Clinical trial NCT04503941: Ultrasound Examination of Inguinal Lymph Node Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis
Official title: Ultrasound Examination of Inguinal Lymph Node and Knee Joint Slip Fluid Accumulation Was Used to Evaluate the Effect of Acupuncture on Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 122
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 120 patients were enrolled and treated in either the sham-acupuncture (control group) or acupuncture group for 12 weeks, with 8 weeks' follow-up, three times per week.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ribbens diagnostic criteria
timeFrame: 20 weeks
measure: Alder blood flow indexing standard
timeFrame: 20 weeks
measure: Walther standard synovial thickness
timeFrame: 20 weeks
measure: Inguinal lymph node volume
timeFrame: 20 weeks
measure: ratio of length to diameter
timeFrame: 20 weeks
Secondary outcomes:
measure: Western Ontario and McMaster Universities Index
timeFrame: 20 weeks
measure: VAS score
timeFrame: 20 weeks
measure: Lequesne index
timeFrame: 20 weeks
measure: Six-minute walking test
timeFrame: 20 weeks
measure: SF-36 scale
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Longhua Hospital, Shanghai University of TCM
state: Shanghai
Study officials:
affiliation: Shanghai Longhua Hospital
name: Yongjun Wang, Ph.D, M.D
role: STUDY_DIRECTOR
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