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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: Carina Elmqvist, Ass prof; +46772288000; carina.elmqvist@lnu.se

Contact: Karin Säll Hansson, Master of sc; +46772288000; karin.sall_hansson@lnu.se

Locations

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

• Principal Investigator: Carina Elmqvist, Ass prof; Linnaeus University

More Information

• 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
• Last Update Posted: August 26, 2021
• Last Verified: August 2021

• 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:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases