Clinical trial NCT04055012: Effects of Metformin on Low Back Pain
Official title: Metformin and Beyond: Individualizing Care for Low Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Low Back Pain
Keywords: Low Back Pain
Metformin
Placebo
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-08-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Change From Baseline in Numeric Pain Rating Scale
timeFrame: Up to 15 months
measure: Change From Baseline in Oswestry Disability Index (ODI)
timeFrame: Up to 15 months
Secondary outcomes:
measure: Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment
timeFrame: Up to 15 months
measure: Change From Baseline in 10 Meter Walk Test
timeFrame: Up to 15 months
measure: Change From Baseline in Fear Avoidance Questionnaire
timeFrame: Up to 15 months
measure: Change From Baseline in STarT Back Tool
timeFrame: Up to 15 months
measure: Change From Baseline in 6-item Pain Catastrophizing Scale
timeFrame: Up to 15 months
measure: Change From Baseline in Positive Outlook v1.0 - Short Form 6a
timeFrame: Up to 15 months
measure: Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
timeFrame: Up to 15 months
measure: Change From Baseline in General Self-Efficacy - Short Form 4a
timeFrame: Up to 15 months
measure: Change From Baseline in Global Physical Activity Questionnaire
timeFrame: Up to 15 months
measure: Change From Baseline in McGill Pain Questionnaire
timeFrame: Up to 15 months
measure: Change in Charlson Comorbidity Index
timeFrame: Up to 15 months
measure: Change From Baseline in Financial Strain
timeFrame: Up to 15 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Kaufmann Medical Building
state: Pennsylvania
city: Wexford
country: United States
facility: UPMC Wexford Spine Center
state: Pennsylvania
Study officials:
affiliation: The University of Pittsburgh
name: Gwendolyn Sowa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: