The Shell Game for Shills: CTTC Has a New CEO

The Shell Game

Good morning, Dear Readers.

Without the least bit of a gloat and nary a reminder of the soul-sucking, money-stealing, totally bogus health claims made by CALMARE/Scrambler Therapy adherents, the "technology" that has kept CTTC (Competitive Technologies, Inc.) in the top spot of my list of CRPS Scams, I come before you with a heavy heart to announce that the robust company stock is for sale today at a steamy rate of .0553 -- that's per share, not the discounted price for the whole snake oil business, you chuckleheads!

As you know, I keep one ear to the ground -- not by choice, of course; it's more adherence to gravity -- and the word is that tomorrow is BOGO Day for CTTC.

On a more serious note, Competitive Technologies, "patent" capitalists, has come up with another filing to submit to the SEC.  I knew they'd get the hang of notifying the SEC of every smarmy, desperate move one day, after all that time of being unable to throw together something as simple as an earnings report equipped with super-glued pasties spinning the rip-off of people in severe and constant pain.  Just as they circle the drain, they master the art of big business!

It has to do with some staffing issues.  Here's the press release version of it:

FAIRFIELD, CT--(Marketwired - Oct 4, 2013) - The Board of Directors of Competitive Technologies, Inc., (OTCQX: CTTC) (CTI), today announced the appointment of Conrad F. Mir as President and chief executive officer, with full responsibility for running the corporation, and as a member of the Board of Directors. Mr. Mir will also serve as interim chief financial officer while the Board of Directors commences a search process to identify a suitable candidate to fill the role on a permanent basis. 

"With Mr. Mir's expertise in the micro-cap biotechnology space, along with his experience turning around distressed biotech companies, CTI has the right leadership in place to execute its corporate reengineering plan and enhance long-term shareholder value," said Peter Brennan, chairman of the Board of Directors of CTI. 

Mr. Mir has been mandated to implement a corporate reengineering plan (Plan), which he designed and presented to the Board of Directors. The Plan reengineers CTI's core business, cuts expenses, develops the wound care and bone technologies, and furthers our flagship Calmare© platform. 

The Board of Directors also announced the acceptance of Carl O'Connell's resignation as CEO. Mr. O'Connell has chosen to pursue other business opportunities, but will remain on the Board of Directors to provide continuity and ensure the Plan's success. He has agreed to serve as a special advisor to CTI in various medical technology capacities, including the ongoing development of Calmare. 

"Carl has a wealth of knowledge in the medical device field and will continue to be an instrumental part of the CTI team through his direction and guidance in the board room," added Mr. Brennan. 

In addition, CTI will not extend its consulting agreement with Johnnie Johnson, chief financial officer and consultant to CTI. The company is indebted to his hard work and wishes him success in future endeavors. 

About Mr. Mir
Mr. Mir has over twenty years of investment banking, financial structuring, and corporate reengineering experience. He has served in various executive management roles and on the Board of Directors of several companies in the biotechnology industry. Most recently, Mr. Mir was CFO of Pressure BioSciences, Inc., a sample preparation company advancing its proprietary pressure cycling technology. Before that, he was chairman and CEO of Genetic Immunity, Inc., a plasmid, DNA company in the HIV space, and was the executive director of Advaxis, Inc., a vaccine company. Over the last five years, he was responsible for raising more than $40 million in growth capital and broadening corporate reach to new investors and current shareholders. 

Conrad has worked for several investment banks including Sanford C. Bernstein, First Liberty Investment Group, and Nomura Securities International. He holds a BS/BA in Economics and English with special concentrations in Mathematics and Physics from New York University. He is a classically trained pianist and teacher, and a student of the martial arts. He is married with two children, alumni council chairman of Tau Kappa Epsilon fraternity - Tau Alpha chapter (NYU), and a member of NIRI. 

About the Company
Competitive Technologies Inc., (CTI) is a biotechnology company developing and commercializing innovative products and technologies. CTI is the licensed distributor of the non-invasive Calmare® pain therapy medical device, which incorporates the biophysical "Scrambler Therapy"® technology developed to treat neuropathic and cancer-derived pain by Professor Giuseppe Marineo.

[I eliminated the "Forward-Looking Statements" pro forma paragraph because of the dangers it imposed on readers -- a possible choking hazard, a means to the inadvertent snort of hot coffee into sinus cavities, etc.]

The Calmare device is currently being manufactured for sale by GEOMC Co., Ltd. of Seoul, South Korea.
Scrambler Therapy®: www.scramblertherapy.org/english.htm
Calmare®: www.calmarett.com
CTI: www.competitivetech.net 

Contact:Competitive Technologies, Inc.
Conrad Mir
President and CEOEmail Contact
973.798.8882 

JV Public Relations
Janet Vasquez
Managing DirectorEmail Contact
212.645.5498

Feeling duly diligent, I looked into the health of the boat from which Conrad Mir debarked. Pressure BioSciences, Inc and its 12 employees can boast a net profit margin for this year's second quarter of -297.99% , quite the decline from the -278.64% deficit for all of 2012.  They did post an improvement in operating margin, tightening that figure to a satisfying -239.84%.  Remember that old adage:   "If your business sustains a negative operating margin for too long, you might need additional funding"!

