Evaluating the Role of Neuroinflammation in Low Back Pain



Status:Recruiting
Conditions:Back Pain, Back Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 70
Updated:4/17/2018
Start Date:October 10, 2017
End Date:September 2021
Contact:Marco L Loggia, PhD
Email:marco@nmr.mgh.harvard.edu
Phone:617-643-7267

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

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,
placebo (a sugar pill), or no treatment.

This study will be enrolling individuals who have been suffering from sub-acute (short-term)
and chronic low back pain.

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
We found this trial at
1
site
Charlestown, Massachusetts 02129
Phone: 617-643-7267
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Charlestown, MA
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