Subcutaneous Botulinum Toxin for Cutaneous Allodynia - Enriched Responder Trial

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 analgesia following subcutaneous superficial injection of Botulinum Toxin Type A (BTA) in patients with certain types of neuropathic pain. the investigators 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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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