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

NCT04503941 | Unknown DMC

• 1 other identifier: UE of OA
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• Inguinal lymph node volume

  Inguinal lymph node

  20 weeks

• ratio of length to diameter

  Inguinal lymph node

  20 weeks

Secondary Outcomes (5)

• Western Ontario and McMaster Universities Index

  20 weeks

• VAS score

  20 weeks

• Lequesne index

  20 weeks

• Six-minute walking test

  20 weeks

• SF-36 scale

  20 weeks

Study Arms (2)

Active Comparator

EXPERIMENTAL

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

The control group

PLACEBO COMPARATOR

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

Interventions

Acupuncture treatment DEVICE

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.

Active Comparator

False Needle treatment DEVICE

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.

The control group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai University of Traditional Chinese Medicine: lead

Study Sites (1)

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (7)

• 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 Osteoarthritis. Arthritis Rheumatol. 2019 Feb;71(2):244-257. doi: 10.1002/art.40696. Epub 2019 Jan 5.

  PMID: 30144298 RESULT

• 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):562-9. doi: 10.1148/radiol.2292020206. Epub 2003 Sep 11.

  PMID: 12970463 RESULT

• 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):331-8. doi: 10.1002/1529-0131(200102)44:23.0.CO;2-0.

  PMID: 11229463 RESULT

• 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.

  PMID: 11824968 RESULT

• 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 microfocal computed tomography. Arthritis Rheum. 2007 Dec;56(12):4024-37. doi: 10.1002/art.23128.

  PMID: 18050199 RESULT

• 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 randomized controlled trial. Clin Rehabil. 2015 Jun;29(6):570-80. doi: 10.1177/0269215514552082. Epub 2014 Sep 26.

  PMID: 25261425 RESULT

• 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 pilot study. Ann Rheum Dis. 2016 Mar;75(3):566-70. doi: 10.1136/annrheumdis-2015-207345. Epub 2015 Aug 26.

  PMID: 26311723 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yongjun Wang, Ph.D, M.D

  Shanghai Longhua Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Since the acupuncture and sham-acupuncture cannot be blind to the researchers, considering the placebo effect of the subjects, this experiment was blind only to the subjects, namely single-blind. But the researchers did not hint at the treatments received by the patients, and avoided various factors that may have led to bias during the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: June 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 18, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)