elle est belle la seine la seine elle est belle

Welcome to Marlinspike Hall, ancestral home of the Haddock Clan, the creation of Belgian cartoonist Hergé. Some Manor-keeping notes: Navigation is on the right, with an explanation of the blog's fictional basis. HINT: Please read the column labelled "ABOUT THIS BLOG." Enjoy the most recent posts or browse posts by posting date in the Archives. Search the blog for scintillating, obscure topics. Enjoy your stay! There are some fuzzy slippers over there somewhere, too.

Showing posts with label Clinical Trials. Show all posts

Thursday, January 31, 2013

CRPS: Open Clinical Trials (and those not yet recruiting)

My apologies to CRPS-ers for not having updated recently on Clinical Trials. Unfortunately, despite the delay in posting, I recognize the continued inclusion of studies that don't seem to have made much progress or perhaps may not be active. Please perform your own due diligence.

Clinical Trials in Cartoons

***The Effect of Vitamin c on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture
Condition: Ankle Fracture
Interventions: Dietary Supplement: vitamin c; Drug: placebo
NOT YET RECRUITING

***Surgical Treatment Of Complex Regional Pain Syndrome Type II (CRPS II)

ClinicalTrials.gov Identifier: NCT01392599

Condition: CRPS Type II

Procedure: SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)

Sponsor: Medical University of Vienna

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% Lidocaine 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.

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

Suggested Reading for More Information:

--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.

***The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy

Conditions: Diabetic Neuropathies; Complex Regional Pain Syndrome Type II; Resistant Peripheral Neuropathic Pain; Chemotherapy Induced Pain Neuropathy

Device: TDCS/sham procedure on five consecutive days

NOT YET RECRUITING

***Study of Proteins Associated With Complex Regional Pain Syndrome
Conditions: Complex Regional Pain Syndromes
ClinicalTrials.gov Identifier: NCT00033969
Sponsor: National Institute of Nursing Research (NINR)
Detailed Description:

The etiology of Complex Regional Pain Syndrome (CRPS) is unknown but a patient typically presents with a triad of clinical findings: sensory abnormalities, perfusion abnormalities and alterations in motor function. Since some of these findings are seen in other disease states, the diagnosis is often not clear. A response to a sympathetic ganglion block (stellate or lumbar) is also suggestive of the disorder. However, there is no definitive diagnostic test for CRPS. Experience has shown that early aggressive treatment improves the prognosis. Therefore, tests that facilitate the early diagnosis would have important clinical implications.

Advances in laboratory techniques allow analysis of clinical samples to identify protein or patterns of protein changes associated with a disease state. Patients suffering with CRPS who are currently seen in a pain clinic will be asked to participate in this study. The subjects will complete a brief symptom survey, be examined by a co-investigator to document sensory, temperature and trophic changes, and have a blood sample collected for protein and gene expression (RNA) analysis. Blood samples from age-matched controls will be collected from non-CRPS patients. Fifty patient samples collected from each group will be analyzed and used to teach the diagnostic software and an additional 20 samples (10 controls, 10 CRPS patients) will be used to validate diagnostic accuracy.

Contact: Andrew J Mannes, M.D. (301) 594-7328 amannes@mail.nih.gov
Additional Information: NIH Clinical Center Detailed Web Page
Suggested Reading for More Information:
--Bichsel VE, Liotta LA, Petricoin EF 3rd. Cancer proteomics: from biomarker discovery to signal pathway profiling. Cancer J. 2001 Jan-Feb;7(1):69-78. Review.
--Bittner M, Meltzer P, Chen Y, Jiang Y, Seftor E, Hendrix M, Radmacher M, Simon R, Yakhini Z, Ben-Dor A, Sampas N, Dougherty E, Wang E, Marincola F, Gooden C, Lueders J, Glatfelter A, Pollock P, Carpten J, Gillanders E, Leja D, Dietrich K, Beaudry C, Berens M, Alberts D, Sondak V. Molecular classification of cutaneous malignant melanoma by gene expression profiling. Nature. 2000 Aug 3;406(6795):536-40.
--Chelimsky TC, Low PA, Naessens JM, Wilson PR, Amadio PC, O'Brien PC. Value of autonomic testing in reflex sympathetic dystrophy. Mayo Clin Proc. 1995 Nov;70(11):1029-40.

***Near-infrared Spectroscopic Measurement in Complex Regional Pain Syndrome
ClinicalTrials.gov Identifier: NCT01586377
Condition: Reflex Sympathetic Dystrophy
Sponsor: Lawson Health Research Institute
Information provided by (Responsible Party): Geoff Bellingham, Lawson Health Research Institute
Detailed Description:

The pathophysiology of CRPS-1 is unknown yet a considerable number of studies suggest that the fundamental cause of abnormal pain is due to microvascular pathology of deep tissues.

Reduced blood flow to deep tissues such as muscle, nerve, and bone can lead to a combination of inflammatory and neuropathic pain processes (Coderre TJ et al. 2010). Evidence to support this model of microcirculatory dysfunction includes observations that skin capillary oxygenation is decreased and skin lactate is increased in affected limbs of patients (total of 11 patients in lactate study) (Birklein F et al. 2000, Manahan AP et al. 2007). It has also been reported that patients with CRPS-I have abnormal vasodilatory responses after sympathetically-mediated vasoconstriction (Dayan L et al. 2008) and decreased concentrations of nitric oxide in the affected limb (Groeneweg JG et al. 2006).

Near-infrared spectroscopy (NIRS) is a non-invasive method of measuring tissue oxygenation using the differential absorption properties of oxygenated and deoxygenated hemoglobin in biological tissue (Creteur J 2008). Near-infrared light is only transmitted through small vessels with diameter less than 1 mm (arterioles, venules and capillaries). Since NIRS is limited to monitoring only small vessels, it can be used to assess oxygen balance in the microcirculation of skeletal muscle (Creteur J 2008).

Premise 1: Complex regional pain syndrome is associated with microcirculatory dysfunction

After an injury to a patient's limb, it is hypothesized that the pressure exerted by that swelling within a relatively confined anatomical space can occlude the capillaries of adjacent tissues and cause a compartment syndrome-like injury. Coderre et al. (2010) have theorized that the resulting microcirculatory dysfunction causes a persistent inflammatory state which is then responsible for pain generation.

In an animal model of ischemia-reperfusion injury used to study CRPS-1, microscopy of muscle and nerve tissue demonstrates microvascular evidence of a slow-flow/no-reflow phenomenon (Coderre TJ et al. 2010). Existence of a slow-flow/no-reflow state causes persistent inflammation in deep tissue. Animals subsequently develop hyperemia and edema, followed by mechano-hyperalgesia, allodynia, and cold-allodynia lasting for at least 1 month (Coderre et al. 2010). This clinical picture is similar to the clinical signs of those patients afflicted with CRPS-1.

