Low Back Pain
Conditions
Keywords
Low Back Pain, Metformin, Placebo
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.
Interventions
DRUGMetformin
500mg tabs of Metformin Extended Release
DRUGPlacebo
Placebo Tabs
Sponsors
Gwendolyn Sowa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change From Baseline in Oswestry Disability Index (ODI) | Up to 15 months | Scores range from 0% to 100% with higher scores indicating greater disability |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Change From Baseline in STarT Back Tool | Up to 15 months | Scores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms. |
| Change From Baseline in 6-item Pain Catastrophizing Scale | Up to 15 months | Score range from 0 to 24 with a higher score indicating a higher degree of catastrophizing |
| Change From Baseline in Positive Outlook v1.0 - Short Form 6a | Up to 15 months | 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. |
| Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Up to 15 months | 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. |
| Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment | Up to 15 months | Current pain on average reported on 0-10 scale, higher scores indicate greater pain |
| Change From Baseline in Global Physical Activity Questionnaire | Up to 15 months | 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). |
| Change From Baseline in McGill Pain Questionnaire | Up to 15 months | Scores range from 0 to 45 with a higher score indicating more qualitatively severe and impactful pain. |
| Change in Charlson Comorbidity Index | Up to 15 months | Measures overall health with a higher score more likely predicative of mortality or higher resource use. Scale is scored 0-37. |
| Change From Baseline in Financial Strain | Up to 15 months | Measures strain of finances. Score ranges from 1-4. The lower the score the harder the financial strain. |
| Change From Baseline in General Self-Efficacy - Short Form 4a | Up to 15 months | 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. |
| Change From Baseline in 10 Meter Walk Test | Up to 15 months | Subject is timed walking at self-selected speed. A faster time (fewer seconds to complete the walk) is associated with better outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 8 |
| 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 | 4 |
| 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 | 3 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Metformin Recall | 1 | 1 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 | 1 | 0 |
Baseline characteristics
| Characteristic | High Dose Metformin | Low Dose Metformin | High Dose Placebo | Low Dose Placebo | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 4 Participants | 3 Participants | 21 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 16.31826321 | 48 years STANDARD_DEVIATION 11.86155254 | 42 years STANDARD_DEVIATION 20.82266393 | 45 years STANDARD_DEVIATION 16.19670748 | 47 years STANDARD_DEVIATION 14.83639367 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants | 8 Participants | 4 Participants | 2 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 5 Participants | 7 Participants | 3 Participants | 2 Participants | 17 Participants |
| Region of Enrollment United States | 8 participants | 8 participants | 4 participants | 3 participants | 23 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 2 Participants | 3 Participants | 18 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 8 | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 6 / 8 | 6 / 8 | 2 / 2 | 1 / 3 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 2 | 0 / 3 |
Outcome results
Primary
Change From Baseline in Numeric Pain Rating Scale
Scores range from 0 to 10 with a higher score indicating more severe pain
Time frame: Up to 15 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Dose Metformin | Change From Baseline in Numeric Pain Rating Scale | change in pain score | -1.16 score on a scale | Standard Deviation 0.98 |
| High Dose Metformin | Change From Baseline in Numeric Pain Rating Scale | baseline pain score | 5.33 score on a scale | Standard Deviation 1.03 |
| Low Dose Metformin | Change From Baseline in Numeric Pain Rating Scale | baseline pain score | 5.75 score on a scale | Standard Deviation 2.22 |
| Low Dose Metformin | Change From Baseline in Numeric Pain Rating Scale | change in pain score | -1.5 score on a scale | Standard Deviation 0.58 |
| High Dose Placebo | Change From Baseline in Numeric Pain Rating Scale | change in pain score | -1.5 score on a scale | Standard Deviation 0.71 |
| High Dose Placebo | Change From Baseline in Numeric Pain Rating Scale | baseline pain score | 6 score on a scale | Standard Deviation 2.83 |
| Low Dose Placebo | Change From Baseline in Numeric Pain Rating Scale | change in pain score | 0.33 score on a scale | Standard Deviation 3.06 |
| Low Dose Placebo | Change From Baseline in Numeric Pain Rating Scale | baseline pain score | 2.33 score on a scale | Standard Deviation 2.08 |
Primary
Change From Baseline in Oswestry Disability Index (ODI)
Scores range from 0% to 100% with higher scores indicating greater disability
Time frame: Up to 15 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Dose Metformin | Change From Baseline in Oswestry Disability Index (ODI) | average ODI change | -3 score on a scale | Standard Deviation 7.01 |
| High Dose Metformin | Change From Baseline in Oswestry Disability Index (ODI) | baseline ODI | 23.33 score on a scale | Standard Deviation 4.13 |
| Low Dose Metformin | Change From Baseline in Oswestry Disability Index (ODI) | baseline ODI | 26 score on a scale | Standard Deviation 9.38 |
| Low Dose Metformin | Change From Baseline in Oswestry Disability Index (ODI) | average ODI change | -2.5 score on a scale | Standard Deviation 12.37 |
| High Dose Placebo | Change From Baseline in Oswestry Disability Index (ODI) | average ODI change | -8 score on a scale | Standard Deviation 2.83 |
| High Dose Placebo | Change From Baseline in Oswestry Disability Index (ODI) | baseline ODI | 21 score on a scale | Standard Deviation 1.41 |
| Low Dose Placebo | Change From Baseline in Oswestry Disability Index (ODI) | average ODI change | -8.67 score on a scale | Standard Deviation 10.07 |
| Low Dose Placebo | Change From Baseline in Oswestry Disability Index (ODI) | baseline ODI | 20.67 score on a scale | Standard Deviation 10.26 |
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.
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in 10 Meter Walk Test | -2.71 seconds | Standard Deviation 5.26 |
| Low Dose Metformin | Change From Baseline in 10 Meter Walk Test | -0.57 seconds | Standard Deviation 1.91 |
| High Dose Placebo | Change From Baseline in 10 Meter Walk Test | -0.73 seconds | Standard Deviation 0.47 |
| Low Dose Placebo | Change From Baseline in 10 Meter Walk Test | -0.05 seconds | Standard Deviation 1.26 |
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
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in 6-item Pain Catastrophizing Scale | -1.67 score on a scale | Standard Deviation 3.88 |
| Low Dose Metformin | Change From Baseline in 6-item Pain Catastrophizing Scale | 0.75 score on a scale | Standard Deviation 4.79 |
| High Dose Placebo | Change From Baseline in 6-item Pain Catastrophizing Scale | -2 score on a scale | Standard Deviation 1.41 |
| Low Dose Placebo | Change From Baseline in 6-item Pain Catastrophizing Scale | 0.33 score on a scale | Standard Deviation 3.79 |
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
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment | -1.33 score on a scale | Standard Deviation 1.21 |
| Low Dose Metformin | Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment | -1.5 score on a scale | Standard Deviation 1 |
| High Dose Placebo | Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment | 0.5 score on a scale | Standard Deviation 0.71 |
| Low Dose Placebo | Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment | -0.33 score on a scale | Standard Deviation 1.15 |
Secondary
Change From Baseline in Fear Avoidance Questionnaire
Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in Fear Avoidance Questionnaire | -1.67 score on a scale | Standard Deviation 5.2 |
| Low Dose Metformin | Change From Baseline in Fear Avoidance Questionnaire | -0.25 score on a scale | Standard Deviation 8.81 |
| High Dose Placebo | Change From Baseline in Fear Avoidance Questionnaire | -7 score on a scale | Standard Deviation 4.24 |
| Low Dose Placebo | Change From Baseline in Fear Avoidance Questionnaire | -5.67 score on a scale | Standard Deviation 3.79 |
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.
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in Financial Strain | -0.16 score on a scale | Standard Deviation 0.98 |
| Low Dose Metformin | Change From Baseline in Financial Strain | 0 score on a scale | Standard Deviation 0 |
| High Dose Placebo | Change From Baseline in Financial Strain | 0 score on a scale | Standard Deviation 0 |
| Low Dose Placebo | Change From Baseline in Financial Strain | 0 score on a scale | Standard Deviation 0 |
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.
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in General Self-Efficacy - Short Form 4a | -3.97 T score | Standard Deviation 8.01 |
| Low Dose Metformin | Change From Baseline in General Self-Efficacy - Short Form 4a | -0.65 T score | Standard Deviation 3.9 |
| High Dose Placebo | Change From Baseline in General Self-Efficacy - Short Form 4a | 5.45 T score | Standard Deviation 7.71 |
| Low Dose Placebo | Change From Baseline in General Self-Efficacy - Short Form 4a | -8.2 T score | Standard Deviation 9.63 |
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).
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in Global Physical Activity Questionnaire | -1100 MET- minutes per week | Standard Deviation 3325.9 |
| Low Dose Metformin | Change From Baseline in Global Physical Activity Questionnaire | -1825 MET- minutes per week | Standard Deviation 2953 |
| High Dose Placebo | Change From Baseline in Global Physical Activity Questionnaire | 1050 MET- minutes per week | Standard Deviation 551.54 |
| Low Dose Placebo | Change From Baseline in Global Physical Activity Questionnaire | -277.33 MET- minutes per week | Standard Deviation 240.71 |
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.
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in McGill Pain Questionnaire | -4.83 score on a scale | Standard Deviation 3.43 |
| Low Dose Metformin | Change From Baseline in McGill Pain Questionnaire | -2.5 score on a scale | Standard Deviation 5.8 |
| High Dose Placebo | Change From Baseline in McGill Pain Questionnaire | -3.5 score on a scale | Standard Deviation 2.12 |
| Low Dose Placebo | Change From Baseline in McGill Pain Questionnaire | -11.67 score on a scale | Standard Deviation 19.86 |
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.
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in Positive Outlook v1.0 - Short Form 6a | -1.9 T score | Standard Deviation 5.78 |
| Low Dose Metformin | Change From Baseline in Positive Outlook v1.0 - Short Form 6a | 0.225 T score | Standard Deviation 5.97 |
| High Dose Placebo | Change From Baseline in Positive Outlook v1.0 - Short Form 6a | -2.55 T score | Standard Deviation 1.2 |
| Low Dose Placebo | Change From Baseline in Positive Outlook v1.0 - Short Form 6a | -10.27 T score | Standard Deviation 20.35 |
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.
Time frame: Up to 15 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Physical function | -0.62 T score | Standard Deviation 4.26 |
| High Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Anxiety | 0.55 T score | Standard Deviation 5.32 |
| High Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Depression | 2.25 T score | Standard Deviation 6.97 |
| High Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Fatigue | -1.35 T score | Standard Deviation 12.9 |
| High Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Sleep disturbance | 1 T score | Standard Deviation 4.76 |
| High Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Ability to participate in social roles and activities in the past 7 days | -3.1 T score | Standard Deviation 6.44 |
| High Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Pain interference in the past 7 days | -1.55 T score | Standard Deviation 3.22 |
| High Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Cognitive function-Abilities | 0 T score | Standard Deviation 13.28 |
| Low Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Ability to participate in social roles and activities in the past 7 days | -1.575 T score | Standard Deviation 9.45 |
| Low Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Sleep disturbance | 0.275 T score | Standard Deviation 3.24 |
| Low Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Anxiety | -3.075 T score | Standard Deviation 3.27 |
| Low Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Cognitive function-Abilities | 0 T score | Standard Deviation 6.7 |
| Low Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Pain interference in the past 7 days | -4.175 T score | Standard Deviation 7.4 |
| Low Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Fatigue | -3.2 T score | Standard Deviation 6.4 |
| Low Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Depression | 2.3 T score | Standard Deviation 5.72 |
| Low Dose Metformin | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Physical function | -2.075 T score | Standard Deviation 3.089 |
| High Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Pain interference in the past 7 days | -4.8 T score | Standard Deviation 1.7 |
| High Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Depression | -1.35 T score | Standard Deviation 5.87 |
| High Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Fatigue | -0.85 T score | Standard Deviation 6.72 |
| High Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Sleep disturbance | -1.2 T score | Standard Deviation 5.66 |
| High Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Ability to participate in social roles and activities in the past 7 days | -3.5 T score | Standard Deviation 4.95 |
| High Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Cognitive function-Abilities | -6.75 T score | Standard Deviation 3.61 |
| High Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Physical function | -0.6 T score | Standard Deviation 9.48 |
| High Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Anxiety | -6.75 T score | Standard Deviation 1.34 |
| Low Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Depression | -7.8 T score | Standard Deviation 8.17 |
| Low Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Fatigue | 0.43 T score | Standard Deviation 6.36 |
| Low Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Anxiety | -6.63 T score | Standard Deviation 5.75 |
| Low Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Physical function | -1.43 T score | Standard Deviation 2.48 |
| Low Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Sleep disturbance | -1.33 T score | Standard Deviation 1.4 |
| Low Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Cognitive function-Abilities | -1.07 T score | Standard Deviation 1.85 |
| Low Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Pain interference in the past 7 days | 3.07 T score | Standard Deviation 5.31 |
| Low Dose Placebo | Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29 | Change from baseline in Ability to participate in social roles and activities in the past 7 days | 1.27 T score | Standard Deviation 2.19 |
Secondary
Change From Baseline in STarT Back Tool
Scores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms.
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change From Baseline in STarT Back Tool | -1.83 score on a scale | Standard Deviation 2.4 |
| Low Dose Metformin | Change From Baseline in STarT Back Tool | -0.5 score on a scale | Standard Deviation 1.29 |
| High Dose Placebo | Change From Baseline in STarT Back Tool | 0 score on a scale | Standard Deviation 2.83 |
| Low Dose Placebo | Change From Baseline in STarT Back Tool | -0.33 score on a scale | Standard Deviation 3.06 |
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.
Time frame: Up to 15 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose Metformin | Change in Charlson Comorbidity Index | 0.17 score on a scale | Standard Deviation 0.41 |
| Low Dose Metformin | Change in Charlson Comorbidity Index | 0.25 score on a scale | Standard Deviation 0.5 |
| High Dose Placebo | Change in Charlson Comorbidity Index | 0 score on a scale | Standard Deviation 0 |
| Low Dose Placebo | Change in Charlson Comorbidity Index | 0 score on a scale | Standard Deviation 0 |