Effects of Metformin on Low Back Pain
- Registration Number
- NCT04055012
- Lead Sponsor
- Gwendolyn Sowa
- Brief Summary
The purpose of the current study is to determine the effects of metformin in non-diabetic patients with low back pain, and identify novel targets for future treatments
- Detailed Description
Outcome measures were updated after the initial submission to clinicaltrials.gov. The outcomes were changed in the Institutional Review Board protocol but not updated on clinicaltrials.gov. These outcome measures have since been updated to reflect what was collected for the trial.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 23
- Age 18 and above
- Diagnosed with axial low back pain (low back pain more severe than pain in other parts of the body, without radiation of pain into the lower extremities).
- Women of child bearing potential must have a negative serum pregnancy test at baseline.
- Diagnosed with rheumatoid arthritis, lupus, other autoimmune/systemic inflammatory arthropathies
- Progressive lower extremity weakness or numbness
- Recent oral steroid use (within last 3 months)
- NSAID use
- Chronic kidney disease (eGFR <60)
- Diagnosis of diabetes mellitus
- Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
- Unable to take an oral medication in a non crushable pill form
- Taking metformin presently or within the last 6 months
- History of allergy to metformin
- History of lactic acidosis
- Severe Hepatic dysfunction
- Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
- Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
- Currently taking cimetidine
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High Dose Metformin Metformin High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months. Low Dose Metformin Metformin Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months. Placebo Placebo Placebo Group (n=100). Subjects will receive placebo and will be instructed to take either 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months OR take 1 placebo tab for 6 months. Wait-List Control Metformin Control Group (n=100). Subjects will be told that they are in the wait-list control group. They will have a 3 month "waiting period" before they will be randomized again to a treatment group. They will be randomized to one of the previous groups. Wait-List Control Placebo Control Group (n=100). Subjects will be told that they are in the wait-list control group. They will have a 3 month "waiting period" before they will be randomized again to a treatment group. They will be randomized to one of the previous groups.
- Primary Outcome Measures
Name Time Method Change From Baseline in Numeric Pain Rating Scale Up to 15 months Scores range from 0 to 10 with a higher score indicating more severe pain
Change From Baseline in Oswestry Disability Index (ODI) Up to 15 months Scores range from 0% to 100% with higher scores indicating greater disability
- Secondary Outcome Measures
Name Time Method Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment Up to 15 months Current pain on average reported on 0-10 scale, higher scores indicate greater pain
Change From Baseline in 10 Meter Walk Test Up to 15 months Subject is timed walking at self-selected speed. A faster time (fewer seconds to complete the walk) is associated with better outcome.
Change From Baseline in Fear Avoidance Questionnaire Up to 15 months Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs
Change From Baseline in STarT Back Tool Up to 15 months Scores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms.
Change From Baseline in 6-item Pain Catastrophizing Scale Up to 15 months Score range from 0 to 24 with a higher score indicating a higher degree of catastrophizing
Change From Baseline in Positive Outlook v1.0 - Short Form 6a Up to 15 months For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicates a more positive outlook.
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 Up to 15 months The PROMIS (Patient-Reported Outcomes Measurement Information System) 29 is a 29 question assessment of 8 domains of health related quality of life (physical function, fatigue, sleep disturbance, pain interference, anxiety, depression, ability to participate in social roles and activities, and cognitive function. For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. Higher T scores indicates greater report of the concept being measured.
Change From Baseline in General Self-Efficacy - Short Form 4a Up to 15 months For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicate higher self efficacy.
Change From Baseline in Global Physical Activity Questionnaire Up to 15 months This questionnaire developed by the World Health Organization measures physical activity at work or school, household, travel, recreational and sedentary behaviors, measured in MET (metabolic equivalent)-minutes per week (continuous variable).
Change From Baseline in McGill Pain Questionnaire Up to 15 months Scores range from 0 to 45 with a higher score indicating more qualitatively severe and impactful pain.
Change in Charlson Comorbidity Index Up to 15 months Measures overall health with a higher score more likely predicative of mortality or higher resource use. Scale is scored 0-37.
Change From Baseline in Financial Strain Up to 15 months Measures strain of finances. Score ranges from 1-4. The lower the score the harder the financial strain.
Trial Locations
- Locations (2)
UPMC Wexford Spine Center
🇺🇸Wexford, Pennsylvania, United States
UPMC Kaufmann Medical Building
🇺🇸Pittsburgh, Pennsylvania, United States