Oh, and if you are a neophyte investor, like me, you might want to heed Investipedia's advice about profit margins:

• This ratio is not useful for companies losing money, since they have no profit.
• A low profit margin can indicate pricing strategy and/or the impact competition has on margins.

Now, I have to say that Pressure BioSciences, Inc has much more interesting language in its "Forward Looking Statements" section than does poor Competitive Technologies, Inc.  For instance:

Further, given the uncertainty in the capital markets and the current status of the Company’s product development and commercialization activities, there can be no assurance that the Company will secure the additional capital necessary to fund its operations beyond September 2013 on acceptable terms, if at all. 

Not to sully the fine name of Yankee's pitcher Mariano Rivera, I am wondering if we might not hang the moniker of "The Closer" on Mr. Mir. Given that his tenure with Pressure BioSciences began in December 2012 and ended with such a huge leap up the rungs of corporate laddership in September 2013, we might even extend that nickname to another favored by that awesome relief pitcher:  "The Sandman."

Oops!  And "oops" is never a good omen!  I incorrectly calculated the time Mr. Mir spent leading Pressure Biosciences.  He managed to serve as CEO of another biotech endeavor, Genetic Immunity, Inc, in his free time before landing at CTTC.  Genetic Immunity, Inc is a subsidiary of Power of the Dream Ventures, Inc. [O Lord, take me now!] Power of the Dream Ventures, Inc is trading today at a whopping four cents.

Power of the Dream Ventures, Inc., (PDV), incorporated on August 17, 2006, is a holding company focused on technology acquisition and development enabling the delivery of concepts and ready to market products to the international market place. The Company develops, acquire, license or co-develop technologies that originates exclusively in Hungary... As of December 31, 2011, the Company had only realized limited revenues from its discontinued TothTelescope project and had not realized any revenues from other inventions.

The keenest review I could find for the TothTelescope was on a forum for telescope enthusiasts.  Rick said:
"I would be *HIGHLY* (I can't emphasize "HIGHLY" enough) suspect of this scope... The comments I have seen on Astromart and Yahoo BinocularAstronomy about this product echo this....someone even thought the website was meant to be a joke. I'm afraid it is meant to be a scam."

A joke.
A scam.
My, but the world is round, and the bean shuffled seamlessly from one shell to another, confounding even the most keen-eyed players of the game.

At least, in Mr. Mir's past, the sham toys don't seem to be aimed at desperate people living lives of declining quality, full of intense and unrelenting pain.  The pain to which he has limited himself -- until now -- appears to have been the familiar marketplace woe of separating a person from his or her money.

In keeping with my consistent attitude of respect for CTTC and their pseudoscientific, testimonial approach to business, tempered with the ardent compassion of a mature Marquis de Sade, I bid adieu to Carl O'Connell.  He's been the subject of much awe, proving worried parents of college students wrong by audaciously turning a degree in psychology into the fodder needed for growing companies in the related fields of "Neurosurgery, Ophthalmology, Orthopedics-Spine, ENT and Dentistry." You've got to figure Carl will land on his feet.








© 2013 L. Ryan

Dear President Obama: My Experience at the HealthCare.gov Marketplace

Hail to the Chief we have chosen for the nation, 

Hail to the Chief! We salute him, one and all. 

Hail to the Chief, as we pledge cooperation 

In proud fulfillment of a great, noble call. 

Yours is the aim to make this grand country grander, 

This you will do, that's our strong, firm belief. 

Hail to the one we selected as commander, 

Hail to the President! Hail to the Chief! 

Dear President Obama:

Every nerve ending in mine body is frayed, frazzled.

I began the search for coverage via the HealthCare.gov website promptly on September 13.  I know, it didn't go into effect until October 1, 2013, but I was anxious.  At that time, there was but a single insurance company in the bustling marketplace and since easily distraught, I became distraught.  Which led me into the arms of a very nice, calm, optimistic "navigator" -- our helpmates through this process -- Bill Rencher of Georgia Watch.

[Four Ruffles and Fluorishes for him, too!]

Since 1 October, I've been pestering the website dozens of times a day and receiving nothing but the the most polite error messages ever seen in cyberdom.  Repulsed, refused, unrecognized, I had about given up hope, despite the reassurances that the bugs in the system were slowly but surely being smushed into little bug pieces.  A carapace here, long sticky legs there, bulbous eyes strewn about.  Exoskeletons piling up, and with the government shut down, no one to sweep up the entomological detritus.  I say send 'em all to "Cry Me A River" Boehner.

Usually, Mr. President, I give no hints as to my political persuasions.  Yes, I used the plural, for like Whitman I contradict myself, I am large, I contain multitudes.  Ahem.

This morning, at 5 am, revolted by the idea of getting up to do something profitable for the domestic brood around me, I grabbed the computer and hit HealthCare.gov with something like a vengeance, but definitely with weepy eyes and no coffee.

After diddling around a bit, I created a new profile, ditched the old one, and kaboom, shazaam, wowza -- I was in!  Then I screwed up and had to call one of those blessèd telephone helpers, who was also confounded but wished me well.  I think, Mr. President, that she ended up helping out somehow, for a mere half-hour later, the glitch slid into the background of things.  It didn't disappear, but I was able to navigate from screen to screen and ignore the hell out of it.

Navigator Rencher, who helped calm the waters in September, had made several predictions about what my best options might turn out to be, coming from the Affordable Care Act's PCIP program, which ends precisely on 31 December.

He was right on all counts.  If I take up gambling, I'm bringing him with me to the racetrack.

If I could sneak past the First Lady and give you a prim kiss on the forehead, I'd do it in a heartbeat.  But what with all the shooting going on up there, they'd drop me with a head shot, for sure. (Gun control, anyone?  No destruction of the Second Amendment, just no guns for crazy people, registration and permits for all, no assault weaponry or accompanying ordinance, and equal restraint from law enforcement, including the Secret Service and Capitol Cops)

Since I doubt you'd break out into any Al Green on my account, I'll just say this here, in the safe haven of a nondescript blog:  God bless you, and thank you, President Obama.  I am a person with loads of physical woes that are constantly ganging up on my meager finances and limited sanity -- I worry, you see.  I don't want to be a victim, or whine about entitlement.  I don't want to bankrupt this good country.  But damn it, I need help.  My entire work life was dedicated to turning out well-educated citizens, both at university and at the proverbial "urban" high school level. I put my life at risk substitute teaching for the little ones, too, those cagey rug rats!  And I worked in Middle Schools where my status as a rube spread like wildfire, and the tweens often had me cornered between desk and blackboard, forcing me to throw chalk and lob erasers as a distraction.

In all seriousness, I had my life threatened and a student broke my hip in an attempt to escape capture by the kind and courteous police-people chasing him.  When I came back to work, one of my homeroom seniors stole my walker. To this day, I am convinced he was simply finding a novel way to encourage my physical therapy progress...

I was a GREAT teacher, Mr. President.  I loved my subject, I instilled a love for it in whomever the registrars put before me, and my students reveled in the concept of critical thinking and superb writing.  I'm just sayin'.  But these days, living on 60% of my year 2000 salary, no adjustment for the crazed costs of living, I need a little help.

Ted Kennedy would be bear-hugging you about now.

That website is going to drive many a USAmerican bonkers.  People unfamiliar with the terminology and the mathematics of health insurance are going to be breaking the backs of the Emergency Departments around the country as their heads begin to explode. I hope that was worked into the cost analyses.  But, like me, they will figure it out.  They will work with the outstanding navigators in their area, the phone wizards with infinite patience, and the online tech folk who speak plainly and make real suggestions -- even if those suggestions are initially aggravating.

I am now insured -- including a separate basic dental policy -- for less than what ACA's PCIP (a wondrous creation, that!) was charging. There's a whopper of a deductible awaiting me, and some nasty negotiations over medication formularies, and a doctor to switch out (but I've been secretly wanting to lose his Hoity-Toity-ness for some time, anyway).

And then there's the fear that this is all a dream.  That I filled something out wrong.

If I could throw chalk at a few Republicans for you -- I'd be up there in a minute.  But again, Mr. President, I don't want my pedagogical corrective measures to be misconstrued as some sort of attack, thereby ending my entretien with the GOP by a bullet square between my eyes.

Anyway, thanks.

You've done a great thing.

Sincerely,
Me and all the Gang at Marlinspike Hall
Tête de Hergé
(West of the Lone Alp)

P.S.  Should you and your family ever need access to an unmappable, unflappable resort that is impervious to GPS systems, Captain Haddock has ordered us to keep one of our finest wings ready.  He has even offered to ferry you here past the sharp eyes of your protective service, courtesy of an inexplicable undersea network of blackholed miniature submarine passages, all of which end nicely in our moat.

P.S.S. I decided to repost, just under this new letter to you, an older one, so as to aggrandize the scope of my experiences with obtaining heatlh insurance under your administration.  Let's call them bookends.  There are other mentions of you throughout this blog, as you've probably surmised.  My apologies for some of them.  There is even a shot of you in a video made at one of my lowest moments, but even that connection made for a "sí, se puede" rallying cry.

© 2013 L. Ryan

Repost: Dear President Obama

First published July 29, 2010, then again on November 7, 2012, and now brought out again and brushed off on October 6, 2013.

Sometimes it is good to look back, to see how things were, how impossible the situation seemed, and, having come out the other side with only minor wounds, to be grateful.

So let this be a companion piece to today's bookend of rejoicing: Dear President Obama: My Experience at the HealthCare.gov Marketplace.

***************   ***   ***************   ***   ***************

Dear President Obama,

This is a follow-up letter to the one I wrote you exactly one year ago.  I thought you might like an update.

It's been a long time since I cried tears of happiness, and I would like to thank you for creating the opportunity for me to sit here like a complete nitwit, boohooing my teeny-tiny brains out.

Truth be told, the occasional blissful moment in an excellent movie can provoke a brief weep -- but tonight, we're talking floodgates, and bitter saline drawn for release from the Secret Inner Pool.

On September 30, 2009, I became one of the many uninsured.  That's no great story, no Big Whoop, as the kids used to say, and I still do.

One of the many things I admire about you and your administration is your willingness to hear individual stories, and to believe in the integrity of the storytellers.  You don't ridicule instances, you don't seem to fear being overwhelmed by them.

Already permanently disabled by a severe case of one of the most severe of pain syndromes, CRPS/RSD [Complex Regional Pain Syndrome/Reflex Sympathetic Dystrophy], lupus [SLE], avascular necrosis/osteonecrosis [AVN/ON], and Some Other Annoying Crap [SOAC] -- it was a real blow to my quality, and even hope of, life to come down with osteomyelitis in my prosthetic shoulders and in the long arm bones themselves.

A complicated but not unmanageable situation, given enough Local Talent, and I am blessed with Local Talent Galore.  There are three excellent medical schools within spitting distance of Marlinspike Hall.

The Author of My Story decided to spice things up with plot twists:  Make the offending bacteria be so obscure, nasty, and recalcitrant that it could not be identified by the wily microbiologist's eye and proved resistant to any antibiotic made by mortal man;  Create such a snarl of confusion that even the we-have-seen-everything, ennui-stricken researchers at the CDC threw their hands in the air, preferring an honest Ebola virus to my obscure domestic germs;  Dictate that the conditions under which these bacterial cultures could be successfully grown existed only in the warm, moist, rum-soaked environment of my shoulders.

Each shoulder having previously been replaced, the prostheses had to be removed.  Surgical concrete laced with all sorts of charms and amulets took their place for periods of up to 3 months, and then, most often, had to be replaced with new ones, as surgical concrete, like all other things in my life at this point, tends toward entropy.  Seven surgeries, President Obama, in the space of 18 months.  Five stays in ICU, three stints on a ventilator, and two resuscitations.  A partridge in a pear tree. 

It was not easy.

Lest you think that the drama lessened between sessions in the operating room, I also single-handedly supported a cottage industry of infectious disease warriors, and co-opted all the free time of Marlinspike Hall's Manor Denizens.  Back and forth we went, inserting and tending PICC lines, infusing intravenous antibiotics several times a day, making blood offerings to appease the demanding serum levels of Haute Society Pestilence, and so on, and so forth.

None of this would have been possible, of course, without excellent insurance coverage.  It was thanks to the reluctant involvement of the Grand PooPah of Tête de Hergé's Insurance Commission that I had any coverage at all once our version of COBRA ran out (here, it's THE ASP).  I was already in a high risk pool, but it was an unregulated pool over which the Grand PooPah could only utter tsk:tsk:tsk! 

BCBS of Tête de Herge is a wily enterprise, and my insurance premiums began to rise, rise, and then rise a lot more.  Finally, it was decreed that as of October 1, 2009, I was to pay, in U. S. Dollars, $1513 a month, in addition to the annual $5000 deductible/out-of-pocket expenses.  The cost of being insured would now amount to 96.6% of my private disability income of $1996.20/month, an amount never adjusted for inflation, despite the spiraling costs of Everything, Everywhere.

Of course, we all know that if they would just accept Lumps of Pure Gold Studded With Blue Topaz, there'd be no problem.  It's this Social Contract involving Oblong Green Rags of Value that is screwing everything up.  Some proprietary blend of cotton, silk, and linen is worth more than my Studded Lumps?  I don't think so.

Anyway, a 41% hike in the space of 9 months finally forced me into the scary position of being in the middle of a health crisis without benefit of insurance.

If you read my blog, and we all know you don't, you would read account after account of daily fever, pain, sweats, fatigue, and the certainty that I would need to cheer up to be suicidal.  It's nothing but a broken record, and to make matters worse?  I now write like H. P. Lovecraft.

I almost went permanently insane during the Great Health Care Debate, especially when it looked like the Tea Baggers might succeed in excluding Aliens from Tête de Hergé (très décédé, d'ailleurs).  ArseHoles!

You about lost me as a supporter when you stopped fighting for the Public Option, and at several other murky junctures.  I lost a lot of my natural optimism, my well known spunk. When the package was passed, it was not clear to me what was actually about to happen, if anything.  Everyone said it would be years before the real impact of reform would be felt.

But whispers in the dark persisted, and the word on our unpaved back-country roads was that some sort of High Risk Pool for people labelled uninsurable was going to be available... in July 2010!

Tall tales went the rounds about some website somewhere, rumored to be PCIP.gov, that explained the possibilities in accessible language and without endless complication.

I went, myself, to the fabled site -- I saw it with my own eyes -- It is real, it is real!

There was one hoop through which I had to leap, and leap I did.  The application for coverage by the Pre-Existing Condition Insurance Plan required that a rejection letter based on pre-existing conditions be attached for eligibility.  The letter must date from within 6 months of the time of application.

Last weekend, I spent four hours filling out an insurance application from InHumana, detailing every instance of hospitalization, complication, treatment, diagnostic procedure, and ingrown toenail, and sent it off to Underwriter Land with fervent hopes for swift and complete rejection.

My rejection letter, which Fred is having framed, arrived today.  It is riotously funny, a moment of hilarity in the midst of my Personal Health Tragedy Epic Saga -- every Long Boring Story needs comic relief.

