Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients

Microdialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03599180
• Other study ID #: 81590953
• Status: Completed
• Start date: June 1, 2018
• Est. completion date: February 1, 2020

Study information

• Verified date: June 2018
• Source: Chinese Medical Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: February 1, 2020
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 38 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Microdialysis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• microdialysis
Use microdialysis skill to collect dialyzate at sensitization acupoints

Locations

Country	Name	City	State
China	Shuguang	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	WOMAC score	The WOMAC score of KOA patients was compared with healthy volunteers.	2018-7-12---2020-7-1