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Metformin for Low Back Pain
Study Summary
This trial is testing if metformin, typically used to treat diabetes, can also help treat non-diabetic patients with low back pain by reducing inflammation.
- Lower Back Pain
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 156 Patients • NCT02002221Trial Design
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Who is running the clinical trial?
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- You have taken oral steroids in the last 3 months.You have long-term kidney disease with a specific measure called eGFR less than 60.You have been diagnosed with diabetes.You are currently taking a medicine called a carbonic anhydrase inhibitor, like topiramate or zonisamide.You are currently taking cimetidine.You have ongoing weakness or numbness in your legs.You are currently taking NSAIDs.You have taken metformin in the last 6 months.You have had an allergic reaction to metformin in the past.You have had lactic acidosis in the past.You have a serious liver problem.You are currently taking certain medications for diabetes.You have been diagnosed with low back pain that is worse than pain in other parts of your body and does not spread to your legs.You have been diagnosed with conditions like rheumatoid arthritis, lupus, or other autoimmune inflammatory joint diseases.Women who could become pregnant must have a negative pregnancy test before starting the study.
- Group 1: Low Dose Metformin
- Group 2: Wait-List Control
- Group 3: High Dose Metformin
- Group 4: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has Metformin been officially sanctioned by the FDA?
"With prior clinical data showing safety but no evidence of efficacy, Metformin is rated a 2 on our scale."
What is the scale of participation in this research endeavor?
"This trial is not in the process of recruiting new patients. Initially posted on July 1st 2020, and last edited on October 28th 2022; if you are looking for alternative studies, there currently exists 332 trials actively enrolling participants with low back pain as well as 170 clinical trials that involve Metformin treatment."
Could you elaborate on any previous investigations that utilized Metformin?
"Currently, 170 clinical studies are being conducted to further research Metformin. Out of the active trials, 43 have moved into Phase 3 and 1902 trial sites can be found across the country. The largest concentration of locations is located in Pittsburgh, Pennsylvania."
Is enrollment open for this investigation?
"Per the clinicaltrials.gov website, this medical trial is no longer actively recruiting patients despite being initially posted on January 7th 2020 and last edited on October 28th 2022. Nevertheless, there are 502 other clinical trials that remain open for enrollment at present time."
What are Metformin's most common usages?
"Metformin is an effective therapy for the management of type 1 diabetes mellitus and diabetic ketoacidosis, as well as a prophylactic measure to reduce the risk of exercise-induced hypoglycemia."
What outcome is this trial looking to achieve?
"This medical trial, which will measure progress over 15 months, is looking to gauge changes from the baseline in Oswestry Disability Index. Secondary objectives involve assessing variance from initial scores on three other scales: McGill Pain Questionnaire (0-45; higher score indicates more pain), Connor-Davidson Resilience Scale 25 (0-100; greater resilience indicated by a higher score) and Catastrophizing Scale (0-36; with a high number indicating increased levels of catastrophizing)."
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