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Effects of Metformin on Low Back Pain

Primary Purpose

Low Back Pain

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metformin
Placebo
Sponsored by
Gwendolyn Sowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Metformin, Placebo

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • UPMC Kaufmann Medical Building
  • UPMC Wexford Spine Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Other

Arm Label

High Dose Metformin

Low Dose Metformin

Placebo

Wait-List Control

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in Numeric Pain Rating Scale
Scores range from 0 to 10 with a higher score indicating more severe pain
Change from baseline in Oswestry Disability Index
Scores range from 0% to 100% with higher percentage scores indicating greater disability

Secondary Outcome Measures

Change from baseline in Connor-Davidson Resilience Scale 25
Scores range from 0 to 100 in which a higher score demonstrates greater resilience
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.
Change from baseline in Fear Avoidance Questionnaire
Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs
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.
Change from baseline in Catastrophizing Scale
Score range from 0 to 36 with a higher score indicating a higher degree of catastrophizing
Change from baseline in Generalized Anxiety Disorder-7
Scores range from 0 to 21 with a higher score indicating more anxiety
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.
Change from baseline in Patient Health Questionnaire-9
Scores range from 0 to 27 with higher scores indicating more depressive symptoms
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
Change from baseline in McGill Pain Questionnaire
Scores range from 0 to 45 with a higher score indicating more pain.

Full Information

First Posted
August 9, 2019
Last Updated
July 18, 2023
Sponsor
Gwendolyn Sowa
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1. Study Identification

Unique Protocol Identification Number
NCT04055012
Brief Title
Effects of Metformin on Low Back Pain
Official Title
Metformin and Beyond: Individualizing Care for Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gwendolyn Sowa

4. Oversight

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

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Metformin, Placebo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose Metformin
Arm Type
Experimental
Arm 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.
Arm Title
Low Dose Metformin
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Wait-List Control
Arm Type
Other
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
Glucophage, Glucophage XR, Metformin Extended Release, Metformin ER
Intervention Description
500mg tabs of Metformin Extended Release
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Tabs
Primary Outcome Measure Information:
Title
Change from baseline in Numeric Pain Rating Scale
Description
Scores range from 0 to 10 with a higher score indicating more severe pain
Time Frame
Up to 15 months
Title
Change from baseline in Oswestry Disability Index
Description
Scores range from 0% to 100% with higher percentage scores indicating greater disability
Time Frame
Up to 15 months
Secondary Outcome Measure Information:
Title
Change from baseline in Connor-Davidson Resilience Scale 25
Description
Scores range from 0 to 100 in which a higher score demonstrates greater resilience
Time Frame
Up to 15 months
Title
Change from baseline in 10 Meter Walk Test
Description
Subject is timed walking at normal speed and also fastest speed possible. A faster time is associated with better outcome.
Time Frame
Up to 15 months
Title
Change from baseline in Fear Avoidance Questionnaire
Description
Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs
Time Frame
Up to 15 months
Title
Change from baseline in Godin Leisure Time Questionnaire
Description
Minimum score is 0 and there is no maximum score. A higher score indicates a more active individual.
Time Frame
Up to 15 months
Title
Change from baseline in Catastrophizing Scale
Description
Score range from 0 to 36 with a higher score indicating a higher degree of catastrophizing
Time Frame
Up to 15 months
Title
Change from baseline in Generalized Anxiety Disorder-7
Description
Scores range from 0 to 21 with a higher score indicating more anxiety
Time Frame
Up to 15 months
Title
Change from baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 16 Questionnaire
Description
This questionnaire is scored on the T-score metric. A higher score indicates a greater amount of whatever concept that the question asks.
Time Frame
Up to 15 months
Title
Change from baseline in Patient Health Questionnaire-9
Description
Scores range from 0 to 27 with higher scores indicating more depressive symptoms
Time Frame
Up to 15 months
Title
Change from baseline in EQ-5D-5L (EuroQol)
Description
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
Time Frame
Up to 15 months
Title
Change from baseline in McGill Pain Questionnaire
Description
Scores range from 0 to 45 with a higher score indicating more pain.
Time Frame
Up to 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwendolyn Sowa, MD, PhD
Organizational Affiliation
The University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC Kaufmann Medical Building
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Wexford Spine Center
City
Wexford
State/Province
Pennsylvania
ZIP/Postal Code
15090
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Metformin on Low Back Pain

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