Sincere in my intent to make application to the PCIP, I poured myself a stiff one this evening, downloaded the .pdf file, printed it out, and girded my loins.

Five minutes later, I was done.

My vision blurred as I read about provisions for those who qualify within Tête de Hergé's territory.  I finally made out that my monthly premium would be $495. 

My hands began to shake when I stumbled on this:

In addition to your monthly premium, you will pay other costs. Covered in-network services are subject to a $2,500 annual deductible (except for preventive services) before the plan starts to pay benefits. Once you’ve met the deductible, you will pay a $25 copayment for doctor visits, $4 to $30 for most drugs at a retail pharmacy for the first two prescriptions and 50% of the cost of the prescriptions after that. If you use mail order, you will pay $10 for generic drugs or $75 for brand drugs on the plan formulary for a 90 day supply. You will pay 20% of the cost of any other covered benefits received from a network provider. Your out-of-pocket costs cannot be more than $5,950 per year.

And it was not long before I was weeping.  Fred, too.  La Bonne et Belle Bianca Castafiore even joined in, though she is well-insured by her operatic company.  Unfortunately, she pays more than your average soprano due to a, uhhh, errr... Cyst Situation.  But we won't talk about that...

I would love to shake your hand and give you a hug, maybe even a kiss on the cheek.  Michelle, too.  The girls and the darned dog, as well.  I don't think the Secret Service would much like that, so please accept the enclosed 2010 ManorFest TeeShirts for you and your whole family, instead.

I hope we guessed right on sizes, as they tend to run small.

Sincerely,

The Retired Educator
Your Greatest Fan




If you have serious medical conditions and cannot get insurance because of them -- this is a good place for helpful information and suggestions: Foundation for Health Coverage Education/Coverage for All.
photo credit: Steve Hopson

PART ONE: CRPS Clinical Trials [Open as of October 2013]

As much as I act like a hypoglycemic brat when I rant against such therapies as CALMARE/Scrambler and bet everyone to move carefully into all invasive procedures and implanted devices, into some of the edgier drug therapies... I do understand desperation.  Intimately!

Some people also have no health insurance and a clinical trial may be their sole access to care.  Others have intractable levels of CRPS but are still driven to try and help others, and so join in the studies to further scientific inquiry.  In studies with a healthy cohort used for comparison, friends and family of CRPSers can also play a helpful role in advancing knowledge of CRPS / RSD.

It's been a while since I've done a Clinical Trials update, using data from the U. S. National Institutes of Health.  There are other trials but I tend toward the conservative in these things, as wild as my politics can be.  Ahem.

What a shocker to see as a header on the NIH page:

Due to the lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. 

The next lawmaker (or pseudo-lawmaker) who treats this shutdown as some sort of triviality, think of kids with pediatric cancer who are fighting the clock to stay alive, whose parents are pounding their keyboards searching for options, while these Washington AssHats smugly think this is a political game.

Ahem.

Moving right along.  I used some judicious picking and choosing, as some of the options that resulted from my search didn't relate to a CRPSers' concerns.

Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)
ClinicalTrials.gov Identifier:  NCT01392599
Sponsor:  Medical University of Vienna
Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS) -- After incision of the skin a subcutaneous area of approximately 16 cm² (2.5 square inches) will be en block removed between dermis and muscle fascia. All prior detected and marked veins in the operating field will be ligated or coagulated precisely.The tissue defect generated by this operation will be closed by a full thickness or a meshed skin graft which arises during the preparation.
Detailed Description:

For 140 years the treatment of Complex Regional Pain Syndromes Type II (CRPS II) has been an unsolved problem. Recent findings in animal models assume that CRPS Type II is maintained by a coupling of newly sprouted sympathetic and sensible fibres. Therapeutic approaches have included conventional pain medication, physical therapy, sympathetic blocks, transcutaneous or spinal cord stimulation, injections or infusion therapies and sympathectomy. Alone or in combination these therapies often yielded unfavorable results. The majority of physicians dealing with CRPS patients are convinced that a surgical treatment of the affected extremity only exacerbates the symptoms, especially its hallmark excruciating pain.

Patients with a CRPS Type II at the upper or the lower limb will be included in the study after ineffective pain therapy for more than 6 months. The most proximal region of pain associated with CRPS can be localized and 2% Lidocain will be injected into that area. If the sympathetic, deep, burning pain can be blocked repeatedly with these injections, the subcutaneous veins in the previously determined area will be surgically removed. This operation should lead to the permanent resolution of symptoms.

A visual analogue scale (VAS), the Nottingham Health Profile (NHP), thermography and physical examinations will be used to evaluate the outcome of the operation.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Contact: Wolfgang Happak, Prof., MD 00431404006980 lukikriechbaumer@hotmail.com
Contact: Lukas K Kriechbaumer, MD 00431404007177 lukas.kriechbaumer@meduniwien.ac.at

Division of Plastic and Reconstructive Surgery, 

Department of Surgery, 

Medical University of Vienna

Vienna, Austria, 1090

Related publications recommended by study investigators:

Bruehl S, Harden RN, Galer BS, Saltz S, Bertram M, Backonja M, Gayles R, Rudin N, Bhugra MK, Stanton-Hicks M. External validation of IASP diagnostic criteria for Complex Regional Pain Syndrome and proposed research diagnostic criteria. International Association for the Study of Pain. Pain. 1999 May;81(1-2):147-54.

Albrecht PJ, Hines S, Eisenberg E, Pud D, Finlay DR, Connolly MK, Paré M, Davar G, Rice FL. Pathologic alterations of cutaneous innervation and vasculature in affected limbs from patients with complex regional pain syndrome. Pain. 2006 Feb;120(3):244-66. Epub 2006 Jan 19.

Oaklander AL, Rissmiller JG, Gelman LB, Zheng L, Chang Y, Gott R. Evidence of focal small-fiber axonal degeneration in complex regional pain syndrome-I (reflex sympathetic dystrophy). Pain. 2006 Feb;120(3):235-43. Epub 2006 Jan 19.

Arnold JM, Teasell RW, MacLeod AP, Brown JE, Carruthers SG. Increased venous alpha-adrenoceptor responsiveness in patients with reflex sympathetic dystrophy. Ann Intern Med. 1993 Apr 15;118(8):619-21. No abstract available.

Baron R, Schattschneider J, Binder A, Siebrecht D, Wasner G. Relation between sympathetic vasoconstrictor activity and pain and hyperalgesia in complex regional pain syndromes: a case-control study. Lancet. 2002 May 11;359(9318):1655-60.

Drummond PD, Finch PM, Smythe GA. Reflex sympathetic dystrophy: the significance of differing plasma catecholamine concentrations in affected and unaffected limbs. Brain. 1991 Oct;114 ( Pt 5):2025-36.

Two Measures of Tactile Acuity in CRPS Type I Patients
ClinicalTrials.gov Identifier:  NCT01888783
Sponsor:  Ruhr University of Bochum
Objective:  This study aims to investigate whether two different measures of tactile acuity lead to comparable results in patients diagnosed with CRPS Type I of the upper extremity. Additionally patients with a neuropathy of the median nerve and healthy controls are included.
Primary Outcome Measures:
tactile acuity as measured by 2-point-discrimination [ Time Frame: unique measurement of maximal one hour duration ] 

Thresholds on the tip of the index finger of boths hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Thresholds are taken from the fit at the distance at which 50% correct answers are given

tactile acuity as measured by the Grating Orientation Task (GOT) [ Time Frame: unique measurement of maximal half an hour duration ] 

Stimuli are taken from a set of dome-shaped plastic gratings with equal groove and ridge widths. Gratings are applied to the immobilized distal fingerpad of the index finger of boths hand with the ridges oriented either along or across the long axis of the finger in randomized sequences of the two alternatives. Subjects have to report the orientation of the gratings as "along" or "across". The largest groove widths in the set is 6mm, the minimal width is 0.5mm. Thresholds were taken from the groove width at which the performance was 75% correct. Unless the performance is exactly 75% for a particular grating, interpolation between gratings spanning the 75% correct responses ared used

Other Outcome Measures:
Touch threshold for light touch [ Time Frame: unique measurement, duration approx. 5 minutes ] 

Touch thresholds are taken from a set of von Frey filaments (0.25 mN - 512 mN). Touch sensitivity is investigated by using a staircase procedure during which subjects are required to close their eyes and report when they perceive an indentation of the skin on the fingerpad of the index finger. The applied forces are decreased in a stepwise manner until the subject no longer perceives the stimulus (lower boundary) and then increased until the stimulus is perceived again (upper boundary). This procedure is repeated 5 times resulting in 10 values that are averaged to provide the touch threshold.

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Inclusion Criteria:

Patients diagnosed with CRPS Type I according to the "Budapest Criteria"
Patients diagnosed with a neuropathy of the median nerve
Healthy Controls,matched in age and gender to both patient cohorts

Exclusion Criteria:

intolerable hyperalgesia
lesions at the fingertips
high grade digit contracture
central neurologic disorders
psychiatric disorders

Contact: Christoph Maier, Prof. Dr. +49 2343023402 Christoph.Maier@rub.de
Head Dep. of Pain Medicine, Ruhr University of Bochum
Contact: Marianne David, Dr. +49 2343023324 Marianne.David@rub.de

Department of Pain Medicine, 

BG Universitätsklinikum Bergmannsheil GmbH

Bochum, Germany, 44789

Effects of Repetitive Electric Sensory Stimulation (RSS) as Intervention in Complex-regional-pain-syndrome Type I (CRPS)
ClinicalTrials.gov Identifier:  NCT01915329
Sponsor:  Ruhr University of Bochum
The purpose of this study is to test a specific nerve stimulation protocol as therapeutic option in patients diagnosed with CRPS (complex regional pain syndrome) of the upper extremity.
Device: RSS (repetitive sensory stimulation)
Device: SHAM-RSS
Primary Outcome Measures:
static tactile 2-point-discrimination threshold [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ]

Thresholds on the tip of the index finger of both hands are assessed using the method of constant stimuli. One single needle and seven pairs of needles with different spacings are tested in randomized order. After each presentation, the subject has to report the sensation of one or two needles by answering immediately "one" or "two." Each distance is presented eight times resulting in 64 single decisions. The summed responses are plotted against distance as a psychometric function for absolute threshold and get fitted by a binary logistic regression. Threshold are taken from the fit at the distance at which 50% correct answers are given.

