Effects of Metformin on Low Back Pain

Gwendolyn Sowa

Status and phase: Terminated; Phase 2

Conditions: Low Back Pain

Treatments: Drug: Placebo; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT04055012

STUDY19010007

Details and patient eligibility

About

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

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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23 participants in 4 patient groups, including a placebo group

High Dose Metformin

Experimental group

Description:

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.

Treatment:

Drug: Metformin

Low Dose Metformin

Experimental group

Description:

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.

Treatment:

Drug: Metformin

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Wait-List Control

Other group

Description:

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.

Treatment:

Drug: Metformin

Drug: Placebo