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

ConditionOsteoarthitis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60-70
SponsorJinchao Xu

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: KOA
Group B: HC

Trial outcomes

Primary outcomes

1

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.

Time frame
Participants were tested immediately after being included in the study.

Secondary outcomes

1

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.

Time frame
Participants were tested immediately after being included in the study.
2

Pattern Element Analysis

A pattern differentiation system would be used to assess the severity of kidney-deficiency-related pathological changes.

Time frame
Participants were tested immediately after being included in the study.
3

Function of Knee Joint

Gait analysis and neutral position (0°) method to evaluate knee joint function.

Time frame
Participants were tested immediately after being included in the study.
4

Volume of Subchondral Cystic Lesions

Knee MRI combined with Mimics software would be used to calculate the volume of subchondral cystic lesions.

Time frame
Participants were tested immediately after being included in the study.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jinchao Xu

Lead sponsor

Fujian University of Traditional Chinese Medicine

Sponsor institution

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