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NCT Number: NCT05008042

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

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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Key information

Conditions

Fibromyalgia Chronic Pain Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Linnaeus University

Vaxjo, Kronoberg County, 352 91, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mecobalamin 5 MG

Drug

The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly

Placebo Comparator : NaCl 9 mg/ml

Other

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

Primary outcomes

  1. Tolerance time

    Time frame: 24 weeks

    Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Linnaeus University

Other

Collaborators

  • Karolinska Institutet
  • Kronoberg County Council
  • Landstinget i Kalmar Län
  • Region Östergötland

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2021
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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