Clinical trial NCT05008042: Evaluation of the Efficiacy of Mecobalamine in the Treatment of Long-term Pain in Women Diagnosed With Fibromyalgia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia,
Chronic pain,
Mekobalamin,
Randomized Controlled Trial
VitaminB12
Lead sponsor: Linnaeus University
Sponsor class: OTHER
Collaborators: name: Landstinget i Kalmar Län
name: Region Östergötland
name: Karolinska Institutet
name: Kronoberg County Council
First posted: 2021-08-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with Three-month follow up
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Tolerance time
timeFrame: 24 weeks
Secondary outcomes:
measure: Pain experience measured by a pressure algometry test
timeFrame: 24 weeks
measure: Possible pain change measured by a pressure algometry test
timeFrame: 24 weeks
measure: Subjective experience of pain measured using Numeric Rating Scale (NRS)
timeFrame: 24 weeks
measure: Possible pain change measured using Numeric Rating Scale (NRS) 0-10
timeFrame: 24 weeks
measure: Ratings of expectation, desire for relief, using Numeric Rating Scale (NRS)
timeFrame: 24 weeks
measure: Ratings of expectation, pain variability, using Numeric Rating Scale (NRS) 0-10
timeFrame: 24 weeks
measure: Activity level, assessed using questionnaire McGills Pain Questionnaire (MPQ).
timeFrame: 24 weeks
measure: Quality of Life are assessed using questionnaires RAND-36.
timeFrame: 24 weeks
measure: Experience of the effect of the drug, assessed using questionnaire Patients´ Global Impression of Change (PGIC).
timeFrame: 24 weeks
measure: Cobalamin in plasma
timeFrame: 24 weeks
measure: Lived experiences of pain, health, suffering and well-being.
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Växjö
country: Sweden
facility: Linnaeus University
state: Kronoberg
Study officials:
affiliation: Linnaeus University
name: Carina Elmqvist, Ass prof
role: PRINCIPAL_INVESTIGATOR
References: