A Pilot Clinical Trial of Sympathetic Blockade With Botulinum Toxin Type A to Treat Complex Regional Pain Syndrome (CRPS): a Randomized, Double-Blind, Controlled, Crossover Trial.
Pain
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:Severe pain in a lower extremity (greater than 6/10) of duration more than 6 months despite aggressive previous therapy including both previous lumbar sympathetic block, and previous trial of at least 4 different pain medications including at least 2 of the following: gabapentin, amitryptiline, desipramine, nortryptiline, imipramine, carbamazepine, valproic acid, mexiletine, oxcarbazepine, topiramate, lamotrigine, flecainide, zonisamide, venlafaxine and levetiracetam.
The severity of the pain must be such that the patient must perceive the function of the lower extremity to be compromised by the pain. Exclusion Criteria:Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy. Any ongoing legal action related to their pain. Any ongoing disability claim. A history of any severe psychiatric disorder. History of any adverse reaction to botulinum toxin. History of botulism. Untreated infection. Coagulopathy. Concurrent use of anticoagulant medications.
Sites / Locations
- Stanford University School of Medicine
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Placebo
Botulinum Toxin Type A
Saline injection
Sympathetic Blockade containing Botulinum Toxin Type A