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AzTrials

Chronic Low Back Pain (CLBP)LBPBNCT06967363

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

An observational study of Chronic Low Back Pain (CLBP) and Acute Low Back Pain, run by Peking University Third Hospital at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Nerve Block, endoscopic spinal disecetomy and Medication
How many people
360 participants
Where
2 sitesChina
Study dates
15 May 2025to 31 Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Peking University Third Hospital

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

China2 sites
  • Peking university third hospital

    Beijing, Beijing Municipality, 100000

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

    jie sun, Dr, +115311426995, jiesu@umich.edu

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Nerve Block, endoscopic spinal disecetomy, Medication, Psychotherapy
Keywords
chronic low pack pain, fMRI, brain function, microbiota, nociplastic pain, treatment
Medical subject headings
Low Back Pain, Chronic Pain, Acute Pain, Mental Disorders, Sleep Wake Disorders, Fibromyalgia, Nociplastic Pain, Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nerve BlockProcedure or surgery

    Also called Selective Nerve Root Block (SNRB), Transforaminal Epidural Injection

    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 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 disecetomyProcedure or surgery

    Also called endoscopic lumbar disecetomy, Endoscopic Discectomy, Percutaneous Endoscopic Lumbar Discectomy

    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 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.

  • MedicationDrug

    Also called celecoxib, ibuprofen, diclofenac, Pregabalin

    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 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.

  • PsychotherapyBehavioural

    Also called cognitive behavioral therapy, Acceptance and Commitment Therapy

    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 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.

Study groups in NCT06967363
Study groupRoleWhat they receive
Non-surgical groupParticipants receiving conventional treatment such as medication , exercise, physical therapy, psychotherapy ( acceptance and realization therapy, pain reprocessing therapy, and cognitive behavior therapy) etc.,
Receives: Drug: Medication; Behavioral: Psychotherapy
Surgical groupParticipants undergoing surgical interventions, such as nerve block, or endoscopic lumbar discectomy.
Receives: Procedure: Nerve Block; Procedure: endoscopic spinal disecetomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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.

    Measured: 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 (58)
  1. 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.

    Measured: 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

  2. 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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  3. 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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  4. 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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  5. Central Sensitization Scale

    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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  6. Brief Family Relationships Scale

    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.

    Measured: Baseline

  7. Family Pain Questionnaire

    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.

    Measured: Baseline

  8. Dietary Patterns (Structured Dietary Questionnaire - Food Frequency Component)

    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.

    Measured: Baseline

  9. Sensory Threshold and Pain Perception as Assessed by Quantitative Sensory Testing (QST) Using Mechanical and Electrical Stimulation

    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).

    Measured: Baseline; 1 day after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  10. Quantitative Sensory Testing (Electrical stimulation)

    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.

    Measured: 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

  11. Oswestry Disability Index

    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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  12. Health-Related Quality of Life as Assessed by the 36-Item Short Form Health Survey (SF-36)

    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.

    Measured: Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  13. Pittsburgh Sleep Quality Index

    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.

    Measured: Baseline; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  14. Polysomnography

    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.

    Measured: Baseline; 1 day after treament; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  15. Insomnia Severity Index

    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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  16. Hamilton Anxiety Scale

    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

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  17. Hamilton Depression Scale

    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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  18. Patient Health Questionnaire-9

    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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  19. Generalized Anxiety Disorder Scale-7

    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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  20. UCLA Loneliness Scale

    This scale is used to assess an individual's feelings of loneliness. Higher scores indicate greater loneliness.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  21. Trail Making Test

    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.

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  22. Stroop Test

    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.

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  23. Attention Network Test

    This test assesses executive functioning, vigilance, orientation, and other abilities by calculating the choice of arrow direction under different conditions.

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  24. Mnemonic Similarity Task

    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).

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  25. Cognitive Flexibility Task

    This test determines cognitive flexibility by choosing the correct figure out of two patterns where the correct answer is reversed after a certain pattern.

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  26. Pain Empathy Task

    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.

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  27. Pain Think/No-Think

    This task is mainly used to study how individuals actively control pain memory and pain experience.

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  28. Microbiota Analysis

    Fecal specimens will be collected, frozen, and centralized for analysis such as macro-genome sequencing.

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  29. Blood Sample Analysis

    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.

    Measured: Baseline; 3 months after treatment; 6 months after treatment; 12 months after treatment

  30. Sleep Diary

    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.

    Measured: 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

  31. MRI Scan

    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.).

    Measured: Baseline; 1 day after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  32. Heart Rate Variability

    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.

    Measured: 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

  33. Adverse Event Record

    This scale is used to record whether adverse reactions such as fever, wound infection, vascular/neurologic injury, headache, fatigue, lower extremity swelling occurred.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  34. Pain Sensitivity Scale

    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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  35. Somatization Symptoms disorder-12

    This scale is a tool used to assess whether an individual experiences somatization symptoms.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  36. Chronic Pain Helplessness Scale

    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.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  37. Thought Control Scale

    This scale is used to assess an individual's ability to control their thinking in response to negative emotions or stress.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  38. Pain Empathy Scale

    This scale is used to assess an individual's ability to empathize with others in pain.

    Measured: Baseline; 2 weeks after treatment; 1 month after treatment; 3 months after treatment; 6 months after treatment; 12 months after treatment

  39. Complete Blood Count

    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.

    Measured: Baseline

  40. Family Depression and Anxiety Scores (PHQ-9 and GAD-7)

    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.

    Measured: Baseline

  41. Family Sleep Quality Score (Pittsburgh Sleep Quality Index - PSQI)

    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.

    Measured: Baseline

  42. Family Functioning Score (Brief Family Relationship Scale)

    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.

    Measured: Baseline

  43. Age

    Participant's age will be collected at baseline as a continuous variable in years.

    Measured: Baseline

  44. Gender (Male/Female/Other)

    Participant's gender identity will be recorded at baseline.

    Measured: Baseline

  45. Height (cm)

    Participant's height measured in centimeters.

    Measured: Baseline

  46. Weight (kg)

    Participant's weight measured in kilograms.

    Measured: Baseline

  47. Ethnicity (Self-Reported)

    Participant's self-identified ethnicity will be recorded at baseline using predefined categories.

    Measured: Baseline

  48. Education Level

    Education level will be self-reported using predefined categories (e.g., high school, college, graduate).

    Measured: Baseline

  49. Employment Status

    Current employment status will be recorded at baseline.

    Measured: Baseline

  50. Marital Status

    Marital status will be collected at baseline (e.g., single, married, divorced).

    Measured: Baseline

  51. Smoking History

    Smoking history will be collected at baseline, including current smoking status and past use.

    Measured: Baseline

  52. Alcohol Consumption

    Alcohol consumption history will be collected at baseline (e.g., frequency and amount).

    Measured: Baseline

  53. Medical History

    Medical history including relevant comorbidities will be collected at baseline via participant self-report and medical record review.

    Measured: Baseline

  54. Blood Biochemistry

    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.

    Measured: Baseline

  55. Electromyography

    By recording the electrical activity of muscles and nerves, muscle function and peripheral nervous system abnormalities are evaluated.

    Measured: Baseline

  56. Income

    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.

    Measured: Baseline

  57. Eating Habits (Structured Dietary Questionnaire - Behavioral Component)

    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.

    Measured: baseline

  58. Bowel Habits (Structured Dietary Questionnaire - Bowel Function Component)

    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).

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start15 May 2025 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
360 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06967363
Sponsor's protocol ID
M2023570
Acronym
LBPB
Status last verified
May 2025
First submitted
22 Apr 2025
Last updated
13 May 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All individual participant data (IPD) that underlie the results reported in the published articles, after de-identification, will be shared. This includes demographic information, primary and secondary outcome measures, and relevant baseline characteristics. Data will be made available upon reasonable request for academic purposes, following institutional data-sharing policies and ethics approval.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Low Back Pain (CLBP) and Acute Low Back Pain, run by Peking University Third Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tingting Li (010-82266699, tingtingli@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.

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