Secondary Outcome Measures:
pain intensity [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ] 

Pain intensity is rated by the patient on a 11-point numerical rating scale (NRS). Pain intensity is rated before the start of the 5 day stimulation phase (baseline,pre) and at the end (post, in combination with the other outcome measures). Additionally pain intensity is rated directly before the start of each daily stimulation session and immediately after each session of 45 minute duration.

Other Outcome Measures:
somatosensory evoked potentials [ Time Frame: before and after the 5 day stimulation phase with a minimum time of 1h between measurements and start/end of the stimulation (day1 pre and day 5 post) ] 

Somatosensory evoked potentials after electrical paired pulse median nerve stimulation are recorded. The median nerve is stimulated by innocuous paired electrical pulses conveyed to the nerve by a block electrode placed on the wrist. For correct positioning the subject has to report a prickling sensation in thumb, index and middle finger. Stimulation intensity is choosen to induce a small muscular twich at the thenar muscles. SEP recordings are done with a 3-electrode array. Two electrodes are fixed on the scalp over the left and right somatosensory cortex. The third (reference) electrode is fixed over the midfront. SEP signals get amplified and filtered and digitized in a PC.

Ages Eligible for Study:   18 Years to 75 Years

Genders Eligible for Study:   Both

Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients diagnosed with CRPS Type I

Exclusion Criteria:

intolerable hyperalgesia
lesions at the fingertips
high grade digit contracture
central neurologic disorders
psychiatric disorders

Location: Department of Pain Medicine, BG Universitätsklinikum Bergmannsheil GmbH
Bochum, NRW, Germany, 44789
Contact: Christoph Maier, M.D., PhD     0049234302 ext 6366     christoph.maier@rub.de    
Contact: Marianne David, Dr.     0049-234-303 ext 3324     Marianne.David@rub.de  

RCT :Thoracic Sympathetic Block for the Treatment of Complex Regional Pain Syndrome I of the Upper Limb
ClinicalTrials.gov Identifier:  NCT01612364
Sponsor:  University of Sao Paulo
Purpose:  This is a double-blind randomized controlled trial to evaluate the efficacy of the sympathetic block via thoracic vertebra T3 for the treatment of CRPS I upper limb. Patients with CRPS I refractory to medical treatment will be subjected to four physical therapy sessions and then the randomized for experimental or control block and then more four physiotherapy sessions. Patients will be evaluated after one month of the blockade (primary outcome) and then up to 12 months. Will be evaluated by analgesic scale (Mcgill, brief pain inventory, dn4 questionnaire, NPSI, VAS), functional (ADM) and quality of life (HAD and WHOQOL-brief).
Primary Outcome Measures:
Analgesia after block [ Time Frame: 1 month ] 
Analgesia (Mcgill, brief pain inventary, DN4 questionaire, VAS) and functional (ADM) evaluation.
Secondary Outcome Measures:
analgesia quality of life [ Time Frame: 1 year ]

Experimental: thoracic sympathetic block //  Sympathetic block of upper limb via thoracic vertebra T3:

Procedure: thoracic sympathetic block
Thoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2%
Other Names:
T2-T3 thoracic sympathetic block
T3 sympathetic block
T2-T3 thoracic dorsal sympathetic block
thoracic sympathetic ganglion block
thoracic sympathetic block

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Inclusion Criteria:

Complex regional pain syndrome (IASP, 1994) involving an upper limb;
Pain scores in excess of five visual analog scale (VAS);
Poor outcome to treatment (less than 50% reduction in VAS scores) 

Exclusion Criteria:

History of severe brain injury, epilepsy and stroke
Patients who had undergone sympathetic ganglion block for treatment of the affected limb, by any technique
Severe systemic disease
Addictive behavior, severe psychiatric disorders, psychiatric diseases untreated
Refusal to participate or not initial adherence to orientations
Refusal to be randomized in a treatment group or with contraindications to any of them pregnancy.

Contact: Roberto O Rocha, MD 551182668553 contato@drrobertorocha.com.br
Hospital das Clinicas, Faculty of Medicine, University of Sao Paulo
Sao Paulo, Brazil, 05403000
Sponsors and Collaborators: University of Sao Paulo; University of Sao Paulo General Hospital

