Evaluation of the Efficiacy of Mecobalamine (Vit B12) in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia: Single-blind Randomized Controlled Trial With Three-month Follow up
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Tolerance time
研究概览
简要总结
Fibromyalgia causes long term pain where mostly women are affected. It is not entirely clear how vitamin B12 affects the human pain system, there are however many primary studies that indicate different interesting approaches. Considering that the receptor of NMDA is involved in both long-term pain and vitamin B12 deficiency its of most importance to evaluate whether vitamin B12 decreases the pain sensitivity and the experience of pain i.e hyperalgesia and allodynia, at persons with fibromyalgia.The aim of this study is therefore to evaluate the effect of Mecobalamin (vitamin B12), and describe lived experiences of pain, health, suffering and well-being in women with diagnosed 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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20-70 years
- •Swedish-speaking
- •Diagnosis of fibromyalgia
- •Safe method of contraception
- •Cobalamin / p (vitamin B12) should be >250 pmol/L < 800 pmol/L
- •Given consent to participate.
排除标准
- •Previous treatment with B12
- •Known hypersensitivity to the active substance Mecobalamin or an additive
- •Vegan as veganism can lead to B12 deficiency
- •Neuroleptics
- •Known heart, kidney or liver disease
- •Reynaud's phenomenon (white fingers)
- •Known neuropathy (impaired sensation)
- •Breastfeeding
- •Pregnancy or plan pregnancy
研究组 & 干预措施
Mecobalamine 5 mg/ml
The active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly.
干预措施: Mecobalamin 5 MG (Drug)
结局指标
主要结局
Tolerance time
时间窗: 24 weeks
Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test
次要结局
- Cobalamin in plasma(24 weeks)
- Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS)(24 weeks)
- Possible pain change measured by a pressure algometry test(24 weeks)
- Subjective experience of pain measured using Numeric Rating Scale (NRS)(24 weeks)
- Quality of Life are assessed using questionnaires RAND-36.(24 weeks)
- Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC).(24 weeks)
- Pain experience measured by a pressure algometry test(24 weeks)
- Possible pain change measured using Numeric Rating Scale (NRS) 0-10(24 weeks)
- Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10(24 weeks)
- Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ).(24 weeks)
- Lived experiences of pain, health, suffering and well-being.(24 weeks)
研究者
Carina Elmqvist
Associate professor
Linnaeus University