N/A N=30 Randomized Treatment

Subcutaneous Botulinum Toxin for Cutaneous Allodynia

Pain

Bottom Line

View on ClinicalTrials.gov: NCT00725322 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2017

Primary outcome: Primary: Time Until Analgesic Failure — 76.3; 79 Days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Botulinum Toxin A (Drug); Placebo - Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stanford University
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Time Until Analgesic Failure	76.3; 79	—
SECONDARY NRS Score Three Weeks After Injection	35.5; 34.7	—

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).

Eligibility Criteria

Inclusion Criteria:- Moderate to severe pain (greater than 4/10) 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

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
A current or history of any severe psychiatric disorder
History of any adverse reaction to botulinum toxin
History of botulism
Untreated infection
Coagulopathy
Females - positive pregnancy test
Surgery within the past 6 months at the site of the painful scar

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00725322). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.