Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Protocol of Sensitized Acupoint Changes in Knee Osteoarthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03599180
Recruitment Status : Completed
First Posted : July 26, 2018
Last Update Posted : February 12, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Microdialysis 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Clinical Research Protocol of Systematic Biology Mechanism for Sensitized Acupoint Micro-physicochemical Environment Changes in Knee Osteoarthritis Patients
Actual Study Start Date : June 1, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. Serotonin concentration [ Time Frame: 2018-7-12---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 :
  1. Histamine concentration [ Time Frame: 2018-7-12---2020-7-1 ]
    The histamine concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.

  2. Adenosine triphosphate concentration [ Time Frame: 2018-7-12---2020-7-1 ]
    The adenosine triphosphate concentration of KOA patients' sensitized acupoints was compared with that of the normal acupoints in healthy volunteers.

  3. WOMAC score [ Time Frame: 2018-7-12---2020-7-1 ]
    The WOMAC score of KOA patients was compared with healthy volunteers.


Biospecimen Retention:   Samples Without DNA
microdialysate of KOA patients' sensitised acupoints


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   38 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of 32 KOA patients and 32 normal volunteers will be included
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03599180


Locations
Layout table for location information
China, Sichuan
Shuguang
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chinese Medical Association
Investigators
Layout table for investigator information
Study Director: Yu Shuguang, Bachelor No.39,Shi'er Qiao road,Jinniu district, Chengdu, Sichuan province, China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Chinese Medical Association
ClinicalTrials.gov Identifier: NCT03599180    
Other Study ID Numbers: 81590953
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: February 12, 2020
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chinese Medical Association:
Knee Osteoarthritis
Sensitized Acupoints
Microdialysis
High performance liquid chromatography(HPLC)
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases