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

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
• Interventions: Drug: Medication; Procedure: Nerve Block; Behavioral: Psychotherapy; Procedure: endoscopic spinal disecetomy

• Registration Number: NCT06967363
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2025-04-22
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-02
• Last Update Submitted: 2025-05-02
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-05-15
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-surgical group	Medication	Participants receiving conventional treatment such as medication , exercise, physical therapy, psychotherapy ( acceptance and realization therapy, pain reprocessing therapy, and cognitive behavior therapy) etc.,
Non-surgical group	Psychotherapy	Participants receiving conventional treatment such as medication , exercise, physical therapy, psychotherapy ( acceptance and realization therapy, pain reprocessing therapy, and cognitive behavior therapy) etc.,
Surgical group	Nerve Block	Participants undergoing surgical interventions, such as nerve block, or endoscopic lumbar discectomy.
Surgical group	endoscopic spinal disecetomy	Participants undergoing surgical interventions, such as nerve block, or endoscopic lumbar discectomy.

Primary Outcome Measures

Name	Time	Method
Pain Intensity (Brief Pain Inventory - Short Form)	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 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)	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 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 Outcome Measures

Name	Time	Method
Income	Baseline	Collect the range of participants' monthly income, in RMB, for example: no income, 1-999, 1000-1999, 2000-3999, 4000-5999, 6000-7999, 8000-9999, 10000-14999, 15000-19999, 20000-24999, 25000-39999, more than 40000.
Eating Habits (Structured Dietary Questionnaire - Behavioral Component)	baseline	Eating habits, including meal frequency, snacking behavior, eating speed, and time of day of food consumption, will be assessed via a behavioral component of the structured dietary questionnaire. Responses are categorical or ordinal, used for descriptive and exploratory correlation analyses without a total score.
Pain Empathy Task	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	This task focuses on an individual's ability to perceive and understand pain in others and the relationship between pain empathy and the experience of pain in the self.
Pain Think/No-Think	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	This task is mainly used to study how individuals actively control pain memory and pain experience.
Microbiota Analysis	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	Fecal specimens will be collected, frozen, and centralized for analysis such as macro-genome sequencing.
Blood Sample Analysis	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	Whole blood will be collected, centrifuged to separate plasma and blood cells, and centralized for analysis of inflammatory factors (IL-1β, TNF-α, IL-6, IL-10, TGF-β, etc), high-throughput gene sequencing.
Sleep Diary	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	The scale will be used to record subjective sleep. Participants actively reported the time to go to bed, time to wake up, sleep medication use, dim or bright sleep environment, and mental state after waking up.
MRI Scan	Baseline; 1 day after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	The MRI scan includes structural imaging (lumbar and head) and functional imaging (Pain Sensitivity Task, Pain Empathy Task, Pain Think/No-Think, Mnemonic Similarity Task, Cognitive Flexibility Task, etc.).
Heart Rate Variability	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	The method is used to record changes in the time interval of the heartbeat, reflecting the degree to which the heart is regulated by the autonomic nervous system.
Adverse Event Record	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to record whether adverse reactions such as fever, wound infection, vascular/neurologic injury, headache, fatigue, lower extremity swelling occurred.
Pain Sensitivity Scale	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to access the degree of sensitivity to pain. Participants will be given different scenarios and access the most compatible pain intensity on a scale of 0-10.
Somatization Symptoms disorder-12	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is a tool used to assess whether an individual experiences somatization symptoms.
Chronic Pain Helplessness Scale	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to assess the participant's feelings of helplessness regarding chronic pain. Participants need to rate each item on a scale of 0 (strongly disagree) to 5 (strongly agree), depending on the situation.
Thought Control Scale	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to assess an individual's ability to control their thinking in response to negative emotions or stress.
Pain Empathy Scale	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to assess an individual's ability to empathize with others in pain.
Complete Blood Count	Baseline	Routine blood count is a test that measures the number and proportion of various cells in our blood, mainly including the number and proportion of red blood cells, white blood cells and platelets.
Family Depression and Anxiety Scores (PHQ-9 and GAD-7)	Baseline	Depression will be assessed using the Patient Health Questionnaire-9 (PHQ-9), with scores ranging from 0 to 27. Anxiety will be assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, with scores ranging from 0 to 21. Higher scores reflect greater symptom severity.
Family Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)	Baseline	The PSQI is a self-rated questionnaire that assesses sleep quality over the past month. It yields a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Family Functioning Score (Brief Family Relationship Scale)	Baseline	Family functioning will be assessed using the Brief Family Relationship Scale, which evaluates cohesion, expressiveness, and conflict. Each subscale is scored separately; higher cohesion and expressiveness scores and lower conflict scores indicate healthier family dynamics.
Age	Baseline	Participant's age will be collected at baseline as a continuous variable in years.
Gender (Male/Female/Other)	Baseline	Participant's gender identity will be recorded at baseline.
Height (cm)	Baseline	Participant's height measured in centimeters.
Weight (kg)	Baseline	Participant's weight measured in kilograms.
Blood Biochemistry	Baseline	This item evaluates liver function, renal function, etc. by examining venous blood. The main test items include: alanine aminotransferase, creatinine, urea nitrogen, serum glucose, triglyceride, total cholesterol.
Electromyography	Baseline	By recording the electrical activity of muscles and nerves, muscle function and peripheral nervous system abnormalities are evaluated.
Bowel Habits (Structured Dietary Questionnaire - Bowel Function Component)	baseline	Bowel habits will be evaluated using items in the dietary questionnaire that assess bowel movement frequency, stool consistency (e.g., via Bristol Stool Form Scale), and presence of gastrointestinal symptoms. Data are collected as categorical variables and will be used descriptively or to correlate with other outcomes (e.g., microbiome profile).
Ethnicity (Self-Reported)	Baseline	Participant's self-identified ethnicity will be recorded at baseline using predefined categories.
Education Level	Baseline	Education level will be self-reported using predefined categories (e.g., high school, college, graduate).
Employment Status	Baseline	Current employment status will be recorded at baseline.
Marital Status	Baseline	Marital status will be collected at baseline (e.g., single, married, divorced).
Smoking History	Baseline	Smoking history will be collected at baseline, including current smoking status and past use.
Alcohol Consumption	Baseline	Alcohol consumption history will be collected at baseline (e.g., frequency and amount).
Medical History	Baseline	Medical history including relevant comorbidities will be collected at baseline via participant self-report and medical record review.
Pain Catastrophizing Scale (PCS)	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	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	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	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	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	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	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	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.
Central Sensitization Scale	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to comprehensively assess an individual's level of central sensitization, with higher scores indicating a higher level of central sensitization and greater sensitivity to painful stimuli. Participants need to rate each item on a scale of 0 (never) to 4 (always), depending on the situation.
Brief Family Relationships Scale	Baseline	This scale is used to assess the quality of family relationships and provides insight into the interaction, support, communication, and conflict among family members. Participants need to rate each item on a scale of 0 (Strongly agree) to 6 (Strongly disagree), depending on the situation.
Family Pain Questionnaire	Baseline	The scale contains 16 questions about pain and pain relief, and each question needs to be scored on a scale of approval, with a scale of 0 to 10 indicating an increase in degree, with higher scores representing greater agreement with the statement.
Dietary Patterns (Structured Dietary Questionnaire - Food Frequency Component)	Baseline	Dietary patterns will be assessed using a structured dietary questionnaire that includes a food frequency component. Participants report the frequency of consumption of various food groups (e.g., fruits, vegetables, dairy, meats, processed foods) over a defined period. Data will be used to calculate dietary diversity and adherence scores. There is no single summary score; results are used descriptively and for correlation analyses.
Trail Making Test	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	This test consists of 2 parts to assess executive function, attention and processing speed. TMT-A is to make a trail in numerical order; TMT-B is to make a trail from small to large alternating numbers and letters.
Sensory Threshold and Pain Perception as Assessed by Quantitative Sensory Testing (QST) Using Mechanical and Electrical Stimulation	Baseline; 1 day after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	Sensory gain or loss will be assessed using Quantitative Sensory Testing (QST) through both mechanical and electrical stimuli applied to multiple body sites (left leg, right leg, lumbar region, left arm, right arm).; Mechanical stimulation will be delivered using Von Frey filaments (0.008g to 300g). The mechanical detection threshold will be recorded in grams. Lower values indicate greater tactile sensitivity.; Electrical stimulation will be administered using surface electrodes with adjustable intensity (0-110 volts). The electrical pain threshold will be recorded in volts. Higher voltage indicates a higher pain threshold.; Participants will also provide subjective ratings of pain unpleasantness on a Numeric Rating Scale from 0 (no unpleasantness) to 10 (most unpleasant imaginable).
Cognitive Flexibility Task	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	This test determines cognitive flexibility by choosing the correct figure out of two patterns where the correct answer is reversed after a certain pattern.
Quantitative Sensory Testing (Electrical stimulation)	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	An electrical stimulation device (STM200) will be used to administer a series of electrical stimulation of different intensities (voltage range 0-100V) to record the sensations corresponding to the different stimulation intensities. The lower the value, the more sensitive the perception.
Oswestry Disability Index	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	The Oswestry Disability Index (ODI) is a validated, self-reported questionnaire used to assess functional disability related to low back pain. It consists of 10 sections measuring limitations in activities such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and traveling.; Each section is scored from 0 to 5, resulting in a total score ranging from 0 to 50, which is then converted to a percentage (0%-100%). Higher scores indicate greater disability.
Health-Related Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36)	Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	The SF-36 is a validated, self-administered questionnaire that evaluates health-related quality of life across 8 domains: physical functioning, role limitations due to physical health, role limitations due to emotional problems, vitality, emotional well-being, social functioning, bodily pain, and general health perceptions.; Scores for each domain range from 0 to 100, with higher scores indicating better health status or functioning. The survey can also be summarized into two component scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS), both scaled from 0 to 100.
Pittsburgh Sleep Quality Index	Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale mainly assesses subjective sleep in the past month, including sleep duration, sleep efficiency, sleep medication use, and sleep disorders. The total score ranges from 0-21, with higher scores indicating worse sleep quality.
Polysomnography	Baseline; 1 day after treament; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	Polysomnography, a device produced by Compumedics, is used to record and analyze physiological indicators of the human body during sleep, including electroencephalography, electrocardiography, electromyography, electrooculography, oral and nasal airflow, blood oxygen saturation, leg movement, right leg movement, pulse rate, etc.
Insomnia Severity Index	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to assess the severity of insomnia symptoms in the past two weeks, including difficulty falling asleep, difficulty maintaining sleep, early waking, and concern about sleep problems. The higher the score, the more serious the insomnia symptoms.
Hamilton Anxiety Scale	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered assessment used to measure the severity of a patient's anxiety. It includes 14 items, each assessing a symptom of anxiety (e.g., tension, fears, insomnia, somatic complaints).; Each item is scored on a scale from 0 (not present) to 4 (severe), producing a total score ranging from 0 to 56. Higher scores indicate more severe anxiety. Scores can be interpreted as: 0-17: mild severity; 18-24: mild to moderate severity; 25-30: moderate to severe
Hamilton Depression Scale	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to assess the severity of depressive symptoms. The total score is between 0 and 63. The higher the score, the more severe the depression.
Patient Health Questionnaire-9	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to self-assess the severity of depressive symptoms. The total score is between 0 and 27. The higher the score, the more severe the depression.
Generalized Anxiety Disorder Scale-7	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to self-assess the severity of anxiety symptoms. The total score is between 0 and 21. The higher the score, the more severe the anxiety.
UCLA Loneliness Scale	Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment	This scale is used to assess an individual's feelings of loneliness. Higher scores indicate greater loneliness.
Stroop Test	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	This test consists of four colors, "red, blue, yellow, and green," and requires that the meaning of the words be ignored and that choices be made based on the color. It is designed to assess cognitive inhibition and executive function.
Attention Network Test	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	This test assesses executive functioning, vigilance, orientation, and other abilities by calculating the choice of arrow direction under different conditions.
Mnemonic Similarity Task	Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment	This test determines hippocampal functioning by learning a series of images and then categorizing the images, including old images (exactly the same as those that have appeared before); new images (not at all the same as those that have appeared before); and similar images (similar to those that have appeared before but with differences).

Trial Locations

Locations (2)

Peking university third hospital; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China