Brain Network Functional ConnectivityNCT07308249
Brain Network fMRI Analysis in Proprioceptive Training for Chronic Low Back Pain
An observational study of Brain Network Functional Connectivity, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Brain Network Functional Connectivity
- What is being tested?
- Multimodal Imaging Evaluation
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2025to 30 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 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Brain Network Functional Connectivity
- Being tested
- Multimodal Imaging Evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Imaging EvaluationOther
Functional connectivity analysis of brain networks based on functional magnetic resonance imaging (fMRI) technology
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
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.
Measured: After 4 weeks of treatment
JOA
The Japanese Orthopaedic Association (JOA) efficacy assessment criteria for low back disorders were applied to evaluate lumbar function.
Measured: After 4 weeks of treatment
Secondary outcomes (1)
MRI
Magnetic resonance imaging was used to assess the effects of treatment on brain networks.
Measured: After 4 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start20 Dec 2025 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Network Functional ConnectivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308249
- Sponsor's protocol ID
- KY-2025-304
- Status last verified
- Dec 2025
- First submitted
- 15 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07308249
- Acronym / sponsor ID
- KY-2025-304
- Conditions
- Brain Network Functional Connectivity
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 20 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Age between 18 and 60 years old;
Key exclusion criteria (4 listed)
- Fractures, dislocations, structural abnormalities, prior surgery, metal implants, or lumbar disc herniation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Imaging EvaluationFunctional connectivity analysis of brain networks based on functional magnetic resonance imaging (fMRI) technology | Other | – |
Primary outcome
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.
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.
1 secondary outcome
MRI
Time frame: After 4 weeks of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Network Functional Connectivity, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine.
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 2 inclusion and 4 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 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 yongxiang li (15267370425, 8017074@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: After 4 weeks of 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 29 Dec 2025.