Treatment of Complex Regional Pain Syndrome With Once Daily Gastric-Retentive Gabapentin (Gralise)
ClinicalTrials.gov Identifier:  NCT01623271
Sponsor:  Massachusetts General Hospital
Purpose: This research is being conducted to see if the drug Gralise can help people with Complex Regional Pain Syndrom Type I (CRPS I) without causing too many side effects. CRPS I is one of the most common conditions of neuropathic pain (pain that results from damage to nerves in the peripheral nervous system). Gralise is approved by the U.S. Food and Drug Administration (FDA) to treat postherpetic neuralgia (a complication of the disease Shingles, which is caused by the chickenpox virus), but is not approved to treat CRPS I.
Primary Outcome Measures:  Visual Analog Scale (VAS) [ Time Frame: 1 year ]
Secondary Outcome Measures:
Functional status [ Time Frame: 1 year ] 
Using the SF-MPQ questionnaire we can determine the subject's health and well-being, especially relating to their daily activities.
Side Effect Profile [ Time Frame: 1 year ] 
Common side effects include: dizziness, drowsiness, headaches, and swelling in extremities. Other side effects may include suicidal behavior or ideation and depression.
Drop Out Rate [ Time Frame: 1 year ]

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Inclusion Criteria:

Subject will be between 18 to 80 years of age.
Subject has not been on Gralise.
Subject has not been on gabapentin for at least one month.
Subject agrees to make no change in his/her current pain medications during the study period to ensure that comparisons can be made before and after the Gralise treatment.
Subject has a VAS pain score of 5 or above at the beginning of the study.
Subject has had CRPS I for at least three months to avoid clinical uncertainty and minimize the study variation.
Female subjects of childbearing age must have a negative urine pregnancy test at the initial visit.

Exclusion Criteria:

Subject has severe liver or renal disease that will affect the elimination of Gralise. (Renal dysfunction is defined as eGFR < 60. Hepatic dysfunction is defined as LFTs ≥ 3X ULN.)
Subject has pending litigation related to his/her CRPS I condition.
Subject is pregnant or lactating.
Subject is allergic to gabapentin or Gralise.
Subject has a positive urine (illicit) drug test.
Subject has any history of suicidal thoughts or behaviors, as self reported or in documented medical history.
Subjects with known seizure disorders (except febrile seizures) and/or taking antiepileptic drugs.

Contact: Trang T. Vo, B.A. 617-724-6102 tvo3@partners.org
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Principal Investigator: Jianren Mao, M.D., Ph.D.     
Related Publications Recommended by Study Investigators:
Mao J. Translational pain research: achievements and challenges. J Pain. 2009 Oct;10(10):1001-11. Epub 2009 Jul 22. Review.

Mao J, Chen LL. Systemic lidocaine for neuropathic pain relief. Pain. 2000 Jul;87(1):7-17. Review.

Mao J, Gold MS, Backonja MM. Combination drug therapy for chronic pain: a call for more clinical studies. J Pain. 2011 Feb;12(2):157-66. Epub 2010 Sep 17. Review.

Sindrup SH, Jensen TS. Efficacy of pharmacological treatments of neuropathic pain: an update and effect related to mechanism of drug action. Pain. 1999 Dec;83(3):389-400. Review.

van de Vusse AC, Stomp-van den Berg SG, Kessels AH, Weber WE. Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1 [ISRCTN84121379]. BMC Neurol. 2004 Sep 29;4:13.

TMS for CRPS - Pilot Study
ClinicalTrials.gov Identifier:  NCT01926119
Sponsor:  Stanford University
Purpose:  The purpose of this pilot study is to test whether Transcranial Magnetic Stimulation (TMS) may alleviate the symptoms of Complex Regional Pain Syndrome (CRPS). The investigators will test various methods of TMS in a small pilot study to investigate what methods may have clinical potential. This is a small pilot study to determine feasibility and signal to potentially inform future trials.
Primary Outcome Measures:
Change in pain [ Time Frame: End of each of the 5 treatment sessions and at 1-week follow-up compared to baseline ] 
Secondary Outcome Measures:
Change in motor function and coordination [ Time Frame: End of 5-day treatment series and at 1-week follow-up relative to baseline ] 
As assessed by functional capacity exam and physical exam
Change in sensory perception [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ]
Change in vasomotor function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] 
Change in sudomotor function [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] 
Trophic changes [ Time Frame: End of each treatment session and at 1-week follow-up as compared to baseline ] 
Change in motor strength and joint range of motion [ Time Frame: End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline ]
Experimental: TMS Intervention - TBS followed by High Frequency
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation
Experimental: TMS Intervention - High frequency stimulation followed by TBS
Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of High Frequency stimulation followed by Theta Burst Stimulation

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Inclusion Criteria:

Age 18 or older
Diagnosis of CRPS (complex regional pain syndrome)
Average pain level reported on Numerical Rating Scale meets entry criteria
Ability to perform the experimental task and procedures.

Exclusion Criteria:

MRI contraindication (metal implants or devices, claustrophobia)
TMS Contraindication (eg metal implant or devices near the site of stimulation)
History of epilepsy
History of a psychological or psychiatric disorder that would interfere with study procedures, at the discretion of the researcher.
Neurologic illness that would interfere with brain integrity
Current medical condition or medication use that would interfere with study procedures or data integrity, at the discretion of the researcher.
Currently pregnant or planning to become pregnant.
On going legal action or disability claim.

Contact: Sean Mackey, MD, PhD smackey@stanford.edu
Stanford University School of Medicine
Palo Alto, California, United States, 94304
Contact: Rebecca McCue     650-724-2795     snapl@stanford.edu    

© 2013 L. Ryan