NCT03599180

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 12, 2020

Status Verified

June 1, 2018

Enrollment Period

1.3 years

First QC Date

July 15, 2018

Last Update Submit

February 10, 2020

Conditions

Microdialysis

Keywords

Knee OsteoarthritisSensitized AcupointsMicrodialysisHigh performance liquid chromatography（HPLC）

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Histamine concentration

    2018-7-12---2020-7-1

  • Adenosine triphosphate concentration

    2018-7-12---2020-7-1

  • WOMAC score

    2018-7-12---2020-7-1

Study Arms (2)

Knee Osteoarthritis group

KOA patients without accept treat in the past month

Device: microdialysis

Control group

Heathly volunteers

Device: microdialysis

Interventions

microdialysisDEVICE

Use microdialysis skill to collect dialyzate at sensitization acupoints

Control groupKnee Osteoarthritis group

Eligibility Criteria

Age38 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shuguang

Chengdu, Sichuan, 610075, China

Location

Related Publications (1)

  • 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.

    PMID: 31702640DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

microdialysate of KOA patients' sensitised acupoints

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Microdialysis

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

DialysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Yu Shuguang, Bachelor

    No.39,Shi'er Qiao road,Jinniu district, Chengdu, Sichuan province, China

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2018

First Posted

July 26, 2018

Study Start

June 1, 2018

Primary Completion

September 30, 2019

Study Completion

February 1, 2020

Last Updated

February 12, 2020

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)