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

NCT05008042 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

  • Fibromyalgia

Interventions

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.

Sponsors & Collaborators

  • Landstinget i Kalmar Län

    collaborator OTHER

  • Region Östergötland

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • Kronoberg County Council

    collaborator OTHER_GOV

  • Linnaeus University

    lead OTHER

Principal Investigators

  • Carina Elmqvist, Ass prof · Linnaeus University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2024-03-26
Completion
2024-03-26

Countries

  • Sweden

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008042 on ClinicalTrials.gov