Sean Mackey, M.D., Ph.D.
Subcutaneous Botulinum Toxin for Cutaneous Allodynia
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
Superficial injection of Botulinum toxin has been advocated for cosmetic purposes but has also been reported to be helpful for some pain conditions. We have observed prolonged profound analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. We propose to study if addition of BTA extends pain relief compared to placebo when injected subcutaneously into areas of cutaneous allodynia (the property that a normally non-noxious stimulus is perceived as painful).
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Botulinum Toxin A
Phase:
N/AEligibility
Ages Eligible for Study:
18 years to 100 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Moderate to severe pain (greater than 2/10) of duration more than 6 months despite previous therapy.
- The patient exhibits at least 80% pain relief following injection of local anesthetic subcutaneously into scar as assessed by change in NRS.
- The patient reports the presence of hyperalgesia, allodynia, dysesthesia, or hypoesthesia surrounding the scar.
- Age 18-100
- Ability to read, write, and converse in English, provide informed consent, and follow study procedures
Key Exclusion Criteria:
1. Any neuromuscular disorder such as myasthenia gravis, eaton lambert, muscular dystrophy.
2. Any ongoing legal action related to their pain.
3. Allergy to local anesthetics.
4. A current or history of any severe psychiatric disorder.
5. History of any adverse reaction to botulinum toxin.
6. History of botulism.
7. Untreated infection.
8. Coagulopathy.
9. Females - positive pregnancy test
10. Surgery within the past 6 months
Additional Study Details
Official Title:
Subcutaneous Botulinum Toxin for Cutaneous AllodyniaAnticipated start date:
12/18/2007Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Cross OverEndpoints:
EfficacyPrimary Outcomes:
- Time until analgesic failure
Secondary Outcomes:
- Proportion of patients experiencing a reduction of 2 points or more on NRS, three weeks after injection, compared to baseline NRS
- Reduction in area of allodynia and hyperalgesia
- Improvement in psychosocial function as assessed by outcomes as dictated by the IMMPACT Guidelines
Total Number to be Enrolled:
33Total Number to be Enrolled at Stanford:
33More Information
Secondary ID(s):
- 11830
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
6/26/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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