrambles” or re-boots nerves left frayed and over-sensitized by chronic pain.
“You feed in artificial nerve impulses designed to confuse the nerves, scramble the pain information that they’re sending, and allow them to re-set,” says Smith.
Although the studies are promising, they’ve been small and haven’t made much of splash in the medical community. Originally developed by Giuseppe Marineo, an Italian scientist, about three dozen Scrambler devices are now in use at pain clinics in the United States, mostly on the east coast.
They are licensed to Competitive Technologies, Inc. (OTC: CTTC) a small technology company in Fairfield, Connecticut that distributes and leases the Scrambler under the name Calmare pain therapy. In Italian, the word “calmare” means “to ease” or “to soothe”.
“If this were a very rich company, it would invest $3 million and do a 60 patient sham controlled trial in a heartbeat. But the company doesn’t have that money,” says Smith.
Perhaps the biggest barrier to making the Calmare Scrambler more widely used is that the therapy is not usually covered by Medicare or private insurance companies. As a result, many patients pay in cash, usually about $150 to $200 per treatment. That can add up to thousands of dollars after a standard course of ten treatments.
“We are not what is called a ‘standard of care’ yet. And believe me, if we were, the number of people that could be treated with this would escalate dramatically,” said Johnnie Johnson, Competitive Technologies’ chief financial officer.
“When we go out to sell this device, my guess is out of ten calls that we make, we probably get two sales. If we got insurance reimbursement regularly for this, we’d probably get six.”
Johnson says Calmare therapy is more cost effective than prescription painkillers or other types of pain treatment that are reimbursed by insurance companies.
“A narcotic type drug or a very expensive drug could cost $400 to $1,200 a month. If you took half that money and applied it to Calmare, the payout on that is pretty quick,” says Johnson.
But Calmare therapy doesn’t work for everyone. Beth Stillitano, a North Carolina woman who suffers from a chronic pain condition called Reflex Sympathetic Dystrophy (RSD), had a very mixed experience with Calmare therapy. The first few treatments went well, leaving her pain free for the first time in 16 years.
“Within 15-20 minutes of starting the therapy, my RSD pain seemed to diminish,” Stillitano  wrote in her blog. “After treatment I went an hour and forty-five minutes with no RSD pain!!!!! It is so incredible to walk and not feel pain with every step.”
But a second course of therapy, held months later, did not go well. Stillitano stopped the treatment after just two sessions.
“I was in a lot of pain, and I could not even drive. My sister said watching me have an hour session of Calmare therapy was torture for her. That night, I went into complete flare-up,” Stillitano told National Pain Report.
Dr. Smith says more studies are needed to fully understand how the Calmare Scrambler works – and why it doesn’t for some patients.
“There are probably 20 percent of people who don’t respond to anything, but it seems like the other 80 percent get at least minimal, if not substantial relief. We’ve had people where you can actually see the redness and pain and inflammation diminish over a couple of days as the pain gets re-set,” Smith says.
“It could be that some of this is placebo. And I’m more than willing to accept that,” he adds.
Although it’s been used primarily to treat neuropathy, Calmare has been used with some success to treat other chronic pain conditions such as fibromyalgia, phantom limb pain, back pain, and Chronic Regional Pain Syndrome (also known as RSD).
This fall, Smith starts work on yet another study – this one on breast cancer patents – which is being funded by the Avon Foundation. The study will test the Scrambler’s effectiveness in relieving neuropathic pain cause by chemotherapy.

Vai all’articolo:




Stage 4 Cancer and Chemotherapy-induced Peripheral Neuropathy (CIPN)

Ms. G.L.

This treatment helped me to cope with the pain since I cannot take any pain medicine. It’s a godsend. It’s a miracle that it actually helped me without taking medication since I have an allergic reaction to all medications. I cannot even have chemotherapy with stage 4 cancer. Your device helped me endure the pain. I cannot tell you enough how it helped with the pain with no side effects like medication.

Ms. M.M.

My pain from the cancer was at least a 10 and these treatments completely removed all pain. I did not need any pain medication.

Reflex Sympathetic Dystrophy (RSD)

Ms. J.D.

“Over the past year and a half, I have taken my daughter to the top hospitals in the country trying to find relief for her chronic pain which was a consistent 10/10 on the pain scale. But after driving from Indiana to New Jersey for Calmare treatments, I can touch her for the first time in years without her reeling in pain. Today, she’s like any other 16-year-old girl, enjoying her life again.”

Failed Back Surgery

Mr. P.S.

My pain went from a level of 7 to 8 to a 1 to 2 on average. I found that I can do more without the resistance of pain. I lowered my pain medication and was able to go to the gym and work out as I did before. I am still feeling the positive effects from the last treatment I had which was on August 28, 2009.

Ms. N.P.

I was very satisfied with the treatments. I get around much better after treatments. I lowered my pain medication intake since I did not need as much. I got a better quality of life from these treatments and would like to continue.

Sciatic Pain

Mr. J.M.

I have been suffering from severe pain. On a scale of 1 to 10, it was a 10. After treatment it was about a 2. I am sleeping better and have been pain free for over 3 weeks now.

