Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB) (NCT06967363) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)
China360 participantsStarted 2025-05-15
Plain-language summary
This prospective cohort study investigates the neurobiological, genetic, and psychosocial mechanisms underlying acute and chronic low back pain (LBP). Core objectives include establishing a high-quality biobank to support future research in connectomics, genomics, and biomarker discovery, and identifying predictors of pain progression and treatment response.
The study will also assess the impact of comorbid conditions such as anxiety, depression, and sleep disturbances on pain perception and clinical outcomes. Longitudinal analyses will explore the dynamic interplay between emotion, cognition, sleep, and pain to inform precision, mechanism-based interventions.
Functional imaging will be used to examine brain responses to nociceptive modulation, aiming to identify neural circuits involved in pain chronification. By integrating multimodal data-including neuroimaging, neurophysiology, microbiota profiling, polysomnography, and molecular assays-the study will define LBP subtypes, with a particular focus on nociceptive, neuropathic, and nociplastic mechanisms. The ultimate goal is to establish prognostic biomarkers and advance personalized strategies for LBP prevention and treatment.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. Adults aged 18 to 80 years.
✓. Diagnosis of low back pain, defined as pain located between the lower costal margins and the gluteal folds, with or without leg pain.
✓. Eligible for surgical or non-surgical treatments.
✓. Willingness to undergo neuroimaging (fMRI), microbiota sampling, psychological assessments, and other related study procedures. Ability to provide written informed consent.
Exclusion criteria
✕. Severe neurological deficits requiring emergency surgery.
✕. Antibiotic or probiotic use within the past 4 weeks. Suffering from digestive diseases such as irritable bowel syndrome, gastric ulcer, duodenal ulcer, etc.;
✕. Known severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that would interfere with study participation.Head trauma; history of substance abuse.
What they're measuring
1
Pain Intensity (Brief Pain Inventory - Short Form)
Timeframe: Baseline; 1 week after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
2
Pain Interference (Brief Pain Inventory - Short Form)
Timeframe: Time Frame: Baseline; 1 week after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment