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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05008042

Enrollment

Registered

2021-08-17

Start date

2019-02-06

Completion date

2024-03-26

Last updated

2024-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

Fibromyalgia,, Chronic pain,, Mekobalamin,, Randomized Controlled Trial, VitaminB12

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.

Interventions

DRUGMecobalamin 5 MG

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

OTHERPlacebo Comparator : NaCl 9 mg/ml

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Randomized controlled trial with Three-month follow up

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tolerance time	24 weeks	Primary outcome is tolerance time, maximized to Three minutes, tested using the Cold Pressure test

Secondary

Measure	Time frame	Description
Possible pain change measured by a pressure algometry test	24 weeks	Possible pain change measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
Subjective experience of pain measured using Numeric Rating Scale (NRS)	24 weeks	Subjective experience of pain measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
Possible pain change measured using Numeric Rating Scale (NRS) 0-10	24 weeks	Possible pain change measured using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome .
Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS)	24 weeks	Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10	24 weeks	Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10 where 0 is the best outcome.
Pain experience measured by a pressure algometry test	24 weeks	Pain experience measured by a pressure algometry test performed on the shoulder, hip, knee and elbow.
Quality of Life are assessed using questionnaires RAND-36.	24 weeks	Quality of life are assessed using questionnaires RAND-36 score 0-100
Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC).	24 weeks	Experience of the effect of the drug, score 1-7
Cobalamin in plasma	24 weeks	Control of vitamin B12 is done by measuring cobalamin in plasma.
Lived experiences of pain, health, suffering and well-being.	24 weeks	Qualitative in-depth interviews will be conducted to capture women's lived experiences of pain, health, suffering and well-being.
Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ).	24 weeks	Activity level are assessed using questionnaire McGills Pain Questionnarie (MPQ). Short version score 0-45.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026