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Low Back PainPhase 2IGNITENCT03106740

Evaluating the Role of Neuroinflammation in Low Back Pain

A Phase 2 study testing Minocycline Hydrochloride 100mg Capsule and Magnetic Resonance-Positron Emission Tomography Imaging in people with Low Back Pain and Back Pain With Radiation, run by Marco Loggia at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Minocycline Hydrochloride 100mg Capsule and Magnetic Resonance-Positron Emission Tomography Imaging
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteUnited States
Study dates
10 Oct 2017to 30 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Minocycline Hydrochloride 100mg Capsule, Magnetic Resonance-Positron Emission Tomography Imaging, Placebo Capsule
Keywords
Microglia, Minocycline, Magnetic Resonance Imaging, Positron Emission Tomography, Pain, Astrocytes, Glia, Human, Back Pain
Medical subject headings
Low Back Pain, Back Pain, Chronic Pain, cyclopia sequence, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minocycline Hydrochloride 100mg CapsuleDrug

    Also called Minocin, Solodyn, Dynacin, Myrac

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

  • Magnetic Resonance-Positron Emission Tomography ImagingDiagnostic 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 CapsuleOther

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

Study groups in NCT03106740
Study groupRoleWhat they receive
Minocycline ArmExperimentalEvaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after a 2-week trial of Minocycline Hydrochloride, 100mg capsule
Receives: Drug: Minocycline Hydrochloride 100mg Capsule; Diagnostic Test: Magnetic Resonance-Positron Emission Tomography Imaging
Placebo ArmPlacebo comparatorEvaluation with Magnetic Resonance-Positron Emission Tomography Imaging and/or behavioral pain assessment before and after 2 weeks of treatment with a placebo capsule.
Receives: Diagnostic Test: Magnetic Resonance-Positron Emission Tomography Imaging; Other: Placebo Capsule

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Thalamic Standardized Uptake Value Ratio (SUVR)

    The ratio of the standardized uptake value (SUV; mean radioactivity divided by the injected dose by weight) of the whole thalamus divided by the SUV of the whole brain (i.e., standardized uptake value ratio or SUVR) derived from the translocator protein positron emission tomography (TSPO-PET) signal. Higher SUVR might be indicative of higher neuroinflammation.

    Measured: The outcome measure was assessed in two time points, before and after a two-week treatment period.

Secondary outcomes (2)

  1. Changes in Spinal PET Signal

    The standardized uptake value (SUV; mean radioactivity divided by the injected dose by weight) of the spine derived from the translocator protein positron emission tomography (TSPO-PET) signal. A higher SUV might be indicative of greater neuroinflammation.

    Measured: 2 weeks

  2. Rate of Change in Daily Modified Brief Pain Inventory (BPI) Severity Subscale

    Estimated Mean Rate of Change of BPI per Day, separately by Treatment Group (Minocycline vs. Placebo), measured as Slope of Change over Time

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2017
  2. Study start10 Oct 2017
  3. Primary completion30 Apr 2024
  4. Study completion30 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03106740
Sponsor's protocol ID
2017P000179
Other IDs
1R01NS095937-01A1
Acronym
IGNITE
Status last verified
Jan 2026
First submitted
28 Mar 2017
Last updated
11 Feb 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Loggia ML, Chonde DB, Akeju O, Arabasz G, Catana C, Edwards RR, Hill E, Hsu S, Izquierdo-Garcia D, Ji RR, Riley M, Wasan AD, Zurcher NR, Albrecht DS, Vangel MG, Rosen BR, Napadow V, Hooker JM. Evidence for brain glial activation in chronic pain patients. Brain. 2015 Mar;138(Pt 3):604-15. doi: 10.1093/brain/awu377. Epub 2015 Jan 12.

    PubMed 25582579

  • Vanelderen P, Van Zundert J, Kozicz T, Puylaert M, De Vooght P, Mestrum R, Heylen R, Roubos E, Vissers K. Effect of minocycline on lumbar radicular neuropathic pain: a randomized, placebo-controlled, double-blind clinical trial with amitriptyline as a comparator. Anesthesiology. 2015 Feb;122(2):399-406. doi: 10.1097/ALN.0000000000000508.

    PubMed 25373391

  • Mohammadian M, Morrissey EJ, Knight PC, Brusaferri L, Kim M, Efthimiou N, Murphy JP, Alshelh Z, Grmek G, Schnieders JH, Chane CA, Sandstrom A, Catana C, Gilman JM, Locascio JJ, Edwards RR, Zhang Y, Napadow V, Loggia ML. Investigating the potential of minocycline in reducing brain inflammation in chronic low back pain: a randomized, placebo-controlled mechanistic clinical trial. Pain. 2025 Apr 9;166(9):2044-2053. doi: 10.1097/j.pain.0000000000003543.

    PubMed 40839604

  • Morrissey EJ, Alshelh Z, Knight PC, Saha A, Kim M, Torrado-Carvajal A, Zhang Y, Edwards RR, Pike C, Locascio JJ, Napadow V, Loggia ML. Assessing the potential anti-neuroinflammatory effect of minocycline in chronic low back pain: Protocol for a randomized, double-blind, placebo-controlled trial. Contemp Clin Trials. 2023 Mar;126:107087. doi: 10.1016/j.cct.2023.107087. Epub 2023 Jan 16.

    PubMed 36657520

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Minocycline Hydrochloride 100mg Capsule and Magnetic Resonance-Positron Emission Tomography Imaging in people with Low Back Pain and Back Pain With Radiation, run by Marco Loggia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Thalamic Standardized Uptake Value Ratio (SUVR) (time frame: The outcome measure was assessed in two time points, before and after a two-week treatment period.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03106740, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.

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