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

Fibromyalgia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05008042
• Other study ID #: EUDRACT 2015-005086-23
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 6, 2019
• Est. completion date: December 2023

Study information

• Verified date: August 2021
• Source: Linnaeus University
• Contact: Carina Elmqvist, Ass prof
• Phone: +46772288000
• Email: carina.elmqvist[@]lnu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Drug:
• Mecobalamin 5 MG
The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is 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.

Locations

Country	Name	City	State
Sweden	Linnaeus University	Växjö	Kronoberg

Sponsors (5)

Lead Sponsor	Collaborator
Linnaeus University	Karolinska Institutet, Kronoberg County Council, Landstinget i Kalmar Län, Region Östergötland

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance time	Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test	24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Quality of Life are assessed using questionnaires RAND-36.	Quality of life are assessed using questionnaires RAND-36 score 0-100	24 weeks
Secondary	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
Secondary	Cobalamin in plasma	Control of vitamin B12 is done by measuring cobalamin in plasma.	24 weeks
Secondary	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