Treatment of post-herpetic neuralgia Infections and Infestations
Conditions
Interventions
The study design is interventional, employing a double-blind randomized controlled design. Patients will receive either a test cream or a placebo, randomized in the hospital's apothecary, and various
Sponsors
University Clinical Centre Maribor
Eligibility
Sex/Gender
All
Age
18 Years to 110 Years
Inclusion criteria
Inclusion criteria: Current key inclusion criteria: 1. Patients with post-herpetic neuralgia experiencing peripheral neuropathic pain and currently under treatment at the Pain Management Clinic of the Department of Anesthesiology, Intensive Therapy, and Pain Management at the University Medical Centre Maribor 2. Adults identified with neuropathic pain using the DN-4 questionnaire, scoring at least 4 points out of 10 Previous key inclusion criteria: 1. Patients experiencing peripheral neuropathic pain and currently under treatment at the Pain Management Clinic of the Department of Anesthesiology, Intensive Therapy, and Pain Management at the University Medical Centre Maribor 2. Adults identified with neuropathic pain using the DN-4 questionnaire, scoring at least 4 points out of 10
Exclusion criteria
Exclusion criteria: 1. Allergy to phenytoin or loperamide 2. Presence of central neuropathy (multiple sclerosis, spinal cord injury, neuropathy following a stroke) 3. Pregnancy or the possibility of pregnancy 4. Treatment of neuropathic pain with any topical preparation in the last 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain measured using a Numeric Rating Scale (NRS) at baseline before the first application of the cream, 45 min after the first application of the cream, 48h after the first application and 14 days after the first application | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcomes as of 14/04/2026: 1. Health-Related Quality of Life measured using the EQ5D questionnaire total score at baseline and 14 days after treatment 2. Neuropathic Pain measured using the Neuropathic Pain Symptom Inventory (NPSI) questionnaire at baseline and 14 days after treatment 3. Placebo Effect measured using the Numeric Rating Scale (NRS) at baseline, 45 minutes after the first application, 48 hours after the first application, and 14 days after the first application 4. Pain Intensity and Treatment Response in Patients with Post-Herpetic Neuralgia measured using the Numeric Rating Scale (NRS) for pain, EQ5D questionnaire total score, Neuropathic Pain Symptom Inventory (NPSI), and Categorized pain relief scale at baseline, 45 minutes after the first application, 48 hours after the first application, 14 days after the first application, and daily measurements 5. Average Pain Level measured using the Numeric Rating Scale (NRS) daily 6. Average Pain Relief measured using the Categorized pain relief scale daily Previous key secondary outcomes: 1. Health-Related Quality of Life measured using the EQ5D questionnaire total score at baseline, 14 days after treatment 2. Neuropathic Pain measured using the Neuropathic Pain Symptom Inventory (NPSI) questionnaire at baseline, 14 days after treatment 3. Placebo Effect measured using the Numeric Rating Scale (NRS) at baseline, 45 minutes after the first application, 48 hours after the first application, 14 days after the first application 4. Subgroup Analysis (for patients with post-herpetic neuralgia) measured using the Numeric Rating Scale (NRS) for pain, EQ5D questionnaire total score for health-related quality of life, Neuropathic Pain Symptom Inventory (NPSI), Categorized pain relief scale at baseline, 45 minutes after the first application, 48 hours after the first application, 14 days after the first application, Daily measurements 5. Average Pain Level measured using the Numeric Rating | — |
Countries
Slovenia
Contacts
Public ContactMatija;Matija Primec;Primec
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Outcome results
None listed