Protocol summary
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Study aim
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Determination of the analgesic effect of metformin in patients with fibromyalgia
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Design
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Randomized, double blinded trial, phase 3, on 30 patients with fibromyalgia, with one control and two intervention groups, which are parallel. Randomization is by block method.
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Settings and conduct
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Research would take place in Booali hospital of Tehran but patients detection will not be limited to Azad University hospitals and some other hospitals would be added if needed. Patient's initial condition would be assessed by two valid questionnaire (Revised Fibromyalgia Impact Questionnaire (FIQR) and Toronto Clinical Neuropathy Scoring System (TCNS)) and some physical examinations. Then, they would be randomly placed in each of three groups. After a 3-month trial and reassessment of patients, the results before and after interventions would be compared. The trial is double blinded (outcome assessor and data analyser).
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Participants/Inclusion and exclusion criteria
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Inclusion Cr: American College of Rheumatology criteria for Fibromyalgia diagnosis - Not using any medication for fibromyalgia and metformin / Exclusion Cr: Comorbid disorders including history of CVD, RA, untreated endocrine abnormalities (except diabetes), autoimmune conditions, neuromuscular diseases, active malignancy, immunodeficiency, advanced renal failure - Taking medications associated with IR such as glucocorticoids, thiazide diuretics, atypical anti-psychotics, beta-blockers, niacin, statins and NSAID - Drug or alcohol abuse - Opium addiction or cigarette smoking - Using any medication for fibromyalgia and metform
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Intervention groups
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A. Standard medication of fibromyalgia including either Norepinephrine Reuptake Inhibitors or Membrane Stabilizing agents (control group) B. metformin alone C. Combination therapy with both medications
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Main outcome variables
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Fibromyalgia severity, Pain severity, Neuropathy severity, Tender points
General information
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Reason for update
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According to the method of blinding which includes the outcome assessor and the data analyser, I changed the type of blinding from single blinding to double blinding.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210306050589N1
Registration date:
2021-04-28, 1400/02/08
Registration timing:
prospective
Last update:
2021-05-02, 1400/02/12
Update count:
1
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Registration date
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2021-04-28, 1400/02/08
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-06-22, 1400/04/01
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Expected recruitment end date
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2021-09-23, 1400/07/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The analgesic effect of metformin in patients with fibromyalgia
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Public title
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The effect of metformin in fibromyalgia
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
American College of Rheumatology criteria for Fibromyalgia diagnosis
Not using any medication for fibromyalgia and metformin
Exclusion criteria:
Comorbid disorders including history of cerebrovascular disease, rheumatoid arthritis, untreated endocrine abnormalities(except diabetes), autoimmune conditions, neuromuscular diseases, active malignancy, immuno-deficiency, advanced renal failure
Taking medications associated with insulin resistance such as glucocorticoids, thiazide diuretics, atypical anti-psychotics,beta-blockers, niacin, statins and NSAID
Drug or alcohol abuse
Opium addiction or cigarette smoking
Using any medication for fibromyalgia and metformin
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Age
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No age limit
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method would be based on block randomization with the block size of 3. For each possible cases numbers are assigned as mentioned below:
ABC(1), ACB(2), BAC(3), BCA(4), CAB(5), CBA(6)
Then a number between 1-6 would be assigned for each block using random number table, so that the therapeutic group for each participant is determined.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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A person other than the main researcher of the project determines the intervention and control groups with the name of A, B and C, put the medications in appropriate boxes with the name of group and provide them to the main researcher as they are sealed. In fact, the main researcher who acs the role of clinical care giver, outcome assessor and data analyst as well, would be unaware of the patients assignment to either control or intervention group until the end of the project. And would only deal with the group names A, B and C and also would not know the patients' name during clinical care in order to prevent possible bias of the project.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-01-18, 1399/10/29
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Ethics committee reference number
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IR.IAU.TMU.REC.1399.459
Health conditions studied
1
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Description of health condition studied
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Fibromyalgia
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ICD-10 code
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M79.7
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ICD-10 code description
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Fibromyalgia
2
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Description of health condition studied
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Idiopathic peripheral autonomic neuropathy
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ICD-10 code
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G90.0
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ICD-10 code description
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Idiopathic peripheral autonomic neuropathy
Primary outcomes
1
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Description
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Pain severity
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Timepoint
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At the first visit and 3 month after the beginning of interventions
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Method of measurement
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Numeric Pain Rating Scale (NPRS)
2
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Description
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Fibromyalgia severity
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Timepoint
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At the first visit and 3 month after the beginning of interventions
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Method of measurement
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Revised Fibromyalgia Impact Questionnaire (FIQR)
3
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Description
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Tender points
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Timepoint
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At the first visit and 3 month after the beginning of interventions
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Method of measurement
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Counting
Secondary outcomes
1
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Description
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Neuropathy severity
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Timepoint
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At the first visit and 3 month after the beginning of interventions
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Method of measurement
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Toronto Clinical Neuropathy Scoring System (TCNS)
Intervention groups
1
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Description
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Control group (group A): The control group would be on the treatment with the standard medication of fibromyalgia (based on the latest available guidelines) including either Norepinephrine Reuptake Inhibitors (amitriptyline ,duloxetine or milnacipran) or Membrane Stabilizing agents (pregabalin or gabapentin). The duration of treatment would be 3 month. (For most patients we would prescribe Amitriptyline (with the initial dose of 5-10 mg/d 3 hour before bedtime and gradually increasing the dose to 25-50 mg/d if needed and tolerated). If there is sever fatigue or depression in patients we would use either Duloxetine (with the initial dose of 20-30 mg/d in the morning and gradually increasing the dose to 60 mg/d) or Milnacipran (with initial dose of 12.5 mg/d in the morning and gradually increasing the dose to 50-100 mg twice daily if needed and tolerated) and occasionally if there is sever sleep disturbance we would use either Pregabalin (with initial dose of 25-50 mg/d at bedtime and gradually increasing the dose to 300-450 mg/d if needed and tolerated) or Gabapentin (with initial dose of 100 mg/d at bedtime and gradually increasing the dose to 1200-2400 mg/d in divided doses if needed and tolerated)) Predicted Pharmaceutical companies: Amitriptyline: Pars Darou, Duloxetine: Dr. Abidi , Pregabalin: Sobhan Darou, Gabapentin: Razak. Because Milnacipran is not made in Iranian companies, we use Duloxetine instead.
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Category
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Treatment - Drugs
2
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Description
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First ntervention group (group B): The first intervention group would be on the treatment with metformin alone. The duration of treatment would be 3 month. (Metformin would be prescribed with the initial dose of 500 mg/d, and would be increased gradually until it reaches 1500 mg/d (the effective dose) if tolerated.) Predicted Pharmaceutical companies: Metformin: Razak
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Category
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Treatment - Drugs
3
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Description
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Second intervention group (group C): The second intervention group would be on the combination therapy with both medications, standard medication of fibromyalgia and metformin together, according to the order of these two groups. The duration of treatment would be 3 month. Predicted Pharmaceutical companies: Amitriptyline: Pars Darou, Duloxetine: Dr. Abidi , Pregabalin: Sobhan Darou, Gabapentin: Razak, Metformin: Razak.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Islamic Azad University
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no plan to publish it.
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable