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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly
Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.
Linnaeus University
Vaxjo, Kronoberg County, Sweden
Tolerance time
Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test
Time frame: 24 weeks
Pain experience measured by a pressure algometry test
Pain experience measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
Time frame: 24 weeks
Possible pain change measured by a pressure algometry test
Possible pain change measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
Time frame: 24 weeks
Subjective experience of pain measured using Numeric Rating Scale (NRS)
Subjective experience of pain measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
Time frame: 24 weeks
Possible pain change measured using Numeric Rating Scale (NRS) 0-10
Possible pain change measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
Time frame: 24 weeks
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS)
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
Time frame: 24 weeks
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
Time frame: 24 weeks
Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ).
Activity level are assessed using questionnaire McGills Pain Questionnarie (MPQ). Short version score 0-45.
Time frame: 24 weeks
Quality of Life are assessed using questionnaires RAND-36.
Quality of life are assessed using questionnaires RAND-36 score 0-100
Time frame: 24 weeks
Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC).
Experience of the effect of the drug, score 1-7
Time frame: 24 weeks
Cobalamin in plasma
Control of vitamin B12 is done by measuring cobalamin in plasma.
Time frame: 24 weeks
Lived experiences of pain, health, suffering and well-being.
Qualitative in-depth interviews will be conducted to capture women's lived experiences of pain, health, suffering and well-being.
Time frame: 24 weeks
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