OsteoarthitisNCT06977282
The 'Bone-Brain' Crosstalk Mechanism of Subchondral Bone Nociceptive Sensitization Activating SPP1-Positive Microglia in the vlPAG Region Elucidates the Theoretical Connotation of Treating Knee Osteoarthritis Based on Kidney Differentiation
An observational study of Osteoarthitis, run by Jinchao Xu.
Trial summary
The aim of this observational study is to investigate the relationship between pain severity and alterations in bone-derived and brain-derived signaling molecules (including serum neurotransmitters and inflammatory cytokines), as well as structural and functional changes in the ventrolateral periaqueductal gray… Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthitis
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 30 Dec 2026
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with knee osteoarthritis of kidney deficiency type from the Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine. And the healthy volunteers recruited by the research team.
Who may be able to join
- Clinical diagnosis of KOA
- Age between 60-70 years.
- Kellgren-Lawrence grade IV on anteroposterior and lateral knee X-rays.
- Scheduled for total knee arthroplasty.
- Voluntarily signs informed consent.
Who cannot join
- Clinical diagnosis of ankylosing spondylitis, rheumatoid arthritis, gout, or other related conditions.
- Presence of metabolic bone diseases, acute trauma, malignancies, infections, or other complications severely affecting knee function.
- Use of drugs affecting bone metabolism (e.g., corticosteroids, zoledronic acid) within the past 6 months.
- Presence of psychiatric disorders or serious cardiovascular, pulmonary, renal, hepatic, hematologic, or other systemic diseases.
- Contraindications to MRI.
About this study
The aim of this observational study is to investigate the relationship between pain severity and alterations in bone-derived and brain-derived signaling molecules (including serum neurotransmitters and inflammatory cytokines), as well as structural and functional changes in the ventrolateral periaqueductal gray (vlPAG) region in patients with kidney-deficiency type knee osteoarthritis (KOA). The central question it seeks to address is whether changes in these signaling molecules and vlPAG alterations are associated with the degree of pain.
Patients scheduled to undergo total knee arthroplasty (TKA) due to KOA will be enrolled prior to surgery. Before the operation, they will undergo questionnaire assessments, physical examinations, imaging evaluations, and blood sample collection. The resected tibial plateau tissue obtained during surgery will be used for subsequent laboratory analyses.
- Conditions
- Osteoarthitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| KOA | Patients with knee osteoarthritis of renal deficiency type who meet the diagnostic criteria | |
| HC | Healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
The WOMAC Index is a validated instrument used to assess pain, stiffness, and physical dysfunction in patients with osteoarthritis. It comprises 3 subscales with a total of 24 items, yielding a total score ranging from 0 to 96, where higher scores indicate more severe symptoms and greater functional impairment.
Measured: Participants were tested immediately after being included in the study.
Secondary outcomes (16)
Visual Analog Scale (VAS) score
The VAS score is a subjective measure used to assess pain intensity, typically presented as a continuous scale ranging from 0 to 10, with higher scores indicating greater pain severity.
Measured: Participants were tested immediately after being included in the study.
Pattern Element Analysis
A pattern differentiation system would be used to assess the severity of kidney-deficiency-related pathological changes.
Measured: Participants were tested immediately after being included in the study.
Function of Knee Joint
Gait analysis and neutral position (0°) method to evaluate knee joint function.
Measured: Participants were tested immediately after being included in the study.
Volume of Subchondral Cystic Lesions
Knee MRI combined with Mimics software would be used to calculate the volume of subchondral cystic lesions.
Measured: Participants were tested immediately after being included in the study.
Brain Region Structure
Diffusion Tensor Imaging (DTI) would be employed to investigate microstructural alterations in the vlPAG by assessing the diffusion properties of water molecules, thereby reflecting the integrity and connectivity of white matter tracts.
Measured: Participants were tested immediately after being included in the study.
Brain Region Functional Connection
Resting-state functional magnetic resonance imaging (fMRI) would be used to investigate alterations in functional connectivity of the vlPAG.
Measured: Participants were tested immediately after being included in the study.
Serum Neurotransmitters
Ultra-High Performance Liquid Chromatography-Tandem Mass Spectrometry (UHPLC-MS/MS) would be employed to detect changes in serum levels of excitatory and inhibitory neurotransmitters.
Measured: Participants were tested immediately after being included in the study.
Serum Inflammatory Cytokines
Serum levels of inflammatory cytokines would be measured using the Luminex multiplex liquid-phase assay.
Measured: Participants were tested immediately after being included in the study.
Microarchitecture of Subchondral Bone
Following TKA surgery, the resected tibial plateau would be collected for further analysis. Micro-computed tomography (micro-CT) would be employed to assess differences in subchondral bone microarchitecture between load-bearing and non-load-bearing regions
Measured: One day following TKA surgery.
Morphological Differences of Cartilage and Subchondral
Hematoxylin and eosin (HE) staining would be used to examine the morphological differences in cartilage and subchondral bone between the load-bearing and non-load-bearing regions of the tibial plateau.
Measured: One month following TKA surgery.
Subchondral Bone Osteoclast Activity
Tartrate-resistant acid phosphatase (TRAP) staining would be used to assess osteoclast activity in the subchondral bone of load-bearing and non-load-bearing regions.
Measured: One month following TKA surgery.
Subchondral Bone Osteoblastic Activity
Alkaline phosphatase (ALP) staining would be used to assess osteoblastic activity in the subchondral bone of load-bearing and non-load-bearing regions.
Measured: One month following TKA surgery.
Subchondral Bone Sensory Nerve Fiber Distribution
Karnovsky-Roots staining would be used to assess the distribution of sensory nerve fibers in the subchondral bone of load-bearing and non-load-bearing regions.
Measured: One month following TKA surgery.
Pain-Sensitization-Related Factors in Subchondral Bone
Immunofluorescence staining would be used to evaluate changes in pain-sensitization-related regulatory factors in the subchondral bone (SPP1, Netrin1, TMEM119, PGE2, EP4) of load-bearing and non-load-bearing regions.
Measured: One month following TKA surgery.
Subchondral Bone Osteoclast Marker
Immunofluorescence staining would be used to detect changes in osteoclast marker proteins (TRAP, CTSK) in the subchondral bone of load-bearing and non-load-bearing regions.
Measured: One month following TKA surgery.
Subchondral Bone Nociceptor Distribution
Immunofluorescence staining would be used to detect changes in nociceptor marker proteins (TRPV1, TRPA1, CGRP, TrkA, NF200) in the subchondral bone of load-bearing and non-load-bearing regions.
Measured: One month following TKA surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinchao Xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jinchao Xu, Fujian University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977282
- Sponsor's protocol ID
- SPHFJP-S2025079-1
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The 'Bone-Brain' Crosstalk Mechanism of Subchondral Bone Nociceptive Sensitization Activating SPP1-Positive Microglia in the vlPAG Region Elucidates the Theoretical Connotation of Treating Knee Osteoarthritis Based on Kidney Differentiation
- ClinicalTrials.gov ID
- NCT06977282
- Acronym / sponsor ID
- SPHFJP-S2025079-1
- Conditions
- Osteoarthitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jinchao XuUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 May 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.
The aim of this observational study is to investigate the relationship between pain severity and alterations in bone-derived and brain-derived signaling molecules (including serum neurotransmitters and inflammatory cytokines), as well as structural and functional changes in the ventrolateral periaqueductal gray (vlPAG) region in patients with kidney-deficiency type knee osteoarthritis (KOA). The central question it seeks to address is whether changes in these signaling molecules and vlPAG alterations are associated with the degree of pain.
Patients scheduled to undergo total knee arthroplasty (TKA) due to KOA will be enrolled prior to surgery. Before the operation, they will undergo questionnaire assessments, physical examinations, imaging evaluations, and blood sample collection. The resected tibial plateau tissue obtained during surgery will be used for subsequent laboratory analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KOA | – | –Patients with knee osteoarthritis of renal deficiency type who meet the diagnostic criteria |
| HC | – | –Healthy volunteers |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis of kidney deficiency type from the Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine. And the healthy volunteers recruited by the research team.
Key inclusion criteria (5 listed)
- Clinical diagnosis of KOA
- Age between 60-70 years.
- Kellgren-Lawrence grade IV on anteroposterior and lateral knee X-rays.
- Scheduled for total knee arthroplasty.
- Voluntarily signs informed consent.
Key exclusion criteria (5 listed)
- Clinical diagnosis of ankylosing spondylitis, rheumatoid arthritis, gout, or other related conditions.
- Presence of metabolic bone diseases, acute trauma, malignancies, infections, or other complications severely affecting knee function.
- Use of drugs affecting bone metabolism (e.g., corticosteroids, zoledronic acid) within the past 6 months.
- Presence of psychiatric disorders or serious cardiovascular, pulmonary, renal, hepatic, hematologic, or other systemic diseases.
- Contraindications to MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index
Time frame: Participants were tested immediately after being included in the study.
The WOMAC Index is a validated instrument used to assess pain, stiffness, and physical dysfunction in patients with osteoarthritis. It comprises 3 subscales with a total of 24 items, yielding a total score ranging from 0 to 96, where higher scores indicate more severe symptoms and greater functional impairment.
16 secondary outcomes
Visual Analog Scale (VAS) score
Time frame: Participants were tested immediately after being included in the study.
Pattern Element Analysis
Time frame: Participants were tested immediately after being included in the study.
Function of Knee Joint
Time frame: Participants were tested immediately after being included in the study.
Volume of Subchondral Cystic Lesions
Time frame: Participants were tested immediately after being included in the study.
Brain Region Structure
Time frame: Participants were tested immediately after being included in the study.
Brain Region Functional Connection
Time frame: Participants were tested immediately after being included in the study.
Serum Neurotransmitters
Time frame: Participants were tested immediately after being included in the study.
Serum Inflammatory Cytokines
Time frame: Participants were tested immediately after being included in the study.
Microarchitecture of Subchondral Bone
Time frame: One day following TKA surgery.
Morphological Differences of Cartilage and Subchondral
Time frame: One month following TKA surgery.
Subchondral Bone Osteoclast Activity
Time frame: One month following TKA surgery.
Subchondral Bone Osteoblastic Activity
Time frame: One month following TKA surgery.
Subchondral Bone Sensory Nerve Fiber Distribution
Time frame: One month following TKA surgery.
Pain-Sensitization-Related Factors in Subchondral Bone
Time frame: One month following TKA surgery.
Subchondral Bone Osteoclast Marker
Time frame: One month following TKA surgery.
Subchondral Bone Nociceptor Distribution
Time frame: One month following TKA surgery.
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 18 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthitis, run by Jinchao Xu.
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 5 inclusion and 5 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 18 May 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index (time frame: Participants were tested immediately after being included in the study.). 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 18 May 2025.