Postherpetic Neuralgia

Ms. H.N.

I had nerve pain for about 5 years, and it has been getting progressively worse and worse. I heard about this device, and we drove to Connecticut for three treatments to see if it worked. After these treatments I was able to cook again and do things that I have not been able to do. After three treatments I was pain free for 48 hours. I would love to have the full course of treatments, but I had to return home.

The TENS device and medication has not helped. Nothing else has worked except for your pain device. Please, please come to New Hampshire so that I may receive the full course of treatments. Look what it did after three treatments!

Post Surgical Pain

Ms. C.C.

“After having my arthritic hand operated on in 2004, I had no idea the long-term pain I would endure after surgery. I spent seven long years researching and experimenting with a variety of medications and therapies to relieve the post-surgical pain.

After reading in the newspaper that Calmare was available near my home in New Jersey, I knew it was a sign that relief from the pain was very close at hand. Before Calmare, I was reliant on using the pain medications Percocet and Tramadol every day to fight the constant pain. After a while, they didn’t have any effect. But after 10 Calmare treatments, I’ve said goodbye to all those drugs—for good.”

Knee Pain

Ms. E.M.

I am a 60-year old guidance counselor for a local high school. My right ankle has no cartilage and is just bone on bone. I will be having an ankle replacement in April. In the interim I wanted to walk more to lose weight before the surgery. I am more of aware of the pain in my right knee, which was overshadowed by the pain in my right ankle. I had a knee scraping to remove broken cartilage a few years ago. I am not feeling any pain whatsoever in my ankle. I noticed a reduction of pain after the first treatment in my right knee. I am more mobile now, and I don’t have to think and plan the way I am going to walk in a particular area and compensate for it to save steps.

It’s uplifting. I was depressed before. This device has helped me a lot. This should be available to everyone in pain. It’s a shame that it’s not.

Mr. D.L.

I had all the cartilage removed from my right knee, and I have pain in the inside portion of my leg near my knee. The pain has gone away when I palpate the area. My walking has improved a lot. I refuse to get a knee replacement, and this device has helped me make that decision.

Ms. B.M.

I had a right lateral meniscus tear and was scheduled for knee surgery before my treatments with this device. The pain is gone. I can walk pain free. I cancelled the surgery.

Phantom Limb Syndrome

Mr. A.S.

I was driving my car with my fiancée as the passenger and was hit head on by a drunk driver. It was determined during the investigation that the driver hit us at approximately 70 mph. I was severely injured. After 12 surgeries and unbearable pain, I agreed to have my right leg amputated below the knee.

I have been taking morphine and methadone to help with the pain. The medications do not help that much, especially when I am sitting and lower my stump.

My best friend was participating in the annual American Pain Society convention in Tampa, where I live. He spoke with Competitive Technologies, Inc. employees about the non-invasive pain device. He explained my story to them.

I left work and came to the Tampa Convention Center and was treated for 45 minutes on the pain device. I kept lowering my stump to see if I had any pain and was astonished to find that I did not have any pain or burning. After the treatment I actually walked around for one hour. I felt good that night and had no pain. I took advantage of having no pain and walked more than I should. By the next afternoon the pain had returned.

I can honestly say that I have not been pain free since before my accident. I want one of these devices. I want to be treated again. Anyone with pain should have this device to lead a normal life without having to take the medications, which make them numb and sleepy.

Scrambler Therapy® System Featured in Calmare® Pain Therapy Medical Device Receives U.S. Patent

Febbraio 2013
Scrambler Therapy® System Featured in Calmare® Pain Therapy Medical Device Receives U.S. Patent

…”During the development of Scrambler Therapy, artificial neurons were developed to transmit to the central nervous system (CNS) information recognizable as “self” and “non-pain” in a non-invasive manner through surface C receptors,” Marineo continued. “Compared to the conventional electro-analgesia, the assumed active principle that is currently in use is not to inhibit pain transmission (through A-beta fiber excitation), but to substitute pain information with synthetic ‘non-pain’ information. This theory and the results produced in clinical use in chronic pain contradict consolidated models such as the Gate Control theory, but are also the reason for its effectiveness where other treatments fail.

“The U.S. patent further validates this innovative theory. Together with progressively planned randomized controlled clinical trials (RCT), Scrambler Therapy is bound to become the new scientific reference model to understand and treat chronic pain,”…

articolo completo al link:

5 dicembre 2012 New England Center for Chronic Pain

Il dolore cronico colpisce circa un terzo della popolazione americana. Gli approcci tradizionali sono stati finora limitati a farmaci e chirurgia.  Il dott. C. Evers Whyte, direttore medico del New England Center for Chronic Pain, viene intervistato per  parlare del metodo di trattamento della Scrambler Therapy.
Lo studio indipendente ha restituito risultati importanti,  il dottor Whyte ha sperimentato un sorprendente  tasso di successo  dell’80% da quanto ha iniziato ad utilizzare Calmare M5-5A sui propri pazienti 3  anni fa.
Leggi l’articolo completo e guarda il video dell’intervista :

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