Evaluating the Role of Neuroinflammation in Low Back Pain (IGNITE)

Marco Loggia

Status and phase: Completed; Phase 2

Conditions: Back Ache; Back Pain Lower Back Chronic; Back Pain With Radiation; Pain, Chronic; Back Pain Without Radiation; Low Back Pain

Treatments: Drug: Minocycline Hydrochloride 100mg Capsule; Diagnostic Test: Magnetic Resonance-Positron Emission Tomography Imaging; Other: Placebo Capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03106740

2017P000179

1R01NS095937-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• the ability to give written informed consent
• fluency in English
• on a stable pain treatment
• Chronic or sub-acute low back pain

Exclusion criteria

• no interventional pain procedures during drug trial
• contraindications to MRI and PET scanning (including presence of a cardiac pacemaker or pacemaker wires, metallic particles in the body, vascular clips in the head or previous neurosurgery, prosthetic heart valves, claustrophobia)
• pregnancy or breast feeding
• any use of recreational drugs in the past 6 months
• allergy to minocycline or other tetracyclines, or taking medications known to interact with minocycline
• any other contraindications to minocycline administration

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Minocycline Arm

Experimental group

Description:

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

Treatment:

Diagnostic Test: Magnetic Resonance-Positron Emission Tomography Imaging

Drug: Minocycline Hydrochloride 100mg Capsule

Placebo Arm

Placebo Comparator group

Description:

Evaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule.

Treatment:

Other: Placebo Capsule

Diagnostic Test: Magnetic Resonance-Positron Emission Tomography Imaging