Evaluating the Role of Neuroinflammation in Low Back Pain

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-10

Study Completion Date

2024-04-30

Brief Summary

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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.

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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Minocycline Hydrochloride 100mg Capsule

Intervention Type DRUG

Minocycline 100mg will be administered by mouth daily for 2 weeks

Magnetic Resonance-Positron Emission Tomography Imaging

Intervention Type 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 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.

Group Type PLACEBO_COMPARATOR

Magnetic Resonance-Positron Emission Tomography Imaging

Intervention Type 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

Intervention Type OTHER

1 Placebo Capsule (compounded with lactose powder) will be administered by mouth daily for 2 weeks

Interventions

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Minocycline Hydrochloride 100mg Capsule

Minocycline 100mg will be administered by mouth daily for 2 weeks

Intervention Type DRUG

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.

Intervention Type DIAGNOSTIC_TEST

Placebo Capsule

1 Placebo Capsule (compounded with lactose powder) will be administered by mouth daily for 2 weeks

Intervention Type OTHER

Other Intervention Names

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Minocin Solodyn Dynacin Myrac

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No