About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Peking University Third Hospital
Trial design
Cohort
Prospective
Treatments tested in this trial
Nerve Block
Procedure/SurgeryThe "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 assessment of the underlying pain mechanism. The nerve block is distinguished from other interventions in this study by its localized approach, focusing on pain modulation through direct neural targeting, rather than systemic pain management methods. The procedure may be used either as a standalone treatment or in conjunction with other therapies (e.g., physical therapy, medications) based on the patient's individual needs and response to treatment.
endoscopic spinal disecetomy
Procedure/SurgeryThe 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 traditional open discectomy, which requires larger incisions and muscle dissection, endoscopic discectomy involves the use of a small tubular retractor and specialized instruments, leading to reduced blood loss, shorter recovery times, and less postoperative pain. This procedure is typically performed under local anesthesia, and the patient is often able to go home the same day. It is specifically designed for patients with lumbar disc herniations who have not responded to conservative way.
Medication
DrugThe 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 strengths and limitations, and the decision to use them must take into account factors like patient safety, the risk of side effects, and long-term efficacy.
Psychotherapy
BehavioralCognitive 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 activation. Acceptance and Commitment Therapy (ACT): ACT encourages individuals to accept pain and distressing emotions rather than avoiding them. It emphasizes mindfulness, acceptance, and values-based living, helping patients focus on behaviors that align with their values, despite ongoing pain.
Treatment groups
Trial outcomes
Primary outcomes
Pain Intensity (Brief Pain Inventory - Short Form)
Pain intensity will be assessed using the BPI-SF pain severity subscale, consisting of four 0-10 numeric ratings: worst, least, average, and current pain over the past 24 hours. The primary outcome will be the average of these four items. Higher scores indicate greater pain severity.
Pain Interference (Brief Pain Inventory - Short Form)
Pain interference will be measured using the BPI-SF interference subscale, which includes seven items assessing interference with general activity, mood, walking ability, normal work, relations with others, sleep, and enjoyment of life. Each item is scored on a scale of 0 (does not interfere) to 10 (completely interferes). The mean of the seven items will be reported as the interference score.
Secondary outcomes
Pain Catastrophizing Scale (PCS)
The PCS consists of 13 items, each rated on a 0 (not at all) to 4 (all the time) scale. Total scores range from 0 to 52, with higher scores indicating greater pain catastrophizing. The total PCS score will be used as the outcome.
Pain Coping Strategies Questionnaire
Use of this scale is designed to measure psychological and behavioral strategies for how individuals cope with chronic pain. Participants need to rate each item on a scale of 0 (never) to 6 (always), depending on the situation.
Pain Resilience Scale
This scale is used to assess an individual's mental resilience in response to pain, including the capacity of adaptive, cognitive, affective, and behavioral strategies during the pain experience. Participants need to rate each item on a scale of 0 (never) to 4 (always), depending on the situation.
Pain Self-efficacy Scale
This scale is used to assess an individual's confidence in managing pain, with higher scores indicating greater confidence in pain management. Participants need to rate each item on a scale of 0 (never) to 6 (always), depending on the situation.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University Third Hospital
Lead sponsor
National Natural Science Foundation of China
Collaborator
This trial is not recruiting at the moment. You can still explore other options: