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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
NameTimeMethod
Pain intensity using numeric rating scale4 weeks after intervention
Secondary Outcome Measures
NameTimeMethod
Pain intensity using numeric rating scale1, 8, 12, 24 weeks after intervention
Quality of life using WHOQOL4,8,12 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

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