Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)
Not yet recruitingNCT06967363
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Brain Function in Low Back Pain Patients: a Longitudinal Cohort Study
- Conditions
- Chronic Low Back Pain (CLBP)
- Acute Low Back Pain
- Low Back Pain
- Chronic Pain
- Acute Pain
- Mental Disorders
- Sleep Disorder
- Fibromyalgia (FM)
- Nociplastic Pain
- Neuropathic Pain
- Nonspecific Low Back Pain
- Interventions
- Procedure: Nerve Block
- Procedure: endoscopic spinal disecetomy
- Drug: Medication
- Behavioral: Psychotherapy
- Sponsor
- Peking University Third Hospital
- Collaborators
- National Natural Science Foundation of China
- Start date
- 2025-05-15
- Primary completion
- 2028-12-31
- Sex
- All
- Age range
- from 18 Years to 85 Years
- Results posted
- No results posted in this snapshot
- Countries
- China
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Adults aged 18 to 80 years. 2. Diagnosis of low back pain, defined as pain located between the lower costal margins and the gluteal folds, with or without leg pain. 3. Eligible for surgical or non-surgical treatments. 4. Willingness to undergo neuroimaging (fMRI), microbiota sampling, psychological assessments, and other related study procedures. Ability to provide written informed consent. Exclusion Criteria: 1. Severe neurological deficits requiring emergency surgery. 2. Antibiotic or probiotic use within the past 4 weeks. Suffering from digestive diseases such as irritable bowel syndrome, gastric ulcer, duodenal ulcer, etc.; 3. Diagnosed spinal infections, tumors, fractures, or inflammatory diseases (e.g., ankylosing spondylitis). 4. Known severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that would interfere with study participation.Head trauma; history of substance abuse. 5. Contraindications to MRI scanning (e.g., pacemaker, metallic implants, severe claustrophobia). 6. Pregnant or breastfeeding women. 7. Participation in another interventional clinical trial within the past 3 months. 8. Working at night shifts or travelling across time zones in the past 6 months. 9. Excessive consumption of coffee, tea.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06967363