The Research Department
By Ted Swing, Ph.D.
When a person experiences a broken bone or other injury to one of the extremities, they typically receive medical attention and the fracture heals over time. However, for a small number of people who have such a fracture or other injury they develop a chronic pain condition called complex regional pain syndrome (CRPS). This condition has also been known as reflex sympathetic dystrophy (RSD). In even more rare cases it can occur with no precipitating injury. Symptoms of CRPS include burning or throbbing pain (typically in the injured limb), changes in the skin’s color, temperature, or texture in the area near the injury, sensitivity to touch or cold, swelling, muscle atrophy, and muscle contracture. For some these symptoms go away on their own, but for others they can last months or years.
New Study
Though patients with CRPS may experience relief from various medications and therapies, it has proven difficult to treat for some patients. The FDA has not approved a pharmacological treatment specifically for CRPS in the U.S. However, a pharmaceutical company Grünenthal has begun a clinical trial in the US for one possible CRPS treatment — a drug called neridronic acid. In a previous study of 82 patients conducted in Italy, half of these patients received an infusion of this drug four times over a 10-day period while the other half received infusions of a placebo. Those treated with neridronic acid experienced significant reductions in pain and other CRPS symptoms compared to the placebo group.
The new study, sponsored by Grünenthal, will treat patients with CRPS type I (which makes up roughly 90% of CRPS cases). These patients will be randomly assigned to receive either a high dose of neridronic acid, a low dose of neridronic acid or a placebo infusion. After meeting study enrollment criteria, a patient will come to a surgery center four times (Day 1, Day 4, Day 7 and Day 10) and provide blood and urine samples, and undergoes EKG testing to ensure safety. Once they are safe to proceed, they will receive an infusion of the assigned treatment lasting three hours. After these infusions, patients will return for up to six follow up visits over the next 12 months to assess the safety and efficacy of the treatment.
Adults with CRPS-I who are in a stable treatment for at least one month may qualify if they lack certain exclusionary conditions renal impairment or certain cardiovascular conditions. If you are interested in learning more about this study, you can speak with your pain management providers or contact me directly at Teds@arizonapain.com.
I have Rsd would like to know about Study985-688-7777
Hi Nancy! You can email our Research Director at Teds@arizonapain.com for more information. Thanks!
Hi,I’m so excited so hear you might have a drug that will help me! I have RSD. it started in my rt ankle -foot from a fracture 2 1/2 years ago and spread up my leg into my hip and spread into my left foot and leg now. They are turning black and blue at times bleeding & leaking fluid from the legs being so swollen. I had a doctor but he had to leave his practice. I have been dealing with a lot of pain and watching my feet – legs turn blue/black I need help so very bad. Please hurry with this drug my other joints are hurting and it takes a lot to get my legs into a car. I need my life back. God bless you there is a light at the end of the tunnel. I can go through the pain to get to no pain. Sheila place
Does the study only apply to US citizens?
Hi Gemma! You can email our Research Director at Teds@arizonapain.com for more information. Thanks!
I was wondering what are the blood and urine test looking for? The ekg is to make sure the heart is in good enough condition to tolerate medicine ? My husband is thinking of joining the study but I was looking for more information if you could please answer the above questions for now that would be a great start thank you kindly, he has had RSD 1 for approximately 3 years in his left hand and arm
Hi Debi! You can email our Research Director at Teds@arizonapain.com for more information. Thanks!
I wh e been struggling with CRPS/RSD for eight long years. I would love to be a part of your study. Is that possible?
Hi Christine! You can email our Research Director at Teds@arizonapain.com for more information. Thanks!
Hello there..
I have been through the trial. I am looking at going to Italy for another treatment, as the one here did not last (about 2weeks of relief).. Does anyone know of a second infusion? I do not want to spend the money if it will put me at risk.. I know the medication is “side effect free” other than the flu-like symptoms.. I get that, but I now have a RA factor of >650 and am osteopenic.. I am under 50. I never had these tests prior to the infusions, but am confused as to what I should do
Hi Lori! You can email our Research Director at Teds@arizonapain.com for more information. Thanks!