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

• Study Type: Interventional
• Enrollment (Actual): 41
• 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; Glucophage XR; Metformin Extended Release; Metformin ER
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; Glucophage XR; Metformin Extended Release; Metformin ER
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; Glucophage XR; Metformin Extended Release; Metformin ER; 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	Scores range from 0% to 100% with higher percentage scores indicating greater disability	Up to 15 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Connor-Davidson Resilience Scale 25	Scores range from 0 to 100 in which a higher score demonstrates greater resilience	Up to 15 months
Change from baseline in 10 Meter Walk Test	Subject is timed walking at normal speed and also fastest speed possible. A faster time 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 Godin Leisure Time Questionnaire	Minimum score is 0 and there is no maximum score. A higher score indicates a more active individual.	Up to 15 months
Change from baseline in Catastrophizing Scale	Score range from 0 to 36 with a higher score indicating a higher degree of catastrophizing	Up to 15 months
Change from baseline in Generalized Anxiety Disorder-7	Scores range from 0 to 21 with a higher score indicating more anxiety	Up to 15 months
Change from baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 16 Questionnaire	This questionnaire is scored on the T-score metric. A higher score indicates a greater amount of whatever concept that the question asks.	Up to 15 months
Change from baseline in Patient Health Questionnaire-9	Scores range from 0 to 27 with higher scores indicating more depressive symptoms	Up to 15 months
Change from baseline in EQ-5D-5L (EuroQol)	Scores range from 5 to 25 with higher scores indicating more problems. Scores on the visual analogue scale range from 0 to 100 with 100 being the best	Up to 15 months
Change from baseline in McGill Pain Questionnaire	Scores range from 0 to 45 with a higher score indicating more pain.	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 (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

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; Hypoglycemic Agents; Physiological Effects of Drugs; 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