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Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients

Completed
Conditions
Microdialysis
Interventions
Device: microdialysis
Registration Number
NCT03599180
Lead Sponsor
Chinese Medical Association
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
33
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Knee Osteoarthritis groupmicrodialysisKOA patients without accept treat in the past month
Control groupmicrodialysisHeathly volunteers
Primary Outcome Measures
NameTimeMethod
Serotonin concentration2018-7-12---2020-7-1

The serotonin concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.

Secondary Outcome Measures
NameTimeMethod
Adenosine triphosphate concentration2018-7-12---2020-7-1

The adenosine triphosphate concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.

WOMAC score2018-7-12---2020-7-1

The WOMAC score of KOA patients was compared with healthy volunteers.

Histamine concentration2018-7-12---2020-7-1

The histamine concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.

Trial Locations

Locations (1)

Shuguang

🇨🇳

Chengdu, Sichuan, China

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