Cocoa Intake and Muscle Pain Sensation: an Experimental Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in pain intensity by intake of chocolate
研究概览
简要总结
This experimental randomized, double-blind, and controlled study included fifteen young, healthy, and pain-free men and 15 age-matched women.
It lasted for three visits with at least one-week washout. Pain was experimentally induced, twice at each visit, with intramuscular injections of 0.2 mL hypertonic saline (5%), before and after intake of one of the different chocolate-types; white (30% cocoa-content), milk (34% cocoa-content), dark (70% cocoa-content). Pain duration, pain area, peak pain, and pressure pain threshold were assessed every fifth minute after each injection, between the time-points 5 to 30 min.
Prior to inclusion, all participants underwent an examination in a dental chair. This included a clinical examination of the orofacial region according to the Diagnostic Criteria for temporomandibular disorders (DC/TMD) by a blinded examiner. Participants were also examined regarding their psychosocial status prior to inclusion, this included depression, somatization, anxiety, pain catastrophizing and stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The chocolate given to the participant was of a different concentration of cocoa, distributed in a randomized and double-blinded order. The participants where given the chocolate with their eyes closed. A non-blinded examiner fed the chocolate to the participant at each clinical trial, while a blinded examiner did the assessments. The different types of chocolates were given at three different visits to all participants with at least one week of washout in between. To randomize the order in which the chocolates were given to each participant, an internet-based site was used (www.randomization.com; Seed 19525). The randomization was done in five blocks of six participants each, by a researcher who did not participate in the data collection
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •good general health
- •age between 18-40 years
排除标准
- •any pain-related diagnosis of TMD or of the orofacial region
- •any headaches
- •a diagnosis of systemic muscular or joint diseases (fibromyalgia or rheumatoid arthritis)
- •whiplash-associated disorders
- •neurological disorders
- •psychiatric disorders
- •any allergy to the substances used
结局指标
主要结局
Change in pain intensity by intake of chocolate
时间窗: 5 min after injection of hypertonic saline
Pain intensity will be assssed using a 0-100 visual analoge scale (0-no pain; 100-worst pain ever experienced)
Change in peak pain intensity before and after intake of chocolate
时间窗: 5 min after injection of hypertonic saline
Peak pain intensity will be asessed from the 0-100 visual analoge scale (0-no pain; 100-worst pain ever experienced)
Change in pain duration by intake of chocolate
时间窗: Pain duration up to 300 seconds after injection of hypertonic saline
Pain duration is assessed in seconds.
Change in pain area by intake of chocolate
时间窗: Pain area is marked 5 min after injection of hypertonic saline
Pain area will be marked on lateral charts of the head before and after intake of chocolate and measured in au.
次要结局
- Change in pressure pain threshold by intake of chocolate(Pressure pain thresholds are assessed 5 min after injection of hypertonic saline)
研究者
Nikolaos Christidis
Associate professor, senior lecturer, senior consultant
Karolinska Institutet