..."At Rutherford Allied Medical Group in NJ...".....personally, I think the thing is so bogus that I find it reprehensible that anyone should try to foist it on the American public...Italy turns its nose up at it for ten or twelve years so maybe we can sell it to those stupid Americans...by the way, you left out a few details:
(1)...how about talking about the inventor -- "Giuseppe Marineo"...were you aware that he was arrested in 1995 apparently for practicing medicine without a license...it appears he was trying to treat AIDS patients by providing electric current through externally applied electrodes...hmmmm, that sounds a bit similar to the "Calmare"...and I think the article says something about "many describing it as witchcraft"?...my Italian's a bit rusty so I'm not sure if my translation is accurate...
...and did you know that, despite several press releases from Competitive technologies labelling him as "MD, DSc.," that he has neither a "MD" nor a "DSc."...indeed, despite his claim to being a bioengineer, he may not, in fact, have any college degree whatsoever...yet despite that, in 2005, he published a paper wherein he labelled himself "MD, DSc."...I think there's general agreement that it's not proper to grant oneself advanced degrees for articles published in scientific journals, is it not?,,,furthermore, I note some websites refer to him as "Professor Marineo"...where exactly is he or has he ever been a professor?...nowhere that I can find...
...you also might find interesting a paper written by Marineo explaining his idea of treating AIDS by manipulating "entropy" with his device...they won't allow me to post the link so you'll have to google "groups google sci.med.aids marineo"...be sure to read the comment supplied by Christopher J. Batie, Ph.D., of the Dept. Biochemistry and Molecular Biology at Louisiana State University Medical Center...pay particular attention to those paragraphs containing "crackpots," "mess," "strange," "mistaken," "wrong-headed," "magic box," "slickly presented batch of buzzwords and jargon," "meaningless," "waste of bandwidth," "doesn't know what he's talking about"...
...finally, have you examined website for Marineo's alleged research center -- "Delta Research"?...did you notice that it seems to lack any PHYSICAL address...not only that but it appears to lack a telephone number as well...he makes several references to Tor Vergata University on the site but a search of the university's website suggest they aren't aware either he or his "research center" even exists..that strikes me as being most unusual...
(2)...how about a few other pertinent details...for example, how about mentioning a study that concluded the "scrambler" was not significantly different from TENS...again you'll have to google for it but the authors looked at cold pain perception and pain endurance and found no significant difference between TENS and the "calmare"...which confirms what I maintain -- it IS a TENS unit, has always BEEN a TENS unit and will always BE a TENS unit...
...and maybe point out some details from Dr. Smith's paper wherein he reported positive analgesic effects but admitted he couldn't rule out a placebo effect since he neglected to include a control group...MORE IMPORTANTLY, his other results were NOT consistent with the alleged therapeutic benefit -- emphasis mine:
"The secondary endpoints showed MINIMAL change with MC5-A Calmare therapy. There was NO consistent effect on the OTHER pain scales (data NOT shown). There was NO difference in morphine oral equivalent dose from Day 1 to Day 10 or afterward; three patients decreased their dose but the AVERAGE stayed at 110-150 mg morphine oral equivalents per day (data NOT shown.) There was NO change in formal quality of life OR symptoms other than pain, as assessed by the Symptom Assessment Diary (data not shown.)"
... internal consistency is IMPORTANT...the pain scale used SHOULD NOT matter relatively...pain is PAIN on ANY scale...you may not be able to demonstrate significant differences but you SHOULD be able to show AT LEAST a similar trend in the effects produced by the therapy...by the same token, if you claim that you have removed 80% of a patient's pain, then you SHOULD be able to demonstrate a SUBSTANTIAL decrease in analgesic use -- people that aren't hurting DON'T need as much analgesics...and if 80% of a patient's pain is gone then they SHOULD be feeling a LOT better about life in general and that effect SHOULD show up as an improvement in "quality of life"...
