NCT03106740

Evaluating the Role of Neuroinflammation in Low Back Pain

Imaging Glia-mediated NeuroInflammation and Treatment Efficacy (the IGNITE Study)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Marco Loggia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Low Back Pain
• Back Pain With Radiation
• Back Pain Without Radiation
• Back Pain Lower Back Chronic
• Back Ache
• Pain, Chronic

Interventions

Type	Name	Description
DRUG	Minocycline Hydrochloride 100mg Capsule	Minocycline 100mg will be administered by mouth daily for 2 weeks
DIAGNOSTIC_TEST	Magnetic Resonance-Positron Emission Tomography Imaging	Up to 15 millicuries of \[11C\]PBR28 will be administered to each subject at each imaging visit, for a maximum of 2 imaging visits.
OTHER	Placebo Capsule	1 Placebo Capsule (compounded with lactose powder) will be administered by mouth daily for 2 weeks

Timeline

• Start date: 2017-10-10
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2017-04-10
• Last updated: 2026-02-11
• Results posted: 2025-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study