Clinical trial NCT06967363: Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)
Official title: Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Brain Function in Low Back Pain Patients: a Longitudinal Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Keywords: chronic low pack pain
fMRI
brain function
microbiota
nociplastic pain
treatment
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2025-05-13
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Peking University Third Hospital

Brief 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.

Detailed description: Low back pain (LBP) is one of the leading causes of disability globally, yet its underlying mechanisms remain poorly understood. Clinical management is often challenging due to the heterogeneity in symptom presentation and treatment response. Current approaches range from self-management and pharmacological therapies to targeted interventions, including nerve blocks and surgery. To address these challenges, this prospective, longitudinal cohort study is designed to comprehensively investigate the neurobiological, genetic, microbiological, and psychosocial factors contributing to the onset, maintenance, and variability of LBP.

The study includes individuals with both acute and chronic LBP to capture diverse clinical trajectories and identify determinants of recovery versus chronification. A central objective is to establish a well-curated biobank containing high-quality biospecimens (e.g., blood, stool) and multimodal datasets to facilitate future research in genomics, connectomics, microbiome science, and biomarker discovery.

Following a one-week run-in period to confirm eligibility, participants undergo comprehensive, multidimensional phenotyping. This includes clinical evaluation, self-reported outcomes, quantitative sensory testing, polysomnography (PSG), structural and functional magnetic resonance imaging (fMRI), heart rate variability (HRV), and microbiota profiling. Treatments-including conservative care (e.g., medications, health education), interventional procedures (e.g., nerve blocks), or surgery (e.g., endoscopic lumbar discectomy)- will be administered based on individualized clinical assessment.

All participants will undergo deep phenotyping at baseline, with follow-up assessments at 1 month, 3 months, 6 months and 1 year post-enrollment. Functional MRI scans will be conducted at baseline; 1 day before and after surgery or interventional procedures (if applicable); and at 1 month, 3 months, 6 months, and 1 year. If patients do not show significant improvement within 4 weeks or experience worsening symptoms, their treatment will be reassessed, and secondary interventions such as CBT, alternative medications, or further surgery will be considered based on their needs and progress.

The study investigates key systems involved in pain processing and chronification, including brain networks, central and peripheral nervous system activity, immune and inflammatory pathways, autonomic regulation, and the gut-brain axis. Longitudinal tracking will be used to analyze changes in these biological systems and their associations with clinical outcomes such as pain persistence, sleep quality, emotional distress, and functional status. Ultimately, this research aims to identify mechanistic biomarkers and define LBP subtypes to support the development of personalized, mechanism-based interventions for more effective prevention and treatment.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: 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
Secondary outcomes:
measure: Pain Catastrophizing Scale (PCS)
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
measure: Pain Coping Strategies Questionnaire
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Pain Resilience Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Pain Self-efficacy Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Central Sensitization Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Brief Family Relationships Scale
timeFrame: Baseline
measure: Family Pain Questionnaire
timeFrame: Baseline
measure: Dietary Patterns (Structured Dietary Questionnaire - Food Frequency Component)
timeFrame: Baseline
measure: Sensory Threshold and Pain Perception as Assessed by Quantitative Sensory Testing (QST) Using Mechanical and Electrical Stimulation
timeFrame: Baseline; 1 day after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Quantitative Sensory Testing (Electrical stimulation)
timeFrame: Baseline; 1 day after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Oswestry Disability Index
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Health-Related Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36)
timeFrame: Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Polysomnography
timeFrame: Baseline; 1 day after treament; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Insomnia Severity Index
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Hamilton Anxiety Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Hamilton Depression Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Patient Health Questionnaire-9
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Generalized Anxiety Disorder Scale-7
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: UCLA Loneliness Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Trail Making Test
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Stroop Test
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Attention Network Test
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Mnemonic Similarity Task
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Cognitive Flexibility Task
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Pain Empathy Task
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Pain Think/No-Think
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Microbiota Analysis
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Blood Sample Analysis
timeFrame: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Sleep Diary
timeFrame: Baseline; 1 day after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: MRI Scan
timeFrame: Baseline; 1 day after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Heart Rate Variability
timeFrame: Baseline; 1 day after treatment; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Adverse Event Record
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Pain Sensitivity Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Somatization Symptoms disorder-12
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Chronic Pain Helplessness Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Thought Control Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Pain Empathy Scale
timeFrame: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment
measure: Complete Blood Count
timeFrame: Baseline
measure: Family Depression and Anxiety Scores (PHQ-9 and GAD-7)
timeFrame: Baseline
measure: Family Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)
timeFrame: Baseline
measure: Family Functioning Score (Brief Family Relationship Scale)
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Gender (Male/Female/Other)
timeFrame: Baseline
measure: Height (cm)
timeFrame: Baseline
measure: Weight (kg)
timeFrame: Baseline
measure: Ethnicity (Self-Reported)
timeFrame: Baseline
measure: Education Level
timeFrame: Baseline
measure: Employment Status
timeFrame: Baseline
measure: Marital Status
timeFrame: Baseline
measure: Smoking History
timeFrame: Baseline
measure: Alcohol Consumption
timeFrame: Baseline
measure: Medical History
timeFrame: Baseline
measure: Blood Biochemistry
timeFrame: Baseline
measure: Electromyography
timeFrame: Baseline
measure: Income
timeFrame: Baseline
measure: Eating Habits (Structured Dietary Questionnaire - Behavioral Component)
timeFrame: baseline
measure: Bowel Habits (Structured Dietary Questionnaire - Bowel Function Component)
timeFrame: baseline
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jie Sun
role: PRINCIPAL_INVESTIGATOR
References: