Effects of Metformin on Low Back Pain

Metformin and Beyond: Individualizing Care for Low Back Pain

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

Study Overview

• Status: Terminated
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Metformin; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Kaufmann Medical Building
    • Wexford, Pennsylvania, United States, 15090
      • UPMC Wexford Spine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Dose 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.	Drug: Metformin; 500mg tabs of Metformin Extended Release; Other Names: Glucophage; Metformin Extended Release; Metformin ER; Glucophage Extended Release
Experimental: Low Dose 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.	Drug: Metformin; 500mg tabs of Metformin Extended Release; Other Names: Glucophage; Metformin Extended Release; Metformin ER; Glucophage Extended Release
Placebo Comparator: 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.	Drug: Placebo; Placebo Tabs
Other: Wait-List Control; 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.	Drug: Metformin; 500mg tabs of Metformin Extended Release; Other Names: Glucophage; Metformin Extended Release; Metformin ER; Glucophage Extended Release; Drug: Placebo; Placebo Tabs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Numeric Pain Rating Scale	Scores range from 0 to 10 with a higher score indicating more severe pain	Up to 15 months
Change From Baseline in Oswestry Disability Index (ODI)	Scores range from 0% to 100% with higher scores indicating greater disability	Up to 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment	Current pain on average reported on 0-10 scale, higher scores indicate greater pain	Up to 15 months
Change From Baseline in 10 Meter Walk Test	Subject is timed walking at self-selected speed. A faster time (fewer seconds to complete the walk) is associated with better outcome.	Up to 15 months
Change From Baseline in Fear Avoidance Questionnaire	Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs	Up to 15 months
Change From Baseline in STarT Back Tool	Scores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms.	Up to 15 months
Change From Baseline in 6-item Pain Catastrophizing Scale	Score range from 0 to 24 with a higher score indicating a higher degree of catastrophizing	Up to 15 months
Change From Baseline in Positive Outlook v1.0 - Short Form 6a	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.	Up to 15 months
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29	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.	Up to 15 months
Change From Baseline in General Self-Efficacy - Short Form 4a	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.	Up to 15 months
Change From Baseline in Global Physical Activity Questionnaire	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).	Up to 15 months
Change From Baseline in McGill Pain Questionnaire	Scores range from 0 to 45 with a higher score indicating more qualitatively severe and impactful pain.	Up to 15 months
Change in Charlson Comorbidity Index	Measures overall health with a higher score more likely predicative of mortality or higher resource use. Scale is scored 0-37.	Up to 15 months
Change From Baseline in Financial Strain	Measures strain of finances. Score ranges from 1-4. The lower the score the harder the financial strain.	Up to 15 months

Collaborators and Investigators

• Sponsor: Gwendolyn Sowa
• Investigators: Principal Investigator: Gwendolyn Sowa, MD, PhD, The University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2020
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 9, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 31, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Low Back Pain; Metformin; Placebo
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain; Physiological Effects of Drugs; Hypoglycemic Agents; Metformin
• Other Study ID Numbers: STUDY19010007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No