Mannitol Cream in the Treatment of Post-herpeticNeuralgia;a Randomized Placebo-Controlled Crossover Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in worst NRS (Numerical Rating Scale) pain score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Allergies to any of the ingredients of the cream
- •Open lesions or abrasions on the skin where the cream will be applied
- •Using corticosteroids
- •Unwilling to stop using other topical products (creams or patches) for the treatment of post-herpetic neuralgia
- •Pregnant, breast-feeding or not using birth control
- •Suffering from severe chronic pain from a cause other than post-herpetic neuralgia
研究组 & 干预措施
mannitol in vehicle cream /vehicle cream
one week on the mannitol cream (mannitol 30% in vehicle cream), a 3 day washout period, and one week on the placebo cream (vehicle cream alone). To be applied over the painful area as needed for pain. Usual frequency is 2 to 3 times daily.
干预措施: Mannitol cream (Drug)
mannitol in vehicle cream /vehicle cream
one week on the mannitol cream (mannitol 30% in vehicle cream), a 3 day washout period, and one week on the placebo cream (vehicle cream alone). To be applied over the painful area as needed for pain. Usual frequency is 2 to 3 times daily.
干预措施: Placebo (Drug)
vehicle cream /mannitol in vehicle cream
one week on the placebo cream (vehicle cream alone), a 3 day washout period, and one week on the mannitol cream (mannitol 30% in vehicle cream).To be applied over the painful area as needed for pain. Usual frequency is unknown.
干预措施: Mannitol cream (Drug)
vehicle cream /mannitol in vehicle cream
one week on the placebo cream (vehicle cream alone), a 3 day washout period, and one week on the mannitol cream (mannitol 30% in vehicle cream).To be applied over the painful area as needed for pain. Usual frequency is unknown.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in worst NRS (Numerical Rating Scale) pain score
时间窗: 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
Change in average NRS (Numerical Rating Scale) pain score
时间窗: 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
次要结局
- Satisfaction from cream use(Three months after use of mannitol cream was started.)
- Change in pain score from mannitol cream use to mannitol and menthol cream use(1st measurement Three months after use of mannitol cream was started 2nd measurement one month after mannitol and menthol cream started)
- Change in Pain medication intake(Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3,months)
- Change in Alcohol intake(Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months)
- Change in questions from the brief pain inventory score(Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months)
- Change in PHQ-9 (Personal health questionnaire, 9 questions) Score(Before each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months)
- Change in Method of cream application(when each cream is first applied, 7 days later, and for mannitol cream 1,2 and 3 months)
- Change in effect and side effects of the cream(Daily for the 14 days, of the crossover study, then at 1,2 and 3 months)
研究者
Helene Bertrand
MD, CCFP, Clinical instructor, Department of family practice University of British Columbia
University of British Columbia