Premise 2: Vascular occlusion testing measures microcirculatory dysfunction NIRS measurement of peripheral tissue oxygen saturation (StO2), combined with a reproducible ischemia-reperfusion challenge to induce reactive hyperemia (vascular occlusion testing - VOT), has been described as a valid and reliable method for assessing microcirculatory dysfunction (De Backer et al. 2010). This involves a short period of forearm ischemia by inflating a blood pressure cuff on the upper arm. The blood pressure cuff is then released after approximately 3 minutes and this followed by reperfusion of the forearm. This stimulates the release of endogenous nitric oxide (NO) from the microvascular endothelium (Harel et al 2008). Measurement of this hyperemic response using NIRS has been demonstrated to be a feasible non-invasive method of quantifying microcirculatory function. This technique shares strong correlation with the gold-standard method of strain gauge plethysmography (Harel et al. 2008).

Contact: Geoff A Bellingham, MD FRCPC (519) 646-6100 ext 64218 geoff.bellingham@sjhc.london.on.ca
Location: Canada, Ontario
Pain Clinic, St. Joseph's Health Care London Hospitals
London, Ontario, Canada, N6A 4V2

Monday, September 10, 2012

Manor Keeping and Blog Chores

There are so many housekeeping chores that need doing to get this blog back in shape.

I promised to follow three things in particular -- news and developments about missing child Lindsey Baum; news and developments about Dr. Scott Reuben; and updated information on CRPS Clinical Trials.

Now, of course, I would add the four cancer kids that I follow, as well as the continuing truth that Dr. Jose Ochoa is a Turd.

And then, well, there is my fascinated hatred for creatures like Dr. Phil and Oprah, and my desire to wrench others away from their mesmerizing bullshit. These are people of quality who just refuse to trust themselves, who have a tendency to love being on the receiving end of domination. (What? It's only the truth. Domination, even cruelty, equals attention, and they have been denied attention their whole lives. All they want is to be seen and heard -- no matter that they are being used, pimped, fucked.)

Of course, dealing with osteomyelitis and CRPS (the biggies) has completely taken over elle est belle la seine la seine elle est belle, whether I allow a safari vacation into Amerikan politics, French politics, socialist circles, or even the wild and woolly adventures we have in the various kitchens of Marlinspike Hall. My pus-dripping bones and my wildly contorting legs and hands trump the hell out of the Militant Lesbian Existentialist Feminists, even the three of them who'd switch teams in a New York minute if it meant they could hunker down with my oblivious Fred. I did not fall off of the produce truck recently and although I was born at night, they had to use pitocin.

I've put life in The Manor and the many fascinating details of maintaining such a landmark on the blog's back burner, too, but, O! There are reasons for that and fear not, as soon as we are covered by the expected extensions of President Obama's Dream Act to us outlanders, Tante Louise will call off the surveillance.. Okay, so we're not young, but we are illegal, and we are immigrants.

We are squatters!

La Bonne et Belle Bianca Castafiore is so head-over-heels in lust with Sven, and they both are steadfastly and stealthily kept in view by Sven's lad Cabana Boy -- and to tell the truth, this has killed some of my desire to write. They keep the air redolent with stinky tension.

I almost and by complete ACCIDENT killed myself yesterday -- by gentle respiratory depression. Fentanyl patches, according to the manufacturer, are to be changed every 72 hours. My pain guru wants me to change them every 48 hours. I, of course, allow the earlier applied one to stay on an extra day, thereby milking out, or so I hope, every bit of pink-unicorn-fart pain relief.

The things do not stick well to my skin, mostly because I constantly cycle between being hot and dry, having sweats and chills. Also, I bathe. I bathe a lot.

Okay, this bothers me, so just let me get it out of my system, as if it were a bit of toxic fentanyl floating around in my psychic innards. I love a bath. I haven't been able to take a bath since... 2000. I shower. I use a shower chair and one of those wunnerful, wunnerful wand shower heads. I leave the bathroom sobbing and usually have to take a rescue dose of endocet and climb in bed, praying and crying, snot all over the place, sweating, destroying that fresh, clean feeling a shower is supposed to impart. Now, due to weakness and spasms, I shower twice a week. I bathe at the bathroom sink twice a day, usually more often. I use various antiseptic products, especially the ones that are commonly used as preop washes, trying to destroy any goddamn p. acnes bacteria hanging around. I've been told this is a ridiculous thing to do, as well as impossible and perhaps undesirable... but I do it anyway. I stomp on those toxic bastard bacteria.

Whew. Okay. Yeah, so bless my Stepmother who inculcated in me an obsession for cleanliness. Captain Haddock sure gets his money's worth out of my hyperfocus -- there are no cleaner medieval tapestries than the ones hanging on his manor's walls. I was born a maid.

Okay, let's reword that: I was born with maid tendencies. When I took career assessment testing in junior high school, the answer was always, "be a maid."

There are twisted ways that could have gone. I clean up. I believe I'd also have been a great assassin. I used to maintain a list of People Who Need Killing -- but someone, somewhere, must have snagged a copy, because they all just sort of started dying without me doing a doggone thing. And now, the world has changed so much, so quickly, that I am scared of making a mistake -- so no one has been added to the People Who Need Killing List since Pinochet died. Six years of no entries. A rusty assassin is a useless assassin. Just ask Clint Eastwood, or the chair.

I spent the night screaming. Pain. Muscle Deformations. I kept dreaming that my Father, recently deceased, who had been dreamily safely ensconced in a federal prison, had been released and no one knew where he was. I dreamt he was comin' after me. Then I would wake to find my right leg jammed into the wheelchair, and my body turned on my left non-existent shoulder. And so on and so forth. I finally got up at 3 am, mad. Mad at whom, I've no idea, but Fred was up, so I treated him to some of the door-slamming he so loves. He didn't notice a thing, the benevolent abstraction!

So I decided to calm myself and quiet down the door banging by taking a shower.

At which time I discovered FOUR fentanyl patches, all firmly adhering to my skin. All should have been neatly labelled with the day applied (I put a bandaid over them to help keep them on when the sweats and chills kick in, and write the application date onto the bandaid).

To the best of my muddled recollection, twice I thought the thing had fallen off, and so twice had replaced the supposedly missing pain patch with a new one. And in each case, it was the bandaid that was gone, not the patch. Yes, I had opened a new box of Made in the USA bandaids, a pharmacy brand that shall be henceforth banished from this usage, at least.

Yes, my eyes are that bad, also the patches are pretty much translucent. I had been fretting about the cats, fearing that they'd find the fallen fentanyl "pain systems," lick them, play with them, and promptly die. Sven, Bianca, and Cabana Boy? They are more drinkers than druggies. And Fred laughs at the idea that exposure to fentanyl could harm him. I also had a good fret or two over the koi, thinking that maybe the patches went flying out some window and down into the moat.

We've banned the carnies and Cirque du Soleil habitués from entering The Manor, so I couldn't see how the true fierce addicts around me could have gotten hold of them -- and lately, they've all been confined to The Barn. Long story.

Yeah, so I almost died, sorta. I mean, I guess I could have. I was certainly drowsy enough and snoring like a giraffe troubled by amplified adenoids -- before all the pain (despite four fentanyl patches) and contractions pushed me from the bed, to work, to a good sweat, to another shower.

