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

NCT06967363 | Not Yet Recruiting DMC

• 1 other identifier: M2023570
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  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.

  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)

• 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

• 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

• Pain Resilience Scale

  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

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

• Central Sensitization Scale

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

Study Arms (2)

Non-surgical group

Participants receiving conventional treatment such as medication , exercise, physical therapy, psychotherapy ( acceptance and realization therapy, pain reprocessing therapy, and cognitive behavior therapy) etc.,

Drug: Medication; Behavioral: Psychotherapy

Surgical group

Participants undergoing surgical interventions, such as nerve block, or endoscopic lumbar discectomy.

Procedure: Nerve Block; Procedure: endoscopic spinal disecetomy

Interventions

Nerve Block PROCEDURE

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.

Also known as: Selective Nerve Root Block (SNRB), Transforaminal Epidural Injection

Surgical group

endoscopic spinal disecetomy PROCEDURE

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.

Also known as: endoscopic lumbar disecetomy, Endoscopic Discectomy, Percutaneous Endoscopic Lumbar Discectomy

Surgical group

Medication DRUG

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.

Also known as: celecoxib, ibuprofen, diclofenac, Pregabalin, Lyrica, Etoricoxib, loxoprofen

Non-surgical group

Psychotherapy BEHAVIORAL

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.

Also known as: cognitive behavioral therapy, Acceptance and Commitment Therapy

Non-surgical group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Peking University Third Hospital

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• National Natural Science Foundation of China: collaborator

Study Sites (2)

Peking university third hospital

Beijing, Beijing Municipality, 100000, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood; Faces

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Acute Pain; Mental Disorders; Sleep Wake Disorders; Fibromyalgia; Nociplastic Pain; Neuralgia

Interventions

Nerve Block; Dosage Forms; Celecoxib; Ibuprofen; Diclofenac; Pregabalin; Etoricoxib; loxoprofen; Psychotherapy; Cognitive Behavioral Therapy; Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Phenylacetates; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Pyridines; Behavioral Disciplines and Activities; Behavior Therapy

Study Officials

• Jie Sun

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Li

CONTACT

010-82266699; tingtingli@bjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 13, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Individual Participant Data (IPD) and supporting information will be made available starting from the publication date of the study results. The data will be accessible for a period of 5 years, from December 2025 to December 2030. During this period, the data will be available upon reasonable request for academic purposes, in accordance with the institutional data-sharing policies.
• Access Criteria: Only approved researchers from academic institutions, research organizations, and government agencies who have a legitimate academic research purpose will be eligible to access the data. All individuals requesting access must adhere to the data use agreement and ensure the data will be used exclusively for research purposes. Authorized researchers will have access to de-identified individual participant data (IPD), which includes: Participant demographic information Primary and secondary outcome measures such as pain assessments, sleep quality, and neuroimaging data Study protocol, statistical analysis plan (SAP), and clinical study report (CSR) Informed consent form templates and ethics committee approval documents Data and supporting information will be made available through the official data-sharing platform of the research institution.

Locations

CN (2)