Study to Investigate the Potential Pharmacological Effect of Oral Palmitoylethanolamide (PEA) Therapy in the Management of Low Back Pain (Neuropathic Pain): A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Supplement effect on intensity of neuropathic low back pain
研究概览
简要总结
This clinical trial aims to evaluate the potential therapeutic effects of oral supplemental Palmitoylethanolamide (PEA) Phytosome® in managing neuropathic low back pain. The study will involve adult participants diagnosed with neuropathic pain according to established criteria. Eligible participants will be randomized into three groups to receive either PEA Phytosome® supplementation as two different doses or a placebo for a specified period. Data collection will include demographic information, baseline pain intensity, quality of life assessments, and functional outcomes. The primary endpoint will be the reduction in pain intensity, while secondary endpoints will include improvements in quality of life and functional capacity. Safety and tolerability of the supplement will also be assessed. This trial seeks to provide robust clinical evidence of the potential pharmacological effect of PEA's Phytosome® as a potential adjunctive treatment for neuropathic low back pain.
详细描述
Neuropathic low back pain arises from nerve damage or dysfunction, leading to chronic pain characterized by burning, tingling, or shooting sensations. This condition significantly impacts quality of life and is often refractory to conventional treatments. Palmitoylethanolamide (PEA) is an endogenous lipid mediator known for its anti-inflammatory, analgesic, and neuroprotective properties. PEA exerts its effects by modulating the endocannabinoid system and reducing the activation of mast cells and glial cells, which play a crucial role in chronic pain mechanisms. Its potential as a therapeutic agent for neuropathic pain has been demonstrated in preclinical and clinical studies, making it a promising candidate for managing neuropathic low back pain.
In the present randomized, double-blind, placebo-controlled, parallel-group clinical trial, the investigators aim to evaluate the therapeutic effect of a novel bioavailable oral formulation of PEA's Phytosome® in the management of neuropathic low back pain in healthy adult population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults, both Male or female aged ≥ 18 years and ≤ 80 years;
- •Diagnosed with neuropathic lower back pain for at least 3 months, as confirmed by clinical evaluation and DN4 (neuropathic pain 4 questions) screening questionnaire with score ≥
- •Pain intensity score ≥ 5 measured by NRS (Numerical Rating Scale) score, over the past week.
- •Willingness to adhere to study protocol, including visits, assessments, and self-reporting of symptoms.
- •Ability to provide informed consent and comply with study requirements.
排除标准
- •Known intolerance or allergy to any component of the tested nutraceuticals
- •Presence of acute systemic disease
- •Presence of significant organic pathology
- •Current or past history of alcohol or drug abuse
- •History of malignancy within the past 5 years
- •Any significant concomitant disease or clinical condition that could compromise participant safety or interfere with study completion
- •Women of childbearing potential not using reliable contraceptive methods
- •Pregnancy or breastfeeding
- •Severe psychiatric disorders (e.g., major depression, schizophrenia) that could affect pain perception or adherence.
- •Inability to adhere to the study requirements due to lifestyle, transportation, or cognitive impairment.
- •Use of other cannabinoid-based therapies, investigational drugs, or concurrent participation in another clinical trial.
- •Dependence on opioid analgesics or recent opioid use that may interfere with pain assessment.
- •Current use of other supplements with potential anti-inflammatory or analgesic effects, including Omega-3 Fatty Acids, Turmeric/Curcumin, Glucosamine and Chondroitin, Boswellia Serrata, Methylsulfonylmethane.
结局指标
主要结局
Supplement effect on intensity of neuropathic low back pain
时间窗: 8 weeks
Change in neuropathic pain intensity measured by the Numerical Rating Scale (NRS) score, with 0 representing no pain and 10 representing the worst pain.
Supplement effect on neuropathic low back symptoms pain as experienced by the patients
时间窗: 8 weeks
Change in The Douleur Neuropathique 4 (DN4) questionnaire score, a 10-item, clinician-administered tool used to identify neuropathic pain. A score of 4 or more out of 10 is the cut-off for defining the presence of neuropathic pain.
Supplement effect on intensity of neuropathic low back pain
时间窗: 8 weeks
Change in neuropathic pain intensity measured by the Numerical Rating Scale (NRS) score, with 0 representing no pain and 10 representing the worst pain.
次要结局
- Supplement effect on patients degree of disability(8 weeks)
- Supplement effect on patients quality of life(8 weeks)
- Supplement effect on patients sleep quality(8 weeks)
- Change in the number of times the rescue Non-steroidal anti-inflammatory drugs (NSAIDs) needed per week(8 weeks)
- Supplement effect on patients degree of disability(8 weeks)
- Supplement effect on patients quality of life(8 weeks)
- Supplement effect on patients sleep quality(8 weeks)
- Change in the number of times the rescue Non-steroidal anti-inflammatory drugs (NSAIDs) needed per week(8 weeks)
研究者
Dr. Amjad Khan
Professor
Liaquat University of Medical & Health Sciences