©2024 Stanford Medicine
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.
Not Recruiting
Trial ID: NCT00637533
Purpose
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 these patients lower extremity pain can be reduced or abolished
temporarily by blocking sympathetic nerves by doing a lumbar sympathetic block. Patients who
respond only transiently to sympathetic blocks often choose between potentially dangerous
lumbar sympathetic block with neurolytic agents, surgical sympathectomy, continued severe
refractory debilitating pain or other risky invasive surgical procedures such as spinal cord
electrical stimulation.. It is hypothesized that Botulinum Toxin Type A (BTA) injected in a
lumbar sympathetic block can provide extended sympathetic blockade and thus pain relief. This
pilot study aims to see if BTA can be used safely in lower extremity sympathetic blocks, and
might be useful in providing prolonged pain relief.
Official Title
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.
Eligibility
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.
Intervention(s):
procedure: Lumbar sympathetic block with Botulinum Toxin type A
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Ian Carroll
6504986885