Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)

Официальное название

Multi-modality Imaging and Collection of Biospecimen Samples in Understanding Brain Function in Low Back Pain Patients: a Longitudinal Cohort Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Nerve Block
  The "nerve block" intervention in this study involves the targeted administration of anesthetic agents and corticosteroids to specific nerves or nerve roots to alleviate pain associated with low back pain. This procedure is performed under imaging guidance (e.g., fluoroscopy or ultrasound) to ensure precise delivery of the medication to the affected nerve. It aims to temporarily block the transmission of pain signals from the affected area to the brain, providing relief and allowing for a better
• Процедура endoscopic spinal disecetomy
  The Endoscopic Lumbar Discectomy is a minimally invasive surgical procedure designed to treat symptomatic lumbar disc herniations by removing the protruding or damaged disc material that is pressing on the nerve roots. This intervention is distinguished by the use of endoscopic technology, which allows for a smaller incision, real-time visualization of the affected area via an endoscope, and the removal of herniated disc tissue with minimal disruption to surrounding structures. Unlike traditiona
• Препарат Medication
  The treatment of lumbar pain typically involves a multimodal approach combining medications based on the specific type of pain and patient needs. NSAIDs, acetaminophen, and muscle relaxants are often first-line treatments for nociceptive pain, while opioids and anticonvulsants like pregabalin are used for more severe or neuropathic pain. The choice of medication is guided by the severity of the pain, its underlying causes, and the patient's response to treatment. Each class of medication has its
• Поведенческое Psychotherapy
  Cognitive Behavioral Therapy (CBT): This structured, goal-oriented therapy focuses on identifying and changing negative thought patterns, cognitive distortions, and maladaptive behaviors associated with chronic pain. CBT equips patients with coping strategies to reframe thoughts, reduce pain-related anxiety, and enhance emotional regulation, thereby improving overall function and quality of life. CBT can include techniques such as cognitive restructuring, relaxation training, and behavioral acti

Первичные конечные точки

• Pain Intensity (Brief Pain Inventory - Short Form) [Срок оценки: 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]
• Pain Interference (Brief Pain Inventory - Short Form) [Срок оценки: 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]

Вторичные конечные точки (12)

• Pain Catastrophizing Scale (PCS) [Срок оценки: 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]
• Pain Coping Strategies Questionnaire [Срок оценки: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment]
• Pain Resilience Scale [Срок оценки: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment]
• Pain Self-efficacy Scale [Срок оценки: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment]
• Central Sensitization Scale [Срок оценки: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment]
• Brief Family Relationships Scale [Срок оценки: Baseline]
• Family Pain Questionnaire [Срок оценки: Baseline]
• Dietary Patterns (Structured Dietary Questionnaire - Food Frequency Component) [Срок оценки: Baseline]
• Sensory Threshold and Pain Perception as Assessed by Quantitative Sensory Testing (QST) Using Mechanical and Electrical Stimulation [Срок оценки: Baseline; 1 day after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment]
• Quantitative Sensory Testing (Electrical stimulation) [Срок оценки: 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]
• Oswestry Disability Index [Срок оценки: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment]
• Health-Related Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36) [Срок оценки: Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.;
• Diagnosed spinal infections, tumors, fractures, or inflammatory diseases (e.g., ankylosing spondylitis).
• Known severe psychiatric disorders (e.g., schizophrenia, bipolar disorder) that would interfere with study participation.Head trauma; history of substance abuse.
• Contraindications to MRI scanning (e.g., pacemaker, metallic implants, severe claustrophobia).
• Pregnant or breastfeeding women.
• Participation in another interventional clinical trial within the past 3 months.
• Working at night shifts or travelling across time zones in the past 6 months.
• Excessive consumption of coffee, tea.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 2 центра

• Peking university third hospital — Пекин
• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT06967363 · M2023570

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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