Comparing the Efficacy and Safety of Pregabalin Monotherapy With Pregabalin Combined Dexmedetomidine in the Treatment of Fibromyalgia: A Multicenter Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The average pain intensity
研究概览
简要总结
Fibromyalgia (FM) is a chronic pain syndrome characterized by widespread pain, fatigue, and emotional disorders. Its onset is related to factors such as central sensitization and imbalance of neurotransmitters. The current mainstream treatments include pregabalin, but the efficacy of pregabalin is limited, with only 25%-40% pain relief rate, and adverse reactions are common. Dexmedetomidine, a highly selective α2-adrenergic receptors agonist, could improve sleep disorders, making it a possible treatment option for treating FM. The investigators hypothesize that the combination of pregabalin with dexmedetomidine may offer greater pain relief compared pregabalin monotherapy, without a significant increase in adverse effects for patients with FM.
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
- None
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
- •Diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria;
- •Aged 18 years or older;
- •Experiencing moderate to severe FM that have not been effectively alleviated by non-pharmacological treatments and has not received currently recommended pharmacological treatment for FM;
- •Numeric rating scale (NRS) score ≥ 4 at baseline;
- •Aspartate aminotransferase and alanine aminotransferase levels less than twice the upper limit of normal;
- •Estimated glomerular filtration rate of 30 mL/min per 1.73 m2 or higher;
- •Willing to sign the informed consent form and possessing sufficient cognitive and language abilities to comply with all the study requirements.
- •Exclusion criteria
- •History of hypersensitivity to pregabalin, venlafaxine or any of its excipients;
- •History of epilepsy, or depression requiring antidepressant medications;
- •Pregnancy or breastfeeding;
- •Presence of serious systemic diseases, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac dysfunction;
- •With acute or chronic pain conditions other than FM.
排除标准
- 未提供
研究组 & 干预措施
Monotherapy group
Pregabalin
干预措施: Pregabalin (Drug)
Combination therapy group
Pregabalin with dexmedetomidine
干预措施: Pregabalin with dexmedetomidine (Drug)
结局指标
主要结局
The average pain intensity
时间窗: At the 4-weeks
The average pain intensity over the past 24 hours, rated each morning upon awakening and averaged over 7 days at the 4 weeks. This will be measured based on NRS, where 0 represents no pain and 10 represents worst pain imaginable.
次要结局
- The worst pain intensity(At the weeks 1, 2, 4, and 8)
- The proportion of patients achieving pain reduction(At the weeks 1, 2, 4, and 8)
- The Revised FM Impact Questionnaire(At the weeks 1, 2, 4, and 8)
- The Brief Pain Inventory (BPI) severity (BPI-S) and interfere (BPI-I) subscales(At the weeks 1, 2, 4, and 8)
- The short-form 36 Health Survey (SF-36)(At the weeks 1, 2, 4, and 8)
- The Medical Outcomes Study Sleep Scale (MOS)(At the weeks 1, 2, 4, and 8)
- The Beck Depression Inventory-Ⅱ (BD-Ⅱ)(At the weeks 1, 2, 4, and 8)
- Adverse Events(Through study completion, an average of 8 weeks)
研究者
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital