Randomized Placebo-Controlled Trial of Palmitoylethanolamide for Chronic Inflammatory Pain Conditions
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain Level
研究概览
简要总结
The goal of this clinical trial is to evaluate if a supplement called palmitoylethanolamide (PEA) is effective in reducing the pain in patients with chronic inflammatory pain conditions. The main question the trial aims to answer is if PEA works better at treating a patients pain and improving their function better than a placebo.
Participants will be divided into two equal groups and asked to take either PEA or a placebo for 8 weeks.
详细描述
Chronic inflammatory pain conditions, such as rheumatoid arthritis, fibromyalgia, and neuropathic pain syndromes, present a significant burden on individuals and healthcare systems worldwide. Despite advancements in pain management, many patients continue to experience inadequate relief, and the long-term use of conventional analgesics can be associated with adverse effects.
Palmitoylethanolamide (PEA) is a naturally occurring fatty acid amide that has garnered attention in recent years for its potential therapeutic properties in managing chronic inflammatory pain. PEA is an endogenous lipid mediator and a member of the N-acylethanolamine family. It exerts its effects primarily by interacting with peroxisome proliferator-activated receptor alpha (PPAR-α) and through other molecular pathways involved in neuroinflammation and immune responses.
In Europe where nutraceuticals are more commonly used in conventional practice, research on PEA has shown significant promise in studies on inflammatory pain conditions such as chronic pelvic pain, irritable bowel syndrome, temporomandibular joint arthritis and knee osteoarthritis. Similar studies have not been completed in the United States.
- Anti-Inflammatory Effects:
- PEA has demonstrated anti-inflammatory properties by modulating immune responses, inhibiting mast cell activation, and reducing the release of pro-inflammatory cytokines. These effects suggest its potential in attenuating the underlying inflammation in chronic pain conditions.
- Analgesic Effects:
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)
盲法说明
Double Blinded, patients will receive visually identical capsules from research pharmacist with study label indicating PEA vs Placebo
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic Inflammatory Pain of greater than 3 months duration and greater than or equal to 5/10 intensity that has not responded to other conservative therapies such as rest, ice, compression or other oral medications.
排除标准
- •Severe allergy to any specific food component such as nut, egg or soy
研究组 & 干预措施
Placebo
Participants randomized to the placebo arm will receive a visually identical placebo capsule
干预措施: placebo (Other)
Palmitoylethanolamide
Participants randomized to the experimental arm will receive the supplement Palmitoylethanolamide (PEA) at a dose of 600mg twice a day
干预措施: Palmitoylethanolamide 600mg twice a day (Drug)
结局指标
主要结局
Pain Level
时间窗: 4 and 8 weeks
Pain level will be assessed using the Defense and Veterans Pain Rating Scale (DVPRS) Where the minimum value is 0 indicating no pain and the maximum value is 10 indicating worst possible pain
次要结局
- Patient Reported Outcome Measurement Information System (PROMIS) (Pain interference, Social satisfaction; Physical function)(4 and 8 Weeks)
- Pain interference and function(4 and 8 weeks)
- Pain Catastrophizing Scale (PCS)(4 and 8 weeks)