Explain Pain in Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Change in Visual Analog Scale
研究概览
简要总结
Education of pain physiology is described as an educational session or sessions describing the neurobiology and neurophysiology of pain, and pain processing by the nervous system. There is compelling evidence that an educational strategy addressing neurophysiology and neurobiology of pain can have a positive effect on pain, disability, catastrophization, and physical performance in chronic musculoskeletal pain disorders. Although pain physiology education has been studied in patients with chronic low back pain, chronic whiplash, and chronic fatigue syndrome in combination with widespread pain, studies in fibromyalgia (FM) are limited to a 2013 study with limited results.
The investigators propose a study with a higher dose of education of pain physiology (i.e. a higher number of educational sessions and total education time) to study if this generates a larger treatment effect in patients with fibromyalgia.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American College of Rheumatology classification criteria for FM, both 1990 and 2010
- •Reported average pain intensity ≥ 4 on a 0 to 10 cm visual analogue scale based on 1 week of daily pain diaries
- •On stable doses of medications for FM ≥ 4 weeks
排除标准
- •Suffer from an inflammatory rheumatic conditions
- •Have a planned elective surgery during the study period
- •Have ongoing unresolved disability claims
- •Experience symptoms of bipolar disorder, major depressive disorder, panic disorder, or psychosis
- •Do not speak Spanish fluently
研究组 & 干预措施
Educational program High Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises
干预措施: Educational program (Other)
Educational program Control Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: talk about medical issues (drugs, nutrition, importance of sleep...)
干预措施: Educational program (Other)
Educational program Diluted Low Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 6 sessions: 45 minutes of educational sessions about the neurophysiology of pain + 15 minutes of relaxation exercises
干预措施: Educational program (Other)
Educational program Concentrated Low Dose Group
6 group sessions: 1h/session - 1 session/week - 6 weeks 4 first sessions: relaxation exercises 2 last sessions: educational sessions about the neurophysiology of pain
干预措施: Educational program (Other)
结局指标
主要结局
Change in Visual Analog Scale
时间窗: Baseline - 6 weeks - 3 months
On this continuous, horizontal scale used, where 0 is ''no pain" and 100 is ''worst possible pain" (0-100 mm line), subjects will be asked to mark the line with a cross somewhere between both extremes that best reflect their sensation
次要结局
- Change in Medical Outcomes Study Short Form 36 (SF-36)(Baseline - 6 weeks - 3 months)
- Change in Fibromyalgia Impact Questionnaire(Baseline - 6 weeks - 3 months)
- Change in Pressure Pain Threshold(Baseline - 6 weeks - 3 months)
- Change in Manual Tender Point Survey(Baseline - 6 weeks - 3 months)
- Change in Patient Global Impression of Change Scale(Baseline - 6 weeks - 3 months)
- Change in Depression subscale of the Hospital Anxiety and Depression Scale(Baseline - 6 weeks - 3 months)
- Change in Fatigue Severity Scale(Baseline - 6 weeks - 3 months)
- Change in Jenkins Sleep Scale(Baseline - 6 weeks - 3 months)
- Change in Neurophysiology of Pain Test(Baseline - 6 weeks - 3 months)
研究者
J.J. Amer-Cuenca
Head of Department
Cardenal Herrera University