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

Not Applicable

• Conditions: Knee Osteoarthritis
• Interventions: Device: Acupuncture treatment; Device: False Needle treatment

• Registration Number: NCT04503941
• Lead Sponsor: Shanghai University of Traditional Chinese Medicine

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-06
• Study First Posted: 2020-08-07
• Study Start: 2021-06-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-18
• Primary Completion: 2025-01-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator	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.
The control group	False Needle treatment	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.

Primary Outcome Measures

Name	Time	Method
Walther standard synovial thickness	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.
Inguinal lymph node volume	20 weeks	Inguinal lymph node
Ribbens diagnostic criteria	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.
Alder blood flow indexing standard	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.
ratio of length to diameter	20 weeks	Inguinal lymph node

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Longhua Hospital, Shanghai University of TCM; 🇨🇳 Shanghai, Shanghai, China