- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07308249
Brain Network fMRI Analysis in Proprioceptive Training for Chronic Low Back Pain
December 15, 2025 updated by: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Research on the Application of Brain Network Functional Connectivity Analysis Based on Functional Magnetic Resonance Imaging in Proprioceptive Training for Chronic Non-Specific Low Back Pain
Through longitudinal analysis of dynamic changes in DMN functional connectivity before and after sensory training intervention, combined with pain behavioral and functional improvement indicators, this study systematically reveals the central neural remodeling patterns in CNLBP and establishes an objective efficacy evaluation system based on multimodal imaging.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
This phase of the research aims to elucidate the neuroplasticity mechanisms induced by CNLBP treatment, providing a theoretical basis for the future development of personalized rehabilitation protocols based on brain network subtypes, ultimately achieving the clinical goals of reducing pain recurrence rates and improving long-term prognosis in patients.
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: yongxiang li
- Phone Number: 15267370425
- Email: 8017074@zju.edu.cn
Study Contact Backup
- Name: yali liu
- Phone Number: 15988537921
- Email: 8017039@zju.edu.cn
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
All patients were assigned numbers from 1 to 40.
Starting at any row and column in a random number table, 40 random numbers were sequentially recorded in correspondence with the patient numbers.
The random numbers were then ranked in ascending order, with ranks 1-20 assigned to the experimental group and ranks 21-40 to the control group.
All patients continued to receive conventional treatment and comprehensive rehabilitation therapy.
Description
Inclusion Criteria:
Age between 18 and 60 years old;
- Current or past low back pain lasting more than three months; ③ No abnormal sensation or reflex abnormalities in the lower limbs; ④ Able to commit to participating in training three times per week for three months.
Exclusion Criteria:
Fractures, dislocations, structural abnormalities, prior surgery, metal implants, or lumbar disc herniation;
Comorbidities such as severe cardiovascular diseases, neurological disorders, osteoporosis, or metabolic diseases; ③ Low back pain caused by visceral diseases;
VAS score (range 1-10) exceeding 8 points;
- Pregnant or lactating women; ⑥ Symptoms of nerve root irritation; ⑦ Recent participation in core stability training.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VAS
Time Frame: After 4 weeks of treatment
|
The Visual Analogue Scale (VAS) was used to assess the severity of low back pain, with 0 indicating no pain and 10 indicating unbearable severe pain.
|
After 4 weeks of treatment
|
|
JOA
Time Frame: After 4 weeks of treatment
|
The Japanese Orthopaedic Association (JOA) efficacy assessment criteria for low back disorders were applied to evaluate lumbar function.
|
After 4 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
MRI
Time Frame: After 4 weeks of treatment
|
Magnetic resonance imaging was used to assess the effects of treatment on brain networks.
|
After 4 weeks of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
December 20, 2025
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Study Registration Dates
First Submitted
December 15, 2025
First Submitted That Met QC Criteria
December 15, 2025
First Posted (Actual)
December 29, 2025
Study Record Updates
Last Update Posted (Actual)
December 29, 2025
Last Update Submitted That Met QC Criteria
December 15, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- KY-2025-304
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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