Status:
COMPLETED
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.
Lead Sponsor:
Stanford University
Conditions:
Pain
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
Lumbar sympathetic blocks are part of the standard of care for treating patients with sympathetically-maintained pain (e.g. in complex regional pain syndrome or reflex sympathetic dystrophy- RSD). In ...
Detailed Description
Lumbar sympathetic block will be performed twice on each patient: once as in the standard of practice with 10 cc 0.5% Bupivicaine and once with 75 units of Botox in 10cc of 0.5% Bupivicaine. These wil...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00637533
Start Date
May 1 2004
End Date
May 1 2007
Last Update
January 19 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University School of Medicine
Stanford, California, United States, 94305