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30% mannitol cream has shown its ability to reduce the activation of the Capsaicin (TRPV1) (Transient Receptor Potential Vanilloid 1) receptor, a likely cause of the pain of post-herpetic neuralgia (PHN). This randomized placebo-controlled crossover study compares PHN pain one week before, for one week on the randomly assigned mannitol versus placebo cream and, after a three day washout, for one week on the other cream. Following this crossover study, participants receive mannitol cream for three months. Pain levels will be checked to assess whether continued use of this cream significantly reduces the pain levels associated with PHN. If pain persists beyond 3 months, participants will be offered mannitol and menthol cream for one month following which their pain levels will be checked.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2018-10-23
What this record can show
This locally preserved record separates the registered protocol from source-reported registry results. Neither is a treatment recommendation.
Registry facts
Pain levels: 0 to 10 Numerical Rating Scale (NRS), medication and alcohol intake will be checked daily for one week prior to randomization in 20 participants with post herpetic neuralgia, lasting more than three months. Following this 10 will be randomized to apply 30% mannitol in vehicle cream and 10 to apply vehicle cream alone for one week during which daily pain levels and use of medication and alcohol will be measured together with the mode of application (rubbing in or applying it to cling wrap then applying the cream coated cling wrap to the skin in cases of severe allodynia). After a three day washout period, they will be given the cream they did not receive previously for one week. The same variables will be recorded daily. The data collected in the first 24 days will be used to generate a power analysis. Following this, all subjects will receive the 30% mannitol cream to apply for three months. Their pain levels, medication intake and method of application will be measured once a month for three months. T-tests will compare the pain levels for mannitol and placebo users before and after one week of the use of each cream to see if the mannitol cream provides better short term pain relief than placebo. Repeated measures ANOVA (Analysis Of VAriance) will compare pain levels before using the mannitol cream and monthly for three months to assess the long-term effects of mannitol cream. Variables collected at each visit, which will not be used for statistical purposes in the current very small pilot project but may be used in a later study, include: application method, effect and side effects of the cream, medication and alcohol use, PHQ - 9 (Personal Health Questionnaire, 9 questions), and questions from the brief pain inventory score. At three months, a satisfaction score will be added to the database. If pain persists beyond 3 months, participants will be offered mannitol and menthol cream for one month, following which their pain levels, PHQ - 9 and brief pain inventory scores will be checked.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Apply to area of postherpetic neuralgia pain as needed for pain control. Usual frequency is 2 to 3 times per day.For crossover study, will be applied for 7 days. For observational study, will be applied up to 3 months
Mannitol in vehicle cream · QR creamApply to area of postherpetic neuralgia pain as needed for pain control.Usual frequency is unknown. For crossover study, will be applied for 7 days. Will not be used after crossover study
Vehicle creamEligibility
primary outcomes
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
In the last 24 hours, how bad was your pain at its worst? No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
In the last 24 hours, how bad was your pain on average? No pain 0 1 2 3 4 5 6 7 8 9 10 Worst pain imaginable
secondary outcomes
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3,months
Number of pills taken for pain in one day. Will decrease as the pain intensity decreases. Write the number of tablets that you took: 1. Tylenol/acetaminophen\_\_\_\_\_\_, 2. Anti-inflammatory medication like Advil/ibuprofen, naproxen, diclofenac, Voltaren, Aleve\_\_\_\_\_\_, 3. Tylenol or ASA (acetylsalicylic acid) plus narcotic like Tylenol 3, or 292 or Tramacet (acetaminophen/tramadol) \_\_\_\_\_\_, 4. Narcotic like morphine, hydromorphone/dilaudid, fentanyl, Demerol, tramadol\_\_\_\_\_\_, 5. Cannabis, marijuana, or pot\_\_\_\_\_\_, The total in each category will be added to calculate the total number of tablets taken in 24 hours.
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Number of alcoholic drinks in one day. May decrease as the pain intensity decreases. Write down the total number of alcoholic drinks you had in the last 24 hours:how many glasses of wine \_\_\_\_\_\_ glasses of hard liquor\_\_\_\_\_\_ bottles of beer\_\_\_\_\_\_. The total number of glasses will be recorded.
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
The total from the following questions will be recorded to measure how much their pain is interfering with their lives: Circle one number. In the last 24 hours, how much has your pain interfered with your: General activity:, Mood: Walking ability: Normal work: (includes both work outside the home and housework) Relations with other people: Sleep: Enjoyment of life: Each of these will be scored as follows: does not interfere 0 1 2 3 4 5 6 7 8 9 10 completely interferes. The scores added up. This sum should decrease as the pain decreases.
Time frame: Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Patients will fill the PHQ - 9 score. http://phqscreeners.com/pdfs/02\_PHQ-9/English.pdf The sum of the answers from this questionnaire, which is used to measure the degree of depression, may decrease as the pain intensity decreases.
Time frame: when each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months
Patients will describe whether they use cling wrap (4), gentle applicator (3) or rubbing in gently (2) or vigourous rubbing (1)
Time frame: Daily for the 14 days, of the crossover study, then at 1,2 and 3 months
How many times did you apply the cream today?\_\_\_\_\_\_\_ Circle one number. How bad was your pain?.. Before you applied the cream? NRS 0-10 1hour after you applied the cream? NRS 0-10 Did the cream relieve your pain? No □ if Yes □ in how many minutes?\_\_\_\_ For how many hours was your pain relieved?\_\_\_\_ Did you experience a side effect from the cream? No □ if Yes □ What was it?\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Any comments?\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
Time frame: Three months after use of mannitol cream was started.
How satisfied were you with the use of this cream? Not at all satisfied 0 1 2 3 4 5 6 7 8 9 10 extremely satisfied
Time frame: 1st measurement Three months after use of mannitol cream was started 2nd measurement one month after mannitol and menthol cream started
Maximum pain score after 3 months of mannitol cream use compared to maximum pain score after one month of mannitol and menthol cream use
Publications
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