Status:
TERMINATED
Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial
Lead Sponsor:
Stanford University
Conditions:
Pain
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. The investigators have observed prolonged profound ...
Detailed Description
Patients with post-herpetic neuralgia, complex regional pain syndrome, and post-surgical neuromatous pain patients have marked cutaneous allodynia. Touching their skin with normally non-painful stimul...
Eligibility Criteria
Inclusion
- Moderate to severe pain (greater than 2/10) of duration more than 6 months despite previous therapy, excluding botox injection
- The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS
- Patient reports more than 3 weeks of greater than 50% pain relief from previous botox injection
- The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar in the absence of the botox injection
- Age 18-100
- Ability to read, write, and converse in English, provide informed consent, and follow study procedures
Exclusion
- Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy
- Any ongoing legal action related to their pain
- Allergy to local anesthetics
- Any ongoing disability claim
- Currently being treated for any severe psychiatric disorder, including anxiety or depression
- History of any adverse reaction to botulinum toxin
- History of botulism
- Untreated infection
- Coagulopathy
- (Females) - positive pregnancy test
- Surgery in the last 6 months
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00822926
Start Date
January 1 2009
End Date
December 1 2013
Last Update
August 15 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305