Effects of Metformin on Low Back Pain

  • STATUS
    Recruiting
  • End date
    Nov 12, 2022
  • participants needed
    400
  • sponsor
    Gwendolyn Sowa
Updated on 12 March 2022
back pain
low back pain

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

Details
Condition Low Back Pain
Treatment Placebo, Metformin
Clinical Study IdentifierNCT04055012
SponsorGwendolyn Sowa
Last Modified on12 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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