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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04503941
• Other study ID #: UE of OA
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: March 2023
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 122
• Est. completion date: May 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Longhua Hospital, Shanghai University of TCM	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (7)

Glimm AM, Werner SG, Burmester GR, Backhaus M, Ohrndorf S. Analysis of distribution and severity of inflammation in patients with osteoarthitis compared to rheumatoid arthritis by ICG-enhanced fluorescence optical imaging and musculoskeletal ultrasound: a — View Citation

Melo Mde O, Pompeo KD, Brodt GA, Baroni BM, da Silva Junior DP, Vaz MA. Effects of neuromuscular electrical stimulation and low-level laser therapy on the muscle architecture and functional capacity in elderly patients with knee osteoarthritis: a randomiz — View Citation

Proulx ST, Kwok E, You Z, Papuga MO, Beck CA, Shealy DJ, Ritchlin CT, Awad HA, Boyce BF, Xing L, Schwarz EM. Longitudinal assessment of synovial, lymph node, and bone volumes in inflammatory arthritis in mice by in vivo magnetic resonance imaging and micr — View Citation

Ribbens C, Andre B, Marcelis S, Kaye O, Mathy L, Bonnet V, Beckers C, Malaise MG. Rheumatoid hand joint synovitis: gray-scale and power Doppler US quantifications following anti-tumor necrosis factor-alpha treatment: pilot study. Radiology. 2003 Nov;229(2 — View Citation

Walther M, Harms H, Krenn V, Radke S, Faehndrich TP, Gohlke F. Correlation of power Doppler sonography with vascularity of the synovial tissue of the knee joint in patients with osteoarthritis and rheumatoid arthritis. Arthritis Rheum. 2001 Feb;44(2):331- — View Citation

Wang W, Lin X, Xu H, Sun W, Bouta EM, Zuscik MJ, Chen D, Schwarz EM, Xing L. Attenuated Joint Tissue Damage Associated With Improved Synovial Lymphatic Function Following Treatment With Bortezomib in a Mouse Model of Experimental Posttraumatic Osteoarthri — View Citation

Wauke K, Nagashima M, Ishiwata T, Asano G, Yoshino S. Expression and localization of vascular endothelial growth factor-C in rheumatoid arthritis synovial tissue. J Rheumatol. 2002 Jan;29(1):34-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ribbens diagnostic criteria	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
Primary	Alder blood flow indexing standard	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
Primary	Walther standard synovial thickness	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
Primary	Inguinal lymph node volume	Inguinal lymph node	20 weeks
Primary	ratio of length to diameter	Inguinal lymph node	20 weeks
Secondary	Western Ontario and McMaster Universities Index	Western Ontario and McMaster Universities Index for 20 weeks	20 weeks
Secondary	VAS score	VAS score assessed for 20 weeks.	20 weeks
Secondary	Lequesne index	Lequesne index assessed for 20 weeks.	20 weeks
Secondary	Six-minute walking test	Six-minute walking test for 20 weeks.	20 weeks
Secondary	SF-36 scale	Imaging inspection (MRI) assessed for 20 weeks.	20 weeks