Randomized Trial of Mannitol Cream for Pain Relief After a Long Run
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Change in NRS (Numeric rating scale) pain score
研究概览
简要总结
Mannitol cream has been shown clinically to be effective for pain control. To determine if this effect is worth testing on a larger scale, 170 runners will receive a sample of 25% mannitol cream to apply on one leg, and the cream base without the mannitol on the other leg following a 10 km or longer run, and for the following five days. Mannitol and control legs will be chosen at random for each runner. Pain scores before and after cream application will be acquired each day for each leg. Means and standard deviations found will be used to determine the size of a larger study.
详细描述
The hypothesis for this study is that Mannitol cream will reduce post long run pain more than vehicle cream alone. In this parallel design, 170 runners who usually experience a pain level greater than 5/10 on a numerical rating scale from 0 to 10 where zero is no pain and 10 is the worst pain ever, will be given a cream containing 25% mannitol to apply on one leg and the vehicle cream to apply on the other leg. The cream assignment will be randomized, and the runner, the person supplying the cream and the person inputting the data will be blinded as to which leg received which cream. Pain levels in each leg following the long run will be recorded, via an e-mail questionnaire, or, failing this, by telephone, the day of the run, and each day, for five days following the run. Mean and standard deviations for pain levels will be calculated for each treatment leg, and a repeated measures ANOVA (Analysis Of VAriance) will be done comparing the pain levels in each leg over the six days. Using this information, if the NRS (Numeric rating scale) pain levels differ by more than 1/10 between the two groups, a larger study will be conducted using the information gathered in this study to determine sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •never ran 10 km or more, or;
- •NRS pain level greater than 5/10 in both legs following a 10 km or more run
排除标准
- •no major skin allergies
- •no allergy to mannitol
研究组 & 干预措施
Mannitol cream
cream containing 25% mannitol, applied as often and as much as needed to one leg ( chosen at random), on the day of a 10 km run, following the run and for five days afterwards
干预措施: Mannitol cream (Drug)
Placebo cream
Same carrier cream as that containing the active ingredient, mannitol, but without the active ingredient. Placebo cream to be applied to the painful areas of the other leg, chosen at random, on the day of a 10 km or more race, following the race, and as needed for the five days after the race. It is to be noted that, as almost no mannitol is absorbed through the skin, it is highly unlikely that this would involve the pain levels in the placebo leg.
干预措施: Placebo Cream (Drug)
结局指标
主要结局
Change in NRS (Numeric rating scale) pain score
时间窗: For six days following run
NRS (Numeric rating scale) pain score from zero, no pain, to 10 worst pain ever. Change in pain score will be measured daily starting on day of race, comparing pain following the race, prior to the first cream application, to the daily scores for the subsequent five days. Pain levels in leg given mannitol cream, and leg given placebo cream will be compared according to the change in their pain scores.
次要结局
- side effects of cream(For six days, starting on day of race.)