Status:
NOT_YET_RECRUITING
Multimodal Imaging and Biospecimen Collection for Low Back Pain (LBPB)
Lead Sponsor:
Peking University Third Hospital
Collaborating Sponsors:
National Natural Science Foundation of China
Conditions:
Chronic Low Back Pain (CLBP)
Acute Low Back Pain
Eligibility:
All Genders
18-85 years
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-quali...
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 sy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 15 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06967363
Start Date
May 15 2025
End Date
December 31 2028
Last Update
May 13 2025
Active Locations (2)
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1
Peking university third hospital
Beijing, Beijing Municipality, China, 100000
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191