The irony is that this week I am meeting with a lawyer to rework my living will, my standard will, my various powers of attorney, and seeking guidance on getting a DNR.

I can tell you that there is NO news about Lindsey Baum, that Scott Reuben chafes under the restrictions placed upon him (I'm sure it is a mystery to him why trust is so hard to come by), and if you want the latest CRPS clinical trials, it's easy -- just go HERE. The only extra gifts I ever offered in my listings of the clinical trials were my not-so-expert opinions, and adding some suggested reading to better understand what was at stake. But you, Dear Reader, don't require that. It was more along the lines of me, as a high school sophomore, "showing my work" on a geometry test. Yes, a "proof" of some kind.

Of the four young ones fighting cancer that I follow, Hannah is doing great, as is Kate (she shows no evidence of *any* tumor!), Braydon struggles, and the last young man will not live much longer. I am also following a teenager, mostly because I saw her picture after she had died her hair a beautiful punk pink -- before losing it all, of course, by a new course of chemotherapy. She has relapsed but is kicking cancer's big fat butt by a punked out perky attitude, and by loving parents who never leave her side, and who pray all the live long day. There are others -- you cannot help yourself, because the kids you follow all have blogging parents who do not cease to ask for your consideration for the kid in the room next door, or for so-and-so who has developed a nagging pain but whose MRI is not scheduled until October... I can tell you that pediatric oncologists must have a healthy respect for parents and their "gut feelings," their intuition, their "something is not right with my child." In short, my cancer kids are doing better, as a group, than they usually are, and they are inspiring and uplifting, each and every one.

I posted a piece called "Billy" on September 5. He's not a cancer kid, he's a cancer grown-up! He has stage 4 lung cancer, and I will save my speeches on smoking, because, as an ex-smoker, I do understand. No, not true, he continues to smoke, and THAT, I cannot fathom.

Anyway, Dear Readers, Billy and Joyce are an odd couple, getting closer now that it is too late to say their marriage was a good one. But they do understand one another and they do love each other. She has carried on her back the welfare of two grown daughters, both of whom refused to leave home, one of whom has three boys, all with what we like to call "issue." Joyce's siblings and other close relatives all struggle with addiction. She is raising one of her sister's children, which is the working miracle in that child's life, because Joyce never gave in to addiction, never gave in to the lifestyle and values around her. So Shawna is a star student with a bright future. Joyce is disabled now, living entirely on entitlement programs, as is everyone in the family, really.

Billy is schizophrenic. He is a U.S. military veteran.

They have *nothing* but the items in their apartment, in material terms. No vehicle. The vast wealth of their benefits tend to run out before the month does.

And now he has been dumped there, in a hospital bed, with oxygen, a walker, and all that good stuff. Hospice is supposedly on the case, but mostly they have dumped him, too -- telling Joyce to do this, this, and this... and Joyce is sick and tired, and also still overseeing her girls and her three grandsons. She has to walk everywhere, and most of her pain is centered in her legs and back, so those walks, that she used to love, are now akin to traipsing from Bataan to Corregidor.

Give them some money. Christina, one of Joyce's daughters, has set up a fundraiser through the very legitimate FundRazr. Ask questions, if you are dubious. Give a dollar, two, or three. That's more than they have, even after digging under the cushions on the sofa.

Listen -- they save stray cats. They keep those sons and grandsons in scouting, in church. They guard their innocence fiercely. They tend to Billy as best they can but are obsessed with not having the money to bury him. Joyce hates vegetables. Her other daughter is mentally ill but helping out as best she can. Shawna's biological mom is back on drugs and as recently as yesterday, Joyce forced her off the premises with the instincts of a good, protective parent.

The problems are a burden even to listen to. But they're real... and Joyce has begun to turn her life around, and where her life goes, all those other lives glommed onto her for sustenance? They get turned around, too.
I don't want to see one iota of the beautiful progress this beautiful woman has made degraded by something as obscene as CANCER and a Veteran's Administration that just doesn't give a hoot.

That's about it for me right now. One of the 843 smoke and carbon monoxide detectors in Marlinspike Hall is chirping, letting me know it's in need of a fresh battery. I'm going to get The Gun and shoot it. As soon as I find it....

Wednesday, June 29, 2011

CRPS Clinical Trials Open as of June 2011

By open clinical trials, I mean that either recruitment has not yet begun or is ongoing. The U.S. National Institutes of Health listings presently contain 17 such trials:

1. The Effect of Vitamin C on Preventing Complex Regional Pain Syndrome (CRPS Type I) Following Ankle Fracture
ClinicalTrials.gov Identifier: NCT01338129
Location: Rabin Medical Center, Petah Tikva, Israel

2. Graded Exposure (GEXP) in Vivo Versus Physiotherapy in Complex Regional Pain Syndrome Type I (CRPS-I)
ClinicalTrials.gov Identifier: NCT00625976
Responsible Party: Dr. M. Goossens, Maastricht University, Maastricht, The Netherlands

3. Pain Exposure Physical Therapy (PEPT) Versus CBO in Patients With Complex Regional Pain Syndrome Type I (CRPS-1) (PEPTOC)
ClinicalTrials.gov Identifier: NCT00817128
Study Sponsor: Radboud University, Nijmegen, The Netherlands

4. Study of Proteins Associated With Complex Regional Pain Syndrome
ClinicalTrials.gov Identifier: NCT00033969
Location: National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States, 20892

5. Intravenous Immunoglobulins in Complex-regional Pain Syndrome (PAINLESS)
ClinicalTrials.gov Identifier: NCT00949065
Responsible Party: Franz Blaes, MD, Dept. of Neurology, Justus-Liebig-University, Am Steg 14, 35392 Giessen, Germany
franz.blaes@neuro.med.uni-giessen.de

6. Neurotropin to Treat Chronic Neuropathic Pain
ClinicalTrials.gov Identifier: NCT00006289
Location: National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States, 20892
Sponsor: National Institute of Nursing Research

7. Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial
ClinicalTrials.gov Identifier: NCT01118715
Responsible Party: Michael Shuler, MD, J&M Shuler, Inc.
706-424-8438

msimmss@hotmail.com

8. Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)
ClinicalTrials.gov Identifier: NCT01134289
Location/Contact: Department of Anesthesiology and Pain Medicine, Seoul National University Hospital,
Seoul, Republic of Korea, 110744
Soo Young Park, MD 82-2-2072-0881 soo02@snu.ac.kr

9. Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents
ClinicalTrials.gov Identifier: NCT01118988
Responsible Party: Lonnie K. Zeltzer, MD/Professor, Director of UCLA Pediatric Pain Program, UCLA Department of Pediatrics
Contacts: Lonnie K Zeltzer, MD 310-825-0731 LZeltzer@mednet.ucla.edu
Jennie CI Tsao, Ph.D. 310-825-0731 JTsao@mednet.ucla.edu

10. Evaluation and Diagnosis of People With Pain and Fatigue Syndromes
ClinicalTrials.gov Identifier: NCT00677157
Sponsor: National Institute of Nursing Research (NINR)
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov

11. Regional Anesthesia Military Battlefield Pain Outcomes Study (RAMBPOS)
ClinicalTrials.gov Identifier: NCT00431847
Contact: Yolanda S Williams, MPH
(215) 823-5800 ext 2774
yolanda.williams5@va.gov
Contact: Holly Luu, BA
(215) 823-5800 ext 6506
holly.luu@va.gov
Sponsored by the Dept of Ver
Principal Investigator: Rollin McCulloch Gallagher, MD MPH, Pain Management Service
LOCATIONS:
Locations

United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307
Contact: Lt. Col. Chester C Buckenmaier III, MD 202-782-7652

United States, Maryland
National Naval Medical Center
Bethesda, Maryland, United States, 20889
Contact: LCDR Michael Kent, MD 202-782-0917

United States, Pennsylvania
Pain Management Service
Philadelphia, Pennsylvania, United States, 19104
Contact: Lynn A Watson (215) 823-5800 ext 6023 lynn.watson@va.gov
Contact: Yvette Roberts (215) 823-5800 ext 6020 yvette.roberts@va.gov
Principal Investigator: Rollin McCulloch Gallagher, MD MPH
Sub-Investigator: Joan S Thomas
Sub-Investigator: Holly Luu, BA
Sub-Investigator: Yolanda S Williams, MPH

United States, Texas
US Army Institute of Surgical Research/Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Contact: Cpt. Laura McGhee, PhD 210-916-5482

12. Susceptibility to Chronic Post-Traumatic Extremity Pain
ClinicalTrials.gov Identifier: NCT00672711
Contact: Cecile Pestano, RN
248-964-3440
cpestano@beaumont.edu
Contact: Nickole Carlson, RN
248-898-1907
NCarlson@beaumont.edu
Responsible Party: Craig T. Hartrick,MD, William Beaumont Hospital (Royal Oak, Michigan)
Phone: 248-898-1907

13. Efficacy of Etoricoxib on Peripheral Hyperalgesia
ClinicalTrials.gov Identifier: NCT01088256
Responsible party/Contact: Dr. Christoph Maier +49/234/3026366 christoph.maier@rub.de
Ruhr University of Bochum, Germany

14. Adenosine Activity in Producing Venoarteriolar Reflexes
ClinicalTrials.gov Identifier: NCT01280071
Location: Tel-Aviv Sourasky Medical Center, Israel
Contact: Lior Dayan, MD
972504051014
liordayan.3105@gmail.com

15. Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
ClinicalTrials.gov Identifier: NCT00349050
Responsible Party: Jeffrey J. Borckardt, Ph.D., Associate Professor, Department of Psychiatry and Behavioral Sciences, Department of Anesthesiology and Perioperative Medicine, Medical University of South Carolina (Charleston)
(843)867-5142

borckard@musc.edu

16. Dupuytren's Disease and Extracorporeal Shockwave Therapy (DupuyShock-2010)
ClinicalTrials.gov Identifier: NCT01184586
Location: Hannover Medical School, Plastic, Hand and Reconstructive Surgery, Hannover, Germany, 30625

Contact: Karsten Knobloch, MD
0049511532 ext 8864
knobloch.karsten@mh-hannover.de

Contact: Marie Kuehn
0049511532 ext 8864
Marie.Kuehn@stud.mh-hannover.de

17. Effects of Vaporized Marijuana on Neuropathic Pain
ClinicalTrials.gov Identifier: NCT01037088
Contact: Haylee E. Donaghe, MS

916-734-2935
hedonaghe@ucdavis.edu
Principal Investigator: Barth L Wilsey, MD University of California, Davis

Friday, July 30, 2010

August 2010: CRPS Clinical Trials, Part Two

I apologize for leaving you hanging after "Part One." Here are the remainder of the clinical trials currently seeking volunteers, or about to enlist participants.

Some of these studies have been listed... forever, and are also past their own termination dates, so I have not listed them.

As usual, keep a sharp eye for the details -- where the study takes place, eligibility requirements, exclusion criteria, type of treatment (if any). In a few cases, it might be worthwhile to note who is backing or funding the study.

Good luck!

** The Efficacy of Motor Cortex Stimulation for Pain Control
OBJECTIVE: .
Each of these groups of 6 patients (total of 18) will be studied independently and all patients will be implanted with a motor cortex stimulation system. They will be randomised to either a regular or low stimulation setting in the two arms of the study. Each arm will last 3 months...
The aim of this study is to examine the effectiveness of this modality in a controlled blinded manner, which has not been done in previous studies. There are two primary purposes of this study. The first is to compare two different stimulation paradigms: "high" level stimulation (i.e. stimulator activated 'on' for 10 minutes, 'off' for 2 hours; presumed therapeutic dose); versus "low" stimulation ('on' for 1 minute, 'off' for 6 hours; presumed subtherapeutic dose), in a prospective blinded crossover study design.

The second purpose of this study, is to examine the outcome of MCS in three different pain groups. These are:
1.Unilateral upper extremity neuropathic pain such as brachial plexus avulsion, stump pain or phantom limb pain
2.Neuropathic deafferentation facial pain
3.Upper extremity complex regional pain syndrome (CRPS)

Inclusion Criteria:

1.Diagnosis in one of the following three categories:
◦Unilateral upper extremity neuropathic pain such as phantom limb pain, stump pain or brachial plexus avulsion
◦Neuropathic deafferentation facial pain
◦Upper extremity complex regional pain syndrome (CRPS)
2.Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
3.Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
4.Patients who are willing to provide informed consent.

Exclusion Criteria:
1.Patients who are not considered medically fit for neurosurgery.
2.Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation.
3.Patients who are not able to provide informed consent.
4.Patients unable to have magnetic resonance imaging (MRI).

CONTACT: Robert M Brownstone, MD, PhD 902 473 6850 rob.brownstone@dal.ca
Dalhousie University, Queen Elizabeth II Health Sciences Centre CANADA

Publication perhaps of interest: TEMPORARY SPINAL STIMULATION FOR PERIOPERATIVE MANAGEMENT OF CRPS

Dr. Ian Beauprie. MD FRCPC: Dr. Rob Brownstone, MD, PhD, FRCS; Dr. Justin Paletz, MD, FRCS, QEII Health Sciences Centre, Halifax, Nova Scotia -- presented at the Canadian Pain Society Conference, March/April 2010

Select publications from Dr. Brownstone's Lab (Motor Control Laboratory), Dalhousie Univ, Halifax, Nova Scotia. CANADA: click here.

