Effects of Metformin on Low Back Pain

A Phase 2 study testing Metformin in people with Low Back Pain, run by Gwendolyn Sowa at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain
What is being tested?: Metformin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 23 participants
Where: 2 sitesUnited States
Study dates: 7 Jan 2020to 15 Dec 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 15Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UPMC Kaufmann Medical Building
Pittsburgh, Pennsylvania, 15213
UPMC Wexford Spine Center
Wexford, Pennsylvania, 15090

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Low Back Pain
Being tested: Metformin, Placebo
Keywords: Low Back Pain, Metformin, Placebo
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MetforminDrug
Also called Glucophage, Glucophage Extended Release, Metformin Extended Release, Metformin ER
500mg tabs of Metformin Extended Release
PlaceboDrug
Placebo Tabs

Study groups in NCT04055012
Study group	Role	What they receive
High Dose Metformin	Experimental	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. Receives: Drug: Metformin
Low Dose Metformin	Experimental	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. Receives: Drug: Metformin
Placebo	Placebo comparator	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. Receives: Drug: Placebo
Wait-List Control	Other	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. Receives: Drug: Metformin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Numeric Pain Rating Scale
Scores range from 0 to 10 with a higher score indicating more severe pain
Measured: Up to 15 months
Change From Baseline in Oswestry Disability Index (ODI)
Scores range from 0% to 100% with higher scores indicating greater disability
Measured: Up to 15 months

Secondary outcomes (12)

Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment
Current pain on average reported on 0-10 scale, higher scores indicate greater pain
Measured: Up to 15 months
Change From Baseline in 10 Meter Walk Test
Subject is timed walking at self-selected speed. A faster time (fewer seconds to complete the walk) is associated with better outcome.
Measured: 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
Measured: Up to 15 months
Change From Baseline in STarT Back Tool
Scores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms.
Measured: Up to 15 months
Change From Baseline in 6-item Pain Catastrophizing Scale
Score range from 0 to 24 with a higher score indicating a higher degree of catastrophizing
Measured: Up to 15 months
Change From Baseline in Positive Outlook v1.0 - Short Form 6a
For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicates a more positive outlook.
Measured: Up to 15 months
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
The PROMIS (Patient-Reported Outcomes Measurement Information System) 29 is a 29 question assessment of 8 domains of health related quality of life (physical function, fatigue, sleep disturbance, pain interference, anxiety, depression, ability to participate in social roles and activities, and cognitive function. For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. Higher T scores indicates greater report of the concept being measured.
Measured: Up to 15 months
Change From Baseline in General Self-Efficacy - Short Form 4a
For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicate higher self efficacy.
Measured: Up to 15 months
Change From Baseline in Global Physical Activity Questionnaire
This questionnaire developed by the World Health Organization measures physical activity at work or school, household, travel, recreational and sedentary behaviors, measured in MET (metabolic equivalent)-minutes per week (continuous variable).
Measured: Up to 15 months
Change From Baseline in McGill Pain Questionnaire
Scores range from 0 to 45 with a higher score indicating more qualitatively severe and impactful pain.
Measured: Up to 15 months
Change in Charlson Comorbidity Index
Measures overall health with a higher score more likely predicative of mortality or higher resource use. Scale is scored 0-37.
Measured: Up to 15 months
Change From Baseline in Financial Strain
Measures strain of finances. Score ranges from 1-4. The lower the score the harder the financial strain.
Measured: Up to 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 202015 Dec 2023

First posted13 Aug 2019
Study start7 Jan 2020
Primary completion15 Dec 2023
Study completion15 Dec 2023

Why it stopped: Funding closed.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04055012
Sponsor's protocol ID: STUDY19010007
Status last verified: Jan 2025
First submitted: 9 Aug 2019
Last updated: 21 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Metformin and Beyond: Individualizing Care for Low Back Pain
ClinicalTrials.gov ID: NCT04055012
Acronym / sponsor ID: STUDY19010007
Conditions: Low Back Pain
Keywords: Low Back Pain, Metformin, Placebo
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Funding closed.
Enrolment: 23 participants (actual)
Lead sponsor: Gwendolyn SowaUniversity, hospital or other
Study start: 7 Jan 2020 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 15 Dec 2023 (actual)
First posted: 13 Aug 2019 (actual)
Results: Posted 21 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
High Dose Metformin	Experimental	Drug: MetforminHigh 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	Experimental	Drug: MetforminLow 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	Placebo comparator	Drug: PlaceboPlacebo 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.
Wait-List Control	Other	Drug: Metformin, Drug: PlaceboControl 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (15 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MetforminAlso: Glucophage, Glucophage Extended Release, Metformin Extended Release, Metformin ER500mg tabs of Metformin Extended Release	Drug	High Dose Metformin, Low Dose Metformin, Wait-List Control
PlaceboPlacebo Tabs	Drug	Placebo, Wait-List Control

Primary outcome

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
Change From Baseline in Oswestry Disability Index (ODI)
Time frame: Up to 15 months
Scores range from 0% to 100% with higher scores indicating greater disability

12 secondary outcomes

Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment
Time frame: Up to 15 months
Change From Baseline in 10 Meter Walk Test
Time frame: Up to 15 months
Change From Baseline in Fear Avoidance Questionnaire
Time frame: Up to 15 months
Change From Baseline in STarT Back Tool
Time frame: Up to 15 months
Change From Baseline in 6-item Pain Catastrophizing Scale
Time frame: Up to 15 months
Change From Baseline in Positive Outlook v1.0 - Short Form 6a
Time frame: Up to 15 months
Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29
Time frame: Up to 15 months
Change From Baseline in General Self-Efficacy - Short Form 4a
Time frame: Up to 15 months
Change From Baseline in Global Physical Activity Questionnaire
Time frame: Up to 15 months
Change From Baseline in McGill Pain Questionnaire
Time frame: Up to 15 months
Change in Charlson Comorbidity Index
Time frame: Up to 15 months
Change From Baseline in Financial Strain
Time frame: Up to 15 months

Results and safety

Results posted to the registry on 21 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
High Dose Metformin	8	6
Low Dose Metformin	8	4
High Dose Placebo	4	2
Low Dose Placebo	3	3

Primary outcome: Change From Baseline in Numeric Pain Rating Scale

Time frame: Up to 15 months. Mean (Standard Deviation). Unit: score on a scale

Measure	High Dose Metformin n = 6	Low Dose Metformin n = 4	High Dose Placebo n = 2	Low Dose Placebo n = 3
change in pain score	-1.16 (0.98)	-1.5 (0.58)	-1.5 (0.71)	0.33 (3.06)
baseline pain score	5.33 (1.03)	5.75 (2.22)	6 (2.83)	2.33 (2.08)

Primary outcome: Change From Baseline in Oswestry Disability Index (ODI)

Time frame: Up to 15 months. Mean (Standard Deviation). Unit: score on a scale

Measure	High Dose Metformin n = 6	Low Dose Metformin n = 4	High Dose Placebo n = 2	Low Dose Placebo n = 3
average ODI change	-3 (7.01)	-2.5 (12.37)	-8 (2.83)	-8.67 (10.07)
baseline ODI	23.33 (4.13)	26 (9.38)	21 (1.41)	20.67 (10.26)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: up to 15 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
High Dose Metformin	0 of 8 (0%)	6 of 8 (75%)	0 of 8
Low Dose Metformin	0 of 8 (0%)	6 of 8 (75%)	0 of 8
High Dose Placebo	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Low Dose Placebo	0 of 3 (0%)	1 of 3 (33.3%)	0 of 3

Limitations and caveats (from the sponsor): The study was halted early due to funding redirection. Due to limited sample size, formal statistical analysis for between group comparisons was not feasible, and no clear trends were established.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gwendolyn Sowa, MD, PhD principal investigator

The University of Pittsburgh

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Metformin in people with Low Back Pain, run by Gwendolyn Sowa at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Numeric Pain Rating Scale (time frame: Up to 15 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04055012.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.