Comparing the Efficacy and Safety of Conventional Therapy With Conventional Therapy Combined Esketamine 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
- 92
- 试验地点
- 1
- 主要终点
- The median pain relief time
研究概览
简要总结
Fibromyalgia is a chronic pain syndrome where current medications have limited efficacy and a slow onset of action. Esketamine shows potential as a rapid-acting analgesic, but previous low-dose studies failed to demonstrate long-term benefits. The efficacy of higher-dose ESK as an adjunctive therapy when standard treatments are insufficient remains unclear.
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
- •Patients between ages over 18 years with proper cognitive function and language skills for the study;
- •Patients diagnosed with FM as defined by the ACR FM diagnostic criteria;
- •Patients who have experienced insufficient symptom relief with non-pharmacological treatments and have not previously received recommended pharmacological treatment for FM;
- •A score of ≥ 4 on the average pain intensity over 7 days on the numeric rating scale (NRS) at baseline.
排除标准
- •Patient refusal;
- •Inability to sign informed consent;
- •Had other secondary FM, this is, hypothyroidism, nutritional deficiency, diabetes mellitus, connective tissue disorder;
- •Had psychiatric disorder, this is, schizophrenia and other psychotic disorder, bipolar disorder, or personality disorder;
- •Obstructive sleep apnea syndrome or a STOP-Bang score ≥ 3;
- •History of treatment with pregabalin and/or venlafaxine for any disease;
- •History of treatment with intravenous ketamine or ESK for chronic pain;
- •Presence of other painful ailments such as inflammatory rheumatic disease;
- •Uncontrolled diabetes, refractory hypertension, malignancies, narrow-angle glaucoma, hyperthyroidism, severe cardiovascular disease or any other contraindications to esketamine;
- •History of prescription drug abuse, alcoholism or illicit drug use;
- •Pregnant or lactating women;
- •Allergic to any of the study drugs.
研究组 & 干预措施
Control group
Pregabalin and venlafaxine concomitant therapy
干预措施: Pregabalin and venlafaxine concomitant therapy (Drug)
Treatment group
Esketamine plus pregabalin and venlafaxine concomitant therapy
干预措施: Esketamine plus pregabalin and venlafaxine concomitant therapy (Drug)
结局指标
主要结局
The median pain relief time
时间窗: At 15 minutes, 1 hour, and 3 hours following termination of treatment, days 1, 3, 5, weeks 1, 2, 4, 8, and 12 for a total of 12 weeks.
The median pain relief time, defined as the time of 50% decrease in NRS score from baseline. Pain intensity will be measured using the NRS, where 0 indicates no pain, and 10 represents the worst imaginable pain.
次要结局
- Average pain intensity(At the weeks 1, 2, 4, 8, and 12)
- Worst pain intensity(at weeks 1, 2, 4, 8, and 12)
- Proportion of patients achieving pain reduction at 50% and 30%;(at weeks 1, 2, 4, 8, and 12)
- The maximal tolerated doses of pregabalin and venlafaxine(at weeks 1, 2, 4, 8, and 12)
- The Revised FM Impact Questionnaire (FIQR)(At the weeks 4, 8, and 12)
- Hospital Anxiety and Depression scale (HADS)(At the weeks 4, 8, and 12)
- The short-form 36 Health Survey (SF-36)(At the weeks 4, 8, and 12)
- Multidimensional Fatigue Inventory (MFI)(At the weeks 4, 8, and 12)
- Medical Outcomes Study Sleep Scale (MOS)(At the weeks 4, 8, and 12)
- Plasma concentrations of esketamine and its metabolites at the end of infusion(At the end of esketamine infusion, that is at day 0)
- Adverse events(Through study completion, an average of 12 weeks)
研究者
Fang Luo
Director, Department of Pain Management, Principal Investigator, Clinical Professor
Beijing Tiantan Hospital