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

Sponsor
Peking University Third Hospital
Study ID
NCT06967363
Status
Not Yet Recruiting

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Conditions

  • Acute Low Back Pain
  • Acute Pain
  • Chronic Low Back Pain (CLBP)
  • Chronic Pain
  • Fibromyalgia (FM)
  • Low Back Pain
  • Mental Disorders
  • Neuropathic Pain
  • Nociplastic Pain
  • Nonspecific Low Back Pain
  • Sleep Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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.

Study Details

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.

Key Dates

First listed
May 13, 2025
Start date
May 15, 2025
Status verified
May 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
360 participants (estimated)

Arms

  • Arm: 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.,
  • Arm: Surgical group
    Participants undergoing surgical interventions, such as nerve block, or endoscopic lumbar discectomy.

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 ]

Central Contacts

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