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Effects of Metformin on Low Back Pain

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ClinicalTrials.gov Identifier: NCT04055012
Recruitment Status : Not yet recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Gwendolyn Sowa, University of Pittsburgh

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
Low Back Pain Drug: Metformin Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

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 2 tabs per day (1 metformin tab (500mg) and 1 placebo tab in pre-packaged blister pack) for the first week then increase to 3 tabs per day (1 metformin tab (500mg) and 2 placebo tabs (in pre-packaged blister pack) for the remaining 6 months.
Drug: Metformin
500mg tabs of Metformin Extended Release
Other Names:
  • Glucophage
  • Glucophage XR
  • Metformin Extended Release
  • Metformin ER

Drug: Placebo
Placebo Tabs

Placebo Comparator: Placebo
Placebo Group (n=100). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.
Drug: Placebo
Placebo Tabs

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




Primary Outcome Measures :
  1. Change from baseline in Numeric Pain Rating Scale [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Up to 15 months ]
    Scores range from 0 to 45 with a higher score indicating more pain.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04055012


Contacts
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Contact: Lauren Wilcox (412) 692-2084 kesslerl@upmc.edu

Locations
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United States, Pennsylvania
UPMC Kaufmann Medical Building Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Lauren Wilcox    412-692-2084      
Principal Investigator: Gwendolyn Sowa, MD, PhD         
UPMC Wexford Spine Center Not yet recruiting
Wexford, Pennsylvania, United States, 15090
Contact: Lauren Wilcox    412-692-2084      
Principal Investigator: Gwendolyn Sowa, MD, PhD         
Sponsors and Collaborators
Gwendolyn Sowa
Investigators
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Principal Investigator: Gwendolyn Sowa, MD, PhD The University of Pittsburgh

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Responsible Party: Gwendolyn Sowa, Professor and Chair Department of Physical Medicine and Rehabilitation, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04055012     History of Changes
Other Study ID Numbers: STUDY19010007
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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, University of Pittsburgh:
Low Back Pain
Metformin
Placebo

Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs