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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:
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:
This study is divided into two phases, separated by 30 days.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants, placebo cream | Placebo Comparator | In this crossover study, all the participants will take part as their own control group. |
|
| All participants, active cream | Active Comparator | In this crossover study, all the participants will take part as their own control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine (23%) + Tetracaine (7%) | Drug | Application 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Enrollment to the end of treatment at 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MarÃa Francisca Elgueta, MD Associate Professor | Contact | +56 9 6218 7863 | panchielgueta@gmail.com | |
| Victor Contreras, M.Sc. Nurse Practitioner | Contact | +56 9 8189 5232 | vecontre@uc.cl |
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| 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. |
|
| From enrollment to the end of treatment at 2 months |
| 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:
| From enrollment to the end of treatment at 2 months. |
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D013748 | Tetracaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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