INTRODUCTION

Since our What's NEW? page amasses a great deal of information, we collected all the CRPS related articles, news and events for 2005 to display here. Any new or ongoing items in 2006 will be on the regular WHAT"S NEW? page.

NEWS IN 2005

You missed it! Read about PARC's FALL Information Night on November 4, 2005 in Toronto.

FEMALE FIREFIGHTER FINDS HOPE: Sheila Grady's story about RSD/CRPS.

NEW YORKER MAGAZINE Oct. 10th issue has article on RSD/CRPS.

RSD/CRPS CAN DEVELOP AFTER SURGERY : Do you know the statistics on arthroscopic knee surgery, carpal tunnel, ankle fractures?

Read about an upcoming multi-center clinical trial on Lenalidomide in USA.

Two great new BOOKS to read!

Articles on PAIN and CRPS. Congratulations to RSD SOCIETY OF HOPE awareness article.

PAULA ABDUL, American Idol Judge, was diagnosed with CRPS last November. Read about it here!

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FEMALE FIREFIGHTER FINDS HOPE FOLLOWING HAND INJURY

One year ago, Sheila Grady did something that would change her life – something she regretted instantly. The Hamilton firefighter injured her hand– not during a heroic rescue on the job but rather during a typical day on her farm. In an attempt to stop one of her horses from kicking, Sheila distractedly hit the horse on the butt and shattered bone in her right hand. Surgeons from Hamilton Health Sciences inserted pins into her hand to help the shattered bone heal. However, shortly after, strange things started happening to her hand. It became swollen and purple. She could’t even touch her hand because her skin hurt so much. She went to a multitude of doctors and specialists. Some suspected she had Complex Regional Pain Syndrome (CRPS) while others thought she may have osteoporosis.

Ten weeks after Sheila’s injury, Dr. Gareth Rhydderch from the Pain Management Centre at the General Hospital confirmed Sheila had CRPS.

CRPS (formerly known as Reflex Sympathetic Dystrophy - RSD) begins with an injury, often a minor one to a limb, and becomes a debilitating disorder. The sympathetic nervous system reacts to the injury, causing the limb to swell, change colour and temperature, and burn with pain. These symptoms result in decreased movement of the limb. Dr. Rhydderch says the syndrome isn't’t that common in the general population and there is still not a lot known about the condition.

"It is difficult to standardize research because patients come at varying stages of the disorder, with varying severity, and cooperation varies as well,” said Dr. Rhydderch.

One thing that is known is that early diagnosis increases the chances of recovery.

Since Sheila was diagnosed within three months of her injury, her chances of recovery were 80 per cent. Even so, Sheila became depressed after reading negative accounts of CRPS on the Internet, so to counter her fears, Dr. Rhydderch guaranteed her that she would be cured. He made this guarantee to put Sheila in a positive frame of mind, but he was also certain that she would overcome her CRPS .Sheila spent five months in treatment. Twice a week she would go to the Pain Management Centre(PMC) for stellate ganglion blocks. These injections into her neck blocked nerve impulses to her arm,causing temporary pain relief. She took advantage of this temporary relief and went to the Hand Clinic, conveniently located down the hall from the PMC, for therapy. The pain blocks allowed Sheila and her therapists to work together to increase her hand's passive and active range of motion.When Sheila first started at the Hand Clinic, she couldn't move any of her fingers. Two occupational therapists and a physiotherapist helped Sheila reeducate her muscles, so she could return to normal patterns of movement. They measured the strength and sensation in her hand and monitored her progress so they could adjust her program accordingly.

“Seeing my progress really helped because I felt like was actively doing something to advance my recovery,” said Sheila.

While much of Sheila’s recovery can be attributed to the Pain Management Centre and the Hand Clinic, she also spent six to seven hours a day doing therapy at home.“Sheila’s level of energy was phenomenal,” said Pam Ball, an occupational therapist at the Hand Clinic.“Because Dr. Rhydderch does many of his stellate ganglion blocks on the same day, and those patients go to the hand clinic afterwards, the hand clinic is somewhat of an informal support group,” said Ball.With this support group, patients can exchange suggestions, stories, and a lot of hope for each other .There is an overwhelming consensus that the unique relationship between the PMC and the Hand Clinic is beneficial to patients with CRPS.

“Patients get more out of therapy when they’ve had a block,” said Dr. Rhydderch. “It’s the best situation possible.”Since the clinics work so closely together, both clinics and surgeons can refer patients to each other at a fast and efficient rate."

“It’s kind of a triangle of service with the patient in the middle,” said Ball.“They’re all really interlinked now, and I think that has made a huge, huge difference .”Today, Sheila is back at work as a firefighter, and while one of her fingers is still a little stiff and swollen, she is living a normal life again. She feels incredibly lucky that she lives in Hamilton and didn’t have to travel across the province, like some other patients, to be treated at Hamilton Health Sciences.

If Sheila could send one message to those recently diagnosed with CRPS, it would be:

“Fighting RSD is a full time job. Find a doctor with the attitude and game plan to beat it. Couple that with constant physical therapy, mental imaging and do whatever it takes to keep you positive".

SPECIAL THANKS TO:Hamilton Health Sciences Insider Newsletter

CRPS/RSD AFTER SURGERY

Did you know that CRPS can develop after certain surgeries?

PARC presents:

CRPS FALL INFO NIGHT

COMPLEX REGIONAL PAIN SYNDROME:

presented by

Gareth Rhydderch MD FRCPC

Anesth. and Pain Management,

Hamilton Pain Clinic

DATE: November 4, 2005.

TIME: 7:00 PM

PLACE: Rivers of Life Int'l Ministries

5 Kodiak Cr. Bldg. 5,Unit 8, Downsview. Ontario

ADMISSION DONATION ACCEPTED.

REFRESHMENTS SERVED

SEATING IS LIMITED.

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UPDATE NOVEMBER 4, 2005.

Our second INFO NIGHT was held in Toronto at the Rivers of Life Int'l Ministry Church. We would like to thank Sharon Shore, her family, and her busy army of volunteers who helped us make everything run smoothly. Special thanks to Pastor R Torres, Pastor S Torres, and his volunteers (Fely, Eunice, Helen, Edna) who so kindly helped with set up, refreshments and parking.

Special thanks to Hudson (aka Houdini), who materialized a wheelchair ramp out of thin air, just for this event! WOW!

Read about it. Click here.

UPDATE MAY 28:

We had a great response to our first INFO NIGHT here in St. Catharines.

People came from Toronto, Hamilton, London, Ridgeway, Niagara Falls, Mississauga and St. Thomas. Many thanked us for holding this event, the first known event of its kind in Canada! MANY THANKS TO OUR SPONSORS: Niagara this Week, Welland Ave. Chiropractic and Massage,278 Welland Ave., St. Catharines and Skyway Digital, Lake Street, St. Catharines,

Read about it and see the photos. Click here.

NEW YORKER MAGAZINE

The Big Hurt
Issue of 2005-10-10
Posted 2005-10-03

This week in the magazine, Jerome Groopman writes about reflex sympathetic dystrophy, a type of intense chronic pain, and how a better understanding of R.S.D. might help to explain certain fundamental aspects of the nervous system. Here, with Ben Greenman, he discusses the topic.

BEN GREENMAN: What first interested you in R.S.D.?

JEROME GROOPMAN: Several people I know developed it, and they saw a number of physicians until the correct diagnosis was made. Along the way, they were given a lot of misinformation and misdiagnoses. I became intrigued. I didn’t know much about it myself. And, the more I looked into it, the more I realized that it was important. It was not that rare a condition. And thinking about pain in this new way had the potential to give us a window into a new understanding of the central nervous system.

How much is known about pain in general? In medicine, obviously, it’s managed all the time, for surgical procedures and terminal illnesses and everything in between. But pain itself seems poorly understood. Why is one of the most common conditions also one of the most elusive?

I think that, in classic medical education, pain has either been overlooked or disliked. It’s the kind of situation that is often very frustrating to doctors. The therapies are not easy or pleasing. Until recently, it did not have its own specialty. In the past, physicians would just write a prescription for a narcotic and hope that the patient found enough relief not to come back and bother them. A lot of the patients in my article, the ones suffering from R.S.D., would have entered a medical purgatory, where they were largely shunned by the medical establishment. More recently, two things have happened. There’s been increased understanding of the biology of pain, and I talk about that in the article. Also, there are very committed physicians who believe that this is an important clinical issue, and they have begun to devote themselves to the care of these patients.
One of the things about pain that you mention in the article, and that people intuitively understand, is that it’s subjective. When you take a history of a patient’s pain, you have an essentially subjective complaint. Thresholds are different, and there aren’t always visible or measurable symptoms—although, in R.S.D., there is skin-temperature increase and inflammation. The subjectivity of pain must be something that thwarts and frustrates physicians.
I just got off the phone with a close friend who fell yesterday and smashed her arm. Luckily, nothing’s broken, but she has an extraordinary pain threshold. She does not take Novocain when she goes to the dentist, and it’s not because she’s a masochist; it just doesn’t bother her that much.

So is that the kind of person who might, in theory, have a low-lying case of chronic pain?

Well, there are some pains that wouldn’t register with her. But I think that what’s interesting about R.S.D.—and what distinguishes it from any other pain syndromes—is that it can affect anyone. It’s not predicted based on people’s prior pain thresholds. For example, the woman who is the main figure in this week’s piece, whom I call Barbara, is someone who’s very athletic and active. She doesn’t have the “classic pain personality,” which physicians have portrayed in the literature: people who don’t want to work, people who are not motivated, people who are terrible complainers, people who have a little bump and think it’s the end of the world. This is a woman who has been thrown from a horse, fallen down a flight of stairs, torn her hamstring, and hardly complained about any of her injuries. Then R.S.D. came along and affected her the same way it affects everyone—it’s debilitating. So the mystery of this is that the psychological predisposition to reacting to pain doesn’t seem to be determinative.

Can you explain the difference between adaptive and maladaptive pain?

Adaptive pain is pain that assists the body in healing or protects the body. So, classically, you’ll withdraw your hand from a flame, or you’ll have surgery and the area will become inflamed and swollen and painful, and you’ll be forced to rest it, so that healing can occur. It’s either protective or it fosters the natural healing process. Maladaptive pain—and R.S.D. is a severe version of it—is essentially a neurological disease. You develop circuits in the spinal cord and in the brain which are signalling continual pain, despite the fact that there is no painful stimulus. Or you develop circuits in the spinal cord and in the brain in which peripheral nerves—nerves from your fingers or feet or legs, which normally carry innocuous or even pleasant sensations, like a breeze fluttering or a soft touch—now send signals that are interpreted in the brain as being painful. That’s maladaptive. It gives no benefit to you, and actually is extremely destructive.

What are the effects of defining something like R.S.D. as a disease, as a neurological condition in which signals are crossed or distorted?

By focusing on the authentic biology and casting it as a neurological disease, it takes away the negative stigma and elicits not only sympathy but concentrated clinical attention.
The cases cited in the article seem to involve truly excruciating pain. One woman who was a friend of Barbara’s has committed suicide, and Barbara admits that she has considered it.

If someone is afflicted with R.S.D. in a foot, would amputating the foot help?

The stump would still be excruciatingly painful.

So the pain remains whether or not the limb does?

Correct.
And the effect seems to be to drive people out of their minds, and out of their lives.
That’s exactly what it does. The only analogy that I can think of is being under constant torture. For people who were in concentration camps or at prisons under Saddam—those kinds of places where every day you are subjected to excruciating pain, with no guarantee that it is ever going to be alleviated—their lives would have become empty, and not only empty but torture.
Traditionally, as you say, pain has been treated with narcotics, and there are often side effects—addiction to painkillers being the most obvious. As you point out in the piece, therapies like nerve blocks are used to treat R.S.D. as it becomes better understood.

Are there also cases where old, blunt, and not so efficient therapies are being abused? Or, for that matter, are there crank therapies?

It’s interesting. These people generally don’t have a very high addiction problem, because they don’t have what’s called an “addictive personality.” They have terrible pain, and they use their medicines very judiciously. In fact, a lot of them don’t even want to use their medicines, because they don’t like the side effects. So they’re not psychologically predisposed to addiction. I think there is still a tremendous need for better therapies. As the biology has become better understood, there are drugs emerging that target specific neurotransmitters, specific channels, and so on, which can help these people. The more extreme interventions, with nerve stimulators, for example, are a relatively recent development—in some cases the results are tremendous, and in others the technique doesn’t succeed. I haven’t seen a lot of crank therapies, because there is not much placebo effect here. You tend to see crank therapies proliferate where the placebo effect is profound. But the kind of pain that these patients are having is not amenable to suggestion or emotional state.

Do you have any sense of how common something like R.S.D. is?

There seem to be diseases that crop up more and more often—because of the way people live now, or because of environmental conditions. Carpal tunnel is one.

Is there any sense of whether R.S.D. belongs in this category?

I wrote a piece for The New Yorker a while ago about fibromyalgia, and how, historically, there have been poorly understood pain syndromes that were related to the introduction of new technology. For example, there was something called railway spine, chronic and disabling injuries sustained as a result of minor railway accidents, often, when railroads were first introduced, in the nineteenth century, and clearly that’s gone. This is different. To me, it was fascinating to trace this back to the Civil War. And I’m sure it antedated that as well. This doesn’t, to my knowledge, have any cultural or sociological overlay.

So this has probably existed with the same prevalence as long as there have been people but has only recently been better classified and understood?

That’s right. And I think there are large numbers of people who aren’t diagnosed. Some of them are fortunate, because in the acute setting, in the initial setting, if you can tolerate the pain to some degree and keep functioning, the nervous system may be able to rewire itself. Other people, unfortunately, who are not diagnosed, who have chronic R.S.D., just go from pillar to post, basically, and suffer terribly.

As this particular syndrome is better understood, is it likely that the medical community will develop a deeper understanding of larger neurological issues?

If you’re asking whether more attention to this will lead to a proliferation of diagnoses, what distinguishes this from other pain syndromes is that there are objective findings. If you look at the limb of a person with R.S.D., it’s not as though someone has carpal tunnel or someone has railway spine and they’re complaining of pain and there are no objective clinical findings. Here, there are really impressive and bizarre clinical findings. You touch the person with cotton and they’re on the ceiling. I hope that one of the consequences of the article will be that people who have this will realize they have it, and physicians like myself, and even specialists who were never formally schooled in this, will be more alert to it. It’ll be on the radar screen, so that patients can be referred to get help by specialists, and also so that the research that’s done on this condition may lead to better treatments.

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Source: New Yorker Magazine October 10th issue:
http://www.newyorker.com/online/content/articles/051010on_onlineonly01

For the complete magazine article, "WHEN PAIN REMAINS", written by Jerome Groopman, please see the above site or your local library.

PAULA ABDUL

Paula Abdul: Idol judge says she has a rare neurological disorder.
By Paul Hawhorne, Getty Images

"Drugs? I'm not addicted to pills of any kind," Abdul says in the new issue of People magazine (on newsstands Friday).

Abdul, 42, says she has been battling chronic pain that began after a cheerleading accident at age 17 left her with an injured disc in her neck.

The pain got worse after "a couple of car accidents" in the 1980s and a plane crash in 1992, which led to seizures, bulimia and depression, she says. In search of relief, Abdul had 12 operations and used medications she says left her so "loopy" that she chose to live with the pain.

Abdul says she kept her condition secret from her fellow Idol judges but decided to go public after reading message boards about her behavior on and off the set.

"The turning point came last summer, she says, when she began taking Enbrel, an anti-inflammatory drug normally used to treat rheumatoid arthritis and psoriasis.

A spokeswoman for the drug says it does not have psychological side effects.

In November, Abdul says, she was diagnosed with Reflex Sympathetic Dystrophy (aka Complex Regional Pain syndrome), a chronic neurological disorder that causes severe, debilitating pain. It affects 500,000 to 1 million Americans and is more prevalent in women, according to the Reflex Sympathetic Dystrophy Syndrome Association.

The disease is treatable and usually involves physical and sometimes psychological therapy, says Norman Harden, director of the Center for Pain Studies at the Rehabilitation Institute of Chicago. "People can do well and get on with their lives."

Abdul Between getting up and dancing at the drop of a hat, and her refusal to let Simon (Cowell) finish a sentence ... she's become both distracting and annoying," says Idol fan Steve Walker of Memphis.

Abdul says she is now pain-free, and her happy-go-lucky demeanor is proof of how good she feels.

"If people only knew what I've gone through with pain and pills. I'm dancing for joy at the fact that not even a year ago I was in so much pain I could barely get up," she tells People.

Last month, she was sentenced to two years' probation after pleading no contest to a misdemeanor count of hit-and-run driving. Idol producers and her castmates declined to comment on Wednesday.

"It was getting ugly with the lies people were saying," Abdul tells Entertainment Tonight in an interview airing today and Friday. "It was time to set the record straight. I want America to know that I have never been addicted to anything, no chemical dependency, nothing for recreational purposes."


USATODAY.com partners: USA Weekend Sports Weekly Education Space.com © Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Patients Spend Five Days in Coma to Manage Pain
Desperate Patients Undergo Risky Procedure as Last Resort

DeFilippo's pain was a result of something called RSD, or Reflex Sympathetic Dystrophy, a chronic neurological syndrome characterized by severe burning pain, pathological changes in bone and skin, excessive sweating, tissue swelling, and extreme sensitivity to touch. An injury DeFilippo suffered during the accident brought on RSD, which sent his nervous system out of control and triggered pain signals that were out of proportion to reality.
Dr. Robert Schwartzman, professor and chairman of neurology at the MCP Hahnemann School of Medicine in Philadelphia, has researched RSD for more than 30 years.

He says it's important to understand that this is not a psychological condition.

"That injury changes the genetics of the spinal cord," Schwartzman said. "It happens in children and it can happen to anybody. And it is absolutely not psychological."
In DeFilippo's case, he says the pain was paralyzing — often sending him into blackouts.
Lindsay Wurtenberg, 14, says her life was turned upside down by RSD after she was bitten by a spider. She ended up with such crippling pain that she needed a wheelchair.
"It just kept getting worse and worse and worse every week," Wurtenberg said.
DeFilippo, of Langhorne, Pa., and Wurtenberg, of Mickletown, N.J., turned to a new treatment, only being offered outside of the United States, when they figured there were no other options left.
Both patients traveled to Germany, where doctors used huge amounts of the anesthetic ketamine to put them into a coma for five days.
The procedure is not performed in the United States because the Food and Drug Administration does not approve of coma inducement for longer than two days.
Schwartzman, the only American doctor working with the German team, says the anesthetic — when administered for five days — works wonders on RSD patients.
What we're doing is changing your spinal cord back to normal. The downside is, yes, it's very risky," Schwartzman said.
Risks related to the procedure include blood clots in the lungs and infections from catheters. But Wurtenberg's mother says the risky process gave her daughter her life back.
Schwartzman says that while the procedure has helped Wurtenberg and DeFilippo, it hasn't helped every patient with RSD.
He says the process only blocks the extreme pain patients experience, but doesn't fix the underlying problem. As a result, the pain associated with RSD can return.
DeFilippo says the procedure has completely changed his life.
"Luckily enough, I was given the opportunity to be able to undergo the treatment and it virtually has changed my life," DeFilippo said. "I was in such a state of agony. My life — quality of life — was nonexistent. Now I have everything looking up for me."

Source: abcnews.com ABC News affiliate WPVI in Philadelphia contributed to the "Good Morning America" report.

NOTE: This procedure is not yet available in Canada. PARC has been monitoring this treatment for two years since the studies began. More studies are needed but the future is promising.

PAIN IGNORED

HEARING TOLD

Jason Tchir Toronto Sun August 6, 2004.

A Scarborough Grace hospital doctor denies allegations that a 73 year old woman was in agonizing pain and that he told her family that it was all in her head, a medical review board was told by his lawyer yesterday.
"He told us she was mental", Sandi Rait testified at a Health Professions Appeal and review Board Panel into allegations against Scarborough Grace internist Dr Ponnuthurai Sivaji,
“We were talked to like we were 2 year old children," she said.

Rait was appealing a College of Physicians and Surgeons finding that Sivaji had take an appropriate care of Rait's mother, Helen Nicoll, when she was admitted to hospital in October 2002 after she fell twice.
Sivaji is out of the country and could not appear before the panel his lawyer, Brian Wasyliw, said.
Rait and her sister, Kathy Hasted, said Sivaji granted them only two brief meetings and refused to acknowledge their complaints that their mother was screaming in pain.

Wasyliw said the doctor has denied ever saying that the pain was imaginary.
The charts show he ordered tests quickly and her ordered referrals to five other specialists". Wasyliw said.
He took it seriously."
The panel said it would deliver a written decision within 90 days.

Editor's comments: This situation, unfortunate though it may be, goes on every day in the hospitals in Canada. Doctors do not listen to patients in pain and we admire these ladies for calling the doctor out on his deplorable behaviour.

December 13, 2004.

Complex Regional Pain Syndrome affects Hundreds of Albertans

350,000 Albertans suffer from chronic pain. Recently experts have started a program to help educate family doctors in Alberta on ways of treating those patients.
There is good medication available, but sometimes it's not enough.
Two years ago Jackie Valdemar's life changed. She suffered a minor injury.
A glass broke and she got hundreds of tiny shards of glass in the palm of her right hand. She has never recovered.
"I lost friends, people don't understand, just how much pain there is and how debilitating it is."
Jackie developed Complex Regional Pain Syndrome. Typically there are changes in the colour and temperature of the skin.

To read this article go to http://cfcn.theglobeandmail.com. Search for CRPS.

Congratulations to RSD Society of Hope for promoting awareness of RSD/CRPS!

NO MORAL CONSCIENCE

by Sharon Shore

Six years ago, a vivacious ten year old girl, Lisa Shore, was admitted to Toronto's Sick Kids Hospital to be treated for pain from Complex Regional Pain Syndrome (RSD).

This book is the story of her parents' struggle to find the truth about Lisa's untimely death and their quest for justice. The book is still available despite ongoing efforts to block its release.

Read an excerpt from the book at:

www.lisashore.com

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POSITIVE OPTIONS FOR RSD

by Elena Juris

Interspersed with patient testimonies, Positive Options for Reflex Sympathetic Dystrophy combines the latest medical information, adaptive living strategies and nurturing support in a language that does not overwhelm the reader. In addition to offering interviews with medical experts, this book is also the first to provide information on complementary/alternative therapies for RSD-treatments that can be crucial for maximizing the potential for healing. 

It's available at Amazon .com and amazon.ca, and can also be ordered at your local Barnes and Noble bookstore.  For more information, you can also try the publisher, www.HunterHouse.com.

Read a review by Dr Pollett in the Spring 2005 Issue of the PARC PEARL.

CLINICAL TRIAL



Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Complex Regional Pain Syndrome Type 1


Sponsored by: Celgene Corporation

Information provided by: Celgene Corporation

Purpose

This is a multicenter, double-blind, placebo-controlled study in adult subjects with Complex Regional Pain Syndrome (CRPS) Type 1.
One hundred eighty (180) subjects diagnosed with unilateral CRPS Type 1 will be enrolled and randomized to receive orally either 10 mg/day of lenalidomide or placebo (90 subjects per treatment arm). For each subject, the study consists of three phases: Pre-randomization Phase (2 weeks), Treatment Phase (12 weeks) and Extension Phase (up to 52 weeks).

Condition Treatment or Intervention Phase
Complex Regional Pain Syndrome (RSD) Type 1 Drug: Lenalidomide Phase II

MedlinePlus related topics: Reflex Sympathetic Dystrophy

Study Type Interventional
Study Design Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Group Assignment, Safety/Efficacy Study.

Further Study Details

Expected Total Enrollment 180
Study start January, 2005
Study completion January, 2007

Eligibility

Ages Eligible for Study 18 years and above
Genders Eligible for Study Both

Criteria

Inclusion Criteria

Age 18 years at the time of signing the informed consent form
Understand and voluntarily sign an informed consent form
A diagnosis of CRPS Type 1 as defined by modified International Association for the Study of Pain criteria for at least one-year duration. Unilateral involvement of a distal limb (hand or foot) with or without proximal spread must be present. In the presence of upper and lower limb involvement, the most severely affected limb will be designated the CRPS-affected limb.
Screening (Visit 1): CRPS pain intensity score in the CRPS-affected limb
must be at least 4 on an 11-point (0-10) PI-NRS
Randomization (Visit 2): Average PI-NRS score for randomization
purposes (Visit 2) will be based on AM and PM assessments made during the 7 days prior to randomization:
At least eight PI-NRS scores during this 7-day period are
required and
Average PI-NRS score in the CRPS-affected limb during this
period must be at least 4 on an 11-point (0-10) PI-NRS.
Measurable (by electrophysiology methods) sural, median sensory,
median motor and peroneal motor nerves at the screening nerve
conduction study.
Opioid analgesics, non-opioid analgesics, non-steroidal anti-inflammatory drugs, anticonvulsants, antidepressant drugs and other non-drug therapies may be continued provided that the subject is on stable doses/regimens for at least four weeks prior to the start of the Treatment Phase (Visit 2).
Able to adhere to the study visit schedule and other protocol
requirements.
Women of childbearing potential (WCBP) must have a negative serum or urine pregnancy test within 7 days of starting study drug. In addition, sexually active WCBP must agree to use adequate contraceptive methods (tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on study drug. The use of steroid-based contraceptives (oral, injectable or implanted) is not permitted in this study. WCBP must agree to have pregnancy tests every 4 weeks while on study drug.
A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months).
Exclusion Criteria

The presence of any of the following will exclude a subject from study enrollment:

History of deep vein thrombosis (DVT) or stroke in the past 5 years.
Documented peripheral neuropathies to include diabetic neuropathy
and other metabolic or toxic neuropathies.
Current signs or symptoms of severe, progressive or uncontrolled renal,
hepatic, hematological, endocrine, pulmonary, cardiac, neurological or
cerebral disease.
Any other serious medical condition, laboratory abnormality, or
psychiatric illness that would prevent the subject from signing the
informed consent form.
White blood cell count (WBC) < 3.5 x 109 / L at Visit 1.
Bilirubin, alanine transaminase (ALT), aspartate transaminase (AST) or
alkaline phosphatase levels more than two times the upper limit of the
normal range at Visit 1.
Abnormal thyroid function test values at Visit 1.
Any condition, including the presence of laboratory abnormalities,
which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
Use of concomitant medication(s), including steroid-based
contraceptives (oral, injectable or implanted) and hormone replacement
therapies which could increase the risk for developing DVT.
Concurrent use of thalidomide.
Prior development of an allergic reaction/hypersensitivity while taking
thalidomide.
Prior development of a moderate or severe rash or any desquamation
while taking thalidomide.
Prior treatment with lenalidomide.
Location Information (United States)

Arizona Pivotal Research Centers, Peoria, Arizona 85381
California Loma Linda Institution, Loma Linda, California, 92354
  UCSD Center for Pain and Palliative Medicine, La Jolla, California, 92093,
Florida Space Coast Neurology, Palm Bay, Florida 32905
Illinois Rehab Institute of Chicago, Chicago, Illinois, 60611
Iowa University of Iowa, Iowa City, Iowa, 52242
Maryland Johns Hopkins Hospital, Baltimore, Maryland 21287
Massachusetts Baystate Medical Center, Springfield, Massachusetts, 01199,
  Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02115

Minnesota
Mayo Clinic, Rochester, Minnesota 55905
Missouri Washington University Pain Management Center, St. Louis, Missouri 63141
New York Hospital for Joint Disease, New York, New York, 10003
North Carolina Carolinas Pain Institute, P.A. & The Center for Clinical Research, LLC,
Winston-Salem, North Carolina, 27108
  Duke University Medical Center, Durham, North Carolina, 27705
  UNC Hospitals University of North Carolina, Chapel Hill, North Carolina, 27599
  Womack Army Medical Center, Fort Bragg, North Carolina 28310
Oregon Oregon Health & Science University, Portland, Oregon, 97239
Pennsylvania Drexel University College of Medicine, Philadelphia, Pennsylvania, 19102
  Knobler Institute of Neurologic Disease, Ft. Washington, Pennsylvania, 19034
Texas Texas Tech Medical Center, Lubbock, Texas, 79430
Virginia University of Virginia Pain Management Center, Charlottesville, Virginia,
22903
Washington Swedish Pain Services, Seattle, Washington, 98104



More Information

Study ID Number: CC-5013-CRPS-002
Record last reviewed:
Last Updated:
Record first received:
ClinicalTrials.gov Identifier:
Health Authority: United States: Food and Drug Administration


For more information contact us at PARC.