Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Drug: Mecobalamin 5 MG
* Other: Placebo Comparator : NaCl 9 mg/ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial with Three-month follow up
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mecobalamine 5 mg/ml<br>The active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly. | Drug: Mecobalamin 5 MG<br>* The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly<br>|
| Placebo Comparator: NaCl 9mg/ml<br>Placebo substance given in the study is Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) given intramuscularly. | Other: Placebo Comparator : NaCl 9 mg/ml<br>* Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance time | Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain experience measured by a pressure algometry test | Pain experience measured by a pressure algometry test performed on the shoulder, hip, knee and elbow. | 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. | 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 . | 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 . | 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. | 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. | 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. | 24 weeks | 
| Quality of Life are assessed using questionnaires RAND-36. | Quality of life are assessed using questionnaires RAND-36 score 0-100 | 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 | 24 weeks | 
| Cobalamin in plasma | Control of vitamin B12 is done by measuring cobalamin in plasma. | 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. | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia,, Chronic pain,, Mekobalamin,, Randomized Controlled Trial, VitaminB12