** Analysis of Photoplethysmographic Signal in Lumbar Sympathetic Block (park001)
Historical versions of this study are available here.
[Excuse the intrusion of this blogger's opinion, here, but I have qualms about a study that perpetuates the notion and practice of sympathetic blocks as diagnostic for CRPS.]
Inclusion Criteria:

•Physically examined for complex regional pain syndrome on lower extremity,
•Scheduled for diagnostic lumbar sympathetic blockade.
Exclusion Criteria:
•Graded as ASA 3 or higher,
•Below 18 or above 70 years of age, or
•Had any other contraindication for regional anesthesia.
LOCATION: REPUBLIC OF KOREA, Clinical Research Institute, Seoul National University Hospital
NO CONTACT INFO LISTED

** Peer Mentorship: An Intervention To Promote Effective Pain Self-Management In Adolescents
DETAILED DESCRIPTION/PRESENTATION OF PRELIMINARY DATA:
Background:

Chronic intractable non-malignant pain, including such functional disorders as irritable bowel syndrome is now recognized as a significant problem in children and adolescents, with potential long-term impact on the child's physical, social, and academic functioning, as well as on the family as a whole. A recent study of more than 5000 Dutch school children under 18 found that more than 25% reported suffering recurrent or continuous pain for more than 3 months, with the prevalence increasing with age; and a survey of 735 German children aged 10-18 using a modified version of the same instrument found the same for 45.5%. The most common types of pain in these two studies were headache, abdominal pain, limb pain, and back pain. This data would appear to confirm earlier estimates that recurrent headache, including migraine, occurs in 11% to 26% of children ages 7-15; recurrent abdominal pain in 10-15% and recurrent limb pain in 4-18% in children ages 7-15. Many such children apparently continue to function effectively, attending school and continuing normal activities, with medical intervention only for acute episodes. A smaller, but significant, number, however, find themselves unable to self-manage their pain. They become patients with chronic pain and disability, falling into a cyclical pattern of pain, impaired functioning in physical, school, social, and even family and self-care domains, "doctor-seeking" and over-utilization of medications, and psychosocial distress, including anxiety and depression.

Functional impairment, particularly in academic work and social participation, is likely to have long-term effects on the individual's quality of life, even aside from the possibility that pain and physical limitations may persist into adulthood. Several well-designed studies using quantitative measures have provided evidence that impaired functioning in children with chronic pain is strongly associated with psychosocial distress and with lower quality of life. In particular, children with unexplained chronic pain, pain not associated with an organic diagnosis, often report significant dysfunctions in normal activities, such as schoolwork, sleep, family activities, and athletic activities. But, although impaired functioning is a major factor in lower quality of life for children with chronic pain, we still know relatively little about the prevalence and severity of functional impairment, why some children experience more limitations than others, and which treatment interventions are the most effective in improving function.

The available evidence also indicates that children show different levels of adjustment to chronic pain over time. Chronic idiopathic musculoskeletal pain has been shown to persist in 59% of cases for as long as nine years; in this study, the authors found the children to have pain and disability levels comparable to children with juvenile chronic arthritis, but lower levels of psychosocial functioning. Hunfeld, Perquin, and colleagues in Rotterdam have traced the persistence of chronic benign pain in 30-45% of cases for up to two years and three years, with no increase in intensity or frequency. In the latter study, open-ended interviews elicited information about functioning and coping skills, and identified continuing problems with physical activity, mental concentration, social interaction, and psychological stress (becoming "moody"), particularly when the pain was severe. The researchers found, however, that several children had developed their own strategies to maximize functionality despite the continuing pain: "…pain had become part of the daily lives of several adolescents, who structured their activities and sleeping hours to prevent aggravation of pain". A recent cluster analysis of 117 children with chronic pain divided them into three groups on the basis of a set of psychosocial and behavioral measures: those who were highly distressed and disabled; those who showed low levels of distress and disability; and those who showed only moderate levels of distress and disability, but whose family environment scored low on cohesion.

Although several factors may account for children's differential ability to function and to adjust to persistent chronic pain, the child's sense of self-competence has been identified as a key variable in recent literature. Claar and colleagues, for example, found that in adolescents and young adults with irritable bowel syndrome, the relationship between pain and functional disability was moderated by the individual's sense of academic, social, and athletic competence. The concept of self-competence (a general sense of mastery) overlaps with that of self-efficacy (a task-specific sense of mastery), developed by Albert Bandura in the late 1970s and early 1980s 18. The concept of self-efficacy suggests an explanation for the relationship between coping skills, perceived ability to cope, and reduction in physical and psychological disability. Bandura argued that a sense of self-efficacy enables the individual to persist even with a task of great difficulty until it is mastered, to reject negative thoughts and to "bring cognitive or cerebral productions into being" that will assist in achieving the goal.

To summarize briefly, impaired functioning in all domains is a major and potentially a long-term problem for children with recurrent or chronic pain and their families, which are a significant segment of the American population. Children show significant variations in their ability to cope with pain and continue to function, and some children learn better functioning over time. The child's own sense of self-competence, or task-specific self-efficacy, is one important factor which may reinforce or moderate the child's functioning. Functional disability is clearly associated with psychosocial distress. But these factors are also mutually reinforcing; while children with more psychosocial distress may have more problems functioning with pain, certainly children who experience pain and attendant functional problems are likely to react with anxiety and/or depression.

Current Therapeutic Interventions: When chronic pain can not be fully alleviated, the optimal goal is for the patient to learn effective ways to continue functioning and to self-manage pain; several therapeutic programs have been developed, based on theories of health behavior change, to assist the patient in this process. The earliest of these, the operant learning model developed by Wilbert Fordyce and colleagues in the late 1970s, demonstrated that individuals could be induced to alter their behavior - specifically, to engage in active exercise and limit dependence on medication - in response to social and other forms of positive reinforcement. Fordyce's program proved helpful to many patients, but was criticized for its determinist emphasis on observable behavior and disregard of the fact that patients are "active information processors", and that their behavior is not merely a response to learned cues but shaped by cognitive processes, such as expectations of increasing pain or anxieties about physiological harm.

The revised therapeutic programs that developed in response to these criticisms drew on overlapping models linking health beliefs to health behavior and to self-efficacy as described by Bandura. These new models rely on an expectancy-value theory of behavior; that behavioral change is not a simple learned response to reinforcement, but that learning is influenced by the individual's cognitive belief (expectancy) that s/he will be able to change functioning with positive consequences (self-efficacy) and by his/her expectations (values) of the potential benefits of and barriers to behavioral change. Thus the new therapeutic programs, the most well-known and widely practiced of which is cognitive-behavioral therapy (CBT), seek to mediate behavioral change through cognitive relearning. The cognitive behavioral therapist uses a number of methods -- including education about pain, verbal reinforcement for positive cognitions and actions, biofeedback, group therapy allowing patients to observe and learn from each other, and teaching of cognitive tools to repress negative thoughts -- to help the patient develop positive expectations of behavior change, minimize negative expectations, and internalize the conviction of his/her own ability to overcome barriers and effectively self-manage pain In effect, the patient becomes the agent of change.

CBT has been shown to be effective in controlled trials of treatment pain in cancer patients; of chronic low-back pain; of osteoarthritic knee pain; of sickle cell disease; of pediatric migraine; and of recurrent abdominal pain in children. CBT with family involvement has been found to be an effective intervention for adolescents with chronic pain and chronic fatigue 31-33. Flor, Fydrich, and Turk's 1992 analysis of 65 studies of multidisciplinary treatments for chronic low back pain in adults, covering a number of variants of cognitive, behavioral, and coping skills training packages, noted that many of the studies were "marginal" in quality, but nevertheless demonstrated that these methods were superior to no treatment and to single-modality treatment -- medical or physical therapy -- in decreasing pain and impairment, improving mood, promoting return to work, and decreasing health services utilization. "Even at follow up, patients...are functioning better than 75%" of control groups; the findings of efficacy are "quite impressive". A recent systematic review of behavioral treatment for low back pain again found only six studies "of high quality". The authors nevertheless thought the evidence strong that behavioral therapy had at least "a moderate positive effect" on pain intensity and "small positive effects" on functional status; but they noted that "it is still unknown what type of patients benefit most" from behavioral therapies.

