Trial Search Results

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.

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Procedure: Lumbar sympathetic block with Botulinum Toxin type A

Phase:

N/A

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.

Ages Eligible for Study

21 Years - 80 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ian Carroll
6504986885
Not Recruiting