Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients

Study Overview
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Brief Summary
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Based on the research background and the preliminary research basis of the research group, in order to answer the material basis and micro-physical environment change characteristics of knee osteoarthritis sensitization acupoints and provide scientific basis for in-depth study of sensitization of acupoints. This study plans to use knee osteoarthritis as a research vehicle, and use microdialysis combined with high performance liquid chromatography to analyze the local material basis and key indicators of common sensitization points in knee osteoarthritis.

Detailed Description
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This trial is a single-centre, normal controlled, parallel group, clinical trial. The trial is an explorative, pilot trial designed to reveal the change of the main material group in sensitized acupoints caused by knee osteoarthritis, and provide the key signal substance and its changing characteristics of knee osteoarthritis sensitized acupoints.

Official Title
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Clinical Research Protocol of Systematic Biology Mechanism for Sensitized Acupoint Micro-physicochemical Environment Changes in Knee Osteoarthritis Patients

Conditions
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Microdialysis

Intervention / Treatment
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* Device: microdialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets the diagnosis criteria of knee osteoarthritis. Age between 45 and 70 years. Meets imaging examination X-ray Kellgren and Laerence classification standards grade I-III. Patients who meet the criteria for early or mid-term stage of knee osteoarthritis. Discontinue use of pain medications and hormone drugs during the trial. The patient's vital signs are stable, can read his own medical history, and can cooperate with the relevant examination and treatment. Signed the informed consent voluntarily. Exclusion Criteria: Seriously patients with surgical indications Associated systemic arthropathies, e.g. rheumatoid arthritis and gout Heart failure Bleeding diathesis Liver failure knee arthroplasty There are diseases that may seriously endanger life, such as cardiovascular and cerebrovascular diseases, renal and liver failure, hematopoietic system diseases, etc. Patients with mental illnesses that cannot be completed or are not suitable for treatment and examination Patients who received treatment including traditional Chinese medicine, western medicine, acupuncture, massage and physiotherapy within the past month Patients on steroids History of intra articular injection of steroid within last six months Joint irrigation or arthroscopy has been performed within the past year Have had knee arthroplasty At the same time participate in other studies

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Knee Osteoarthritis group<br>KOA patients without accept treat in the past month | Device: microdialysis<br>* Use microdialysis skill to collect dialyzate at sensitization acupoints<br>|
| Control group<br>Heathly volunteers | Device: microdialysis<br>* Use microdialysis skill to collect dialyzate at sensitization acupoints<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotonin concentration | The serotonin concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers. | 2018-7-12---2020-7-1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histamine concentration | The histamine concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers. | 2018-7-12---2020-7-1 | 
| Adenosine triphosphate concentration | The adenosine triphosphate concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers. | 2018-7-12---2020-7-1 | 
| WOMAC score | The WOMAC score of KOA patients was compared with healthy volunteers. | 2018-7-12---2020-7-1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee Osteoarthritis, Sensitized Acupoints, Microdialysis, High performance liquid chromatography（HPLC）