Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia
- Registration Number
- NCT05008042
- Lead Sponsor
- Linnaeus University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mecobalamine 5 mg/ml Mecobalamin 5 MG The active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly.
- Primary Outcome Measures
Name Time Method Tolerance time 24 weeks Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test
- Secondary Outcome Measures
Name Time Method Cobalamin in plasma 24 weeks Control of vitamin B12 is done by measuring cobalamin in plasma.
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) 24 weeks Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
Possible pain change measured by a pressure algometry test 24 weeks Possible pain change measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
Subjective experience of pain measured using Numeric Rating Scale (NRS) 24 weeks Subjective experience of pain measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
Quality of Life are assessed using questionnaires RAND-36. 24 weeks Quality of life are assessed using questionnaires RAND-36 score 0-100
Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC). 24 weeks Experience of the effect of the drug, score 1-7
Pain experience measured by a pressure algometry test 24 weeks Pain experience measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
Possible pain change measured using Numeric Rating Scale (NRS) 0-10 24 weeks Possible pain change measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 24 weeks Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ). 24 weeks Activity level are assessed using questionnaire McGills Pain Questionnarie (MPQ). Short version score 0-45.
Lived experiences of pain, health, suffering and well-being. 24 weeks Qualitative in-depth interviews will be conducted to capture women's lived experiences of pain, health, suffering and well-being.
Trial Locations
- Locations (1)
Linnaeus University
🇸🇪Växjö, Kronoberg, Sweden