Effect of a Sham Anti-inflammatory Diet on Inflammation and Participant Blinding in Spinal Cord Injury: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Diet Compliance
研究概览
简要总结
This pilot study will evaluate the effects of a placebo anti-inflammatory diet in individuals with spinal cord injury. It is being performed to ensure that the placebo diet does not induce reductions in inflammation and also adequately conceals group allocation.
详细描述
Anti-inflammatory diet is a novel treatment that may be beneficial for managing chronic inflammation and neuropathic pain (NP) after Spinal Cord Injury (SCI). NP is a common complication following SCI that significantly decreases quality of life. Treatment options are limited, and current treatments can have significant side effects. Those with SCI have identified a need for additional treatment options, particularly those that are not medications.
As pain is a subjective outcome, awareness of group allocation could influence treatment expectations and participant rated scores of neuropathic pain. It is therefore important to ensure that an adequate placebo intervention is utilized. This pilot study will assess whether the placebo diet to be used in an upcoming RCT provides sufficient group allocation concealment (i.e. ensure participants are unaware of whether they are on the anti-inflammatory diet or placebo diet). This pilot study will also assess whether the placebo diet is in fact inflammation neutral (ie. induces no reductions in inflammation).
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
No other parties will be masked for the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent obtained prior to any study-related activities
- •A spinal cord injury at least 6 months duration, nonprogressive for at least 6 months
- •Dosing of other pain medications (NSAIDs, opioids, non-opioid analgesics, anti-epileptic drugs, antidepressants) should be stable for at least 1 month prior to study entry.
排除标准
- •Current infection of any kind.
- •Presence of other neurologic conditions, medical conditions or pain that could confound the assessment of neuropathic pain after SCI
- •Currently enrolled in another clinical trial
- •Any other significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or affect the patient's ability to participate in the study
- •Following a physical examination, the patient has any abnormalities that, in the opinion of the investigator would prevent the patient from safe participation in the study
结局指标
主要结局
Diet Compliance
时间窗: Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)
Diet compliance will be assessed following the intervention. Compliance to the specific diet will be assessed by a detailed analysis of all diet records. Each food item will be categorized as either a "food to consume," a "food to avoid," or a "neutral food" based on the parameter of the diet participants who were instructed to follow. Food will also be categorized into servings in accordance with Canada's Food Guide. Therefore, compliance score will be based on standard servings of foods subjects were instructed to eat vs. foods they were instructed to avoid. To account for differences in total energy intake, compliance scores will be expressed as a ratio of the servings of foods to consume over the total servings of food (avoid + consume) multiplied by 100. The percent compliance will then be generated.
C-Reactive Protein
时间窗: Baseline and Week-5 (post measures collected following 1-week group allocation period and 4-week intervention)
Change in plasma C-reactive protein from baseline to post intervention.
次要结局
未报告次要终点