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

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ClinicalTrials.gov Identifier: NCT03106740
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Marco Loggia, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Low Back Pain Back Pain With Radiation Back Pain Without Radiation Back Pain Lower Back Chronic Back Ache Pain, Chronic Drug: Minocycline Hydrochloride 100mg Capsule Diagnostic Test: Magnetic Resonance-Positron Emission Tomography Imaging Other: Placebo Capsule Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Imaging Glia-mediated NeuroInflammation and Treatment Efficacy (the IGNITE Study)
Actual Study Start Date : October 10, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Minocycline Hydrochloride 100mg Capsule
Minocycline 100mg will be administered by mouth daily for 2 weeks
Other Names:
  • Minocin
  • Solodyn
  • Dynacin
  • Myrac

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.

Placebo Comparator: 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.
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




Primary Outcome Measures :
  1. Changes in brain PET signal [ Time Frame: 2 weeks ]
    The investigators will test for the presence of a significant treatment*time interaction in the brain [11C]PBR28 signal.


Secondary Outcome Measures :
  1. Changes in spinal PET signal [ Time Frame: 2 weeks ]
    The investigators will test for the presence of a significant treatment*time interaction in the spinal [11C]PBR28 signal.

  2. Changes in pain outcomes as measured by self report on a 0-100 numerical pain rating scale [ Time Frame: 2 weeks ]
    The investigators will test for the presence of a significant treatment*time interaction in pain outcomes on a self reported numerical (0-100) pain rating scale.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106740


Contacts
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Contact: Marco L Loggia, PhD 617-643-7267 marco@nmr.mgh.harvard.edu
Contact: Atreyi A Saha 617-643-6748 asaha3@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Marco Loggia, PhD    617-643-7267    marco.loggia@mgh.harvard.edu   
Sponsors and Collaborators
Marco Loggia
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Marco L Loggia, PhD Massachusetts General Hospital
Publications:
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Responsible Party: Marco Loggia, Assistant Professor of Radiology, Research Staff, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03106740    
Other Study ID Numbers: 2017P000179
1R01NS095937-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marco Loggia, Massachusetts General Hospital:
Microglia
Minocycline
Magnetic Resonance Imaging
Positron Emission Tomography
Pain
Astrocytes
Glia
Human
Back Pain
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Minocycline
Anti-Bacterial Agents
Anti-Infective Agents