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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NS095937-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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In this research, the study team will use brain imaging to evaluate the presence of neuroinflammation in the brains and spinal cords of patients with low back pain. The efficacy of minocycline use for low back pain treatment will also be evaluated by observing whether short-term minocycline administration will reduce neuroinflammation and low back pain symptoms.
The goal of this research study is to evaluate whether the central nervous systems of those with low back pain are different from those of healthy, pain-free individuals. Specifically, the researchers will test whether "glial cells" (the immune cells of the brain and spinal cord) are more active in patients with low back pain than in healthy volunteers. The investigators' previous study showed that patients with chronic low back pain demonstrated elevations in brain levels of the 18kDa translocator protein (TSPO), a marker of glial activation.
To test this hypothesis, the study team will image the brains and spinal cords of patients suffering from low back pain using integrated magnetic resonance- positron emission tomography (MR-PET), and a radiotracer called [11C]PBR28, which tracks levels of glial activation.
The efficacy of minocycline as a treatment for chronic low back pain will also be evaluated. A recent study demonstrated a statistically significant reduction in pain in those with lumbar radiculopathy after treatment with minocycline, leading the investigators of this study to believe that minocycline may have potential efficacy in treating other back pain populations.
The study team will observe whether a short course of minocycline hydrochloride may reduce glial activation along with self-reported low back pain symptoms. To this end, patients will be evaluated clinically and/or re-scanned after completing a 2-week trial of minocycline or placebo (a sugar pill).
This study will be enrolling individuals who have been suffering from sub-acute (short-term) and chronic low back pain.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minocycline Arm | Experimental | Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 2-week trial of Minocycline Hydrochloride, 100mg capsule |
|
| Placebo Arm | Placebo Comparator | Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minocycline Hydrochloride 100mg Capsule | Drug | Minocycline 100mg will be administered by mouth daily for 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Thalamic Standardized Uptake Value Ratio (SUVR) | The ratio of the standardized uptake value (SUV; mean radioactivity divided by the injected dose by weight) of the whole thalamus divided by the SUV of the whole brain (i.e., standardized uptake value ratio or SUVR) derived from the translocator protein positron emission tomography (TSPO-PET) signal. Higher SUVR might be indicative of higher neuroinflammation. | The outcome measure was assessed in two time points, before and after a two-week treatment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Spinal PET Signal | The standardized uptake value (SUV; mean radioactivity divided by the injected dose by weight) of the spine derived from the translocator protein positron emission tomography (TSPO-PET) signal. A higher SUV might be indicative of greater neuroinflammation. | 2 weeks |
| Rate of Change in Daily Modified Brief Pain Inventory (BPI) Severity Subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco L Loggia, PhD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25582579 | Background | Loggia ML, Chonde DB, Akeju O, Arabasz G, Catana C, Edwards RR, Hill E, Hsu S, Izquierdo-Garcia D, Ji RR, Riley M, Wasan AD, Zurcher NR, Albrecht DS, Vangel MG, Rosen BR, Napadow V, Hooker JM. Evidence for brain glial activation in chronic pain patients. Brain. 2015 Mar;138(Pt 3):604-15. doi: 10.1093/brain/awu377. Epub 2015 Jan 12. | |
| 25373391 | Background | Vanelderen P, Van Zundert J, Kozicz T, Puylaert M, De Vooght P, Mestrum R, Heylen R, Roubos E, Vissers K. Effect of minocycline on lumbar radicular neuropathic pain: a randomized, placebo-controlled, double-blind clinical trial with amitriptyline as a comparator. Anesthesiology. 2015 Feb;122(2):399-406. doi: 10.1097/ALN.0000000000000508. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Minocycline Arm | Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 2-week trial of Minocycline Hydrochloride, 100mg capsule. Minocycline Hydrochloride 100mg Capsule: Minocycline administered by mouth daily for 2 weeks Magnetic Resonance-Positron Emission Tomography Imaging: Up to 15 millicuries of [11C]PBR28 administered to each subject at each imaging visit, for a maximum of 2 imaging visits. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2022 |
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| Magnetic Resonance-Positron Emission Tomography Imaging | Diagnostic Test | Up to 15 millicuries of [11C]PBR28 will be administered to each subject at each imaging visit, for a maximum of 2 imaging visits. |
|
| Placebo Capsule | Other | 1 Placebo Capsule (compounded with lactose powder) will be administered by mouth daily for 2 weeks |
|
Estimated Mean Rate of Change of BPI per Day, separately by Treatment Group (Minocycline vs. Placebo), measured as Slope of Change over Time |
| 2 weeks |
| 40839604 | Derived | Mohammadian M, Morrissey EJ, Knight PC, Brusaferri L, Kim M, Efthimiou N, Murphy JP, Alshelh Z, Grmek G, Schnieders JH, Chane CA, Sandstrom A, Catana C, Gilman JM, Locascio JJ, Edwards RR, Zhang Y, Napadow V, Loggia ML. Investigating the potential of minocycline in reducing brain inflammation in chronic low back pain: a randomized, placebo-controlled mechanistic clinical trial. Pain. 2025 Apr 9;166(9):2044-2053. doi: 10.1097/j.pain.0000000000003543. |
| 36657520 | Derived | Morrissey EJ, Alshelh Z, Knight PC, Saha A, Kim M, Torrado-Carvajal A, Zhang Y, Edwards RR, Pike C, Locascio JJ, Napadow V, Loggia ML. Assessing the potential anti-neuroinflammatory effect of minocycline in chronic low back pain: Protocol for a randomized, double-blind, placebo-controlled trial. Contemp Clin Trials. 2023 Mar;126:107087. doi: 10.1016/j.cct.2023.107087. Epub 2023 Jan 16. |
| FG001 | Placebo Arm | Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule. Placebo Capsule: Placebo (lactose powder) administered by mouth daily for 2 weeks. Magnetic Resonance-Positron Emission Tomography Imaging: Up to 15 millicuries of [11C]PBR28 administered to each subject at each imaging visit, for a maximum of 2 imaging visits. |
| COMPLETED |
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| NOT COMPLETED |
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While 60 participants were randomized, 12 participants (5 in the minocycline arm and 7 in the placebo arm) did not complete the study, resulting in a final sample size of 48. Please see the Reasons Not Completed section of the Participant Flow table for more detailed information.
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| ID | Title | Description |
|---|---|---|
| BG000 | Minocycline Arm | Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 2-week trial of Minocycline Hydrochloride, 100mg capsule. Minocycline Hydrochloride 100mg Capsule: Minocycline administered by mouth daily for 2 weeks Magnetic Resonance-Positron Emission Tomography Imaging: Up to 15 millicuries of [11C]PBR28 administered to each subject at each imaging visit, for a maximum of 2 imaging visits. |
| BG001 | Placebo Arm | Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule. Placebo Capsule: Placebo (lactose powder) administered by mouth daily for 2 weeks. Magnetic Resonance-Positron Emission Tomography Imaging: Up to 15 millicuries of [11C]PBR28 administered to each subject at each imaging visit, for a maximum of 2 imaging visits. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Genotype | Participants were genotyped for Ala147Thr TSPO polymorphism to predict their TSPO binding affinity for the radiotracer used in the PET scans (i.e., [11C]PBR28) and those with the Thr/Thr genotype (i.e., low-affinity binders) were excluded from further participation. Ala/Ala (i.e., GG) and Ala/Thr (i.e., GA) genotypes (high-affinity and mixed-affinity binders, respectively) were eligible for participation. | Count of Participants | Participants |
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| 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 | Changes in Thalamic Standardized Uptake Value Ratio (SUVR) | The ratio of the standardized uptake value (SUV; mean radioactivity divided by the injected dose by weight) of the whole thalamus divided by the SUV of the whole brain (i.e., standardized uptake value ratio or SUVR) derived from the translocator protein positron emission tomography (TSPO-PET) signal. Higher SUVR might be indicative of higher neuroinflammation. | Posted | Mean | Standard Deviation | Standardized uptake value ratio | The outcome measure was assessed in two time points, before and after a two-week treatment period. |
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| Secondary | Changes in Spinal PET Signal | The standardized uptake value (SUV; mean radioactivity divided by the injected dose by weight) of the spine derived from the translocator protein positron emission tomography (TSPO-PET) signal. A higher SUV might be indicative of greater neuroinflammation. | Not Posted | Feb 2027 | 2 weeks | Participants | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Rate of Change in Daily Modified Brief Pain Inventory (BPI) Severity Subscale | Estimated Mean Rate of Change of BPI per Day, separately by Treatment Group (Minocycline vs. Placebo), measured as Slope of Change over Time | Posted | Number | 95% Confidence Interval | The Brief Pain Inventory score per day | 2 weeks |
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Between 14 and 43 days from the pre-treatment scan.
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Three types of adverse event data are to be reported: "All-Cause Mortality," "Serious," and "Other (Not Including Serious)" Adverse Events.
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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 | Minocycline Arm | Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 2-week trial of Minocycline Hydrochloride, 100mg capsule. Minocycline Hydrochloride 100mg Capsule: Minocycline administered by mouth daily for 2 weeks Magnetic Resonance-Positron Emission Tomography Imaging: Up to 15 millicuries of [11C]PBR28 administered to each subject at each imaging visit, for a maximum of 2 imaging visits. | 0 | 30 | 1 | 30 | 9 | 30 |
| EG001 | Placebo Arm | Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule. Placebo Capsule: Placebo (lactose powder) administered by mouth daily for 2 weeks. Magnetic Resonance-Positron Emission Tomography Imaging: Up to 15 millicuries of [11C]PBR28 administered to each subject at each imaging visit, for a maximum of 2 imaging visits. | 0 | 30 | 0 | 30 | 15 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stroke | Nervous system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ecchymosis | Injury, poisoning and procedural complications | Systematic Assessment | Bruising, pain, and swelling from the arterial line procedure. |
| |
| Vasovagal syncope | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Claustrophobia | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Discomfort | Injury, poisoning and procedural complications | Non-systematic Assessment | Discomfort with study procedures (e.g., electrical stimulation, shoulder pain or dizziness from scan) |
| |
| Gastrointestinal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| COVID-19 infection | Infections and infestations | Non-systematic Assessment |
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| Shingles | Infections and infestations | Non-systematic Assessment |
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| Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Pain after running a marathon |
| |
| Skin cancer removal | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marco Loggia | Massachusetts General Hospital | (617) 643-7267 | marco.loggia@mgh.harvard.edu |
| Dec 18, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D001416 | Back Pain |
| D059350 | Chronic Pain |
| C562573 | cyclopia sequence |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008911 | Minocycline |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| GA |
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| Units | Counts |
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| Participants |
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