The Effect of Soy Protein on Neuropathic Pain: Randomized N-of-1 Trials
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
Neuropathic pain is one form of chronic pain lacking effective pharmacotherapy. Interest in the role of complementary and alternative medicine is growing and diet is at the forefront of the search for alternative treatments for pain. Soy protein is one of the most promising dietary ingredients tested for its pain-relieving properties. Results from animal studies show that soy-enriched diets reduce pain due to nerve injury. The purpose of this study is to determine the effects of soy protein supplementation on facial pain.
详细描述
Neuropathic pain is a complex disorder with mixed results in response to pain medication due to a high degree of variability between patients. To address this issue, we are implementing a unique methodology using a series of N-of-1 or single subject randomized, double blind, controlled studies. With this, we will explore the role of soy protein supplementation in neuropathic pain patients. Each patient will be exposed in 3-week intervals to soy protein and a control, milk protein, in three paired treatment periods for a total of 18 weeks. This method allows for the measurement of treatment efficacy in individual distinct patients and has the potential for immediate and continued medical benefit using a simple and readily available dietary ingredient.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 18 years old
- •Chronic neuropathic pain with tactile allodynia > 6 months
- •Suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary)
- •Pain intensity score ≥ 5 on 11-point numerical rating scale (NRS) during 1-week screening period prior to randomization
- •Stable medication use (if any) over 4 weeks before starting the trial. Current medication use will be maintained and no additional pharmacotherapy may be introduced during the trial.
- •Up to date mammogram and gynecological evaluations.
排除标准
- •History of significant heart, gastro-intestinal, liver or kidney disease
- •History of alcohol/narcotic abuse or current excessive alcohol consumption
- •History or diagnosis of cancer
- •History of breast tumors, predisposition to breast cancer or a family member with breast cancer
- •History of hormonal or gynaecological disease
- •Current use of hormonal replacement therapy (HRT), except thyroid HRT
- •Pregnant or breastfeeding women
- •Use of any anticoagulant or blood thinner except acetylsalicyclic acid
- •Malabsorption of any kind
- •Diagnosed lactase deficiency;
- •Known allergy to any of the dietary products
- •Known allergy to acetaminophen
- •Daily consumption of soy protein in quantities exceeding 10 g/day
- •Strict vegetarians (i.e. no animal derived dietary sources)
- •Antibiotic use within the last 3 months
- •Any previous psychiatric diagnosis before pain onset
- •Body mass index > 35
研究组 & 干预措施
Soy Protein
30g of soy protein from whole soybean soymilk powder given daily for 3 weeks
干预措施: Whole soybean soymilk powder (Dietary Supplement)
Milk Protein
30g of milk protein from whole milk powder given daily for 3 weeks
干预措施: Whole milk powder (Dietary Supplement)
结局指标
主要结局
Pain Intensity
时间窗: Baseline and 3 times during the last week of every treatment period
次要结局
- Area of dynamic allodynia(Baseline and at the end of every treatment period)
- Quality of life(Baseline and at the end of every treatment period)
- Depression(Baseline and at the end of every treatment period)
- Dietary intake(Baseline, once a week during the first treatment period, once during the second week of the remaining treatment periods.)
- Pain Quality(Baseline and 3 times during the last week of every treatment period)
- Dynamic tactile allodynia(Baseline and at the end of every treatment period)
- Body weight(Baseline and at the end of every treatment period)
- Analgesic medication use(Baseline and 3 times during the last week of every treatment period)
- Adverse events(The full 18 weeks until the end of the last treatment period)
研究者
Dr. Yoram Shir
Doctor
McGill University Health Centre/Research Institute of the McGill University Health Centre