...in conclusion, it's a TENS unit...it's a TENS unit that was approved as such by the FDA...it's a TENS unit that ALREADY has CPT codes...it's a TENS unit that is ALREADY reimbursed by insurance companies when the physician says it's medically necessary...TENS units can be bought for 40-50 bucks on Amazon...now, everybody that wants to pay 50 THOUSAND bucks for a TENS unit, raise your hands...anybody....any...
...by the way, NOW CTT says its applied for CPT codes specific to the "calmare"...however, their application is for Category III CPT codes and they gloss overthe FACT that such codes are of use ONLY as tags to help collect trial data and are NOT used in any way, shape, or form for REIMBURSEMENT...that's typical of the shenanigans that come from Competitive Technologies -- the company promoting the device...
(3)...and I won't even go into their bizarre history but suffice it to say it amazes me that they hired Thomas Kocherans as a distributor...in case you haven't kept up with my other posts, he's the former stockbroker who was sued not once but TWICE by the SEC for attempting to manipulate a stock's price; the second time the SEC sued him AND several others -- including CTT -- for attempting to manipulates CTT's stock price...the SEC fined him $50,000 for attempting to manipulate CTT stock and lo and behold he's now working for CTT!...check out the calmare pump page on Facebook under Spero Clinic...it looks like he has his entire family pumping the thing there!...the "Penny" that authors the page I'm guessing is his wife...and then there's Kelly Kocherans(sister?) who likes it...so does Theresa Kocherans(daughter?)..... look there would you, Ruth Larson Kocherans not only likes it but she even had her chronic back pain cured it!...
...maybe it's just me but it looks a tad "hinky" to employ a guy who was was sued for manipulating your stock's price, doesn't it?...ESPECIALLY when Tom's usual job is selling real estate!...makes you wonder, doesn't it?.
(4)...there are many other details...indeed, I felt compelled to file complaints with the FDA and the Federal Trade Commission about marketing of the device...after wading through several awkward webpages, I finally managed to send off:
"Basically, CTT sells a FDA approved TENS device it calls the "Calmare"...in marketing and selling this device, they make what I consider to be outrageous, physiologically impossible claims about how it works...for example, in their brochure, they claim their device "incorporates electromedical equipment for stimulation, and uses the nerve fiber as a passive
means to convey a message of normality to the central nervous system (CNS) by a procedure defined as scrambling or tricking of information, which then enables the CNS to modify the reflex adaptive responses."
...any neuroscientist will tell you that's just gobbledygook that sounds impressive but is basically nonsense...
...in that same brochure, they also say that "Doctors at a major US military medical center refer to it as TEMPR – Transcutaneous
Electrical Modulation Pain Reprocessor."...even aside from using the vague military reference to lend credence to their claim, they are clearly trying to change this thing from a TENS device to a "TEMPR" device -- even though there there really is no such thing as a "TEMPR" device and despite the device being approved ONLY as a TENS device...
...further in the same brochure, they say, "Using TEMPR technology, the patient does not become desensitized to treatments over extended cycles."...well, again, not only is there no such thing as "TEMPR technology," they have nowhere proved that patients do not become "desensitized" -- whatever "desensitized" means in this context...
...this device has started to appear in some clinics and the falsity continues...for example, from Sperotherapy's website comes this:
"Is this device similar to a TENS unit?
No. The Calmare® MC-5A device creates a low energy electrical impulse which travels through the patients nerves delivering a “no-pain” signal to the brain."
...well, it IS a TENS unit and claiming otherwise is simply false...and there is no such thing as a "no-pain signal"...then from your own website comes this:
"Calmare Pain Therapy Treatment (MC-5A) patented technology creates a series of complex artificial neuronal messages that are transmitted to the brain via the body’s dermatome pathways."
...again, more nonsense...it's physiologically impossible to send "a series of complex artificial neuronal messages" via "dermatome pathways" or any other pathway using electrodes applied to the skin...
...these treatments cost 150-250 dollars each and require -- so they claim -- 7 to 10 treatments to be effective...people seeking relief from pain shouldn't be exposed to double-talk and specious claims...it's a TENS device and should not be allowed to make claims beyond what is allowed for all other TENS devices..."
...I could have written considerably more but they only allow you 5000 words...
