Diabetic Nerve Problems, Diabetic Neuropathy, Diabetic Complications Neurological
Conditions
Brief summary
The study aims to compare the effectiveness and tolerability of using lidocaine 5% patch to 8% capsaicin patch in patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study
Detailed description
The aim of the present study was to compare the efficacy and tolerability of using lidocaine 5% patch to 8% capsaicin patch in south Asian male patients with diabetic neuropathy. Assessment of analgesic effectiveness was assessed by observing any change in the Numeric Pain Rating Scale (NPRS) score, average daily pain Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) and Patient Global Impression of Change (PGIC). Assessment of capsaicin and lidocaine safety and identifying treatment adverse effects were secondary endpoints in this study
Interventions
5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm
DRUGCapsaicin 8% Patch, Per 10 Square Centimeters
8% Capsaicin patch \[8% w/w\] 640 µg/cm² of adhesive, patch area 280 cm2 (20 cm x 14 cm), (Qutenza®; capsaicin 179 mg patch, Astella Pharma Europe Ltd. Chertsey, UK)
Sponsors
Corporacion Parc Tauli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded study, the investigators, patients and care providers were not aware of the identity of the administered patch. The codes 11 were used for the capsaicin patch, 12 for the control patch and 33 for the lidocaine patch. These codes were retained by a hospital staff member who was not involved in the study and were revealed to the researchers after all the data was collected and analyses.
Intervention model description
This present study was a double blinded, placebo controlled, parallel group study
Eligibility
Sex/Gender
MALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males aged 40 - 60 * Type 2 diabetes of \>10 years duration * Symptoms of peripheral neuropathic painpresent by scoring on Diabetic neuropathic score (minimum score 1)
Exclusion criteria
* Diabetic foot ulcer * Deformed or contracted foot * Neurological complications * Presence of neurological disease * Presence of cardiovascular or peripheral vascular disease, * Usage of topical analgesics or implanted medical device six weeks prior to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Outcome 1 Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) scores | 24 weeks | Brief Pain Inventory (BPI) for painful diabetic peripheral neuropathy (BPI-DPN Q4) scores. diabetes at its worst over the past 24 hours). Each BPI item uses a 0-10 numeric rating scale anchored at zero for no pain and 10 for pain as bad as you can imagine for Severity, and does not interfere to completely interferes for Interference. |
| Outcome 2 Patient Global Impression of Change score | 24 weeks | Patient Global Impression of Change score. PGIC is a 7 point scale depicting a patient's rating of overall improvement. The PGIC was patient-reported, and asked the subject to indicate how you feel now, compared to how you felt before receiving treatment in this study on a 7-point scale of -3 (very much worse), 0 (no change), to +3 (very much improved). |
Countries
Pakistan
Outcome results
None listed