Neuralgia
Conditions
Brief summary
The purpose of this study is to determine whether botulinum toxin A is effective in the treatment of neuropathic pain in patients with diabetic peripheral polyneuropathy.
Interventions
BIOLOGICALBotulinum toxin type A
OTHERNormal saline
Placebo
Sponsors
Medy-Tox
Catholic University of Korea Saint Paul's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • more than twenty years of age * patients should have 4 or more items positive among the 10 items of the DN4 questionnaire. * persistence of neuropathic pain for more than three months or remission and recurrence of neuropathic pain for more than six months * a pain score of 4 or more on the numeric rating scale
Exclusion criteria
* • neuropathic pain caused by confounding factors other than diabetic neuropathic pain * contraindicated for botulinum toxin type A * a change in pain medication one month prior to study enrollment * a condition involving neuromuscular junction (Ex. Eaton Lambert disease, myasthenia gravis) * person who received botulinum toxin type A within three months prior to study enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity using numeric rating scale | 4 weeks after intervention |
Secondary
| Measure | Time frame |
|---|---|
| Pain intensity using numeric rating scale | 1, 8, 12, 24 weeks after intervention |
| Quality of life using WHOQOL | 4,8,12 weeks after intervention |
Countries
South Korea
Outcome results
None listed