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| Name | Class |
|---|---|
| Landstinget i Kalmar Län | OTHER |
| Region Östergötland | OTHER |
| Karolinska Institutet | OTHER |
| Kronoberg County Council |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mecobalamine 5 mg/ml | Active Comparator | The active substance of vitamin B12 given in the study is Mecobalamin 5mg / ml 2 ml ie 10 mg and is given intramuscularly. |
|
| NaCl 9mg/ml | Placebo Comparator | Placebo substance given in the study is Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) given intramuscularly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mecobalamin 5 MG | Drug | The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance time | Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test | 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carina Elmqvist, Ass prof | Linnaeus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Linnaeus University | Vaxjo | Kronoberg County | 352 91 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36997252 | Derived | Sall Hansson K, Lindqvist G, Stening K, Fohlman J, Wojanowski A, Ponten M, Jensen K, Gerdle B, Elmqvist C. Efficacy of mecobalamin (vitamin B12) in the treatment of long-term pain in women diagnosed with fibromyalgia: protocol for a randomised, placebo-controlled trial. BMJ Open. 2023 Mar 30;13(3):e066987. doi: 10.1136/bmjopen-2022-066987. |
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Metadata and analysis scripts
from 2025 - 2035
anyone requesting the metadata can access the data
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| C019476 | mecobalamin |
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| OTHER_GOV |
Randomized controlled trial with Three-month follow up
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| Placebo Comparator : NaCl 9 mg/ml | Other | Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly. |
|
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 |
| D009422 |
| Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |