T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale of Pain Intensity
研究概览
简要总结
Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet american college of rheumatology criteria for fibromyalgia
- •at baseline report an average pain of 4 or more on a brief Pain Inventory.
- •can climb 2 flights of stairs without shortness of breath.
排除标准
- •new medication change in the last 2 months
- •any cardiac disease at all
- •known thyroid disease before or after thyroid screening bloodwork
- •unstable medical or psychiatric disease.
- •Known inflammatory or rheumatic disease other than fibromyalgia
- •substance abuse in the last year
- •suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
- •concomitant herbal medications
- •multiple severe medication allergies
- •the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
- •Known uncontrolled hypertension
- •known uncontrolled hypercholesterolemia
研究组 & 干预措施
Placebo followed by T3
Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.
干预措施: T3 (Drug)
结局指标
主要结局
Visual Analogue Scale of Pain Intensity
时间窗: 12 weeks
Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).
次要结局
未报告次要终点
研究者
Sean Mackey
Assistant Professor
Stanford University