Clinical trial NCT03599180: Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients
Official title: Clinical Research Protocol of Systematic Biology Mechanism for Sensitized Acupoint Micro-physicochemical Environment Changes in Knee Osteoarthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microdialysis
Keywords: Knee Osteoarthritis
Sensitized Acupoints
Microdialysis
High performance liquid chromatography（HPLC）
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2018-07-26
Enrollment: 33
Sex: ALL
Minimum age (years): 38
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 32 KOA patients and 32 normal volunteers will be included

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serotonin concentration
timeFrame: 2018-7-12---2020-7-1
Secondary outcomes:
measure: Histamine concentration
timeFrame: 2018-7-12---2020-7-1
measure: Adenosine triphosphate concentration
timeFrame: 2018-7-12---2020-7-1
measure: WOMAC score
timeFrame: 2018-7-12---2020-7-1
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Shuguang
state: Sichuan
Study officials:
affiliation: No.39,Shi'er Qiao road,Jinniu district, Chengdu, Sichuan province, China
name: Yu Shuguang, Bachelor
role: STUDY_DIRECTOR
References:
citation: Li S, Chai XN, Zuo CY, Lv P, Tang Y, Tan HJ, Liu LZ, Yin HY, Yu SG. Metabolic profiling of dialysate at sensitized acupoints in knee osteoarthritis patients: A study protocol. Medicine (Baltimore). 2019 Nov;98(45):e17843. doi: 10.1097/MD.0000000000017843.