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

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.

Study Overview

• Status: Recruiting
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Mecobalamin 5 MG; Other: Placebo Comparator : NaCl 9 mg/ml

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Carina Elmqvist, Ass prof; Phone Number: +46772288000; Email: carina.elmqvist@lnu.se
• Study Contact Backup: Name: Karin Säll Hansson, Master of sc; Phone Number: +46772288000; Email: karin.sall_hansson@lnu.se

Study Locations

• Sweden
  • Kronoberg
    • Växjö, Kronoberg, Sweden, 352 91
      • Recruiting
      • Linnaeus University
      • Contact: Carina Elmqvist, Ass prof; Phone Number: +46772288000; Email: carina.elmqvist@lnu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Quality of Life are assessed using questionnaires RAND-36.	Quality of life are assessed using questionnaires RAND-36 score 0-100	24 weeks
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
Cobalamin in plasma	Control of vitamin B12 is done by measuring cobalamin in plasma.	24 weeks
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

Collaborators and Investigators

• Sponsor: Linnaeus University
• Collaborators: Karolinska Institutet; Region Östergötland; Kronoberg County Council; Landstinget i Kalmar Län
• Investigators: Principal Investigator: Carina Elmqvist, Ass prof, Linnaeus University

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2019
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Chronic pain,; Fibromyalgia,; Mekobalamin,; VitaminB12
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: EUDRACT 2015-005086-23

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No