Peripheral Diabetic Neuropathy
Conditions
Keywords
capsaicin, neuropathic pain, diabetic neuropathy, topical lotion
Brief summary
To study that 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial
Detailed description
Neuropathy is one of the most common complications in both type 1 and type 2 diabetes mellitus. The most common symptom is a symmetrical, chronic, axonal, length-dependent sensorimotor polyneuropathy. Topical capsaicin formulations are widely used to manage pain. Low-concentration creams, lotions, and patches intended for daily skin application have been available in most countries since the early 1980s. We study 0.075% capsaicin lotion is safe, well tolerated and provide significant pain relief in patients with PDN compared with placebo lotion as a randomized, double- Blind, crossover, placebo-controlled trial for 20 weeks throughout the study in 42 participants. All participants are provided both 0.075% capsaicin lotion and placebo lotion. Each agent will be applied for 8 weeks then stop for 4 weeks, after that another agent will be used for 8 weeks. We keep following up all of them by calling and appointment to get information in effectiveness and adverse effect at 0,2,4,8,12,14,16,20 week, respectively.
Interventions
DRUG0.075% Capsaicin Lotion
To apply 3-4 times per day, every day until 8 weeks then stop
DRUGplacebo
To apply 3-4 times per day, every day until 8 weeks then stop
Sponsors
Thammasat University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized controlled trial, double blind
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. DM type 2 over 1 year 2. Clinical presentation of peripheral sensory such as burning pain 3. DN4 score from 4 points 4. Good consciousness to tell their score with informed consent agreement 5. No adding dosage of previous pain control medications at least 4 weeks 6. HbA1C 6.5-9.0%
Exclusion criteria
1. Improper application site of skin for topical drugs such as abrasion wound. 2. Allergic history of Capsaicin 3. No intention to join the study with any reasons 4. Other previous medications used that effect to peripheral neuropathy such as Carboplatin, Cisplatin, Colchicine, Dapsone, Etoposide, Ethambutol, Indomethacin, Isoniazid, Lithium, Metronidazole, Phenytoin, Pyridoxine, Statins, Stavudine (d4T) or conditions worsening peripheral nerves following that poor nutrition, kidney failure, chronic alcoholism, vitamin deficiency, Hypothyroidism
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (0-100 mm.) | 20 week | scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short-form McGill Pain Questionnaire(SF-MPQ) | 20 week | scale |
| Neuropathic Pain Scale (NPS) | 20 week | scale |
Countries
Thailand
Outcome results
None listed