A well-designed intervention, it appears, is not enough: not all patients will benefit from CBT. As Dennis Turk, the leading exponent of CBT, has stated, patient motivation is at least one of the critical factors in successful outcomes of this therapeutic model. Jensen and colleagues have recently proposed a cogent general model that integrates the varied theoretical approaches to describe a dynamic process that pivots on this concept of motivation, or readiness to change. An individual's readiness to change, they argue, is essential to his/her ability to learn successful pain self-management through new behaviors; and readiness is a dynamic function of 1) his/her perceived importance of the change (beliefs of the costs and benefits of change, past experience with change (learning history), and current contingencies (availability of social and material support) and 2) his/her self-efficacy beliefs (personal experience, modeling provided by others, verbal persuasion, and perceived barriers). They suggest some clinical approaches for enhancing readiness and promoting change, including encouragement to practice self-management; allowing the patient to observe other pain patients practice self-management; support of positive beliefs and non-judgmental non-support of negative beliefs; and development of a plan to address real or perceived barriers; and they call for research into interventions along these lines to enhance motivation.

Another formulation recently proposed by Sharp stresses the patient's cognitive activity in appraising and evaluating his or her pain, and its ongoing and interactive effects on mood, behavior, and somatic focus. The patient's initial response to the pain is a function of cultural beliefs, learning history, and current contingencies, he argues, but then is continually reinterpreted with ongoing events. In particular, anxiety about recurrent pain and avoidance of activity that might cause pain will help to perpetuate the patient's hypervigilance for signs of recurring pain (as described by Eccleston and Crombez) and his/her perceived inability to manage the pain. Moreover, Sharp contends that this attitude of "learned helplessness" may be perpetuated by physicians who have failed to offer helpful treatment or even to confirm the physical reality of the patient's suffering. "That is, patients could start to believe that 'nothing has worked so far so why would any future treatment help?" A patient who has reached this point is likely to have a negative assessment both of the benefits of pain self-management and of his/her own ability or self-efficacy to learn these skills, and will therefore show a lack of readiness to change.

In this study, we will consider adolescent pain patients and whether a new type of innovation can promote their readiness to change and to learn pain self-management skills, that will promote positive outcomes in pain reduction and improved functioning.

Findings from our Current Research: Our interdisciplinary group, comprised of researchers from anthropology, history, pediatrics, psychology, and sociology, has collected quantitative and interview data on 74 adolescent children presenting between 2003 and 2006 to the Pediatric Pain, Pediatric Gastroenterology, and Pediatric Neurology Clinics with recurrent or persistent pain. We have completed preliminary analysis of the qualitative data for a subset of 37 (28 girls and 9 boys, average age 13.97) for whom intake and six-month follow-up data was obtained. These children reported suffering pain for periods ranging from one month to "all my life": the average computed duration was 53.6 months, or about 4.5 years. All of them had seen at least one physician prior to referral to UCLA and the majority had seen three or more.

The children's levels of functioning varied considerably on the quantitative measures, but the evidence from the long, semi-structured interviews (conducted prior to the first Clinic appointment and at 6 months) shows that virtually all were distressed by some level of impairment. Those who had had pain for several years reported that pain had become part of daily life and that they adjusted their lives around it: Many of the children also stated that their unexplained chronic pain, which a series of doctors had not been able to diagnose, had given them a sense of isolation and difference from others, and a sense of powerlessness, that contributed to their distress:

Those children seen in the Pediatric Pain Clinic (28, or 76% of the 37) were given recommendations to choose one or more of a list of complementary and alternative medicine (CAM) providers who work with the clinic; these include several who teach pain self-management skills, including a physical therapist, yoga therapist, biofeedback trainer, and guided imagery/hypnotherapist. These recommendations were made in addition to those for tests, changes in medication or other therapies. Children seen in the GI or Neuro Clinic might be given a recommendation for PT or another CAM treatment, but it was not a standardized part of the treatment plan. At the follow-up interview, the children were asked whether their pain and functioning had improved, and also to talk about their participation in any of the CAM therapies:

Better, pain improved or resolved by medication change - 8; 22%
Better, participation in active CAM had helped - 8; 22%
Better, medication change and participation in an active CAM therapy - 4; 11%
Same, meds had not helped, no interest in CAM - 6; 16%
Same, meds had not helped, CAM not tried because not recommended or because of reimbursement issues - 5; 13%
Same, meds had not helped, child tried CAM but did not persist - 2; 6%
Worse, meds had not helped, no interest in CAM - 1; 3%
Worse, meds had not helped, CAM too expensive - 1; 3%
Worse, meds had not helped, child tried CAM but did not persist - 1; 3%
Worse for other reasons (intervening surgery had increased pain) - 1; 3%

These findings are not presented as supportive evidence of the benefits of CAM therapy. Rather, they indicate, that, in this group of children, aside from a small group helped by a medication change and one outlier case, those who were self-motivated to participate in a therapy that taught them active self-management consistently reported better outcomes than those who were not self-motivated or who were unable to do so.

Why did 16 of the children choose not to participate or persist in participating in recommended CAM therapy? One possible explanation is that they lacked confidence that a new therapy will work when many others have failed to work and believed that their pain was a different and intractable problem that doctors did not know how to treat and that they could not manage themselves. Another is that they were not given the opportunity to observe others; were not given sufficient reinforcement from family or other significant contacts for participation; and were not helped to overcome any perceived barriers to access.

On the basis of this preliminary data, considered in the light of current theoretical models, we propose the following hypotheses:
•Adolescents who participate actively in learning a pain-management skill will show more improvement in pain and functioning at 2 and 4 months than those who do not.
•Adolescents who lack peer support for learning a pain management skill will not follow through with learning such a skill without further reinforcement, even if recommended as part of a treatment plan.
•Adolescents may be helped to adhere to treatments that involve learning a pain management skill which will improve their pain and functioning by talking to others who have learned such a skill; by receiving ongoing positive reinforcement; and by being helped to overcome perceived barriers.

We propose to test our hypotheses through a trial of a peer mentorship intervention, using trained adolescents who have successfully learned pain management skills as mentors. The mentor will help to relieve the child's sense of isolation and difference by relating their similar experiences, provide models of successful skill learning and reinforce the mentored subject's participation in skill learning activities.

Qualifying conditions:
•Irritable Bowel Syndrome (IBS)

•Functional Abdominal Pain
•Fibromyalgia
•Complex Regional Pain Syndrome (CRPS)
•Myofacial Pain
•Chronic Daily Headaches
•Migraine Headaches
•Chronic Pain

[I'm sorry... but I do have qualms about lumping CRPS in with conditions of a functional origin...]
INTERVENTION: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties.

