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Effects of Metformin on Low Back Pain

Sponsor
Gwendolyn Sowa (Other)
Overall Status
Recruiting
CT.gov ID
NCT04055012
Collaborator
(none)
400
Enrollment
2
Locations
4
Arms
46.8
Anticipated Duration (Months)
200
Patients Per Site
4.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Metformin and Beyond: Individualizing Care for Low Back Pain
Actual Study Start Date :
Jan 7, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in Numeric Pain Rating Scale [Up to 15 months]

      Scores range from 0 to 10 with a higher score indicating more severe pain

    2. Change from baseline in Oswestry Disability Index [Up to 15 months]

      Scores range from 0% to 100% with higher percentage scores indicating greater disability

    Secondary Outcome Measures

    1. Change from baseline in Connor-Davidson Resilience Scale 25 [Up to 15 months]

      Scores range from 0 to 100 in which a higher score demonstrates greater resilience

    2. Change from baseline in 10 Meter Walk Test [Up to 15 months]

      Subject is timed walking at normal speed and also fastest speed possible. A faster time is associated with better outcome.

    3. Change from baseline in Fear Avoidance Questionnaire [Up to 15 months]

      Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs

    4. Change from baseline in Godin Leisure Time Questionnaire [Up to 15 months]

      Minimum score is 0 and there is no maximum score. A higher score indicates a more active individual.

    5. Change from baseline in Catastrophizing Scale [Up to 15 months]

      Score range from 0 to 36 with a higher score indicating a higher degree of catastrophizing

    6. Change from baseline in Generalized Anxiety Disorder-7 [Up to 15 months]

      Scores range from 0 to 21 with a higher score indicating more anxiety

    7. Change from baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 16 Questionnaire [Up to 15 months]

      This questionnaire is scored on the T-score metric. A higher score indicates a greater amount of whatever concept that the question asks.

    8. Change from baseline in Patient Health Questionnaire-9 [Up to 15 months]

      Scores range from 0 to 27 with higher scores indicating more depressive symptoms

    9. Change from baseline in EQ-5D-5L (EuroQol) [Up to 15 months]

      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

    10. Change from baseline in McGill Pain Questionnaire [Up to 15 months]

      Scores range from 0 to 45 with a higher score indicating more pain.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UPMC Kaufmann Medical Building Pittsburgh Pennsylvania United States 15213
    2 UPMC Wexford Spine Center Wexford Pennsylvania United States 15090

    Sponsors and Collaborators

    • Gwendolyn Sowa

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gwendolyn Sowa, Professor and Chair Department of Physical Medicine and Rehabilitation, University of Pittsburgh
    ClinicalTrials.gov Identifier:
    NCT04055012
    Other Study ID Numbers:
    • STUDY19010007
    First Posted:
    Aug 13, 2019
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Gwendolyn Sowa, Professor and Chair Department of Physical Medicine and Rehabilitation, University of Pittsburgh
    Low Back Pain
    Metformin
    Placebo
    Additional relevant MeSH terms:
    Back Pain
    Low Back Pain
    Metformin

    Study Results

    No Results Posted as of Jun 23, 2022