The goal of this clinical trial is to learn if the topical anesthetic cream works to treat neuropathic chronic pain in older adults who have not found sufficient relief undergoing other pain treatments and/or medications. The safety of this drug has already been tested in other studies. The main questions it aims to answer are:
* Does the anesthetic cream lower the pain of participants? * Can the participants return to daily activities that they have quit due to chronic pain? * What medical problems do participants have when using this cream?
Researchers will compare the anesthetic cream to a placebo (a look-alike substance that contains no drug) to see if it works to treat neuropathic chronic pain.
Participants will:
* Use the anesthetic cream or a placebo every day for 14 days * Visit the clinic once every 2 weeks for checkups and tests * Keep a diary of their symptoms and the number of times they use the anesthetic cream.
This study is divided into two phases, separated by 30 days.
* Phase 1: Application of the active cream (Lidocaine 23% / Tetracaine 7%) twice daily: once in the morning upon waking and once at night before bed. * Phase 2: Application of the placebo cream under the exact same conditions.
The order of administration (active/placebo) will be randomly assigned.
Procedure: Participants will sign the informed consent form. A baseline evaluation will be conducted, assessing VAS (Visual Analog Scale) score, functionality, and quality of life.
The use of other medications will be recorded. The creams will be applied at home with weekly telephone follow-up and daily patient self-reporting. Evaluations will be conducted on day 14 of each phase. Follow-up controls will occur one and two months after the treatment is suspended. Adherence and adverse effects will also be logged.
Age 60 years or older.
Clinical diagnosis of peripheral neuropathic pain that has lasted for at least 6 months.
Baseline Visual Analog Scale (VAS) pain score of 6 or higher.
Ability to understand and sign the informed consent form.
Known hypersensitivity (allergy) to lidocaine, tetracaine, or any excipients (inactive ingredients) in the preparation
Dermatological lesions (skin damage or sores) in the intended application area.
Concomitant use of other topical therapies (creams, gels, patches) in the affected area.
Severe cognitive impairment or unstable medical comorbidity.
Crossover
Lidocaine (23%) + Tetracaine (7%)
DrugApplication of the active cream (combination of both Lidocaine 23% / Tetracaine 7%) twice daily: once in the morning upon waking and once before sleep, for two weeks.
Placebo cream application
Drug(After a 30 day washout period) Application of the placebo cream twice daily under the same conditions as the active cream: once in the morning upon waking and once before sleep, for two weeks.
Reduction in pain (treatment area)
The Visual Analog Pain Scale, will be used to assess the reduction of pain, being 0 no pain and 10 the worst pain ever experienced.
Better outcomes in daily function and quality of life
The World Health Organization Disability Assessment Schedule scale: A tool used to measure overall disability and functioning across different life domains (e.g., cognition, mobility, participation). Every life domain will be asigned to a specific score in percentage: * 1% best case scenario, no disability and appropriate function. * 100% worst case scenario, fully dependent in most life domains.
Better outcomes in daily function and quality of life
EuroQol 5-Dimension 5-Level: A standardized instrument for measuring health-related quality of life. The participant will answer an every day task sheet, which will provide a specific score from 1 to 5: * being the best case scenario: no problem on completing the task. * 5 being the worst case scenario: not being able to complete the task.
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This trial is not recruiting at the moment. You can still explore other options:
