Efficacy and Safety Study of Topical Capsaicin in Painful Diabetic Neuropathy
- Registration Number
- NCT00993070
- Lead Sponsor
- Thammasat University
- Brief Summary
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain, but there is no data in lower concentration. This is the efficacy and safety of 0.025% topical capsaicin in treatment of painful diabetic polyneuropathy.
- Detailed Description
Patient is randomized to receive either 0.025% topical capsaicin or vehicle control (placebo) for 8 weeks. After one week wash-out period, patients will be switched to the other group for 8 weeks.
Outcome will be assessed by visual analog scale, neuropathic pain scale, SF-MPQ, SF-36. Safety and tolerability will be recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
Inclusion Criteria
- History of type 2 Diabetes mellitus
- Peripheral neuropathy
- Stabilized on pain medication for at least one month
- No previous invasive intervention for pain relief
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Exclusion Criteria
- Local wound or skin abnormality in the applicable area
- Allergic to capsaicin
- Refuse to participate or give consent
- Has other significant disease or receive medication that may worsen neuropathy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Capsaicin Capsaicin - placebo placebo -
- Primary Outcome Measures
Name Time Method Pain relief from pain score reduction, using visual analog scale (VAS) 8 weeks
- Secondary Outcome Measures
Name Time Method Overall clinical improvement, measured by Clinician Global Impression of Change(CGIC) 8 weeks
Trial Locations
- Locations (1)
Thammasat University Hospital
🇹ðŸ‡Pathumthani, Thailand