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

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ClinicalTrials.gov Identifier: NCT05008042
Recruitment Status : Recruiting
First Posted : August 17, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborators:
Landstinget i Kalmar Län
Region Östergötland
Karolinska Institutet
Kronoberg County Council
Information provided by (Responsible Party):
Carina Elmqvist, 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Drug: Mecobalamin 5 MG Other: Placebo Comparator : NaCl 9 mg/ml Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trial with Three-month follow up
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 6, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Mecobalamin

Arm Intervention/treatment
Active Comparator: 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.
Drug: Mecobalamin 5 MG
The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly

Placebo Comparator: NaCl 9mg/ml
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
Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.




Primary Outcome Measures :
  1. Tolerance time [ Time Frame: 24 weeks ]
    Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test


Secondary Outcome Measures :
  1. Pain experience measured by a pressure algometry test [ Time Frame: 24 weeks ]
    Pain experience measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.

  2. Possible pain change measured by a pressure algometry test [ Time Frame: 24 weeks ]
    Possible pain change measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.

  3. Subjective experience of pain measured using Numeric Rating Scale (NRS) [ Time Frame: 24 weeks ]
    Subjective experience of pain measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .

  4. Possible pain change measured using Numeric Rating Scale (NRS) 0-10 [ Time Frame: 24 weeks ]
    Possible pain change measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .

  5. Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) [ Time Frame: 24 weeks ]
    Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.

  6. Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 [ Time Frame: 24 weeks ]
    Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.

  7. Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ). [ Time Frame: 24 weeks ]
    Activity level are assessed using questionnaire McGills Pain Questionnarie (MPQ). Short version score 0-45.

  8. Quality of Life are assessed using questionnaires RAND-36. [ Time Frame: 24 weeks ]
    Quality of life are assessed using questionnaires RAND-36 score 0-100

  9. Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC). [ Time Frame: 24 weeks ]
    Experience of the effect of the drug, score 1-7

  10. Cobalamin in plasma [ Time Frame: 24 weeks ]
    Control of vitamin B12 is done by measuring cobalamin in plasma.

  11. Lived experiences of pain, health, suffering and well-being. [ Time Frame: 24 weeks ]
    Qualitative in-depth interviews will be conducted to capture women's lived experiences of pain, health, suffering and well-being.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05008042


Contacts
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Contact: Carina Elmqvist, Ass prof +46772288000 carina.elmqvist@lnu.se
Contact: Karin Säll Hansson, Master of sc +46772288000 karin.sall_hansson@lnu.se

Locations
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Sweden
Linnaeus University Recruiting
Växjö, Kronoberg, Sweden, 352 91
Contact: Carina Elmqvist, Ass prof    +46772288000    carina.elmqvist@lnu.se   
Sponsors and Collaborators
Linnaeus University
Landstinget i Kalmar Län
Region Östergötland
Karolinska Institutet
Kronoberg County Council
Investigators
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Principal Investigator: Carina Elmqvist, Ass prof Linnaeus University
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Responsible Party: Carina Elmqvist, Associate professor, Linnaeus University
ClinicalTrials.gov Identifier: NCT05008042    
Other Study ID Numbers: EUDRACT 2015-005086-23
First Posted: August 17, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carina Elmqvist, Linnaeus University:
Fibromyalgia,
Chronic pain,
Mekobalamin,
Randomized Controlled Trial
VitaminB12
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases