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Funding closed.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 500mg tabs of Metformin Extended Release |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Numeric Pain Rating Scale | Scores range from 0 to 10 with a higher score indicating more severe pain | Up to 15 months |
| Change From Baseline in Oswestry Disability Index (ODI) | Scores range from 0% to 100% with higher scores indicating greater disability | Up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 15 months |
| Change From Baseline in 10 Meter Walk Test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gwendolyn Sowa, MD, PhD | The University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Kaufmann Medical Building | Pittsburgh | Pennsylvania | 15213 | United States | ||
| UPMC Wexford Spine Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Metformin: 500mg tabs of Metformin Extended Release |
| FG001 | 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. Metformin: 500mg tabs of Metformin Extended Release |
| FG002 | High Dose Placebo | High Dose Placebo Group (n=50). 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. Placebo: Placebo Tabs |
| FG003 | Low Dose Placebo | Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months. Placebo: Placebo Tabs |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Metformin: 500mg tabs of Metformin Extended Release |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Numeric Pain Rating Scale | Scores range from 0 to 10 with a higher score indicating more severe pain | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
up to 15 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Metformin: 500mg tabs of Metformin Extended Release |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abnormal Lab Value - Low Vitamin B12 | General disorders | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Coordinator | The University of Pittsburgh | 412-692-2084 | kesslerl@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 17, 2022 | Dec 11, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 11, 2024 | Dec 12, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 17, 2022 | Dec 9, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Placebo Tabs |
|
Subject is timed walking at self-selected speed. A faster time (fewer seconds to complete the walk) is associated with better outcome.
| 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 | 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. | 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 | 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. | 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. | 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. | 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). | 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. | 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. | 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. | Up to 15 months |
| Wexford |
| Pennsylvania |
| 15090 |
| United States |
| Metformin Recall |
|
| 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. Metformin: 500mg tabs of Metformin Extended Release |
| BG002 | High Dose Placebo | High Dose Placebo Group (n=50). 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. Placebo: Placebo Tabs |
| BG003 | Low Dose Placebo | Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months. Placebo: Placebo Tabs |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | High Dose Placebo | High Dose Placebo Group (n=50). 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. Placebo: Placebo Tabs |
| OG003 | Low Dose Placebo | Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months. Placebo: Placebo Tabs |
|
|
| Primary | Change From Baseline in Oswestry Disability Index (ODI) | Scores range from 0% to 100% with higher scores indicating greater disability | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Up to 15 months |
|
|
|
| Secondary | Change From Baseline in Fear Avoidance Questionnaire | Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
|
|
| Secondary | Change From Baseline in STarT Back Tool | Scores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms. | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T score | Up to 15 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T score | Up to 15 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | T score | Up to 15 months |
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | MET- minutes per week | Up to 15 months |
|
|
|
| Secondary | Change From Baseline in McGill Pain Questionnaire | Scores range from 0 to 45 with a higher score indicating more qualitatively severe and impactful pain. | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
|
|
| Secondary | Change From Baseline in Financial Strain | Measures strain of finances. Score ranges from 1-4. The lower the score the harder the financial strain. | Posted | Mean | Standard Deviation | score on a scale | Up to 15 months |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 6 |
| 8 |
| EG001 | 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. Metformin: 500mg tabs of Metformin Extended Release | 0 | 8 | 0 | 8 | 6 | 8 |
| EG002 | High Dose Placebo | High Dose Placebo Group (n=50). 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. Placebo: Placebo Tabs | 0 | 2 | 0 | 2 | 2 | 2 |
| EG003 | Low Dose Placebo | Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months. Placebo: Placebo Tabs | 0 | 3 | 0 | 3 | 1 | 3 |
| Abnormal Lab Value - Elevated ESR | General disorders | Non-systematic Assessment |
|
| Abnormal Lab Value - Low Alkaline Phosphatase | General disorders | Non-systematic Assessment |
|
| Abnormal Lab Value - Hypoglycemia | General disorders | Non-systematic Assessment |
|
| Abnormal Lab Value - Elevated CBC | General disorders | Non-systematic Assessment |
|
| Abnormal Lab Value - Hypercalcemia | General disorders | Non-systematic Assessment |
|
| Abnormal Lab Value - Elevated Potassium | General disorders | Non-systematic Assessment |
|
| Low Iron | General disorders | Non-systematic Assessment |
|
| Gastrointestinal Discomfort | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Acid Reflux | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gas | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Abdominal Cramping | Gastrointestinal disorders | Non-systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| baseline ODI |
|
| Change from baseline in Anxiety |
|
| Change from baseline in Depression |
|
| Change from baseline in Fatigue |
|
| Change from baseline in Sleep disturbance |
|
| Change from baseline in Ability to participate in social roles and activities in the past 7 days |
|
| Change from baseline in Pain interference in the past 7 days |
|
| Change from baseline in Cognitive function-Abilities |
|