Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Microdialysis
• Intervention / Treatment: Device: microdialysis

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.

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610075
      • Shuguang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 32 KOA patients and 32 normal volunteers will be included

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Knee Osteoarthritis group; KOA patients without accept treat in the past month	Device: microdialysis; Use microdialysis skill to collect dialyzate at sensitization acupoints
Control group; Heathly volunteers	Device: microdialysis; Use microdialysis skill to collect dialyzate at sensitization acupoints

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese Medical Association
• Investigators: Study Director: Yu Shuguang, Bachelor, No.39,Shi'er Qiao road,Jinniu district, Chengdu, Sichuan province, China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): February 1, 2020

Study Registration Dates

• First Submitted: July 15, 2018
• First Submitted That Met QC Criteria: July 15, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 12, 2020
• Last Update Submitted That Met QC Criteria: February 10, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Microdialysis; Knee Osteoarthritis; Sensitized Acupoints; High performance liquid chromatography（HPLC）
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 81590953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No