Ultrasound Examination of Inguinal Lymph Node Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis

April 17, 2023 updated by: Shanghai University of Traditional Chinese Medicine

Ultrasound Examination of Inguinal Lymph Node and Knee Joint Slip Fluid Accumulation Was Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis

Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability. Previous studies on the pathogenesis of this disease mainly focus on cartilage degeneration, but lack of attention to synovitis lesions, and even believe that it is a secondary change in the pathogenesis of osteoarthritis.In recent years, a large number of studies at home and abroad have pointed out that the occurrence and development of knee osteoarthritis are accompanied by synovitis at each stage, and synovial lesions may be the primary manifestation of knee osteoarthritis and affect the evolution of knee osteoarthritis.To this end, some scholars proposed that synovitis lesions as a starting point, may be a new target for the treatment of knee osteoarthritis.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Knee osteoarthritis (KOA) is a major public health problem among the elderly and is associated with considerable disability.Under normal circumstances, synovial fluid in the knee joint cavity is absorbed by lymphatic vessels, and the balance of secretion and absorption of synovial fluid in the knee joint is maintained by the lymphatic system.

When there is some kinds of injury of the knee joint synovial received cartilage stimulate, stimulate the synovial vasodilation, synovial cell proliferation activity, produce a large number of joint synovial fluid and secrete a large number of inflammatory liquid, lymphatic metabolism disorder, make joint cavity inflammatory liquid secretion is greater than the absorption, due to the repeated joint fluid absorption and secretion, articular synovial hyperplasia gradually, eventually lost its normal function, a swelling in the knee joint, and the content of inflammatory cytokines in joint fluid, obvious rise, stimulate the immersion in the subchondral bone nerve pain in synovial fluid.In the formation of inflammatory response, the pressure difference between the tissue fluid and the lymphatic vessels promotes the increase of lymphatic reflux, while the input lymphatic vessels tend to converge to the drainage lymph nodes in different regions.Therefore, the observation of changes in lymphatic reflux is more conducive to the evaluation of synovial inflammation and the occurrence of lymph node metastasis. Therefore, regional drainage lymph node metastasis can also be used as an important biological indicator for the evaluation of prognosis and the formulation of treatment strategies.

Acupuncture could be a promising treatment option for knee OA due to the effectiveness of the pain relief and the rarity of adverse effects. In order to get some more reliable data to confirm acupuncture effectiveness on KOA, a long-term follow up interventional study with clear design, standard criteria, control group, will be started to confirm the effects of long term for acupuncture treatment.

Study Type

Interventional

Enrollment (Anticipated)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Longhua Hospital, Shanghai university of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients who meet the western medicine diagnostic criteria of knee osteoarthritis;
  2. Aged between 50 and 75 years;
  3. Patients in line with the 0-III level of radiological classification for knee osteoarthritis degeneration;
  4. Patients who did not use glucocorticoid via oral administration or intramuscular, articular, or soft tissue injection four weeks before accepting the test agent;
  5. Normal line of force;
  6. Patients who signed the informed consent and ensured the compliance.

Exclusion Criteria:

  1. Patients with long-term oral administration of agents for knee osteoarthritis, and still in the drug effect period, without elution;
  2. Patients with severe heart, brain, liver, kidney or lung dysfunction;
  3. Patients with other knee diseases found in arthroscopic surgery;
  4. Patients who have accepted other relevant treatments, which may affect the observation on the effects of this study;
  5. Patients with mental illness;
  6. Patients with coagulation dysfunction;
  7. Patients with articular surgical treatment;
  8. Patients with a history of abuse of opioid analgesics, sedative hypnotics or alcohol;
  9. Patients with poor compliance, who were unable to meet the requirements for follow-up.
  10. Pregnant and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Comparator
Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Device: Acupuncture treatment
Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Placebo Comparator: The control group
False Needle treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
Device: False Needle treatment
False Needle treatment treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ribbens diagnostic criteria
Time Frame: 20 weeks

Ribbens grading of intra-articular effusion in the ultrasonic knee joint.The thickness of > LMM in the anechoic zone was judged to be joint effusion.

Classification: level 0: no effusion; level I: small amount of effusion; level II: moderate amount of effusion; level III: large amount of effusion.
20 weeks
Alder blood flow indexing standard
Time Frame: 20 weeks
Alder blood flow indexing standard for intra-articular effusion in knee joint by ultrasonic Blood flow classification of articular synovium: level 0: no blood flow signal was found in the synovium;Level I: a small amount of blood flow signals can be seen in the synovium, and the blood flow can be seen at points 1-2.Level II: moderate blood flow signal, 1 main blood vessel or 2-3 small blood vessels can be seen at the same time;Class III: rich blood flow, more than 4 blood vessels are visible, or the blood vessels are connected in a network.
20 weeks
Walther standard synovial thickness
Time Frame: 20 weeks
Walther standard synovium thickness is divided into 4 grades, grade I: thickness <2 mm;Class II: thickness 2-5 mm;Class III: thickness 5-9 mm;Class IV: thickness > 9 mm.
20 weeks
Inguinal lymph node volume
Time Frame: 20 weeks
Inguinal lymph node
20 weeks
ratio of length to diameter
Time Frame: 20 weeks
Inguinal lymph node
20 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Index
Time Frame: 20 weeks
Western Ontario and McMaster Universities Index for 20 weeks
20 weeks
VAS score
Time Frame: 20 weeks
VAS score assessed for 20 weeks.
20 weeks
Lequesne index
Time Frame: 20 weeks
Lequesne index assessed for 20 weeks.
20 weeks
Six-minute walking test
Time Frame: 20 weeks
Six-minute walking test for 20 weeks.
20 weeks
SF-36 scale
Time Frame: 20 weeks
Imaging inspection (MRI) assessed for 20 weeks.
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai University of Traditional Chinese Medicine

Investigators

  • Study Director: Yongjun Wang, Ph.D, M.D, Shanghai Longhua Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UE of OA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

available

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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