Phase 2 N=60 Randomized Quadruple-blind Basic Science

Evaluating the Role of Neuroinflammation in Low Back Pain

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

Bottom Line

View on ClinicalTrials.gov: NCT03106740 ↗

Enrolled (actual)

Serious AEs

1.7%

Results posted

May 2025

Primary outcome: Primary: Changes in Thalamic Standardized Uptake Value Ratio (SUVR) — 1.188; 1.166; 1.189; 1.165 Standardized uptake value ratio — p=0.956

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Minocycline Hydrochloride 100mg Capsule (Drug); Magnetic Resonance-Positron Emission Tomography Imaging (Diagnostic_test); Placebo Capsule (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Marco Loggia
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Thalamic Standardized Uptake Value Ratio (SUVR)	1.188; 1.166; 1.189; 1.165	0.956
SECONDARY Changes in Spinal PET Signal	—	—
SECONDARY Rate of Change in Daily Modified Brief Pain Inventory (BPI) Severity Subscale	-0.04; -0.03	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03106740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.