MENTOR Criteria
Inclusion criteria:
•between the ages of 14 and 18
•any patient who has been successfully treated in the UCLA Pediatric Pain Program
•access to telephone
•access to internet enabled computer

MENTOR Exclusion criteria
•younger than 14
•older than 18
•new patient
•no access to telephone
•no access to internet enabled computer

MENTEE CRITERIA
Inclusion Criteria:

•chronic pain diagnosis
•between the ages of 12 and 17
•access to telephone
•access to internet enabled computer
•new to UCLA Pediatric Pain Clinic
•plans to utilize program CAM therapies

Exclusion Criteria:
•already utilizing UCLA Pediatric Pain Program CAM therapies
•unable to read, speak, or understand english
•younger than 12 or older than 17
•no access to telephone
•no access to internet enabled computer
•not new patient to UCLA Pediatric Pain Clinic
•does not plan to utilize program CAM therapies

CONTACTS:
Contact: Lonnie K Zeltzer, MD 310-825-0731 LZeltzer@mednet.ucla.edu
Director of UCLA Pediatric Pain Program, UCLA Department of Pediatrics

Contact: Jennie CI Tsao, Ph.D. 310-825-0731 JTsao@mednet.ucla.edu

** Regional Anesthesia Military Battlefield Pain Outcomes Study (RAMBPOS)
The purpose of this study is to examine the short and long-term benefits of implementing early regional anesthesia techniques for pain control after a major traumatic injury to one or more extremities during combat in the Iraqi/Afghanistan war, including the effects on acute and chronic pain, quality of life, and mental health.

BACKGROUND:

Adequate pain management for combat casualties balances the need for emergent, life-saving care with the urgency to remove soldiers from harm's way. Control of pain in traumatic battlefield situations may be impossible until safe evacuation to a surgical facility is achieved and a wounded soldier can receive general anesthesia. Recent evidence suggests that neural plasticity in the central nervous system coupled with hyperstimulation of central neuronal pathways lead to neuropathological remodeling. This neural rewiring may result in chronic pain for patients who have experienced severe, unrelieved acute pain. In addition, the stress of combat along with the suffering of prolonged uncontrolled pain may contribute to psychological disorders, such as post-traumatic stress disorder, depression, and substance abuse.

OBJECTIVE:
The purpose of this study is to evaluate the effect of early and aggressive advanced regional anesthesia on the chronic neuropathic pain, health related quality of life, and mental health of OEF/OIF veterans who have suffered a major limb injury in combat. An additional aim of this study is to quantify and characterize the short-term and long-term effects of traumatic combat limb injuries on post-injury acute pain, chronic pain, health related quality of life, functional status, social reintegration, psychological adjustment, and substance abuse behaviors in a population of injured military personnel.

METHOD:
This study employs a cohort repeated measures study design involving prospective data collection at scheduled intervals. Interviews with participants provide data on pain outcomes, psychiatric morbidities, and quality of life. Follow up evaluations conclude at the two year anniversary of the start of combat injury rehabilitation. Medical records information collected retrospectively from armed services treatment facilities provide data on the use of pain management therapies as well as individual responses to regional anesthesia.

IMPLICATIONS FOR RESULTS:
The findings of this study may impact the clinical field by providing information on the effectiveness and benefits of early advanced regional anesthesia for chronic pain control. This study may also provide data to determine whether regional anesthesia pain treatments prevent or reduce the development of psychological maladjustment disorders such as post-traumatic stress disorder, depression, and substance abuse in a population of military personnel with combat limb injuries.

Procedure: Regional Anesthesia

Subject received regional anesthesia to affected limb(s) within 72 hours of traumatic event.
•1 Soldiers with one or more mangled or amputated limbs from the Iraq/Afghanistan war aggressively treated with regional anesthesia for pain control.

Intervention: Procedure: Regional Anesthesia
•2 Soldiers with one or more mangled or amputated limbs from the Iraq/Afghanistan war receiving standard treatment for pain control.

ELIGIBILITY CRITERIA:
Inclusion Criteria:

•Major injury in one or more extremities requiring hospitalization and inpatient rehabilitation.

Exclusion Criteria:
•Major head trauma,
•Cognitive deficits,
•Inability to concentrate
•Poor judgment and impulse control,
•Substantial hearing loss
•Bilateral upper extremity amputation with no alternate means to complete the survey forms

CONTACTS:
(Dept of Veterans Affairs)
Yolanda S Williams, MPH (215) 823-5800 ext 2774 yolanda.williams5@va.gov [Pain Management Service]
Holly Luu, BA (215) 823-5800 ext 6506 holly.luu@va.gov

•Walter Reed Army Medical Center

•Brooke Army Medical Center
** Efficacy of Etoricoxib on Peripheral Hyperalgesia

This study is not yet open for participant recruitment.
[Does anyone else wonder if Dr. Scott Reuben's criminal fraud perpetrated on the medical (pain management) community makes this study more important/necessary than one would expect? The good doctor, in case you were wondering, is in prison for a whopping... SIX MONTHS.]

The purpose of the study is to determine the efficacy of etoricoxib on pain patients. The investigators assume that patients with neuropathic pain will have greater pain relief then patients on placebo.

Detailed Description Animal experiments analysing anti-hyperalgesic effects of Coxibs show inconsistent results due to different used dosages and varying different pain models. Theoretical the use of NSAIDs is rational, particularly of Coxibs as a part of the neuropathic pain management. But in the newest topical review, there is no valid information available about the effectiveness of these drugs in human neuropathic pain models or in patients with different underlying mechanism, e.g. with or without hyperalgesia.

Conditions accepted:
•Causalgia

•Polyneuropathy
•Postherpetic Neuralgia
•Peripheral Nerve Injury
•Radiculopathy
ELIGIBILITY REQUIREMENTS:
Inclusion Criteria:

•Patients over 18 years with
•Persistent moderate or severe pain (> 4 on NRS (1..10)) at rest (average of three daily assessments using a diary for at least two days) .
•Neuropathic pain associated with a clinical and neurologically proven peripheral nerve injury, radiculopathy, postherpetic neuralgia or polyneuropathy or CRPS
•One of the two following QST phenotypes at the baseline assessment:
◦signs of peripheral hyperalgesia (that means, pathological decreased heat pain threshold and/or pathological decreased muscle pain threshold)
◦without signs of peripheral hyperalgesia (no pathological decreased heat - and/or muscle pain threshold)
•Patients of both gender
•Signed consent form
•Patients with the ability to understand and follow the instructions of the doctor

Exclusion Criteria:
•Excluded will be patients Parkinson's disease or a history of cerebral vascular insult or nerve injury.

