Botulinum Toxin Type A for Neuropathic Pain in Patients With Diabetic Peripheral Polyneuropathy
Early Phase 1
Terminated
- Conditions
- Neuralgia
- Registration Number
- NCT02460107
- Lead Sponsor
- Catholic University of Korea Saint Paul's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 9
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain intensity using numeric rating scale 4 weeks after intervention
- Secondary Outcome Measures
Name Time Method Pain intensity using numeric rating scale 1, 8, 12, 24 weeks after intervention Quality of life using WHOQOL 4,8,12 weeks after intervention
Trial Locations
- Locations (1)
St. Paul's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of
St. Paul's Hospital, The Catholic University of Korea🇰🇷Seoul, Korea, Republic of