Excluded will be also all patients with contradictions for the use of Etoricoxib:
•Hypersensitivity to the active substance or to any of the excipients.
•Active peptic ulceration or active gastrointestinal (GI) bleeding.
•Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetyl-salicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors.
•Pregnancy and lactation
•Severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
•Estimated renal creatinine clearance <30 ml/min.
•Inflammatory bowel disease.
•Congestive heart failure (NYHA II-IV).
•Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
•Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
•Intake of one of the following drugs (current or in the last 3 days)
◦selective-serotonin-reuptake-inhibitor
◦cetoconazole
◦rifampicin
◦phenytoin
◦carbamazepine
◦dexamethasone or other systemic corticoids
◦traditional nonsteroidal antiphlogistics
◦cyclooxygenase-inhibitors
◦immunosuppressives
◦TNF-α-inhibitors
CONTACT: Christoph Maier, Dr. med +49/234/3026366 christoph.maier@rub.de
University hospital Bergmannsheil department of pain therapy GERMANY
STUDY SPONSOR: Ruhr University of Bochum, GERMANY

** Transcranial Magnetic Stimulation (TMS) Effects on Pain Perception
The purpose of this study is to investigate the effects of transcranial magnetic stimulation on pain perception.

Chronic pain represents a huge public health concern and is generally poorly understood at a basic neurobiological level. Transcranial magnetic stimulation (TMS) is a non-invasive technique that uses electromagnetic pulses to temporarily stimulate specific brain areas in awake people (without the need for surgery, anesthesia, or other invasive procedures). Previous research suggests that TMS may be effective in reducing pain perception in healthy adults and in patients with various types of pain conditions, such as neuropathic pain. However, there is relatively little research on TMS and pain that addresses optimal TMS device parameters, optimal cortical targets, and potential differences in response to TMS between healthy persons and those with chronic pain.

The purpose of this trial is to study the effects of TMS on pain perception. Specifically, this study will determine optimal device parameters (dose) and brain targets for stimulation with TMS in order to reduce pain in patients with neuropathic pain and in healthy adults using laboratory pain methods.

Participants with Neuropathic Pain:
After an initial screening, eligible participants with neuropathic pain will receive a magnetic resonance imaging (MRI) scan to help determine the best target for TMS stimulation later in the study. Participants will be asked to record their pain experiences every day for 2-4 weeks before receiving the first of 2 laboratory pain assessments. The laboratory pain assessment uses a small device, controlled by a computer and attached to the underside of the forearm, to produce different temperature stimulations. As the device reaches a level considered painful to the participant, he/she can push a button to return to a level of comfort.

The next part of the trial involves two, 20-minute TMS treatment sessions per day for 5-days. Participants will be randomly assigned to one of two groups. Group A will receive real TMS and Group B will receive "sham" TMS. Study participation time for individuals with TGN is about 8 weeks, including about 10 hours (7 visits) at the Medical University of South Carolina (MUSC).

Healthy Volunteers:
In addition to an interview with researchers regarding medical history, healthy participants will complete a self-report screening to assess pain history and level of depression and anxiety. Eligible participants will be given a laboratory pain assessment, and be randomly assigned to one of two groups: group A will receive real TMS and group B will receive "sham" TMS. After TMS, participants will receive another full laboratory pain assessment and complete questionnaires. For healthy volunteers, participation in the study will take about 3 hours and may be completed in one or two visits.

INCLUSION CRITERIA:
For Healthy Adults:
•Between age of 21 and 60
•No prescription medications in previous 3 months
•No seizure history
•No depression
•Not suicidal
•No anxiety
•No hospitalizations or surgeries in previous 6 months
•No history of chronic pain conditions
•No implanted metal devices (e.g., pacemakers, metal plates, wires)
•Not pregnant
•No alcohol abuse/dependence history in previous 6 months
•No illicit drug use in previous 6 months
•Capable of reading, writing, giving consent, following instructions
•No history of brain surgery or history of loss of consciousness >15 minutes
•No history of autoimmune or endocrine disorder
•No significant anxiety about entering MRI scanner

For Patients with neuropathic pain:
•Between age of 21 and 75
•No seizure history
•Not taking medications shown to increase seizure risk (6 months)
•Not suicidal
•No hospitalizations or surgeries in previous 3 months
•No implanted metal devices (e.g., pacemakers, metal plates, wires)
•Not pregnant
•No alcohol abuse/dependence history in previous 6 months
•No illicit drug use in previous 6 months
•Capable of reading, writing, giving consent, following instructions
•Chronic pain (>6 months), not significantly relieved by pharmacological treatment
•No significant anxiety about entering MRI scanner
CONTACT: Contact: Jeffrey J. Borckardt, Ph.D. (843)867-5142 borckard@musc.edu
Associate Professor, Department of Psychiatry and Behavioral sciences Department of Anesthesiology and Perioperative Medicine, Medical University of South Carolina
STUDY SPONSOR: Medical University of South Carolina
COLLABORATORS: National Institute of Neurological Disorders and Stroke (NINDS)

** Effects of Vaporized Marijuana on Neuropathic Pain
The specific aim of this study is to measure the pain-relieving effects of vaporized marijuana in subjects with neuropathic pain. An evaluation of pain relief with mood, cognitive impairment, and psychomotor performance will also be collected to help evaluate the utility of vaporized marijuana in a neuropathic pain population.

The case for marijuana's medical use for pain is primarily from experimental studies with normal subjects, which have yielded conflicting results. Experimental subjects have been shown to have significant dose-dependant antinociception effect that is not reversed by opioid antagonism. In contrast to this positive antinociceptive effect, other experiments demonstrated hyperalgesic activity and probably enhancement of the perception of pain upon acute exposure in chronic users of marijuana.

In addition to studying spontaneous pain antinociception, it would be useful to evaluate the response to marijuana following evoked pain. Such evoked pain is produced by stimulation of the skin that is normally not noxious.

Because of the potential side effects of marijuana administration, one of the aims of the present study is to analyze inter-individual variability and the occurrence of dose-dependant analgesia of marijuana with an eye on defining tolerable dosing in clinical neuropathic pain syndromes.

Comparisons: Neuropathic and experimentally induced pain scores will be compared after the administration of escalating doses of low, high, and placebo marijuana cigarettes as provided by the National Institutes on Drug Abuse (NIDA).

CONDITIONS:
•Neuropathic Pain

•Reflex Sympathetic Dystrophy
•Peripheral Neuropathy
•Post-herpetic Neuralgia
•Post Stroke Pain
•Spinal Cord Injury
•Multiple Sclerosis

RELATED PUBLICATIONS: A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain.
Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S.

ELIGIBILITY:
Inclusion Criteria:

•Age greater than 18 and less than 70
•Visual Analogue Scale (VAS pain intensity) greater than 3/10
•A negative urine drug screening test, i.e., no evidence of IV drug abuse
•Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury

Exclusion Criteria:
•Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
•Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
•Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
•History of traumatic brain injury
•Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).
•Current use of marijuana (e.g., within 30 days of randomization)
•Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.
CONTACT: Haylee E. Donaghe, MS 916-734-2935 hedonaghe@ucdavis.edu
Responsible Party: Barth L. Wilsey, MD, Univeristy of California, Davis

Study Sponsor: University of California, Davis
Collaborators:
•Center for Medicinal Cannabis Research
•VA Northern California Health Care System
Principal Investigator: Barth L Wilsey, MD University of California, Davis